Tag Archives: Good clinical practice

CTTI Releases 2015 Annual Report

Clinical trials, Informed Consent, Patient engagement, , , , , , , ,

The Clinical Trials Transformation Initiative (CTTI) has released its Annual Report for 2015. The report describes major achievements from the previous year, including new recommendations and related tools and checklists for improving the safety, efficiency, and overall quality of clinical research.

Cover page of CTTI Annual Report with embedded link to CTTI webpage containing report.
2015 CTTI Annual Report

Highlights of the 2015 Annual Report include recommendations on topics including:

  • Ethics review processes
  • Good Clinical Practice training for trial investigators
  • Research protocol design
  • Engagement of patient groups as equal partners in clinical research
  • Informed consent processes
  • Safety reporting systems for research participants

A public-private partnership whose many stakeholders include government agencies, advocacy groups, professional societies, academic research organizations, and representatives from the medical products industry, CTTI’s mission is to “identify and promote practices that will increase the quality and efficiency of clinical trials.”

A PDF version of the report is available here. Previous Annual Reports are also available on the CTTI website.

 

GCP Guidance and Pragmatic Clinical Trials: Opportunities for Harmonization

Pragmatic clinical trials, Regulatory issues,

A new article published in Circulation by a group of authors from the Duke Clinical Research Institute describes tensions between pragmatic clinical trial design and Good Clinical Practice (GCP) guidelines, which were established in 1996 to help ensure the safety of participants in clinical trials and the validity of trial findings. Pragmatic clinical trials (PCTs) are designed to test interventions in real-world settings and populations rather than under highly controlled conditions, and thus rely on simplified procedures, such as those used for screening, informed consent, and participant follow-up.

The authors concede that many PCT features appear to be at odds with GCP guidance, which has arguably led to improvements in the consistency and quality of trial conduct. However, they also note data suggesting that the intensive approach to monitoring and documentation fostered by GCP may ultimately increase trial cost and complexity by emphasizing minutia that “may direct focus away from critical aspects of trial conduct.”

The authors go on to suggest that GCP guidance should be updated to account for a growing proportion of research that incorporates aspects of pragmatic trial design and is conducted with data gathered from electronic health records and registries. They also offer a path forward for pragmatic research under current GCP guidelines by outlining strategies for areas that include participant enrollment, monitoring, study visits, participant follow-up, and documentation.

The authors conclude that collaborative efforts from trial sponsors, regulators, clinical trialists, and patients will be necessary to realign the guidance with contemporary trial conduct while preserving its central goal of protecting trial participants.

For further information:

For additional reading:

Introduction to PCTs

eBook on PCTs (University of Colorado Denver)

Ethics and regulatory issues in PCTs articles

NIH Collaboratory PCT: Time to Reduce Mortality in End-Stage Renal Disease (TiME)

NIH Collaboratory PCT: Blood Pressure Medication Timing Study (BPMedTime)

PCORnet PCT: ADAPTABLE, the aspirin study

Clinical Trials Transformation Initiative Quality by Design Project

Clinical Trials Transformation Initiative GCP Training Project