The US Food and Drug Administration (FDA) recently made two announcements indicating a commitment to addressing questions about the clinical trial process for clinical trial stakeholders, The National Law Review reports.
FDA announced two actions in late January that should be of interest for those involved in clinical trials:
- FDA published updates in the Information Sheet on Payments and Reimbursements to Research Subjects, clarifying that reimbursement for travel expenses is acceptable
- the agency scheduled a public meeting in April regarding clinical trial enrollment criteria.
Regarding payments and reimbursements to research subjects
The updated Information Sheet for Institutional Review Boards (IRBs) and clinical investigators, FDA “explicitly stated that it does not consider reimbursement for travel expenses to and from a clinical trial site and associated costs, such as airfare, parking, and lodging, to raise issues regarding undue influence. Such expenses, however, must be reasonable, and would also be subject to IRB review.”1 However, FDA cautions IRBs to be sensitive to other proposed participation payments to ensure that they do not interfere with participants’ voluntary informed consent.
FDA’s public meeting on inclusion/exclusion criteria
The April 2018 public meeting, entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials”, will bring together stakeholders together to discuss topics related to eligibility criteria, their potential impact on patient access to investigational drugs, and the facilitation of diverse clinical trial patient populations.1 The meeting implements the mandate within the FDA Reauthorization Act of 2017 to convene a public meeting to discuss eligibility criteria and will inform FDA guidance on the same topic.
Discussion topics will include:
- “The risks and benefits of participation in clinical trials as well as potential regulatory, geographical, and socioeconomic barriers to participation.
- The rationale for eligibility criteria in clinical trials, as well as the impact of exclusion criteria on the enrollment of populations, such as infants, children, pregnant and lactating women, elderly, individuals with advanced disease, and individuals with co-morbid conditions.
- Alternative clinical trial designs that may increase enrollment of more diverse patient populations, while facilitating the collection of data to establish safety and effectiveness.
- How appropriate patient populations can benefit from the results of trials that employ alternative designs.
- How changes to eligibility criteria may impact the complexity and length of clinical trials, as well as the strength of data necessary to demonstrate safety and effectiveness.
- Opportunities for using data from expanded access trials.”1
Pearl IRB is equipped to support clinical trial stakeholders with timely review services to ensure that research and participants are enrolled on time. Contact us today to discuss how we can help.
Referenced documents:
Information Sheet on Payments and Reimbursements to Research Subjects