James Riddle, VP of Client Services

by James Riddle

Adopting Layperson Summaries in the United States

In April 2014, the European Parliament and the Council of the European Union issued a regulation on clinical trials comprising dozens of articles applicable to any clinical trial conducted in an EU member state. One such article mandates that at the end of a clinical trial, “the sponsor should submit a summary of the results of the clinical trial together with a summary that is understandable to a layperson.”

Providing a summary that is understandable to a layperson does not mean returning individual research test results to participants or providing a technical summary suitable for other scientists. A summary understandable to a layperson would see the simplification of technical jargon and the omission of individual results and most aggregate technical data. The purpose of the layperson summary is to inform the participant and reinforce the value of his or her participation in research.

Both the European Union and the United States have already developed systems by which a sponsor may summarize clinical trial results (the EUDRA CT and ClinicalTrials.gov, respectively), but the United States does not currently require that the summaries be understandable to a layperson.

 

Should layperson summaries of clinical trials results be required in the U.S.?

The Center for Information & Study on Clinical Research Participation (CISCRP), is in favor of establishing a similar requirement in the U.S.

An article published by CISCRP poignantly notes that, while almost all participants involved in clinical trials (a median of 90 percent of participants over 15 separate studies) wanted to know the results of the trials they were in, “almost [none] are being told their trial’s results.”

As the article goes on to explain, the chasm between what participants want and what they are getting could be a “substantial barrier to the success” of research.

Other supporters of a layperson summary requirement include the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard.

SACHRP has evaluated the return of study results through several lenses. Pertaining to the return of general data, the committee advises that providing summary data “is supported by the principles of Respect for Persons and Beneficence,” and that providing research results “helps build a sense of participation and partnership” in the research process and “makes [the participants’] experience more fulfilling.”

An MRCT workgroup designed to develop recommendations for the return of aggregate results and define recommendations for returning individual results firmly supports the return of aggregate results in “plain language” because it “allows for investigators and sponsors to honor the essential contributions and voluntarism of study participants in multi-regional clinical trials, while improving the transparency of those trials.”

And in a recent article in IRB Advisor, my colleague, Mitchell Parrish, and I further explore why increasing transparency through layperson summaries is a smart move that will maintain the clinical research ecosystem and strengthen the perception of clinical trials.

Given what we know of participants’ wishes regarding study results, and going back to the key principle of voluntarism in clinical trials, it seems only appropriate that participants be told the results of the trials in which they take part.

 

Central IRBs Are Well Positioned to Review Layperson Summaries

A lingering question about the adoption of layperson summary requirements is the review of those summaries.

Central IRBs are already well positioned to review layperson summaries, and as the role of central or single IRBs grows, wrapping review of layperson summaries into the existing review process seems an efficient use of available resources.

  • The boards comprise scientific, medical, ethical, and lay members and lay claim to a collective knowledge necessary for distilling complex data into a relatable format
  • They scrutinize all study materials, from the protocol and consent to advertisements and study diaries, so they have strong foundational knowledge of individual studies as well as feeder studies and trials with similar compounds
  • They conduct continuing and closing review of protocols, including an analysis of the safety data, the efficacy analyses, and statistical plans
  • To meet the FDA requirement 21 CFR 50.20, that “the information that is given to the subject or the representative shall be in language understandable to the subject or the representative,” they often have policies and services in place to ensure that these materials meet certain criteria for understandability. Quorum Review IRB, for example, regularly modifies consent forms to achieve an 8th grade reading level

In short, central IRBs have the processes, capacity, and applicable background information to conduct a meaningful review of lay summaries of clinical trial results.

 

Incorporating Layperson Summaries Will Require Collaboration

An article published in the American Medical Writers Association (AMWA) brings up important questions that sponsors, central IRBs, and regulators must answer, especially pertaining to the interpretability of the actual EU requirements, before fully committing to the return of aggregate results, including overcoming vague language that is open to interpretation.

For example, the regulation requires a description of the “overall results of the trial.” The AMWA article astutely notes that this could refer to primary endpoints or secondary endpoints, efficacy or safety data, or other factors that may or may not be of interest to participants. However, factors like quality of life (QoL) may be of great interest to participants, but if relevant data about QoL were not gathered, summarizing QoL data may be impossible.

Central IRBs, sponsors, and regulators should work together to establish baseline interpretations of the regulation in order to meaningfully transmit results to participants.

 

Attending MAGI Clinical Research Conference West in Las Vegas?

James Riddle will be co-presenting a session entitled “Emerging Issues in Human Subjects Protections,” where he will discuss, among other topics, the importance of layperson summaries in the U.S. His session is on Monday, October 24. Attend his session and schedule a meeting with James during the conference.

 

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