Deborah Collyar, President of Patient Advocates In Research (PAIR) explains one of her long-term efforts to engage patients as partners
If you personally enrolled in a clinical trial, wouldn't you want to know how it turned out? After all, your informed consent form said something about receiving "important information about this study." You may also have been told you 'make adifference to future patients. 'And yet, clinical trial participants rarely receive updates that explain the results of their contributions. Family members and other patients also feel deserted without coherent information that could assist them with their needs. Sponsors and clinicians obviously need to share accurate clinical trial results that put those results into real-life context.
Some sponsors may lament "one more thing to do," but simple summaries offer a highly constructive communication strategy that:
Shows respect to trial participants
Creates goodwill for the sponsor
Shows how clinical trial participation contributes to future medical advances for everyone (not just those who profit from approvals)
Help from Regulators
Honoring commitments to trial participants has clearly failed to spur sponsors to create simple study result summaries, so the European MedicinesAgency (EMA) has now provided tangible motivation to deliver general (aggregate) study results. Annex V of Regulation (EU) No.536/2014 describes content requirements for a "summary of the results of the clinical trial for laypersons. "While the term "laypersons" promotes an outdated hierarchy that can deter modern patient engagement efforts, the regulation does offer cogent guidelines for every public summary.Requirements include items, such as:
Clinical trial identifiers
General information about the trial (e.g. why, what, where, when, objectives)
Medicinal products used
The type and frequency of adverse effects (better called 'side effects')
Overall results of the trial and comments about the outcome
Whether or not the trial will be followed up
Where to find additional information about the trial
Please note that this includes all clinical trials, 12 months after study end. To patients, there are no 'negative' trials. We expect everyone to be able to build on what is learned about diseases and medical conditions from each clinical trial, what doesn't work, and what can be done to stop them.
A Long Time Coming
The alltrials.net international initiative and various data-sharing efforts have helped create a more positive environment in which to share trial results with research colleagues and the Public.Some in the U.S. have also refused to wait for the Food and Drug Administration (FDA) or the Department of Health and Human Services (HHS) to follow EMA's lead. Various efforts to create guidance documents, templates, and actual plain language study result summaries have produced outcomes that can now assist in the quest to explain clinical trial results. I have been involved in these efforts since the 1990s, and am honored to present examples here that any sponsor may use to create their own summaries.
Building A Foundation of Communication
After endless discussions on how to re-position clinical trial approaches toward patient needs, the Cancer and Leukemia Group B (CALGB) clinical trials group, sponsored by the U.S. National Cancer Institute (NCI), created a multi- stakeholder Patient Issues Committee in 1998. We created pilots for new approaches to protocol development, accrual, and communication strategies to build long-term patient-oriented relationships through clinical trials.
2003: Research Leads to Online Public Study Result Summaries
A young investigator (Ann Partridge, MD, MPH) joined me as Co-Chair of the re-named CALGB Committee on Advocacy, Research Communications, Ethics, and Disparities (CARE) in 2003, and we started to research attitudes and methods toward giving research results to trial participants. Several references about our work are included at the end of the paper. These findings led to recommendations, some of which were accepted by CALGB. Our first study result summary was produced in 2008, after learning what patients viewed as valuable. When CALGB merged into the Alliance for Clinical Trials in Oncology (Alliance), study result summaries were retained as an important initiative. Over 40 public study result summaries now exist on the Alliance website.
Guidance on Result Summaries
In early 2014, the Harvard Multiregional Clinical Trials Center (MRCT) created the Return of Results (ROR) Working Group (WG) in response to EMA regulations. Laurie Myers (Merck & Co., Inc.) and I co-chair the ROR WG, and members of this multi-stakeholder group represent pharmaceutical, academic, patient advocacy, non-profit, and ethics communities. Objectives included the review of current efforts and regulations in returning aggregate results to study participants; and the creation of a guidance document and toolkit that details process, logistics and content. Collaborations with TransCelerate Biopharma, Inc. and the UK National Health Service's Health Research Authority (as part of the European Forum on Good Clinical Practice) continue to improve the MRCT tools through a continuous, iterative process.
All of these efforts employ health literacy and numeracy principles. Some effective resources in these areas include:
U.S. Center for Disease Control and Prevention (CDC) Clear Communication Index
Originally scheduled in 2016, latest rumors about the EMA regulations seem to indicate a delay in the activation of public summaries into 2017. Nevertheless, it is clearly past time for all sponsors (academic, private, commercial, and government) to embrace the opportunity to engage patients in new and potentially meaningful ways.
Some sponsors may opt to develop in-house processes to create public result summaries, while others may decide to use service providers with both medical and plain language writing expertise. The Harvard MRCT documents provide information on both approaches. In addition, I am working with Barbara Godlew from The FAIRE Company, LLC to offer services and expertise from an experienced team of writers and editors who are dedicated to providing clear, concise patient-oriented trial summaries from sponsors.
There is much work to be done to transform complex endpoints into research results that patients can realistically use on their own. It is the right thing to do, with or without regulatory enforcement. Thank you for being part of the solution!
Contact Deborah for more information at: Deborah@tumortime.com Twitter: @deborahcollyar LinkedIn: Deborah-Collyar
Also: read Deborah's blog here - https://collyar.wordpress.com/
Partridge AH, et al. "Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants." J Natl Cancer Inst. 2004 Apr 21;96(8):629-32. PMID: 15100341
Demmy TL, et al. "Managing Accrual in Cooperative Group Clinical Trials." J Clin Oncol. 2004 Aug 1;22(15):2997-3002. PMID: 15284251
Collyar DE. "How have patient advocates in the United States benefited cancer research?" Nat Rev Cancer. 2005 Jan;5(1):73-8.PMID: 15630417
Stark N et al. "A Survey of Survivors." Applied Clinical Trials Jul1, 2007. http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp? id=439808&pageID=1&sk=&date=. Accessed on 4/1/13.
Collyar D. "An Essential Partnership: Patient Advocates and Cooperative Groups." Seminars Oncol. 2008 Oct;35(5):553-5. PMID: 18929153
Partridge AH el al. "The impact of sharing results of a randomized breast cancer clinical trial with study participants." Breast Cancer Res Treat. 2009 May;115(1):123-9. Epub 2008 Jun 10.PMID: 18543100
Collyar, D. "A patient advocate perspective on oncology drug development." Clin Adv Hematol Oncol. 2009 Feb;7(2):98-9. No abstract available. PMID: 19367248