NIH Clinical Research Trials and You
The Need for Awareness of Clinical Research
Clinical research should be seen as the social good that it is. The first step in tackling this challenge is regularly getting the public to think about participating in clinical research. People need to consider how they can help advance the prevention, diagnosis, and treatment of disease. It is never too early to consider participation whether or not someone ultimately chooses to join a study.
The ethics of promoting greater awareness of clinical research must be considered carefully. The focus of any awareness campaign should be to advocate for consideration of participation, rather than to encourage participation. Providing resources to help individuals make informed decisions about research involvement promotes understanding of the true benefits and risks of participation. It also increases awareness about the importance of clinical research. (Alvins, 2007)
The Role of the National Institutes of Health
Clinical research is vital to the National Institutes of Health (NIH) mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. For instance, through clinical research we gain insights and answers about the safety and effectiveness of drugs and other therapies. Groundbreaking scientific advances in the present and the past were possible only because of the participation of clinical research volunteers, both healthy and ill. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As NIH-supported clinical research opens new doors to advancing prevention, treatments, and cures for disease and disability, clinical trial volunteer participants are essential to this progress.
How Awareness Helps
Several studies indicate that awareness changes attitudes toward clinical trials, enrollment, and the benefits of participation. (Harris Interactive Survey, 2001)
- 85% of patients were either unaware or unsure that participation in a clinical trial was an option at the time of diagnosis.
- 75% of these patients said they would have been willing to enroll had they known it was possible.
When given information about clinical research, survey respondents affirmed its importance:
- 32% of American adults indicate they would be very willing to participate in a (cancer) clinical trial if asked.
- 28% indicated they would consider it, but hold some reservations. (Comis, 2003)
- Focus groups with the public and caregivers found that many lacked familiarity with clinical trials and were unaware of opportunities for participation by healthy volunteers. They generally expressed negative attitudes about participation. These attitudes significantly changed after learning more about clinical trials. (NIH CRA Focus Groups, 2011)
Learning About and Participating in Clinical Research
In two separate studies, the Internet and general media were identified as the primary sources for learning about clinical trials (ACRP, 2009; Taylor, 2004). Those who participated in clinical research increasingly cited the “information [they] read, saw, or had heard” about the study as being a major influence on their decision to participate (28% in 2001 versus 41% in 2004). (Taylor, 2004)
Health care providers play an important role in raising awareness about the option of clinical trial participation. By having a focused conversation about treatment options including clinical trials, a patient can be made aware of, and invited to enroll in a clinical research study.
- 77% of patients who participate in a trial learned about it from their health care provider.
- 32% of patients who participated in clinical trials reported that their health care providers took the time to explain the trial clearly
- In a 2005 survey of nearly 2,000 cancer patients, 73% of those who joined a clinical trial said they did so because of their health care provider’s awareness of clinical trials.
- Participating patients were more likely to have first learned about clinical trials through a doctor, have had a doctor explain the pros and cons of participation, and found an appropriate trial with the help of their health care provider. (Comis, 2009)
Alvins A, Goldberg H. Creating a culture of research. Contemp Clin Trials. 2007; Jul 28(4); 557-62.
Association of Clinical Research Professionals (ACRP). (2009, April). CenterWatch 2008 National Survey of Study Volunteer Experiences. Paper presented at the ACRP 2009 Global Conference and Exhibition.
Comis R, Miller J, Aldige C, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003; March; 21(5); 830-35.
Comis R, Aldige C, Stovall E, Krebs L, Risher P, Taylor H. (2000). A quantitative survey of public attitudes towards cancer clinical trials. Coalition of National Cancer Cooperative Groups, Cancer Research Foundation of America, Cancer Leadership Council and Oncology Nursing Society. Available at: www.cancertrialshelp.org/CTHpdf/308-9.pdf and www.cancertrialshelp.org/CTHpdf/1226-9.pdf
Comis R, Miller J, Colaizzi D, Kimmel L. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. J Oncol Pract. 2009 Mar;5(2):50-6.
Harris Interactive. 2001. Misconceptions and lack of awareness greatly reduce recruitment for cancer clinical trials. Health Care News 1(3). Accessed at www.harrisinteractive.com/news/newsletters/healthnews/
Pretesting NIH clinical trial awareness messages: A focus study with patients, caregivers, and the general public. Bethesda, MD: National Institutes of Health, April, 2011.
Taylor, H. (Ed.). Public awareness of clinical trials increases: New survey suggests those conducting trials are doing a better job of informing potential participant of opportunities. Health Care News. 2004; June 4(11).