Lack of Basic Knowledge on Clinical Trials Makes Study Recruitment Harder
When people are deciding whether to participate in a study, most consider the possible risks, the amount of time involved, and possible compensation. How much they know about trials also comes into play.
Aisha T. Langford, PhD, MPH, studies reasons why people choose to participate in clinical trials, and was interested in exploring general knowledge of trials among U.S. adults. Using the National Cancer Institute Health Information National Trends Survey data, Langford and colleagues analyzed 2,648 responses on clinical trial knowledge.1
More than one-third (37.4%) of respondents said they “don’t know anything” about clinical trials. Most (62.6%) knew either “a little bit” or “a lot” about clinical trials. The study team only evaluated self-reported knowledge on trials, as opposed to the ability to gauge understanding of the purpose of informed consent or the phases of clinical trials.
Based on the responses, “several factors affect knowledge of clinical trials,” Langford says. Respondents with a history of cancer and those who have heard of ClinicalTrials.gov knew more about trials. Such knowledge also was more abundant among college graduates and those who had been asked to participate in a trial.
Participants were asked if they had used a computer, smartphone, or other electronic means to look for health information for themselves in the last 12 months. Those who did so knew more about clinical trials. “This finding is consistent with general calls to make information about clinical trials more accessible on the internet vs. relying mainly on in-clinic conversations about clinical trials,” says Langford, assistant professor of population health and co-director of CTSI Recruitment and Retention Core at NYU Grossman School of Medicine.
Lacking basic knowledge of how clinical trials work can impede study participation. “We have a large oncology clinical research unit in our center. We felt it would be interesting to see what will help motivate participation in a trial amongst our patients,” says Ravit Geva, MD, deputy director of the division of oncology at Tel Aviv Sourasky Medical Center in Israel.
Geva and colleagues surveyed 200 patients receiving cancer treatment to evaluate their attitude toward clinical trials and gauge their basic knowledge of how clinical trials work.2 People with sufficient basic knowledge of clinical trials were significantly more likely to participate in research.
“Knowledge is known to reduce concerns in many aspects in life. As we described in our study, this applies also to clinical trials,” Geva explains.
Patients who knew more about the aim of a clinical trial, and how the trial was conducted, were less afraid of participating in one. Geva says these findings underscore the duty of researchers to inform patients on what a clinical trial is and its importance.
“This will reduce misconceptions, such as the patient is a ‘lab rat,’ and explain that patients are actively treated under strict ethical and medical guidelines,” Geva says.
People with deep-seated distrust of research probably will not agree to participate. “Most people who sign informed consent are eager to participate — or at least are not distrustful. But there are some elements of distrust that can come up,” says Mary McDermott, MD, professor of medicine at the Northwestern University Feinberg School of Medicine.
Occasionally, research participants develop adverse effects on therapies, which could be either a placebo or an active drug. Naturally, these patients are going to ask questions. It is rarer for an enrolled participant to express second thoughts about signing up for research, but it does happen. In those cases, McDermott, as the principal investigator, typically speaks to the participant and reminds him or her it is their prerogative to not participate in any parts of the research they distrust.
In some cases, someone signs up for research willingly, but a family member objects. In those cases, with the participant’s permission, McDermott offers to speak directly with the family member about their concerns.
“Investigators can dispel distrust by being open, transparent, and honest — and by being available to address questions and concerns,” McDermott observes.
Some people assume clinical trials must be safe simply because their healthcare provider is offering the option. Others believe trials always are unsafe for participants. “The truth is more nuanced and somewhere in between,” says Tricia Teoh, MD, MPH, IRB medical chair at WCG IRB.
Potential risks and benefits of any trial are based on scientific knowledge to date, but ultimately are unknown. “If there are misunderstandings or misconceptions, the ethical concerns are that people are not giving a fully informed consent,” Teoh explains.
Researchers may find it difficult to recruit participants who have no concept of how trials are designed. Trust in the study investigator may be broken if it turns out there is no clinical benefit when the participant expected this, or if something unexpected happens during the study.
“The informed consent process should start with study investigators finding out how much people know about clinical trials,” Teoh says.
Investigators could start with an open-ended question such as: “I think there is a clinical trial you may be interested in. Can you tell me what you know or have heard about clinical trials?”
“This gives investigators and potential participants a common foundation before discussing details of a specific clinical trial,” Teoh concludes.
- Langford AT, Orellana KT, Buderer N. Correlates of knowledge of clinical trials among U.S. adults: Findings from the 2020 Health Information National Trends Survey. Contemp Clin Trials 2022;114:106676.
- Asher N, Raphael A, Wolf I, et al. Oncologic patients’ misconceptions may impede enrollment into clinical trials: A cross-sectional study. BMC Med Res Methodol 2022;22:5.
Survey respondents with a history of cancer and those who have heard of ClinicalTrials.gov knew more about trials. Such knowledge also was more abundant among college graduates and those who had been asked to participate in a trial.
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