A growing number of pharmaceutical, biotechnology and medical device companies are closing the loop with their study volunteers by providing clinical trial results summaries. Also referred to as lay language summaries or plain language summaries, the advent of these documents follow research initiatives showing that most clinical trial participants want to know what the research communities learned from their participation, yet most never hear from the sponsor or site staff at all after the trial has concluded.
To accommodate this void and fulfill other objectives including patient engagement and an ethical obligation to return trial results, research sites are increasingly turning to lay language trial results summaries to provide a digestible summary of the study, trial and outcomes. Read on to learn what exactly a lay language summary is, why more and more sites are using them and how you can promptly and easily deliver one to your study participants following your next clinical research trial.
What are lay language summaries?
Lay language summaries are an important emerging practice by sponsors, regulators and other healthcare authorities in effort to increase data sharing and transparency. Written in easy-to-understand lay (aka as plain) language for a general audience, a lay language summary is a non-promotional regulatory document that addresses and thanks volunteers directly and includes information such as:
- 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 have?
- How has this trial helped patients and researchers?
- Where can I learn more about this trial?
The summaries are often written by a third-party organization, guided by a high-quality, patient-focused editorial process and disseminated to volunteers via their investigative site. To accommodate different learning styles, summaries can be developed in multiple formats such as print, electronic and audio.
Why do you need lay language summaries?
There are many reasons to utilize lay language summaries, including fulfilling an ethical obligation to return trial results as well as to demonstrate to volunteers that they are respected as true partners in the clinical research process. While results summaries are not currently required by the FDA, studies consistently show that most volunteers want to know what was learned from their contribution:
- Participants want to know what was learned from their participation in a trial: 84% of clinical trial participants said it is ‘very important’ or ‘somewhat important’ to receive the results of their trial.1
- Patients need lay language summaries to comprehend the technical results: 91% of clinical trial participants understood the results of their trial well after reviewing a lay language summary when prior to review, basic facts about the trial were understood by less than 11%.2
- Lack of communication may negatively impact the clinical research enterprise: 91% of clinical trial participants want to be informed about research findings from their trial and would reportedly not participate in future clinical trials if left uninformed.3
While results are posted to scientific and medical journals and websites such as ClinicalTrials.gov, the writing is 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 Deborah Zarin, Director of ClinicalTrials.gov. Beyond that, other reasons sponsors are planning and implementing summary programs include supporting their patient engagement and retention objectives, nurturing relationships with investigative site personnel, anticipating regulatory pressure and reform, and finally, informing discussion between study volunteers and their healthcare providers.
How do you develop and deliver lay language summaries?
An accurate lay language summary is to be written at a validated 6th-8th grade reading level; when translating highly technical results into scientifically accurate lay language however, this is easier said than done. Most research sites and sponsors choose to work with an independent third-party to write their lay language summaries which includes the following considerations:
- Inclusion of non-promotional and unbiased plain language
- Use of a high-quality, patient-focused editorial process
- Adherence to regulatory compliant methods, including global mandates
- Use of proper patient protections
- Adherence to sponsor company specifications and operating practices
The timing of when to distribute the summary to study volunteers is up to the sponsor’s overall strategy – but often site staff will inform volunteers about the summary which can be expected a few months after the conclusion of the study. Available in multiple formats such as print, electronic and audio, a lay language summary is available to volunteers online and often provided in-person.
How do I get started developing lay language summaries for my patients?
If you’re interested in returning trial results and demonstrating to your volunteers that they’re regarded as true partners in the clinical research process, consider lay language summaries. At CISCRP, we’ve partnered with 30 of the top pharmaceutical companies to create and deliver lay language summaries that are non-promotional, unbiased and written in a way that participants will understand and appreciate. To give back to the participants who gave you their time, schedule a free 30-minute consultation with us today.
Do you need other clinical research assistance, education or information? Contact CISCRP today.
- 2017 CISCRP P&I Study, n=12,427.
- Getz et al. 2012. Expert Rev. Clin. Pharmacol. 5(2): 149-156.
- Sood et al. 2009. Mayo Clinic Proceedings. 84(3): 243-247.