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September 26, 2018updated 12 Jul 2022 1:12pm

Clear Clinical Trial Information is the Key to Patient Engagement

Deborah Collyar, Patient Advocates in Research (PAIR) and Catina O’Leary, Health Literacy Media, show why public study summaries need more than plain language to be effective

Most clinical trial sponsors are aware of the EMA requirement to produce and distribute public clinical trial summaries. Some sponsors have begun to set up processes in which to create summaries, and many more are piloting new internal or external approaches.

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While some guidelines exist[1] and a moving deadline has offered a brief reprieve, it looks like all sponsors who conduct clinical trials with sites in Europe will be required to start submitting these summaries in 2019. Canada and the U.S. have also created policies that encourage public study summaries, and experts expect further regulations in the near future.

People Want Clear Information

Regulations have created a reason to produce clinical trial summaries that trial sponsors care about, but just any summary won’t do. The intent is to create information that people can use in their pursuit for understandable medical information to help them make better health decisions.

When people become patients, they enter a very confusing world called health care. Unfortunately, this is somewhat of a misnomer, since most medical systems focus on people who get sick, not on those who are healthy. Patients and their loved ones must quickly learn new medical language while trying to navigate through a maze of confusing sub-specialties, just to get a tangible and accurate diagnosis and ideas on treatment options. This is why patients rely so heavily on their medical providers.

Unfortunately, most medical providers are not involved with clinical trials so their patients will not hear about them unless they search through other sources, such as patient advocacy groups or online resources. Many medical providers also have trouble keeping up with the latest research result. This presents a real concern that at least some patients may not get the most progressive care for their condition.

Public clinical trial summaries can help alleviate part of this problem. By creating useful information about a clinical trial and its results, providers, patients, and other information seekers can learn about options that may be available for them as they make treatment decisions. All of these audiences need to be considered when developing a process to produce clear, effective public result summaries.

Health Literacy is more than Plain Language

Biopharma companies have not traditionally communicated directly with patients, and are understandably wary about how to do so in a respectful, non-promotional way. This is a primary way that health literacy can help.

To date, many companies have grasped the need for plain language result summaries, and this is a step in the right direction. Plain language, however, is only one small piece of health literacy. To be truly health literate, information also has to contain context that the audience can relate to, rather than simply use words that meet an arbitrary reading level guideline, such as 5th or 6th grade. Health literacy includes:

  • Visual explanations of complex concepts, using charts, tables, and drawings
  • Analogies people can relate to, based on use in their everyday lives
  • Clear language that simplifies complex science in accurate ways and helps teach people the words they need to recognize to communicate with their providers
  • A variety of platforms that people use today

To illustrate how important health literacy can be, consider this example that has already created discordance when introducing public clinical trial summaries to patients and their supporters – the term “lay summary” has been the most used phrase for these new public science summaries. From a health literacy perspective, the phrase is first and foremost, not generally used in people’s everyday life. More importantly, it serves to devalue the audience to whom the summary is intended by denying them expertise in their own lives. Use of the term “lay” may actually make people avoid or bypass any information in the document they don’t perceive to be for them. This includes providers, as well as patients.

From an advocacy perspective, if health literacy principles had been aligned in the introduction of the public summary concept, it is likely the regulation and its resulting explanatory guidance would be more fully embraced by patient communities, rather than creating some doubts about the true intentions of the initiative. Some biopharmaceutical companies understand this, and are using health literacy principles to help them align with patient preferences and needs.

Clinical Trial Summaries can lead to Better Patient Engagement

Clinical trials don’t happen without public engagement. If done well, clinical trial result summaries offer opportunities to engage the public and patients in new ways, such as those listed in this prior post and this post as well. For example, they can:

  • Show respect to trial participants
  • Help providers keep up with research advances
  • Show how clinical trial participation can lead to better medical solutions
  • Help patients quickly learn more about their new medical condition, and what to do about it
  • Help patients develop the critical questions they need to make decisions about their health

Public clinical trial summaries also present an opportunity to create information from a patient perspective that can actually engage and involve people in their own medical care, while creating goodwill and better understanding of the scientists and companies who conduct medical research.

Ways to Engage People more Effectively

Research needs public support as much, if not more than, the public benefits from scientific advancements. That means research results need to be clearly communicated. Health literacy is the road map to communicate complex science that is understandable, relevant, and useful.

At Clearly Communicating Clinical Trials (C3T), we have designed and conducted research, written summaries of clinical trials for the public, made consent forms truly informative, created digital formats and messages, tested concepts with patients, and conducted a broad range of health literacy interventions. Based on our experience, health literacy offers the greatest potential to improve and advance clinical trials when used throughout the clinical trial process. Health literacy also leads to greater impact in medical practice.

 

If you would like more information on health literacy and how to incorporate into your public communication, here are some links to more resources:

 

Contact Catina O’Leary for more information at:

Health Literacy Media (HLM)

Coleary@healthliteracy.media

Twitter: @CatinaOLeary

LinkedIn: https://www.linkedin.com/in/catina-o-leary-43625112/

Websites: www.c3t.media and www.healthliteracy.media

 

Contact Deborah for more information at:

Deborah@tumortime.com

Twitter: @deborahcollyar

LinkedIn: https://www.linkedin.com/in/deborahcollyar

Facebookhttps://www.facebook.com/DeborahCollyarAuthor

Also: read Deborah’s blog here  https://collyar.wordpress.com/

 

Additional CTA posts by Deborah Collyar:

 

Reference

[1] https://ind-dev-kgi-verdict-network.pantheonsite.io/uncategorized/clinical-trials-arena/time-to-share-research-results-with-real-people-4705888-2/

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