By Rivka Szafranski and David Polinsky, Esq., ClinicalTrialGuide.com
In 2002, Time Magazine described the demeaning role of patient participants in clinical research in a cover story titled “How Medical Testing Has Turned Millions of Us into Human Guinea Pigs.” The cover depicted a research subject wearing a hospital gown crouched in an animal crate.
Though the clinical trial landscape has improved over the past 20 years, fear remains the main barrier to patient participation. In a comprehensive, first-of-its- kind review of nearly 500 relevant studies published in 2020 in the journal Trials,1 researchers found that fear of testing new treatments and fear of possible side effects were the most common reasons given by patients for not wanting to participate.
Studies have shown that patients are eager 2 to participate – they are motivated by the potential for personal benefit, the chance to help others, and loyalty to trusted doctors or researchers – but they lack the resources to address their fears. A survey of patients’ willingness to participate in cancer trials,3 for example, found that up to 50 percent wanted more information on the study, the drugs, or the procedures involved.
Similarly, a 2018 review4 of factors associated with failed clinical trials concluded that “Communicating with the patient is important at all stages of the clinical trial and supports recruitment, enrollment, and retention.”
Despite this thirst for information, however, the only broad-based source of information, until recently, has been the government website clinicaltrials.gov, which is far from user friendly. In addition to its sheer volume – it lists hundreds of thousands of clinical trials in hundreds of countries – the descriptions are typically written in scientific language that is not designed to be readily understandable to the layman.
While many barriers to trial recruitment are difficult to control, the comprehensive Trials review concluded that the major barrier, fear, can potentially be overcome through increased knowledge and education, including through online interaction.
That review proposed that one of the most effective ways of increasing patient engagement could be “digital provision” because of its potential to reconcile the communication of “universal” information on subjects such as the value of clinical trials and the nature of the clinical trial process with personalized information such as the pros and cons, health consequences, and potential outcomes of a specific trial.
A New Online Resource
It was to answer this need for information that an independent start-up launched clinicaltrialguide.com, a new online resource designed to make learning about clinical trials less stressful and more accessible for patients and their caregivers. It was launched earlier this year.
Through the website, patients can now access the information they need to navigate a clinical trial from enrollment through treatment, while a “Connect” feature to be rolled out later this year will allow them to connect directly through the site with pharmaceutical companies and contract research organizations that have posted information about their trials, written in simple, non-technical language.
Future plans call for patients to be able to connect with clinical trial stakeholders through a live feature, as well as through live webinar sessions in which industry representatives will discuss ongoing trials.
Most importantly, the website presents information in clear language that is readily understandable to the layman. While the Trials study identified failure to address patients’ anxieties and concerns as a primary barrier to participation, it also concluded that information can be a two-edged sword: if presented in a way that is too complex or too vague, it can be a barrier to, rather than an enabler of, participation.
In the review of factors associated with failed clinical trials, for instance, the authors reported on a study that found that patients who dropped out of a trial early were twice as likely to report that it was difficult to understand the informed consent form than patients who completed the trial. Even among patients who completed the trial, the review reported, one in six found the informed consent form “vexing.”
“Sometimes patients are not presented with a clear rationale for why their participation is important,” the researchers concluded.
So, what are the patient fears that need to be addressed?
According to the Trials review and other studies,1,4 patients are held back from taking part by fears about uncertain treatment effectiveness and worries about possible risks and side effects. They are also concerned about the financial and practical burdens of additional procedures and appointments. Common themes were the need for more knowledge about the clinical research process in general and about specific studies.
The Consequences Of Fear
The reasons for fear are important because the failure to address them can have major consequences. Clinical trials are an essential part of delivering new treatments, but recruiting patients is one of the biggest and most costly challenges faced by researchers.
A 2018 webinar5 from the Center for Information & Study on Clinical Research Participation (CISCRP), reported that 50 percent of studies under enroll or fail to enroll a single patient. It also reported that the average dropout rate is 30 percent.
Suboptimal recruitment1 and retention can result in trial delays, in underpowered or inconclusive studies, in under-representative samplings, and even in the discontinuation of a trial – all of which drive up the costs of drug development. The latter is especially unfortunate because it deprives medicine of potentially valuable treatments, to say nothing of the time and effort lost in conducting a trial that fails.
One proposed solution to the need for information is the “patient navigator,” a person with outstanding communications skills whose job it is to educate patients about the trial process and answer questions about specific trials. A demonstration project 6 among cancer patients found that patient navigators increase patients’ knowledge, self-efficacy (belief in their ability to achieve a goal), and likelihood of joining a trial.
But finding, hiring, and training additional staff members to perform the role of patient navigators can be difficult and costly, especially in a tight labor market. By serving as an online patient navigator that helps patients and families address their fears and concerns, an online resource such as Clinical Trial Guide can be an efficient and effective means of increasing clinical trial recruitment and retention.
It also benefits the consumer by reducing costs and time associated with bringing a drug to market, thus improving health and quality of life for patients and their families.
For more information, please visit www.clinicaltrialguide.com.
- Sheridan, R., Martin-Kerry, J., Hudson, J. et al. Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators. Trials 21, 259 (2020). doi.org/10.1186/s13063-020-4197-3
- Center For Information & Study on Clinical Research Participation, 2021 Perceptions and Insights Study. https://www.ciscrp.org/services/research-services/perceptions-and-insights-study/
- Moorcraft SY, Marriott C, Peckitt C, et al. Patients' willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials. 2016;17:17. Published 2016 Jan 9. doi:10.1186/s13063-015-1105-3
- Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018;11:156-164. Published 2018 Aug 7. doi:10.1016/j.conctc.2018.08.001
- Center For Information & Study on Clinical Research Participation. Meaningful Approaches to Patient Engagement: Adding the Right Tools to Your Toolbox. 2018. https://www.ciscrp.org/wp-content/uploads/2019/06/Patient-Engagement-Webinar.pdf
- American Society of Clinical Oncology Educational Book 39 (May 17, 2019) 105-114. doi:10.1200/EDBK_243729
About The Authors:
Rivka Szafranski is the CEO of Clinical Trial Guide. She is a lifelong project manager and a biotech enthusiast and strives to create a better world by building resources for patients and their families. Szafranski has a master’s degree in biotechnology management and entrepreneurship from the Katz School at Yeshiva University and previously worked in business development for both profit and nonprofit companies.
David Polinsky Esq. is the founder of Clinical Trial Guide and is committed to helping those suffering with major unmet clinical needs. Having spent more than 20 years in the pharmaceutical industry, Polinsky founded Clinical Trial Guide to help those seeking information not otherwise readily available.