Trial Result Summaries
What Are Plain (or Lay) Language Summaries?
Prepared in printed, electronic and audio formats to accommodate different learning styles, the plain language summaries are disseminated to volunteers via their investigative site as a way to fulfill researchers’ ethical obligation to return trial results and demonstrate to volunteers that they’re respected as true partners in the clinical research process. Most plain language summaries include:
- Thank you Message to Volunteers
- What is Happening with the Trial Now?
- Why Was the Research Needed?
- What Treatments Did the Patients Take?
- What Happened During the Trial?
- What Were the Results of the Trial?
- What Medical Problems Did the Patients Have?
- How has this Trial Helped Patients and Researchers?
- Where Can I Learn More?
Our Trial Results Summaries Program
Since 2010, CISCRP and clinical research sponsors have worked together to address this critical unmet need in the research enterprise with the creation of lay language summaries. We developed a program to provide study volunteers with the results of their clinical trial by creating and delivering plain language summaries. Working with our editorial panel of medical and health communications experts skilled at writing lay summaries, as well as patient advocates, CISCRP “translates” the technical results of clinical trials into scientifically accurate, non-promotional lay language summaries written at a validated 6th-8th grade reading level.
Given the positive experiences most volunteers (84%) have in trials and the strong response we’ve seen from our program, we believe that sponsors and researchers can influence more positive trial participation experiences and build a substantial base of public support for clinical research by implementing a program for systematically communicating trial results to all volunteers who give the gift of their participation in clinical research.
Why CISCRP for Trial Result Summaries?
We’re proven and experienced
We’ve developed and delivered over 50,000 plain language summaries to over 40 countries around the world, generating best practices that we can apply for the benefit of all of our partners.
We’re independent and trusted
Since we’re not vested in the outcome of the trial, we are dedicated to ensuring every lay language or plain language summary we provide is non-promotional and unbiased toward the drug, product, or sponsor. Our team is fully committed to these goals and we specifically dedicate time and resources to developing practical and ethical approaches to this process.
We’re committed to patient representation through our Editorial Panel
Every trial result summary we provide is reviewed by an Editorial Panel comprised of patients, patient advocates, and health professionals. This type of user-testing allows us to follow a universal best practice in patient and public communication by ensuring the materials we provide are understandable, clear, comprehensive and are not perceived to be promotional or bias.
We‘re continually trained in specialized health communications
Our team has specialized training in content and design principles that arise from the rapidly developing academic field of health communication. We continually develop and operationalize these distinct skill sets to differentiate our capabilities from traditional, technical medical writers and communications service providers. This allows us to produce materials that meet the needs of various audiences by following best practices in patient, public, and lay person communication.
Why Plain Language Summaries Are Important
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).
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
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.]
White paper: Returning Study Results to Research Participants
Learn about the current best practices for the content and preparation of plain language summaries, and the current guidance for how sponsors should work with Institutional Review Boards (IRBs) which have oversight of the clinical trials for which the summaries are provided. Co-authored by WCG
White paper: 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.
Trial Results Samples
See samples of lay language trial results summaries that were prepared by CISCRP in collaboration with the study sponsor and reviewed for scientific accuracy. The summaries translate the technical trial results posted on clinicaltrials.gov into easy-to-understand plain or lay language.
Most lay language summaries feature:
- Thank you Message to Volunteers
- What Is Happening with the Trial Now?
- Why Was the Research Needed?
- What Treatments Did the Patients Take?
- What Happened During the Trial?
- What Were the Results of the Trial?
- What Medical Problems Did the Patients Have?
- How Has this Trial Helped Patients and Researchers?
- Where Can I Learn More?
Request a Consultation
Schedule a complimentary consultation about your next plain language trial results summary.
