Why Lay Language Summaries Are Important

Studies consistently show that most clinical trial participants want to know what the research communities learned from their participation, yet most never hear from the sponsor or research site staff at all after a clinical trial has concluded. Many facts and figures demonstrate the need to provide lay language or plain language summaries to study volunteers. CISCRP’s Communicating Trial Results program engages sponsors and investigative sites and helps to fulfill the ethical obligation of researchers to inform study volunteers about what was learned from their participation in a trial.

Most patients want to know the results of their trial

According to the 2017 Perceptions & Insights Study conducted by CISCRP of 12,427 participants, 72% of respondents indicated that they were most interested in receiving information after participating in a clinical trial. 1

Very few patients are being told their trial’s results

91% of the public finds receiving study summary after participation very important while 53% of participants never received results, according to the 2017 Perceptions & Insights Study conducted by CISCRP of 12,427 participants.1

Lack of participant communication causes a barrier in the clinical research enterprise

A 2009 survey found that, “Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%])”.2 At the conclusion of their participation, most trial participants feel they are “no longer valued” by researchers.3 Unless they are deeply self-motivated to share their experiences, most study volunteers choose not to advocate clinical research among patients who are considering participation.4

ClinicalTrials.gov is not designed for lay persons

Results currently posted to ClinicalTrials.gov are not intended for patients or other lay audiences; rather, the expectation is only that these results would be understandable by an “educated reader of the medical literature”, as stated by the Director of ClinicalTrials.gov, Deborah Zarin.5 The Secretary of HHS has authority to mandate lay-language results on ClinicalTrials.gov under the FDA Amendments Act of 2007 Sec. 801(J)(3)(D)(i).

Whitepaper: Creating a Standard Practice in Communicating Trial Results

Learn more about the critical obligation to provide lay language results to study volunteers, including efforts underway to establish standard practices to routinely deliver these results and the anticipated impact of these programs.

Patients need lay language to understand the results

CISCRP research found that, after independently reviewing a lay language summary, 91.2% of trial participants felt they understood the results of their trial very well or somewhat well, and the portion who understood the basic facts of their trial increased by as much as 65.6 percentage points in a pre/post evaluation. Prior to reviewing a lay language summary, however, basic facts about the trial (such as why the research had been conducted) were understood by no more than 11% of patients.6

Patients want ongoing communication

In a CISCRP survey, 86% of trial participants wanted not only to be told the results of their trial, but also to be updated regularly by mail during the often extensive period of time between their last site visit and when trial results became available. Preferred frequencies ranged from 3-month to annual update schedules.7

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Sources

  1. [2017 CISCRP P&I Study, n=12,427]
  2. [Sood et al. 2009. Mayo Clinic Proceedings. 84(3): 243-247.]
  3. [Getz. The Monitor. September 2008: 17-21.]
  4. [Getz. 2010. Appl. Clin. Trials. 19(5): 32-34.]
  5. [Zarin et al. 2011. N Engl J Med. 364(9): 852-860.]
  6. [Getz et al. 2012. Expert Rev. Clin. Pharmacol. 5(2): 149-156.]