The clinical trials industry has been at the center of public scrutiny following recent news reports of unethical patient recruitment and manipulated trial results. Are these well-publicized stories causing doctors and patients to shy away from experimental treatment? What are the key factors that drive physicians to refer patients into clinical trials and what are patients’ biggest concerns?

To gain a better understanding of the psychology of the clinical trials patient and referring physician, CenterWatch conducted a series of in-depth doctor and patient surveys. The results and related observations, which were presented this June at the Drug Information Association Annual Meeting, are outlined in this CenterWatch Research Brief...

Key Findings

• Convenience in the form of flexible hours – not safety – was the number one concern of patients participating in clinical trials.
• Ninety two percent of clinical trials participants rated their experiences as either good or very good. Ninety one percent said they would participate in a trial again; and 87 percent said they’d recommend that a family member or friend participate in a clinical study.
• The top factors influencing patient involvement with clinical trials were the goals to find a better treatment and to advance science.
• Sixty percent of physicians surveyed have referred patients to clinical trials. Those that have not referred patients into trials cite lack of information about treatments as the number one hindrance to participation. Just 7 percent of physicians said they feared losing the patient.
• The most common therapeutic areas receiving doctor referral were cardiology (10 percent), oncology (10 percent), and psychology (7 percent).

Method

Data for this Research Brief were aggregated from a fall 2005 survey of 7,352 physicians and a winter 2006 survey of 749 clinical trials volunteers. All results have undergone statistical testing, and all comparisons are significant at the 90-percent confidence level, unless otherwise noted.

Observations and Conclusions

Top Patient Concerns

Given the gravity of many clinical trials scenarios it may be surprising to see that the foremost concern among patients participating in trials was convenience. Specifically, 54 percent of survey respondents cited flexible hours as their number one concern upon entering the trial.

The risk level involved with the procedures also ranked high with 46 percent of respondents voicing concerns about risk and invasiveness of the procedure and another 46 percent showing concern about risk of side-effects. Thirty one percent were most concerned about the ability to reach the investigative site on public transportation, and 21 percent were concerned about keeping visits to a minimum. Receiving the placebo was the top concern of 29 percent of respondents.

Patient Experiences

Among the most consistent findings in the CenterWatch survey of clinical trials volunteers was the positive feedback on their experiences. When asked “would you participate in a clinical trial again?” just two percent of respondents said “no.” Moreover, a sizable majority said they would recommend the experience to a family member or friend.

Why Risk It? Factors Impacting Study Participation

Most volunteers in clinical trials seem to be motivated by a scientist’s desire to find a better cure or help advance the state of research. Comparatively few respondents said they entered a clinical trial on the advice of a doctor or family member.

The Referral Pipeline: What Influences Doctors Most

Across the board, physicians’ top concerns about referring patients into clinical trials centered on access to detailed information about the investigational drugs. Among the minority of doctors who have not referred patients into a clinical trial, a very small number cited concerns about the well-being of patients in a trial.

Therapeutic Areas Seeing Most Clinical Trials Action:

A wide variety of therapeutic areas are actively generating patient referrals into clinical trials. While cardiology and oncology remain the two most common areas of focus, they have a marginal lead over other, less commonly discussed areas of clinical trial study.

Conclusion

Pragmatism Reigns Supreme in Minds of Clinical Trials Participants:

The clinical trial sits at a unique intersection between science and human emotion. While the studies themselves are conducted according to the cold logic of the scientific method, the study subjects are often participating based on hope for a cure. Still, despite the strong emotional component, both trial volunteers and referring physicians seem to enter into the clinical trial decision with a logic-based mindset.

This information is instructive to both the clinical trials and medical communities, who – given this understanding of the primary factors driving patient involvement and doctor referral – can drive initiatives that support easy access to treatment for volunteers and transparency about investigational drugs for physicians. It is also compelling to note that, despite the great deal of scrutiny being paid to clinical trials, very few physicians or volunteers seem deterred or even concerned about the potential for harmful outcomes. What’s more, both sides of the doctor/patient equation seem to be having very positive experiences with clinical trials.

You can download the .pdf version of this survey brief.