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trials
ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
MASTER PROTOCOL STUDIES Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes). EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. CONSIDERATIONS IN THE CONDUCT OF REMOTE CLINICAL RESEARCH Considerations in the Conduct of Remote Clinical Research: Findings from Group Interviews David C. Babaian Regulatory Attorney, QuorumReview/Kinetiq
CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
MASTER PROTOCOL STUDIES Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes). EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. CONSIDERATIONS IN THE CONDUCT OF REMOTE CLINICAL RESEARCH Considerations in the Conduct of Remote Clinical Research: Findings from Group Interviews David C. Babaian Regulatory Attorney, QuorumReview/Kinetiq
LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conductAACT DATABASE
CTTI has aggregated and restructured publicly available ClinicalTrials.gov data and made it available here as a relational database to facilitate analysis of the complete set of trials. This database is the Aggregate Analysis of ClincalTrials.gov (AACT). CLICK HERE for an overview of the background on ClinicalTrials.gov and theAACT database.
AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
CTTI RECOMMENDATIONS: DECENTRALIZED CLINICAL TRIALS CTTI Recommendations: Decentralized Clinical Trials September 2018 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. ICH PUBLIC WEB CONFERENCE WILL PROVIDE AN UPDATE ON THE The International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Expert Working Group (EWG) is organizing a public web conference to provide an update on the progress to revise this important and impactful guideline. The EWG is holding two similar web conferences, convened by CTTI, on Tuesday, May 18 from 8-11 a.m. EDT (2-5 p.m. CEST, 9 p.m. – 12 a.m. JST) and NEW CTTI PROJECT AIMS TO INCREASE THE USE OF CLINICAL While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can support regulatory labeling claims. RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. QUALITY RISK MANAGEMENT FOR CLINICAL TRIALS Monitoring • Methods to proactively detect, assess, and remediate the root causes of clinical trial noncompliance in real-time • Includes a range of Clinical Monitoring activities: FDA’S PERSPECTIVE ON GCP TRAINING FDA’s Perspective on GCP Training Bridget Foltz Office of Good Clinical Practice Office of Medical Products and Tobacco Food and DrugAdministration
CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes). CTTI RECOMMENDATIONS: DECENTRALIZED CLINICAL TRIALS CTTI Recommendations: Decentralized Clinical Trials September 2018 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes). CTTI RECOMMENDATIONS: DECENTRALIZED CLINICAL TRIALS CTTI Recommendations: Decentralized Clinical Trials September 2018 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. MASTER PROTOCOL STUDIES Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. IMPLEMENTATION TOOLS Implementation Tools. Below are CTTI-developed tools that can improve the quality and efficiency of your clinical trials today. CTTI's tools are created to facilitate the adoption of our official recommendations. These recommendations are based on evidence generated by engaging all stakeholders involved in the clinical trial process. WEBINARS | CLINICAL TRIALS TRANSFORMATION INITIATIVE CTTI's webinars feature esteemed speakers discussing topics related to innovation and culture within the clinical trials enterprise. Below, you will find information about upcoming webinars, as well as recordings of previous webinars. All webinars listed below are free and open to the public, and we encourage you to invite colleagues involved in the clinical trials enterprise. EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: DECENTRALIZED CLINICAL TRIALS CTTI Recommendations: Decentralized Clinical Trials September 2018 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. STUDY START-UP TIMELINES: IDENTIFYING CHALLENGES 1 EXECUTIVE SUMMARY With medical product development continuing to last up to 10 years and costing hundreds of millions of dollars, the lengthiness of the study start-up (SSU) process has become a key issue for many stakeholders across the clinical trialsAACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to improve the quality and efficiency of STAMPEDE CASE STUDY: USING A MASTER PROTOCOL APPROACH TO https://www.ctti-clinicaltrials.org/projects/master-protocol-studies Page 1 of 4 STAMPEDE Case Study: Using a Master Protocol Approach to Improve Outcomes in Prostate RECOMMENDATIONS EXECUTIVE SUMMARY: ADVANCING THE USE OF Page 1 of 3 Recommendations Executive Summary: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials Mobile technology offers a powerful tool to improve the quality and efficiency of clinical trials. CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes).AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes).AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative.LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. MASTER PROTOCOL STUDIES Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. WEBINARS | CLINICAL TRIALS TRANSFORMATION INITIATIVE CTTI's webinars feature esteemed speakers discussing topics related to innovation and culture within the clinical trials enterprise. Below, you will find information about upcoming webinars, as well as recordings of previous webinars. All webinars listed below are free and open to the public, and we encourage you to invite colleagues involved in the clinical trials enterprise.AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
STUDY START-UP TIMELINES: IDENTIFYING CHALLENGES 1 EXECUTIVE SUMMARY With medical product development continuing to last up to 10 years and costing hundreds of millions of dollars, the lengthiness of the study start-up (SSU) process has become a key issue for many stakeholders across the clinical trials EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: DECENTRALIZED CLINICAL TRIALS CTTI Recommendations: Decentralized Clinical Trials September 2018 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to improve the quality and efficiency of STAMPEDE CASE STUDY: USING A MASTER PROTOCOL APPROACH TO https://www.ctti-clinicaltrials.org/projects/master-protocol-studies Page 1 of 4 STAMPEDE Case Study: Using a Master Protocol Approach to Improve Outcomes in Prostate RECOMMENDATIONS EXECUTIVE SUMMARY: ADVANCING THE USE OF Page 1 of 3 Recommendations Executive Summary: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials Mobile technology offers a powerful tool to improve the quality and efficiency of clinical trials. CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes).AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP 9 •Establish a quality continuum throughout design and conduct •Link to and emphasise ICH E8 focus on achieving quality by good design •ICH E8 General Considerations on Clinical Trials and E6 GCP need modernising to prepare for the future – o future medicines, future trial designs, future technologies, future data sources •Set the foundation for new study designs and conduct ICH E6(R3) GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) •Clinical trials should be designed to protect the rights, safety and well-being of participants and assure the reliability of results. •Clinical trial designs and processes should be proportionate to the risks inherent in the trial and the importance of the data being collected. •Trial designs and processes should be evaluated tominimize
DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALS (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes).AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative.LARGE SIMPLE TRIALS
Facilitating the Use of Large Simple Trials (LST) A large simple trial (LST) is a type of randomized clinical trial (RCT) ideally suited to answer many important clinical questions and because it typically answers only one or 2 questions in a broader patient population, is generally more efficient and less expensive than other large RCTs. MASTER PROTOCOL STUDIES Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. WEBINARS | CLINICAL TRIALS TRANSFORMATION INITIATIVE CTTI's webinars feature esteemed speakers discussing topics related to innovation and culture within the clinical trials enterprise. Below, you will find information about upcoming webinars, as well as recordings of previous webinars. All webinars listed below are free and open to the public, and we encourage you to invite colleagues involved in the clinical trials enterprise.AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
STUDY START-UP TIMELINES: IDENTIFYING CHALLENGES 1 EXECUTIVE SUMMARY With medical product development continuing to last up to 10 years and costing hundreds of millions of dollars, the lengthiness of the study start-up (SSU) process has become a key issue for many stakeholders across the clinical trials EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates. CTTI RECOMMENDATIONS: DECENTRALIZED CLINICAL TRIALS CTTI Recommendations: Decentralized Clinical Trials September 2018 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to improve the quality and efficiency of STAMPEDE CASE STUDY: USING A MASTER PROTOCOL APPROACH TO https://www.ctti-clinicaltrials.org/projects/master-protocol-studies Page 1 of 4 STAMPEDE Case Study: Using a Master Protocol Approach to Improve Outcomes in Prostate RECOMMENDATIONS EXECUTIVE SUMMARY: ADVANCING THE USE OF Page 1 of 3 Recommendations Executive Summary: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials Mobile technology offers a powerful tool to improve the quality and efficiency of clinical trials. CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
MASTER PROTOCOL STUDIES Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. DIGITAL HEALTH TRIALS Using Digital Health Trials to Improve Clinical Trials. Digital Health Trials offer the potential to increase the quality and efficiency of clinical trials—from reducing barriers to participation and improving the participant experience, to capturing more informative real-world data and lowering costs associated with conducting clinicaltrials.
ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALSCLINICAL QUALITY MANAGEMENT MANUALCLINICAL QUALITY MANAGEMENT PLANDATA MANAGEMENT IN CLINICAL RESEARCH (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes). EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates.AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. RECOMMENDATIONS EXECUTIVE SUMMARY: ADVANCING THE USE OF Page 1 of 3 Recommendations Executive Summary: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials Mobile technology offers a powerful tool to improve the quality and efficiency of clinical trials. CLINICAL TRIALS TRANSFORMATION INITIATIVEWHO WE ARECONTACT USSTATE OF CLINICAL TRIALSPRESS RELEASESPUBLICATIONSIMPLEMENTATION TOOLS CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinicaltrials
MASTER PROTOCOL STUDIES Master protocol studies offer innovative opportunities in the design and conduct of clinical trials. The term master protocol is generally used to describe clinical trials that use one overarching protocol to guide multiple, simultaneously occurring sub-studies. DIGITAL HEALTH TRIALS Using Digital Health Trials to Improve Clinical Trials. Digital Health Trials offer the potential to increase the quality and efficiency of clinical trials—from reducing barriers to participation and improving the participant experience, to capturing more informative real-world data and lowering costs associated with conducting clinicaltrials.
ICH E6 GUIDELINE FOR GOOD CLINICAL PRACTICE Disclaimer: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. DEVELOPING EFFECTIVE QUALITY SYSTEMS IN CLINICAL TRIALSCLINICAL QUALITY MANAGEMENT MANUALCLINICAL QUALITY MANAGEMENT PLANDATA MANAGEMENT IN CLINICAL RESEARCH (e.g., unblinded differences in lipids or blood pressure), and modifying study duration, number of events, and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes). EXPANSION OF EXPECTED NET PRESENT VALUE FRAMEWORK FOR 1 I. INTRODUCTION The value of patient engagement is increasingly recognized as an important aspect of clinical trials – one that has the potential to shorten development times and increase technical and regulatory success rates.AACT DATABASE
AACT is a publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov. Content is downloaded from ClinicalTrials.gov daily and loaded into AACT. The Clinical Trials Transformation Initiative (CTTI) enhanced AACT in October, 2016 toinclude the
CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to RECOMMENDATIONS FOR PREGNANCY TESTING IN CLINICAL TRIALS Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. RECOMMENDATIONS EXECUTIVE SUMMARY: ADVANCING THE USE OF Page 1 of 3 Recommendations Executive Summary: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials Mobile technology offers a powerful tool to improve the quality and efficiency of clinical trials. DIGITAL HEALTH TRIALS Using Digital Health Trials to Improve Clinical Trials. Digital Health Trials offer the potential to increase the quality and efficiency of clinical trials—from reducing barriers to participation and improving the participant experience, to capturing more informative real-world data and lowering costs associated with conducting clinicaltrials.
AACT DATABASE
CTTI has aggregated and restructured publicly available ClinicalTrials.gov data and made it available here as a relational database to facilitate analysis of the complete set of trials. This database is the Aggregate Analysis of ClincalTrials.gov (AACT). CLICK HERE for an overview of the background on ClinicalTrials.gov and theAACT database.
CTTI RECOMMENDATIONS: DECENTRALIZED CLINICAL TRIALS CTTI Recommendations: Decentralized Clinical Trials September 2018 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. WEBINARS | CLINICAL TRIALS TRANSFORMATION INITIATIVE CTTI's webinars feature esteemed speakers discussing topics related to innovation and culture within the clinical trials enterprise. Below, you will find information about upcoming webinars, as well as recordings of previous webinars. All webinars listed below are free and open to the public, and we encourage you to invite colleagues involved in the clinical trials enterprise. OFFICIAL RECOMMENDATIONS New recommendations on Investigator Qualification, developed by experts and leaders across the clinical trials enterprise, aim to 1) help sponsors and contract research organization (CROs) implement a more efficient and effective means of qualification and determine whether a site team is a good fit for a particular protocol, and 2) help investigators and their delegates better prepare and CTTI RECOMMENDATIONS: ADVANCING THE USE OF MOBILE Page 1 of 32 CTTI Recommendations: Advancing the Use of Mobile Technologies for 2 Data Capture & Improved Clinical Trials Introduction Mobile technology offers unique opportunities to improve the quality and efficiency of CONSIDERATIONS IN THE CONDUCT OF REMOTE CLINICAL RESEARCH Considerations in the Conduct of Remote Clinical Research: Findings from Group Interviews David C. Babaian Regulatory Attorney, QuorumReview/Kinetiq
OVERVIEW - CLINICAL TRIALS TRANSFORMATION INITIATIVE Page 1 of 8 USE CASE FOR DEVELOPING NOVEL ENDPOINTS GENERATED USING MOBILE TECHNOLOGY: DIABETES MELLITUS OVERVIEW This use case explores the development of a novel endpoint for diabetes studies using continuous glucose monitors (CGMs) as a SIRB FLOWCHART: DETERMINING ENGAGEMENT OF INSTITUTIONS IN PURPOSE: Assist in determining if activities an institution’s employees or agents perform con-stitute human subjects research asoutlined by the
EVALUATION FRAMEWORK FOR THE NIH SINGLE IRB POLICY 3 Introduction Activating high-quality clinical trials is critical to advancing science and improving and saving lives. The Institutional Review Board (IRB) review process has been criticized for delaying clinical trial activation.1-4 In 2014, when the National Institutesnav
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* Learn More About Clinical Trials NEW RESOURCES AVAILABLE New resources provide guidance on implementing a Quality by Design (QbD) approach to clinical trials.Read More
DATABASE UPDATED
CTTI's Feasibility Studies database now has more than 440 studies using digital health technologies available.Read More
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Learn about CTTI’s work and best practices to help address clinical trial issues amid the COVID-19 pandemic.Read More
REPORT NOW AVAILABLE CTTI conducted a global, multi-stakeholder survey with 327 research professionals in 20 regions on GCP renovation. The report highlights findings to help the ICH in its mission to improve GCP.Read More
NEW RWD RECOMMENDATIONS New recs, resources, and case studies provide guidance on how to use real-world data (RWD) to evaluate trial eligibility and recruit potential research participants.Learn More
MISSION: TO DEVELOP AND DRIVE ADOPTION OF PRACTICES THAT WILL INCREASE THE QUALITY AND EFFICIENCY OF CLINICAL TRIALS CTTI now comprises more than 80 organizations from across the clinical trial enterprise. Members include representatives of government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.View All
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CTTI PAPER HIGHLIGHTS CLINICAL CRITERIA THAT CAN HELP IDENTIFY PATIENTS AT HIGH RISK OF HABP/VABPRead More
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RECORDING NOW AVAILABLE: CTTI RELEASES NEW RESOURCES FOR ADOPTION OF A QUALITY BY DESIGN APPROACHRead More
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NEW CTTI PROJECT AIMS TO IMPROVE CLINICAL EVIDENCE WITH PRACTICAL APPROACHES FOR EMBEDDING TRIALS INTO HEALTH CARE SETTINGSRead More
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CTTI PAPER FEATURES TOOL TO HELP SPONSORS AND PATIENT GROUPS IDENTIFY MUTUALLY BENEFICIAL OPPORTUNITIES FOR COLLABORATIONRead More
> CTTI has been cited in the NIH draft Policy>
> on single IRB of record in multi-center trials, the FDA’s newest > draft guidance on IND safety reporting> ,
> the FDA's Guidance on Risk-Based Monitoring> , an
> EMA Reflection Paper> ,
> and 21st Century Cures> .
CTTI POLICY IMPACT
> CTTI’s Quality by Design framework is being used at > AstraZeneca, DCRI, The Medicines Company, PCORNET, Pfizer, Seattle > Genetics, Target Health Inc, and the University of Oxford. ADOPTION OF CTTI'S QBD FRAMEWORK > CTTI’s Central IRB tools & recommendations > have been implemented at Celgene > Corporation, National Institute of Neurological Disorders and Stroke > (NIH), and North Shore-LIJ Health System. ADOPTION OF CENTRAL IRB'SSearch
Who We Are What We Do Briefing Room Take Action Contact UsPROJECTS
* COVID-19
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* Electronic Healthcare Data* Diversity
* Informed Consent
* Informing the Update of ICH E6 * Investigator Community * Investigator Qualification * Large Simple Trials * Long-Term Opioid Data * Master Protocol Studies * Patient Engagement Collaborative * Patient Group Engagement* Pregnancy Testing
* Quality by Design
* Real-World Data
* Recruitment
* Registry Trials
* Safety Reporting
* Site Metrics
* Single IRB
* State of Clinical Trials DISCLAIMER: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. Read our Citation Policyhere .
PROGRAMS OF RELATED PROJECTS PROGRAM: ANTIBACTERIAL DRUG DEVELOPMENT * Project: HABP/VABP Studies * Project: Peds Trials * Project: Streamlining HABP/VABP Trials * Project: Unmet Need PROGRAM: DIGITAL HEALTH TRIALS * Project: Decentralized Clinical Trials * Project: Digital Health Technologies * Project: Novel Endpoints * Project: Engaging Patients and Sites _Copyright © CTTI 2020. All Rights Reserved_ Web Design by NMC| Privacy Policy
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