For patients, finding a clinical trial can be a challenge in and of itself. So imagine the frustration patients feel when they can’t find results of a study in which they have participated.
Many sponsors do post study results on ClinicalTrials.gov. However, patients often are overwhelmed by the sheer number of studies listed, difficulty in navigating the site, and the verbiage used, which can come across as medicalese to non-healthcare professionals.
Here’s where health literacy comes in. Some sponsors also are providing clinical trial plain-language summaries (PLS) on their own websites. These summaries, typically written at a 6th- to 8th-grade reading level, are designed to be easily understood by the public.
Sponsors must be careful to avoid the appearance of any promotional language when it comes to PLS. Regulatory agencies such as the European Medicines Agency (EMA) mandate that PLS be objective and unbiased. That’s why PLS also should be posted on a portal, designed to host PLS, that is open to all sponsors.
The Trial Results Summaries portal is a centralized repository providing a neutral ground where multiple sponsors can post their study results. For a study participant, TrialSummaries.com is the one-stop shop for PLS. Here, in addition to finding results from their own trial, participants can find results for more trials targeting a specific disease, including those of other sponsors.
PLS are more than just a “nice to have” for sponsors. For patients, PLS are “need to know.” A special report, “Assessing the adoption of clinical trial results summary disclosure to patients and the public,” recently appeared in the journal Expert Review of Clinical Pharmacology. The report – authored by Ken Getz, director of the Sponsored Research Program at the Tufts University Center for Drug Development, and Julia Farides-Mitchell, Project Manager at the Center for Information & Study on Clinical Research Participation (CISCRP) – notes that less than 2 percent of all clinical trials completed or terminated within the past three years returned plain-language summaries to study volunteers. This is in stark contrast to statistics from CISCRP’s 2017 Perceptions & Insights Study, revealing that the majority (91 percent) of the public finds receiving a study summary after participation to be very important.
Why are study results so important? Trial participants who receive results feel that their time and efforts were valued and well spent. They feel that they were part of something bigger, that they helped make a contribution to advance medicine.
“At the end of the day, I feel positive in that I have done something to help maybe not myself but to help other people, says clinical trial participant Gail Pedescleaux-Muckle in this eye-opening video. “But I would have loved to have seen the end result.”
When participants feel appreciated, they are likely to refer others to clinical trials. Sponsors that provide regular updates as well as results boost participant retention. These participants see the sponsor in a favorable light. This positive brand perception extends well beyond the actual trial.
As PLS expert Lora Killian says in this video, “… patients have voiced that when they participate in the trial and they give up their time, and then at the end of the trial they don’t hear back, they don’t know what the conclusion is and it’s like someone broke up with them over text.”
A clinical trial should be the start of a long-term relationship between the sponsor and patient. As Killian says, the participant should not feel jilted at the conclusion of a trial.
In short, posting study results on a public-facing online portal is a win-win for both sponsors and patients. As the pharmaceutical industry moves toward greater transparency, sharing study results is another step in the right direction.