Three key ways to improve patient and physician education on clinical trials

This article first appeared in Clinical Leader

Without that perspective, it can be difficult to truly appreciate the importance of clinical research and its impact on society. Despite its importance and society’s reliance on clinical trials, there is still a lot of work to do to improve public perception, education, and trust surrounding the topic. Prior to the COVID-19 pandemic, the pharmaceutical industry ranked last on a list of 25 major industries, making it the most poorly regarded. According to Gallup’s Work and Education Poll, 58% of respondents viewed the pharmaceutical industry negatively, placing it below historically controversial sectors such as the federal government and oil and gas. Since the pandemic and as a result of the herculean efforts of the industry, pharma companies have seen a noticeable boost in positive public perception. Increased media coverage, targeted industry messaging, and a desire by the public to remain educated in the face of a pandemic are key factors contributing to the rise in positive sentiment. However, positive sentiment alone is not enough to support the development of the next generation of medicines. Perception must translate into action and, more importantly, participation in clinical research.

The success of clinical trials and the advancement of clinical research depend on the existence of a large, diverse, and motivated patient pool. Failure to educate, motivate, and engage patients to participate in clinical research could have devastating effects on the industry. An already slow and expensive drug development process could be further accentuated, resulting in a much-reduced ability to manage, treat, or cure diseases. Without a large and diverse patient pool, medicines may be trialed in populations that are not representative of those with the greatest disease burden or incidence. In stark contrast to this scenario, better educating, engaging, and motivating patients could result in faster and more efficient delivery of new and improved medicines. Take, for example, the record-setting speed of COVID-19 vaccine development and the critical role of volunteer participants. The vast availability of data in this instance supports the notion that an educated patient is more likely to be empowered to make decisions and invest in their healthcare, such as participating in a clinical trial (link). With this in mind, we must ask ourselves: How can we do a better job educating patients and the public on clinical research and trials?

There are three key topics that the pharmaceutical and healthcare industries should consider to better educate, engage, and motivate patients. These are accessibility and availability of trustworthy information, motivating factors, and converting knowledge into action.

1. Accessibility and availability of trustworthy information

The accessibility and availability of information is at an all-time high. The power of technology has helped to completely transform channels of information consumption and education, moving them beyond a physical classroom to almost anywhere in the world at any time. But with increased information comes increased noise. Pharma and its industry peers (i.e., healthcare providers, patient groups, etc.) must learn to break through the noise to deliver effective messaging about clinical research and trials. According to research conducted by the Center for Information and Study on Clinical Research Participation (CISCRP), “While the majority (82%) of people around the world self-reported feeling well-informed about clinical research, results indicate that the level of knowledge is superficial.” This finding underpins the need for effective and accurate education by trusted sources. Given the public’s mixed perception of the pharmaceutical industry, pharma companies should look to leverage more indirect and trusted channels for delivering information and education. Healthcare providers, patient support networks, and public/private education systems should be at the top of the list and targeted audiences should also include specific patient populations (e.g., cancer patients).

Utilizing diverse and trusted sources to deliver accurate information can also help to reduce mistrust by underrepresented or socioeconomically disadvantaged populations. Unethical and immoral conduct toward these populations (e.g., Tuskegee Syphilis Study) has caused a ripple effect through modern times and contributes to exacerbated levels of mistrust. High levels of mistrust among diverse populations is an enormous problem that negatively impacts drug development and ultimately those same populations. In the words of the Food & Drug Administration, “Participants in clinical trials should represent the patients that will use the medical products. This is often not the case—people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products.”

Pharma should also be prepared to train the trainer, who in this case is often the healthcare provider. CISCRP’s research cited previously in this article shows that a patient’s perception of participation in clinical research is positively affected by a well-informed healthcare provider. Similarly, there is a strong belief in the importance of healthcare providers having awareness of studies being conducted in the community. Unfortunately, there is a gap between belief and practice. Many individuals report that clinical trials are rarely a treatment option when speaking with their healthcare provider. This supports the idea that simply providing information to healthcare providers may not inherently translate to educating the patient. It’s important that pharma does more than educate healthcare providers before walking away. Not all healthcare providers will be equipped with the skills to know when and how to bring this topic up with patients. In instances where this skill gap is observed, coaching and practice are needed to help turn knowledge into action. One opportunity to help with this is to create communities of healthcare providers that are focused on clinical trials. These communities could serve to raise questions to a group of fellow providers, discuss concerns from patients/potential trial participants, and provide additional resources such as FAQs, community info to support participants, quick links and more. Another opportunity is to identify “champions” for the cause. These could be healthcare providers, patient support networks, and public/private education systems that have successfully promoted clinical trial participation to their stakeholders and can speak to the value and improved health outcomes the participants have seen as a result. Bringing awareness of success stories and participant benefits can help to motivate and influence others to become champions.

Throughout the delivery of information and education is the need for personalized approaches. Personalized approaches enable the provision of learning tools that meet healthcare providers and partners where they are and in the time they have. For example, utilizing nudge learning applications to provide small pieces of information over a longer period of time could be useful in reaching a larger audience with improved receptiveness.

2. Motivating factors

Meaningful outreach and education of patients and the public on clinical research and trials cannot be solved through communication channels alone. The broad availability of information and education opportunities is not enough to guarantee successful engagement. Industry must also understand what motivates different populations to tailor effective messaging. As clinical trials become more personalized, so too should the approaches utilized to engage and educate individuals prior to a decision to enroll in a clinical trial. Altruistic behavior, financial compensation, and opportunities for clinical benefit score highly as benefits or motivating factors for participation in clinical trials. However, these motivators can vary depending on one’s demographics (e.g., age, geographic location) or health status (e.g., healthy, seeking treatment). It’s important to understand the differences among varying demographics. For instance, healthy volunteers in clinical trials are more likely to be motivated by financial compensation, while individuals seeking treatment are more likely to be motivated by potential health benefits. Pharma should work closely with their trusted industry partners (i.e., healthcare providers and patient networks) to fully understand the motivations of their target population to deliver customized and tailored information and education. Patients who decide to join a clinical trial should be engaged after participation to learn whether the benefits communicated were realized. Similarly, patients who chose not to participate should also be engaged to understand if an alternative communication of benefit could have impacted their decision.

3. Converting knowledge to action

Improved public knowledge of clinical research and an understanding of motivations are only part of the larger objective of normalizing participation in clinical trials. True progress toward this objective will only be realized after converting individual knowledge into action – in other words, deliberate decisions to participate in clinical trials. Delivering information and education from trusted sources as well as appealing to individual motivations are two immediately achievable steps for the pharma industry to pursue. But, to maximize the conversion of individual knowledge into action, industry should also consider the role that other predictors of health behavior play. These include “cognitions (e.g., knowledge and beliefs, self-efficacy, and outcome expectancies), affect (e.g., depression), skills (e.g., contraceptive skills), … and intentions.” With a view to the more distant future, pharma should also consider ways to normalize participation of younger populations in clinical research. Involving young and healthy populations in clinical trials of today may result in repeat participation in the future. This idea is supported by research from CISCRP, which found that individuals “who have participated in a clinical trial in the past are much more willing to participate in general compared to those who have never participated in a study.”

More specifically, over 93% of respondents who previously participated in a trial indicated their willingness to participate in another study in the future. This data further supports the importance of converting knowledge into participation, since participation can be defined as more than a single point in time. Understanding the reason for repeat participation should be a routine practice. One method for doing this is to set up focus groups with first time participants to learn what about their experience would or would not lead to repeated participation.

The opportunity to better educate, motivate, and engage patients and the public on the topic of clinical research is right in front of us. Pharma would be remiss not to act in the wake of its improving image during COVID-19, and failing to do so could have large ramifications on the development of the next generation of medicines. Short-term action should include improved collaboration with trusted industry peers as well as an increased focus on training those groups to deliver effective information and education. It should also include a greater assessment of the motivating factors for participating in clinical research so that the information and education delivered resonate at a personal level. Done together, these efforts will help to better convert knowledge into action, setting up a future where the younger generations of today are life-long contributors to clinical research.