Patients Drive Progress—The Need to Improve Patient Participation in Clinical Trials

Clinical trials investigate new ways to prevent, detect, or treat disease. What might the value of a new drug or combination of drugs, a new surgical procedure or device, or a new way to use existing treatments be? Is the new drug, procedure, or device safe? For chronic illness—does the treatment improve patient quality of life? Answers are needed for current and future patients.^1,2

Disease can affect anyone, but not necessarily in the same way. Therefore, it is important to have people of all races, ages, genders, and backgrounds participate in trials so that information becomes available for all diseases and for all types of individuals.²

It is, therefore, obvious that patient participation in clinical trials is imperative to the advancement of medical science. By participating in a trial, the patient may help himself or herself, but he or she is also helping others who may benefit from these findings.² The problem is that the percentage of people who participate in clinical trials remains incredibly low and recruitment is fraught with challenges.^3,4 A recent national public opinion poll conducted by Research America found that 72% of Americans say they would likely participate in a clinical trial if recommended by their doctor, but only 22% say a doctor or other health care professional has ever talked to them about medical research.³ It seems that the advancement of medical science is not enough to drive the expected and desired response from patients.

Problems cannot be properly addressed unless the root causes are understood. So why don’t more individuals participate in clinical trials? Further questioning in the poll revealed that people had a litany of reasons for not taking part. The list includes: lack of awareness of trial availability (53%), lack of trust (53%), concerns regarding adverse effects (51%), fear of adverse health outcomes (44%), little or no monetary compensation (35%), concerns regarding privacy (27%), and worries that trial participation will take too much time (27%).³ Other surveys found additional barriers that include patients’ perception of the cost of trial participation, distaste for random assignment, and the time that it takes to participate.⁴ Another report noted that distrust in researchers and complexity and stringency of the protocol were disincentives.⁵ One key finding of such studies simply stated that patients undervalue the importance of clinical trials in developing new drugs and other therapies.³

If patients don’t participate, trials cost more and take longer. Research progress slows down, delaying the availability of results in clinical practice. And if the targeted sample size in a clinical trial is not achieved, the trial will have less statistical power to convincingly support potentially important results, which might make the results less useful, or not at all applicable in clinical practice—it will, therefore, not improve practice and will waste the contribution of participants who already participated.⁵ In the long run, none of this is good for patients. If more patients would enroll in clinical trials, more treatments would become available to patients sooner. Now that we have a better understanding of the problem, let’s discuss what is needed to correct it.

Physicians, patient advocates, and members in industry, academia, and government must work together to encourage people to participate in clinical research that may afford real medical benefit to them, and pulling on the altruistic cord might generate knowledge about new treatments that could save the lives of others.³ The health care community has a responsibility to educate the public about clinical trials and let them know that their participation really matters. That charge includes^3,6:

(1) Reaffirm the quality of the research being conducted

(2) Explaining how the trial outcomes could potentially help their health and/or the health of others

(3) Reassuring patients regarding their privacy and the confidentiality of their results

(4) Ensuring that participants fully understand the risks and benefits of participating and addressing any and all concerns they may have.

Advancements in medicine are a rational desire. If not now, when?

References

1. National Institutes of Health (NIH). Why should I participate in a clinical trial? – NIH Clinical Research Trials and You. http://www.nih.gov/health/clinicaltrials/whyparticipate.htm. Accessed August 28, 2013.
2. American Society of Hematology. Clinical trials. http://www.hematology.org/Patients/5239.aspx. Accessed August 28, 2013.
3. New national public opinion poll shows majority of Americans would participate in clinical trials if recommended by their doctor. Research America website. http://www.researchamerica.org/2013clinicaltrialspoll. Accessed August 27, 2013.
4. Weckstein
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   DJ, Thomas CA, Emery IF, et al. Assessment of perceived cost to the patient and other barriers to clinical trial participation. J Oncol Pract. 2011;7(5):330-333.

5. Rengerink KO, Opmeer BC, Logtenberg SLM. Improving Participation of patients in Clinical Trials–rationale and design of IMPACT. BMC Med Res Methodol. 2010;10:85.
6. Stryker JE, Wray RJ, Emmons KM, Winer E, Demetri G. Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret. Patient Educ Couns. 2006;63(1-2):104-109.