Deborah Collyar, Patient Advocates In Research (PAIR), explains why sharing results are good for patients and the research community
As a former executive in a computer company, I’m a big believer in sharing preclinical/clinical data, and in utilizing “big data” in ways that can inform and hopefully improve patient experiences.
When it comes to patient engagement, however, we have to get real about turning data into knowledge that people can use. That includes giving them useful and informative clinical trials results, not just a “data dump” that meets government requirements.
Why patients want to know
I’m often asked this perplexing question – why do patients want research results? Well, why wouldn’t they, no matter where they are in the process? For example:
- Clinical trial participants were told they would learn important information related to the trial. What could be more important than what happened?
- Most patients and family members want any information that can help them make important decisions when diagnosed with a serious medical condition or disease
- Other people hope that better answers exist, in case they need them in the future (additional thoughts are available in this guest post)
You see, the public thinks that we fund medical research to make people’s lives better. Often, this belief is based on blind assumptions rather than learning how the system works (or doesn’t). When they find out that patient outcomes are not the top priority, mistrust quickly takes hold. This can be alleviated, in part, by sharing how research works and explaining what clinical trials tell us.
Companies also benefit from sharing results
There is more to patient engagement than focusing on recruitment and retention, or pressuring regulators. Some of us have assisted in these areas, and we also work closely with drug developers to create better-designed trials that answer patient issues and attract more interest during enrollment. This is in addition to encouraging the inclusion of Patient-Reported Outcomes (PROs) and quality of life (QOL) factors in all clinical trials.
Result summaries may not seem connected at first, but they complete an open dialogue, confirming that sponsors are interested in improving patient outcomes as well as profitability. Sharing results can help companies build trust by exercising transparency, setting appropriate expectations, and providing the groundwork that may present reasonable value to patients, their families and insurers. If done well, results may also help foster adaptive learning health systems that can put clinical trial results into practice.
Simple and clear does not mean easy
Plans to produce clinical trial results have become a necessity since the European Medical Agency (EMA) created their 2014 requirements, as Thomas Schindler described last year. The US followed suit with another step in the 2016 Health and Human Services (HHS) ruling and policy from the National Institutes of Health (NIH). All regulations state that public summaries must be created within 12 months of closing adult clinical trials and within six months for pediatric studies. The EMA has also issued specific types of information to include, with a final consultation document expected soon.
So, how do we turn regulations into clear clinical trial summaries that people can understand and patients can use without overloading them with so much data that they give up in frustration? Many challenges exist, including trends toward multiple endpoints, unclear adverse events, non-promotional language, and shorter approval steps.
I have been fortunate to help lead clinical trial result initiatives with the Alliance for Clinical Trials in Oncology, and the MRCT Center of Brigham and Women’s Hospital and Harvard Return of Results Working Group. These experiences, along with managing technical writing departments, help desks and trainers, have taught me how to address the challenges that can thwart our intended purpose of providing useful information. A critical element includes information that is health literate.
Health literacy is key
The best way to provide clear, useful health information is to apply health literacy principles in every communication, including clinical trial result summaries. Unfortunately, most companies and writers know very little about health literacy, which includes much more than plain language. Some helpful resources are listed in this post and this MRCT report for those who want to learn more.
These kinds of communication challenges created an opportunity for me to team up with Health Literacy Media (HLM) to create a new Plain Language Research Summaries service for all trial sponsors. HLM is a health communications non-profit that provides expertise in targeted communications. They excel in health literacy planning, training, writing, review, testing, and in digital media services that include full-service web, video and social media campaigns.
We are currently testing some clinical trial summaries to ensure that they communicate in ways that help the people who need them most – patients and providers. HLM is interested in partnering with sponsors who share their philosophy of building better health outcomes through clear, simple communication. Feel free to contact HLM to learn more.
This is one of those rare moments where we can build win-win solutions for patients, companies, medical research, health systems, and government. Let’s use this opportunity to create useful information that serves its intended purpose – providing clear clinical trial summaries that help patients make informed health decisions, while improving the research system at the same time.
Additional CTA posts by Deborah Collyar:
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