Public Perceptions are Turning the Corner

Given the many—largely upsetting and disturbing—global events that have unfolded within and outside the clinical research enterprise during the month of April 2013, we could all use some uplifting news. The results of a recent global survey conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) may help. The survey, conducted among nearly 6,000 respondents worldwide, shows very promising and positive movement in public attitudes and perceptions about clinical research.

First a word about the international survey: CISCRP developed the survey instrument to gather both general public attitudes and perceptions about clinical research and also patient attitudes and experiences participating in clinical trials. Many of the questions in the survey were included in part to update the results of public polls last conducted five to seven years ago. The survey was conducted online among a global community of health information seekers. In total, 5,701 respondents—58% women and 42% men—from 19 countries completed the survey.

Growing trust

During the period 1997 to 2007, the media widely publicized tragic study volunteer reactions to investigational treatments that resulted in serious harm and death. Research sponsors and investigators were charged and found guilty of data falsification and failures to disclose important safety information. Drugs were withdrawn due to poor safety profiles; physicians were indicted for failure to disclose conflicts of interest; research sponsors, contract research organizations, and investigative sites were accused and found guilty of clinical trial mismanagement and failure to protect the safety of study volunteers.

At the height of this crisis, many may recall a 2007 public poll conducted by the Kaiser Family Foundation showing that the public had a strongly unfavorable view of pharmaceutical and biotechnology companies. In that survey, 27% of respondents said that they don't trust pharmaceutical and biotechnology companies to offer reliable information about drug side effects and safety. And 45% said that they don't trust research sponsors to inform the public quickly when safety concerns about a drug are uncovered. In the recent 2013 CISCRP survey, only 19% of Americans said that they don't trust companies to offer reliable information and 28% said that they don't trust sponsor companies to inform them quickly about safety concerns.

A much higher percentage of the public now considers clinical trials to be relatively safe. In a survey conducted by CISCRP in 2006 among 1,000 US adults, only 14% of respondents reported that they consider clinical trials "very safe," down three percentage points from a survey conducted two years earlier. This most recent 2013 survey shows a strong rebound: more than one-third (36%) of respondents now believe that clinical trials are "very safe."

Numerous initiatives may be playing an important role in helping to change public trust and perceptions with regards to clinical research safety. Efforts on the part of sponsor companies, the Food and Drug Administration and the European Medicines Agency to improve transparency and the disclosure of clinical trial results have likely contributed. Academic institution and federal requirements for professionals to disclose conflicts of interest and payments from sponsor companies have helped assuage public concerns. Clinical research professional commitment to quality and patient safety has also been a critical factor.

Print-based—and to a larger degree—online discussions across a broadening collective of digital and social media communities are likely also playing a role in raising awareness of safety issues and the many motivations of clinical research professionals. To this end, CISCRP has been very actively educating and informing the public during the past seven years both offline and online. Proactive media interactions, articles in the popular press, presentations and webinars, and the active monitoring of social media community discussions are examples of the many outreach initiatives that CISCRP supports to better inform the public. Since 2004, health providers and investigative sites have also distributed nearly one million copies of CISCRP's educational books, DVDs, and brochures worldwide.

I'd like to believe that CISCRP's clinical research education days—AWARE for All events—have also contributed. AWARE events have been held in cities throughout the United States and they are beginning to take root in Europe. These live events bring together health officials, providers, research professionals, patients, and the public to learn about clinical research and to put a face on the local research professional community. Since 2005, CISCRP has held 30 live and web-based events reaching a total of 429,000 households across the United States.

Elevated view of volunteers

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

In a 2005 HarrisInteractive poll, four out of five respondents agreed that volunteers are taking a gamble with their health when they participate in clinical trials. In the 2013 CISCRP survey, only 24% of respondents agree that research volunteers are gambling with their health. In that same HarrisInteractive survey, 46% of respondents said that they consider study volunteers to be "experimental test subjects, not people." In the 2013 CISCRP survey, 35% of respondents agreed with that statement. And in a 2006 CISCRP survey, 34% of Americans said that they "do not admire" people who volunteer for clinical trials. In the 2013 survey, only 16% did so.

It has been hard to inform the public about study volunteers and why they should receive our deepest appreciation. It rarely occurs to the lay public that thousands of volunteers have given the gift of their participation in order for a given medical therapy to enter the marketplace. Clinical research is rarely discussed by the lay public and it is rarely discussed by healthcare providers except as a last resort when a patient has been diagnosed with an illness for which no available treatment exists or for which available treatments are unpleasant, unsafe, and ineffective.

Historically, patient recruitment advertisements have been the primary messages reaching the public regularly. These ads contain virtually no general educational content. They are designed to target and recruit patients for specific studies and, as a result, they are not relevant to the public. Rather, patient recruitment messages are met with a large amount of indifference since the public has no context within which to understand the importance of, and the courageous act behind, participation.

During the past five years, however, broader public exposure to study volunteers in the mass media and in social media communities including Facebook and YouTube has helped to give study volunteers far greater visibility. Interactive discussions and ever-farther-reaching connectivity online is helping to give study volunteers greater presence and identity. CISCRP's Medical Heroes campaign and outreach efforts to amplify and elevate study volunteers may also be playing a key role.

A central objective of CISCRP's outreach efforts during the past 10 years has been to engender higher levels of public appreciation for the gift that study volunteers give to advancing public health. CISCRP's Medical Heroes program—discussed in several Applied Clinical Trials articles over the past five years—is perhaps the most widely recognized initiative in CISCRP's arsenal to meet this objective. The campaign portrays medical heroes in everyday situations to illustrate the point that the brave individuals who give the gift of clinical research participation are all around us.

Since launching the campaign, nearly 200 organizations—patient advocacy groups, investigative sites, government agencies, pharmaceutical, biotechnology, and CRO companies—have used Medical Heroes educational materials including posters and public service announcements. Several sponsors have reported that when the Medical Heroes campaign has been run concurrently with patient recruitment advertisements, monthly enrollment rates have improved by as much as 30% to 40% compared with markets in which only patient recruitment ads were aired.

An ongoing movement

The results of the new 2013 CISCRP international survey of the public and patients provide welcome and uplifting news as well as new insights into areas where the clinical research enterprise is making progress in improving public and patient attitudes and experiences and where it is falling short. We must regularly monitor, assess, and respond to changing attitudes, perceptions, motivations and experiences of patients and the public. The long-term viability and success of the clinical research enterprise depends on it.

I would like to thank 14 pharmaceutical and biotechnology companies as well as Acurian for providing funding and assistance on this important 2013 global survey. If you would like to receive information about the full survey results as well as detailed subgroup analyses by region, age group, gender, and participation experience, please send me an e-mail.

Kenneth A. Getz MBA, is the Director of Sponsored Research at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, e-mail: [email protected]