Lay Language Summaries
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. A growing number of pharmaceutical, biotechnology and medical device companies have recognized this situation and are closing the loop with their study volunteers by providing clinical trial results summaries, also known as lay language or plain language summaries.
What Are Lay Language Summaries?
Prepared in printed, electronic and audio formats to accommodate different learning styles, the lay 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 lay 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 Communicating Trial Results Program
Since 2011, 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 lay 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 Lay Language Summaries?
We’re proven and experienced
We’ve developed and delivered over [50,000 lay 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 results 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.