Getting to the Heart of Public Distrust

National and international public opinion polls document that public confidence and trust in the clinical research enterprise has eroded steadily during the past decade. But despite widely publicized controversies that have damaged the public's trust and confidence in the credibility of stakeholders in the clinical research enterprise, their desire for better health and well-being has not diminished. The public has demonstrated remarkable tolerance for mistakes. As such, there is a unique but closing window of opportunity for the clinical research community to build on this foundation to restore public confidence and trust.

Kenneth A. Getz

Belief in the need

A number of polls indicate consistently that general public support for medical and health research remains strong and has not changed significantly during the past decade. Two HarrisInteractive polls, conducted between two and five years ago among more than 1000 American adults, found that eight out of 10 people believe it is "very important" to "essential" that all new drugs and treatments are tested on human beings in clinical trials before they are approved for general use.

A 2004 poll conducted among 1000 Americans by Research!America, a lobbying group representing academic institutions and foundations, found that 94% believe that medical research is important for the economy and 68% perceive clinical research as having great value for public health. Polls conducted in Western Europe show similar levels of positive attitudes about clinical research among the public. In a 2004 survey among 225 Europeans, 90% considered clinical trials important and 60% acknowledged that clinical research plays an important role in advancing public health. This survey and those sponsored by Research!America were conducted largely among adults who have never participated in clinical trials.

Research community distrust

Although the public clearly holds positive attitudes about the general importance of clinical research, they distrust professionals who oversee, manage, and support that research. The public also distrusts organizations responsible for ensuring patient safety and the patients who are willing to associate with clinical research professionals. Consider the following:

• In national polls conducted in 2006 among 1000 U.S. adults, only 14% of respondents said that they consider clinical trials "very safe," and 48% consider clinical trials "somewhat safe" (CISCRP).

• A 2007 poll found that 27% of U.S. adults don't trust the Food and Drug Administration and only 31% believe that the FDA is effective at ensuring safety (HarrisInteractive).

• Nearly half of Americans (46%) say they don't trust Capital Hill officials who govern regulatory oversight and drug development processes (HarrisInteractive).

• Four out of 10 Americans (42%) don't trust pharmaceutical and biotechnology companies and feel that they have failed to serve consumer interests (HarrisInteractive).

• A January 2008 survey found that nearly half of American adults (45%) don't trust research sponsors to inform the public quickly when safety concerns about a drug are uncovered (Kaiser Family Foundation).

• Half of white respondents (49%) and 73% of minority respondents reported that it is "very likely" or "somewhat likely" that they might be used as guinea pigs without their consent. And more than one out of four minority respondents (25%) and 22% of white respondents believe that their doctors would expose them to unnecessary risk in clinical trials (Braunstein et al., Medicine, 87 (1) 2008).

• One out of four American adults believes that doctors and study staff are primarily motivated to recruit volunteers for money and selfish interests (HarrisInteractive, 2002).

Public distrust in clinical research professionals has tainted the public's view of clinical research volunteers. National and international polls both show that a large percentage of the public considers research subjects to be risk takers, motivated to find clinical trials because they are either greedy or desperately ill.

For example, eight out of 10 Americans believe that study volunteers are taking a gamble with their health, according to a 2002 HarrisInteractive poll. A 2006 survey conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) among 900 U.S. adults found that one out of four believes people choose to participate in clinical research because they are "very sick without any other options" or they are "looking to make money." In that same survey, 34% of Americans said that they "do not admire" people who volunteer for clinical trials.

Poor public trust and confidence, along with low awareness, has diminished appreciation for the gift that participation plays in helping to advance medical knowledge and improve public health.

Drivers of distrust

There is wide agreement that numerous factors have contributed to the erosion of public trust and confidence in clinical research.

During the past 10 years, the media has well publicized tragic study volunteer reactions to investigational treatments that have resulted in serious harm and death. Research sponsors and investigators have been charged and found guilty of data falsification and failure to disclose important safety information. Drugs have been withdrawn from the market due to poor safety profiles. Physicians have been indicted for failure to disclose conflicts-of-interest. Research sponsors, contract research organizations, and investigative sites have been accused and found guilty of clinical trial mismanagement and failure to protect volunteer safety.

In addition, human subject protection programs have been charged and suspended for failing to provide adequate oversight. Pharmaceutical and biotechnology companies have been publicly challenged for submitting fraudulent safety data and manipulating study results in new drug and biologics applications. And the FDA has been charged with lax oversight, operating under capacity, entering into "cozy" relationships with industry, and accepting incomplete and fraudulent safety and efficacy data.

The point is, no stakeholder group has been free from indictment. And, to date, no stakeholder group has responded adequately.

Mums the word

At the same time that clinical research is being depicted in the media in such a negative light, the public has received little to no educational information to counterbalance public concerns and perceived risks. The public generally hears from the clinical research enterprise on two occasions: when a clinical trial is actively enrolling study volunteers, and when a new medical intervention has performed well and is about to be launched. But historically, the public has rarely received general information about clinical research and the mechanisms in place to oversee its performance, quality, and safety.

Although the public is the most trusting of information from health care providers, medical and health professionals are largely absent from educating the public and prospective volunteer communities about clinical research. Only one out of seven Americans are exposed to information about clinical studies from their primary or specialty care physician and only one out of eight Europeans learn about clinical trials from their physicians.

Reform and outreach

Regulatory agencies and the clinical research community have responded to public confusion and distrust by implementing reforms designed to assure higher levels of compliance and reduce errors that might result in physical and ethical harm to clinical trial volunteers.

Since 2001, a growing number of universities have established clinical research degree programs. European and American regulatory agencies have implemented new privacy and conflict-of-interest disclosure guidelines along with new clinical trial registration requirements. Several trade associations have developed investigator certification programs. The National Institutes of Health (NIH) and private sector research sponsors have launched Web-based registries of clinical trial listings and results.

These reforms and measures are an important step in ensuring the credibility of clinical research professionals. But they have not been well communicated to the public.

Outreach and education are also critically needed to engage the public as partners in, and beneficiaries of, clinical research. These initiatives must be comprehensive in scope. CISCRP, an independent nonprofit organization, has been at the forefront of developing and implementing public education and outreach initiatives during the past several years. The impact of these initiatives is only beginning to improve public awareness, understanding, and trust. These initiatives are described in detail on the organization's Web site at www.ciscrp.org.

Despite low levels of trust and confidence today, there is no evidence to suggest that the public will abandon the clinical research enterprise outright. This foundation of general support exists to rebuild confidence and trust through both training and education of clinical research professionals and through public education and outreach.

The clinical research community has no time to lose in consistently supporting efforts—with resources and funding—that strike at the heart of public distrust.

Kenneth A. Getz MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, email: kenneth.getz@tufts.edu