Good clinical practice

June 14, 2019: Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health System (Robert Mentz, MD)

Posted on by Gina Uhlenbrauck

Speaker

Robert J. Mentz, MD, FACC, FAHA, FHFSA
Associate Professor
Director, Duke Cooperative Cardiovascular Society
Associate Program Director, Duke Cardiovascular Disease Fellowship
Duke University Medical Center and Duke Clinical Research Institute

Topic

Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health System

Keywords

International Council for Harmonization (ICH); Good clinical practice (GCP); Learning health system; Pragmatic clinical trials; Institutional review board (IRB); Research oversight; Regulatory issues; Quality by design (QbD)

Key Points

  • Good clinical practice (GCP) guidance details the responsibilities, procedures, and recording that are necessary for appropriate trial conduct; for example, conducting the trial in accordance with an IRB-approved protocol with appropriate adverse event monitoring and reporting.
  • There is an urgent need to streamline randomized trials. Key obstacles are lack of transparency, lack of representativeness, and lack of evidence of competence.
  • In the United States, clinical investigators must abide by guidance from FDA, HHS, and ICH-GCP. Yet it is hard for investigators to keep track and to know how GCP applies to their study.
  • GCP as an overall construct is useful, but it does not deal well with issues particular to pragmatic trials or trials outside the FDA-regulated world.

Discussion Themes

With embedded pragmatic trials, informed consent is more nuanced. New considerations and approaches for consent have arisen since ICH GCP first came into effect.

Establishing quality by design will take time, effort, and educating IRBs to understand how QbD can be used to avoid errors in a trial and collect data that is fit-for-purpose.

It’s crucial that trials address an important question, answer that question reliably, and keep participants safe.

Read more about Dr. Mentz’s study of GCP and pragmatic trials.

Tags

#pctGR, @Collaboratory1, @RobMentz

February 15, 2019: Improving Qualification of Investigators: Recommendations from the Clinical Trials Transformation Initiative (Christine M. Hildebrand, PA-C, Janette Panhuis)

Posted on by Gina Uhlenbrauck

Speakers

Christine M. Hildebrand, PA-C
Physician Assistant
Sub-Investigator
Clinical Operations Lead
Amici Clinical Research

Janette Panhuis
Chief Operating Officer
Population Health Research Institute
David Braley Research Institute

Topic

Improving Qualification of Investigators: Recommendations from the Clinical Trials Transformation Initiative

Keywords

CTTI; Investigator qualifications; Investigator training; Site team training; Good clinical practice; Clinical trials

Key Points

  • There is little evidence that good clinical practice (GCP) training alone sufficiently qualifies investigators in the conduct of clinical trials. What is needed is a targeted and risk-based approach to educating clinical trial investigators and their delegates in GCP principles.
  • A culture shift is needed that eliminates the distinction between “qualification” and “preparation” and moves toward investigators and their delegates assuming greater ownership of training and documenting evidence of their qualification.
  • CTTI recommendations outline how to confirm that site teams are qualified while also reducing inefficiencies in training and increasing preparation for successful study execution.

Discussion Themes

Investigators and site teams come to the table with different levels of research experience, training, and credentials. How can we effectively address gaps in skills and knowledge of GCP principles?

With respect to pragmatic trials conducted within healthcare systems, are there approaches to site monitoring that address issues related to turnover of PIs and clinical and research staff?

Greater ownership of GCP training and qualification by investigators and delegates can lead to active remediation of deficiencies at the clinical site.

CTTI recommendations are meant to be adaptable to the protocol, even when conducted in a real-world clinical setting using electronic health records.

For recommendations and tools for improving investigator qualification, visit CTTI’s Investigator Qualification website.

Tags

#ClinicalTrials, #GCPtraining, #pctGR, @Collaboratory1 @CTTI_Trials