Congratulations to the MRCT Center of Brigham and Women’s Hospital and Harvard and team for winning the 2015 Award for Excellence in Human Research Protection from the Health Improvement Institute! The winning project recommends ways to write public summaries after a clinical trial is over.
Why Is This Important?
- People join clinical trials (research studies) so researchers can learn if new treatments, tests, procedures, or other things work better than what is now offered to patients.
- People who join the trial are research participants, and contribute a great deal – sometimes their very lives.
- Participants are told they’ll learn important things about the study, but they rarely receive a summary of what happened during the trial. Until now (hopefully).
The European Medical Agency (EMA) created a new rule that says ALL clinical trial sponsors must create a public summary within 1 year after a clinical trial is closed (6 months for trials with children). This rule scared sponsors (aka drug companies, government, and private funders), so the MRCT Center assembled a Return of Results (ROR) Working Group (WG) to help.
Why did it take a government regulation to make this happen, you might ask?
Oh, they must have been busy with things more important than telling people what happened (sigh).
What is the Return of Results (ROR) Project?
The MRCT Center ROR project focuses on patient needs (for a change!), instead of just the research system. This means including principles about plain language, health literacy, and how to explain numbers (numeracy) – making sense of clinical trial results for normal people.
The ROR project includes:
- A Guidance Document: how to set up a process to create patient summaries.
- A Toolkit: with helpful templates, non-promotional language, and checklists.
We studied a few groups who actually create clinical trial result summaries, like CISCRP and the Alliance for Clinical Trial in Oncology (disclosure – I run the summary project there).
“The award program recognizes submissions that our judging panel determines have demonstrated excellence in promoting the well-being of human research participants.”
– Dr. Peter G. Goldschmidt, President and Founder of Health Improvement Institute
Quite a mouthful, but nice recognition! They agree the ROR Project puts patients first.
Thanks to All
As Co-Chair of the MRCT Center ROR Working Group, along with Laurie Myers from Merck, we thank all 53 team members (pp. 2-4) for creating ‘how to’ information for all clinical trial sponsors to create plain language study result summaries for real people. Thanks also to Barbara Bierer, Rebecca Li, and the MRCT staff. We’ll continue to update as new information becomes available.
A Plea to Sponsors
The tools exist, so let’s get started NOW! Don’t wait for the EMA ruling or for the U.S. Food & Drug Administration (FDA) to follow suit. Patients, trial participants and the PUBLIC want these NOW. And some of us can help. Really. Contact me!
After all, it’s the right thing to do AND you really need some goodwill, but that’s another story…
What YOU Can Do
Please ask for a public summary of any clinical trial you want to know about. You can find most trials listed at https://clinicaltrials.gov/. And ask them to stop calling them “lay” summaries (what does that really mean, anyway?).
More information on clinical trial result summaries is in this post.
All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.