Letting Clinical Trial Patients Do the Talking

In this era of booming technology, principal investigators of clinical trials have tried all sorts of things to overcome persistent patient recruitment hurdles. Their approaches include study websites, outreach through social media, apps helping willing clinical trial patients find appropriate clinical trials, and more. Enrollment rates, however, remain less than ideal, and recruitment continues to occupy a hefty chunk of a study’s timeline1.

Meanwhile, in various corners of the web, a number of online forums for clinical trial patients to share their experience with the public have emerged. On the website Rate Clinical Trials, patients can discuss their experience with a trial and review the site where it took place. Another site, Patients Like Me, allows users to share their experience with all aspects of health care, including accounts of clinical trial participation. The trend has even found its way into the government: on the section of the National Institute of Health website dedicated to clinical trials, there is a page with dozens of firsthand accounts from clinical trial patients.

Could these patient information-sharing platforms, in which the public is educated about the nature of clinical trial participation from their peers rather than experts and authorities, be harnessed for patient recruitment and retention? Could they ameliorate the hurdles that continue to frustrate clinical researchers?

More trust in clinical trial patients

A 2009 study by Media Effects Research Laboratory indicates that, in commercial situations, people are more likely to buy a product if it has received positive reviews from fellow consumers, and less likely to do so based solely on the recommendation of an expert or some other relevant authority2. Evidence suggests the same may hold true of clinical trial participation. No matter how thoroughly a principal investigator (PI), physician, or other medical authority explains the realities of clinical trials, many potential patients nonetheless retain their skepticism. In Phase I trials, for example, when drugs are administered to human participants before safety data on that drug has been fully collected and analyzed, many liken participation to being the subject of an experiment, and are averse to that notion. This “guinea pig” fear has long caused researchers headaches, and is cited as one of the most common causes of recruitment struggles.

Resistance to PI recruitment efforts can be particularly strong among some ethnic and racial minorities3, an understandable tendency that dates to unethical clinical practices in bygone eras. This creates challenges not just for raw enrollment numbers, but for the task of ensuring that the patients that do enroll comprise a diverse array of demographics. Variations in the ways people of different demographics respond to a given compound have created a new push, in clinical research, toward ensuring not just patient enrollment, but patient diversity. Without the trust of a wide variety of ethnic, age, and gender demographics, PIs will continue to struggle to enroll a diverse enough body of participants to yield thorough and accurate clinical data.

All this has left some wondering if allowing potential participants to hear accounts from actual clinical trial patients could help in overcoming these trust barriers. The appearance of the forums mentioned above reflect that line of thinking. But questions remain about what form such sharing should take. The Senior Vice President of Quintiles, for example, recently penned an article in Applied Clinical Trials encouraging patient experience sharing as a recruitment and retention strategy. Others, however, are concerned with the confidentiality implications of allowing patients to share their experiences in an online setting. Some fear unregulated communication will lead to patients sharing confidential safety or efficacy data, or advising one another on how to recognize placebos4. Indeed, such incidents have occurred.

In response, there have been calls to ensure that such forums are thoroughly regulated. Sponsors can monitor chat rooms. Patients can be restricted from posting about their experiences until the trial is complete. Some websites advise patients on how to self-regulate, offering guidance on how to contribute to public understanding of clinical trials without disclosing sensitive information.

Those working to regulate patient information sharing seem to understand it is impractical to try to keep clinical trial patients off the internet. Rather than abandon the practice, their goal is to position it within safe parameters.

1 Hecht, Jeanne; Coalition Offers Ideas for Raising Trial Awareness; 12 July 2016; Applied Clinical Trials
2 Sundar, S. Shyam; Xu, Qian; Oeldorf-Hirsch, Anne; Authority vs. Peer: How Interface Cues Influence Users; CHI 2009; 4 – 9 April 2009
3 Krisch, Joshua A.; How Lack of Diversity in Clinical Trials Hurts Minorities; Vocativ; 31 July 2016
4 McNair, Lindsay; Social media: The evolving impact on clinical trials; Quintiles; 9 January 2016