Planning Decentralized Trials

Topics Included: Ensuring Quality, Innovative Trials, Patient Engagement, Site Planning

Program: Digital Health Trials

Related Projects: Developing Novel Endpoints, Selecting & Testing a Digital Health Technology, Managing Data, Supporting Sites, Interacting with Regulators

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially decentralized with hybrid approaches, or very similar to traditional “brick and mortar” trials.

Regardless of where your trial is on the decentralized spectrum, CTTI's recommendations can help you plan and conduct a successful trial.

Resources

Site Planning | Resources

Checklist for Sponsors: Considerations in Selecting & Equipping Sites for Clinical Trials with Digital Health Technologies

Checklist for Sponsors: Considerations in Selecting & Equipping Sites for Clinical Trials with Digital Health Technologies

Site Planning | Resources

Checklist for Investigative Sites: Questions to Ask During Budgeting & Contracting

Checklist for Investigative Sites: Questions to Ask During Budgeting & Contracting

Site Planning | Recommendations

Recommendations for using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment

Recommendations for using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment

Site Planning | Publications

Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

Site Planning | Case Studies

The Medicines Company (Novartis) Improves Investigator Qualification Training

The Medicines Company (Novartis) Improves Investigator Qualification Training

Site Planning | Case Studies

The Feinstein Institutes for Medical Research at Northwell Improves Investigator Communication through Establishment of Central Office

The Feinstein Institutes for Medical Research at Northwell Improves Investigator Communication through Establishment of Central Office

Site Planning

Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially...

Site Planning | Publications

More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant

More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant

Site Planning | CTTI News

CTTI Paper Offers Suggested Solutions for Improving Good Clinical Practice Training

A new CTTI paper, detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training, has published in Contemporary Clinical Trials Communications....

Site Planning | Resources

Appendix 1: Resources for Training and Learning

Appendix 1: Resources for Training and Learning

Formats

Stage of Trial

CTTI Paper Offers Suggested Solutions for Improving Good Clinical Practice Training

A new CTTI paper, detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training, has published in Contemporary Clinical Trials Communications.

The paper, “More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant,” outlines feedback on GCP training gleaned from interviews CTTI conducted with clinical investigators and research sponsors. While interview respondents recognized that GCP training addresses critical tasks necessary for the quality conduct of clinical trials, many found it burdensome and repetitive—one interviewee said the training was seen as “just another box to check off.”

CTTI’s paper also highlights respondents’ suggestions for navigating these challenges, noting a need for significant improvement in the design, content, presentation, and training of GCP guidelines. These findings, together with other evidence, informed CTTI’s Investigator Qualification recommendations for alleviating the burden of training and making it more engaging and applicable to real-world clinical research scenarios.