It’s time for the evolution of informed consent.
“There were about five pages which were full of medical jargon... which I frankly couldn’t understand. It was a doctor talking to a doctor, not a doctor talking to a patient.”
—Clinical trial participant
The purpose of informed consent is to help participants make an educated decision about whether they take part, or stay in, a clinical trial. The key word is educated, because being informed is not the same as being educated. However, informed consent as it stands now is not educating participants but overwhelming them. The industry sees it, sponsors recognize it, and sites, participants, and care partners experience it firsthand. Now is the time for a critical evolution of informed consent to what we call Educated Consent.
A shift to Educated Consent™
There is a tremendous need to help participants and their care partners better understand clinical trials and the process of participating in one. They may need assistance in navigating through topics such as eligibility, tests and assessments, the expectations and obligations associated with participation, and how to take the study drug, among other challenges. Subjects like these can be daunting in the best of times, let alone when someone may be dealing with a health concern. That’s why a change in perspective is needed—from informed consent to Educated Consent. Information is passive, whereas education is active and engages the participant. Indeed, education builds the confidence, skills, and knowledge that enable thoughtful decision making and, ultimately, more successful recruitment, retention, and compliance outcomes.
In a 2023 survey assessing attitudes and beliefs about clinical trials among various populations, almost half of respondents said that supportive education is the most important factor for their participation in a clinical trial [1].
Overcoming clinical trial obstacles with education
There’s no question that taking part in a clinical trial requires a significant commitment from participants and their care partners, but Educated Consent is a way to make the process easier. That’s because education delivered at pivotal moments along the journey can help alleviate some of the most common challenges that impact clinical trials. These challenges include the following:
Limited health literacy
Only 12% of Americans are considered to be health literate, a problem that becomes particularly challenging in recruitment and retention. For example, according to an analysis of informed consent forms typically used for clinical trial research, the average reading level required to understand these forms is tenth grade, two grades higher than the recommended eighth-grade reading level [2,3].
Educated Consent seamlessly integrates health literacy and educational design, facilitating understanding, meeting participants and care partners where they are, and enabling action.
Mistrust and misunderstanding of clinical trials
Surveys show that more work needs to be done to increase public knowledge and trust in clinical trial research, a task that may be accomplished with educational tools.
More than 90% of respondents in the Health Information National Trends Survey report little or no knowledge about clinical trials [5]
According to the Pew Research Center, 61% of Black adults say that research misconduct is just as likely to occur now as in the past [6]
Recruiting and retaining participants
Recruitment and retention are established challenges that can significantly impact the success and validity of clinical trials. Strategies that address these issues, such as ongoing, health-literate communication that considers the needs of the target population, are crucial.
Globally, more than 80% of clinical trials fail to enroll on time because of problems with recruitment and retention [7]
Dropout rates in phase 3 trials can be more than 30% [8]
Site staff training and satisfaction
Clinical trial site staff can feel as though they are fighting an uphill battle as they struggle with financial pressures, a lack of needed resources and tools, and staff shortages and turnover.
The turnover rate among participant-facing clinical research professionals ranges from 35% to 61%. [9]
Participants in clinical trials may often be impacted by the ripple effect from these unexpected challenges.
In a 2023 study, only 48% of participants reported feeling “very appreciated” during their trial, whereas 52% reported feeling either “somewhat appreciated,” “not very appreciated,” or “not at all appreciated.” [10]
Leverage the power of Educated Consent
We know the vital importance of clinical trials for emerging new treatments and the hope they hold for participants and care partners alike. We also know that education is a powerful tool to leverage—one that can help your clinical trial run more smoothly, efficiently, and effectively for everyone involved. The critical factor is understanding how to develop and execute solutions and materials that go beyond just informing to engaging and educating. This is the difference that can make a tremendous impact on your study data.
To learn more about the evolution of Educated Consent or our expertise in health education, educational design, and health literacy principles, contact Noelle Limburg at NLimburg@Artcrafthealth.com, or set up time for a conversation that works for you. We look forward to sharing more about how to make the powerful shift from informing to educating.
References
1. Center for Information and Study on Clinical Research Participation. 2023 CISCRP Perceptions and Insights Study: Engagement Preferences. CISCRP website. Accessed April 30, 2024. https://www.ciscrp.org/wp-content/uploads/2023/11/2023PI_Engagement-Preferences.pdf
2. America’s Health Literacy: Why We Need Accessible Health Information. US Department of Health and Human Services website. Accessed April 5, 2024.
3. Hadden KB, Prince LY, Moore TD, James LP, Holland JR, Trudeau CR. Improving readability of informed consents for research at an academic medical institution. J Clin Transl Sci. 2017;1(6):361-365. doi:10.1017/cts.2017.312
4. Grant SC. Informed consent—we can and should do better. JAMA Netw Open. 2021;4(4):e2110848. doi:10.1001/jamanetworkopen.2021.10848
5. Occa A, Merritt AS, Leip A, Stapleton JL. What influences trust in and understanding of clinical trials? An analysis of information and communication technology use and online health behavior from the Health Information National Trends Survey. Clin Trials. 2024;21(1):95-113. doi:10.1177/17407745231204813
6. Funk C. Black Americans’ views of and engagement with science. Pew Research Center website. Published April 7, 2022. Accessed April 30, 2024. https://www.pewresearch.org/science/2022/04/07/black-americans-views-of-and-engagement-with-science/
7. Desai M. Recruitment and retention of participants in clinical studies: critical issues and challenges. Perspect Clin Res. 2020;11(2):51-53. doi:10.4103/picr.PICR_6_20
8. Alexander W. The uphill path to successful clinical trials: keeping patients enrolled. P T. 2013;38(4):225-227.
9. Freel SA, Snyder DC, Bastarache K, et al. Now is the time to fix the clinical research workforce crisis. Clin Trials. 2023;20(5):457-462. doi:10.1177/17407745231177885
10. Center for Information and Study on Clinical Research Participation. 2023 CISCRP Perceptions and Insights Study: Participation Experiences. CISCRP website. Accessed April 30, 2024. https://www.ciscrp.org/wp-content/uploads/2023/11/2023PI_Participation-Experiences.pdf