Reach Out to the People

In recent years, the public's perception of the clinical research industry has eroded to an all-time low. Media coverage of study mishaps combined with the rising cost of prescription drugs have contributed to the growing mistrust between the public and industry.

A survey conducted by the Kaiser Family Foundation back in 1997 found that 79% of individuals felt drug companies did a "good job" of serving the public. The same survey conducted in 2004 found that a majority of Americans felt for the first time that drug companies did a "bad job" of serving their customers.¹ This change demonstrates that the clinical research industry needs to re-establish its credibility to regain public confidence.

Clinicians as educators

Clinical research is a fundamental process that is necessary to bring safe and effective new drugs to the market for public use. Surveys show that 83% of individuals agree that it is either "essential" or "very important" to test new drugs on humans before they are approved for general use.

Although the majority of respondents strongly believe that clinical trials are valuable, only 32% feel that participants receive good medical care, and only 13% believe that participants will not suffer more pain or side effects than if they received standard treatment. In addition, only one in four people indicated they are very confident that "new treatments are tested in clinical trials only after there is good scientific evidence that the treatments are likely to be effective and safe,"² and 62% believe that pharma companies manipulate clinical data.³

The perceptions and attitudes of individuals who have participated in clinical research studies are drastically different from the general public's: 90% rate the quality of care they received during a clinical trial as "excellent,"⁴ and 84% indicate they would participate in another clinical study if given the chance.⁵ This difference in attitude between the general public and those who have actually participated in research indicates a significant gap between what the general public perceives and the positive experiences of research volunteers.

In order to regain public confidence, clinicians and industry leaders need to alter their current patterns of industry promotion and media response. They need to become more active in broad-based advocacy and outreach programs, proactively promote the clinical research industry within the health care community, and improve media relations. These changes will help educate the public about the clinical research process by giving them a more complete understanding of the quality of care subjects receive and how they can find research opportunities and information on clinical research studies for which they may be eligible.

Public perception impact

The cost of trials is rising exponentially. In 1997, it was estimated that the cost to bring a new drug to market was $800 million; costs have soared to nearly $1.5 billion today.⁶ Contributing to rising costs are the longer development timelines required to bring a new drug to market. The average clinical phase time for new biopharmaceuticals increased from less than three years in the 1980s to between six and seven years today, while total R&D spending rose from $21 billion in 1998 to more than $51 billion in 2005.^7,8,9

As mentioned, an increasing number of individuals are growing skeptical of the personal benefits and safety of clinical studies. Of the 50,000 trials taking place in the United States, 80% are delayed at least one month due to unmet enrollment projections.¹⁰ This lack of subject participation stems from a variety of sources, including negative media coverage, poor public perception, and a lack of education. Only one in four people feel that trial patients receive honest and accurate information and are not treated like "guinea pigs."¹¹

The abundance of information indicating public trust has rapidly declined in recent years helps identify why many clinical studies fail to meet enrollment projections. Robert Kelch of the University of Iowa College of Medicine credits two reasons for why this lack of trust has occurred: insufficient clinical advances compared to public expectations, and social and business trends that have changed the public's perception of health care from a social good to a purchasable commodity.

In addition, negative events publicized in the media have caused the public to question how well the industry is governed.¹² Figure 1 illustrates how public trust in clinical research has drastically declined in recent years. For example, between 1996 and 2002 over 50% of people stopped trusting clinical research information, indicating a major negative shift in the reputation of the clinical research industry. The pharmaceutical industry is now perceived as being as honest as the tobacco, oil, and used car industries.⁴

Figure 1

The media's influence

In response to rising health care costs, industry profits, and fraud, the clinical research industry has received a disproportionate amount of negative media coverage over the past decade—which is where the general public receives the majority of its information. With the exception of significant medical breakthroughs, many stories cover fraud, corruption, greed, and significant safety risks to potential patients. These media stories can play a significant role in how likely a patient is to volunteer for a clinical trial.

Recent survey results show that 79% of adults think that research participants are taking a gamble with their health and 75% think that research participants are sometimes treated as guinea pigs.¹³ Ken Getz, founder of the Center for Information and Study on Clinical Research Participation (CISCRP), indicates that sites directly involved in clinical study recruitment report that the media directly affects the attitudes of the general public and clinical research participation.¹⁴ Getz states in a recent article, "[Industry] has done little to address the media's incomplete, sensationalistic, and ill-informed portrayal" and "most journalists have little or no formal knowledge of research and they have little time to learn." In addition, sponsors rarely respond to media coverage for fear of bringing more attention to a story or appearing defensive and self-serving, which helps contribute to a one-sided view of the industry in the media.¹⁵ Thus, clinical research professionals share a portion of the responsibility for poor public perception and will continue to until they proactively promote the benefits of research participation.

In 2002, Time Magazine's cover story, "At Your Own Risk," portrayed the industry as treating study volunteers as guinea pigs.¹⁶ The article suggests the regulations in place pose a great threat to study volunteers, and institutions and sponsor companies do not have to adequately inform patients of the risks that may be involved. In one example, a research investigator at the St. John Medical Center in Tulsa, Oklahoma, hid safety issues from research participants and failed to report adverse events during a vaccine trial for malignant melanoma. However, the article does not mention the severe penalties that should accompany these actions. According to the FDA 1572 form, failure to conduct a study in accordance with 21 CFR Part 312 and report unanticipated problems involving risks to human subjects is a criminal offense.

The author also discredits the regulatory framework that governs the industry, stating, "Thanks to a patchy regulatory system, perhaps a quarter of all clinical research—including some studies on reconstructive surgery, dietary supplements, stem cells, and infertility treatments, for example—get no federal oversight whatsoever. And even where oversight is mandated, it's often applied loosely, if at all." Such statements send a message to the general public that they are not being protected, and the industry does not have an effective system in place to ensure that clinical research participation does not impose significantly greater risks than potential benefits.

Many regulations, laws, and guidelines have been implemented in response to the historical events that have compromised subject safety in the past to prevent such events from recurring in the future. Despite this, the industry still receives an abundance of negative press. Stories of misconduct, such as the death of Jesse Gelsinger in 1999, the unexpected side effects of TeGenero's Phase I biologics study that hospitalized six participants, and the withdrawal of Merck's Cox-2 inhibitor Vioxx, have dominated the headlines, adding to the public's mistrust. These events are not typical in clinical research, but the media portrays them as regular occurrences.

Literature and popular culture

In 2004, Dr. Marcia Angell attacked the pharmaceutical industry with her book, The Truth About Drug Companies: How They Deceive Us and What To Do About It. Throughout the book, Dr. Angell discusses how the pharmaceutical industry has become corrupt and tries to persuade her audience that it is deceptive and should be distrusted. She calls the FDA "the pharmaceutical industry's favorite whipping boy," as the industry manipulates its way into creating shortcuts in research at the expense of patient safety.¹⁷

Her claims suggest that the industry routinely suppresses negative results and designs trials that favor the investigational product. Dr. Angell suggests that the industry offers physicians large bounties that can total up to $12,000 per patient. In reality, the average compensation per enrolled study volunteer was $2320 in 2005,¹⁸ which typically includes reimbursement for very expensive procedures that must be performed during the course of the study and may not be reimbursed for up to six months. In fact, once investigators pay for their overhead costs, which include a research staff, benefits, facility, and equipment, only a small portion of this fee remains.

Negative coverage of the research industry has also found its way into popular culture with the release of such movies as The Constant Gardner, which tells the story of clinical research misconduct in Africa and suggests the pharmaceutical industry customarily exploits citizens of underdeveloped countries. The film fails to tell the audience clinical research is governed by an Institutional Review Board (IRB) that oversees the safety and welfare of the study participants. The severe ramifications of attempting to falsify data submitted to the FDA to obtain drug approval are also overlooked.

Connecting with the public

Inadequate education is one of the primary factors that has contributed to the lack of credibility in clinical research. The majority of the general public is unaware of the clinical research process and the safeguards the FDA has implemented to ensure subject safety. The FDA is under constant pressure to ensure that drugs are safe and effective for public use, but the public may know very little about FDA regulations, Good Clinical Practice, IRBs, and documents such as the Belmont Report and the Declaration of Helsinki, which outline a code of conduct for clinical research.

Over the past two years, the reputation of the FDA has suffered: Seven in 10 adults give the agency a negative rating, and 58% have a negative view of its ability to ensure the safety and efficacy of new drugs. The majority of individuals feel the FDA is influenced more by politics than science and does not have the ability to make independent decisions.¹⁹

Advocacy and outreach

Ken Getz suggests that broad education, outreach, and advocacy programs supported by the entire clinical research community are needed.¹⁴ In 2004, he founded CISCRP, a nonprofit organization that focuses on increasing community awareness through public service announcements, educational brochures, and an AWARE for All Clinical Research Education and Awareness Day program.

These Awareness Days have received very high marks from attendees, and a very high percentage of those attending say they would participate in clinical research studies following the program. The programs have been conducted in four cities, but the organization intends to expand this program nationwide and increase its public service announcements to help educate a larger portion of the general public.

In a 2006 edition of Newsweek, the Coalition of Cancer Cooperative Groups—sponsored by Amgen, Bristol-Myers Squibb, Pfizer, and The Leukemia & Lymphoma Society—published a special advertising section. It encouraged the public to learn about cancer clinical trials and featured Lance Armstrong. The promotion clarified many of the misconceptions people generally have about clinical trials, including placebos and the level of patient care provided. In the campaign, Armstrong offers the following testimony: "There is a big misconception out there that you will get a placebo in a cancer clinical trial. The reality is that you will receive at least the standard therapy. People need to be aware that they are not going to get a sugar pill instead of treatment."

Figure 2 shows the results of the 2005 "The Need to Know" survey, which measured participants' experiences in oncology trials. Ninety-two percent of those surveyed reported having a positive experience, while only 9% felt like a "guinea pig."²⁰

Figure 2

Promoting research in health care

In addition to the lack of public knowledge, 87% of physicians do not participate in clinical research.²⁰ Many do not have formal training in clinical research or good clinical practice and are unable to adequately inform their patients of research opportunities or appropriately respond to research inquiries.

A 2003 survey reported that only 16% of adults believe they have ever had the opportunity to participate in a research study.²² Public awareness could be drastically improved if the health care community was more aware of clinical research opportunities. Many individuals mainly rely on their physicians for their health care information. Since only a small number of eligible physicians are currently active in research, a large number of people do not realize they are eligible to participate in research studies. So in addition to expanding the advocacy and outreach programs in the general public community, the industry could also advocate research and increase awareness in the health care community.

For the public's perception of the clinical research industry to change, health care professionals must believe trial participation is a viable option for patients that can benefit them and the health care community. They must feel comfortable with the level of safety involved in trials before they can recommend participation to patients as a treatment option.

Discussion

The clinical research process is a vital component of the pharmaceutical industry, and it is imperative that clinical research professionals do their part to promote the industry, educate the public, and proactively work with the media to portray a balanced image of clinical research. By supporting CISCRP and other advocacy and outreach programs, the industry can begin to reach out to the public. The Pharmaceutical Research and Manufacturers of America can also help lead the industry in raising awareness by promoting campaigns that educate both the public and nonresearch physicians.

In addition to educational campaigns, our industry leaders need to take more proactive steps to work with the media. Rather than allowing the media to portray an uncontested, one-sided story, we must begin responding to media inquiries and promoting the benefits of the clinical research process.

Opportunities also exist for the research and development community to become involved in helping shape the reputation of the clinical research industry. Research coordinators, clinical research associates, project managers, and others who have intricate roles in clinical research know first-hand the benefits of clinical research participation. As representatives of the R&D community, they can promote clinical research by communicating its benefits, providing resources for more information, and responding to common questions and misconceptions many people have about clinical trials.

These are some of the many opportunities the clinical research community has to improve its reputation. The rapid deterioration of our public image serves as evidence that immediate solutions are needed, and the research community must work together to find and implement strategies to reverse the growing trend of public mistrust in research.

References

1. M. Kaufman, "Drugs Get Good Ratings, but Drugmakers Less So," The Washington Post A03 (26 February 1995).

2. H. Taylor and R. Leitman (Eds.), "There are Many Reasons Why People are Reluctant to Participate in Clinical Trials," Health Care News 7 (2) (26 March 2002).

3. "Pharma's Image Woes," Pharmaceutical Executive, 27(2), 26–27 (2007).

4. K. Getz, "Survey Says?" From Understanding and Reversing the Erosion of Public Trust in Clinical Research, a symposium conducted at the Drug Information Association's 42nd Annual Meeting in Philadelphia, PA (2006).

5. N. Wong and K. Gullo, "New Survey Shows Public Perception of Opportunity to Participate in Clinical Trials has Decreased Slightly from Last Year," Harris Interactive (2005): http://www.harrisinteractive.com/news/printerfriend/index.aasp?NewsID=941 (accessed June16, 2006).

6. C. Milne, "Development Trends Impacting Investigational Sites." From Monitoring and Managing a Changing Investigational Site Landscape, a symposium conducted at the Drug Information Association's 42nd Annual Meeting in Philadelphia, PA (2006).

7. B. Brescia and F. Bachenheimer, "Good Recruitment Practice = Patient Pull: A New Recruitment Initiative Will Help Pharma Bring in Needed Clinical Trial Patients," Pharmaceutical Executive (2002): http://www.pharmexec.com/pharmexec/content/printContentPopup.jsp?id=59367 (accessed June 17, 2006).

8. The Pharmaceutical Research and Manufacturers of America (PhRMA), "About PhRMA," http://www.phrma.org/about_phrma (accessed March 29, 2007).

9. The Pharmaceutical Research and Manufacturers of America, "Drug Discover and development: Understanding the R&D process," http://www.phrma.org/files/RD%20Brochure%20022307.pdf (accessed March 29, 2007).

10. "Facts and Figures," Center for Information & Study on Clinical Research Participation (2006): http://www.ciscrp.org/information/facts.asp (accessed June 17, 2006).

11. S. Shalo, "Guinea Pig? Not Me!" Pharmaceutical Executive, (2002), http://www.pharmexec.com/pharmexec/content/printContentPopup.jsp?id=21500 (accessed June 17, 2006).

12. R. Kelch, "Maintaining the Public's Trust in Clinical Research," The New England Journal of Medicine, 346 (4), 285–287 (2002).

13. N. Wong, "Many Reasons Why People are Reluctant to Participate in Clinical Trials, According to a National Harris Interactive Survey," Harris Interactive (2002), http://www.harrisinteractive.com/news/printerfriend/index.asp?NewsID=439 (accessed July 1, 2006).

14. Personal communication with Ken Getz, July 17, 2006.

15. K. Getz and J. Kremidas, "Educating the Public: A Critical, Unmet Need," Applied Clinical Trials, 2005: http://www.actmagazine.com/appliedclinicaltrials/content/pringContentPopup.jsp?id=149965 (accessed June 11, 2006).

16. M. Lemonick and A. Goldstein, "At Your Own Risk," Time Magazine, April 22, 2002: http://www.time.com/time/archive/printout/0,23657,1002263,00.html (accessed June 17, 2006).

17. M. Angell, The Truth About Drug Companies: How They Deceive Us and What To Do About It (Random House, New York, 2004).

18. K. Getz, "Overview of the Investigative Site Market and Hits Operating Challenges." From Monitoring and Managing a Changing Investigative Site Landscape, a symposium conducted at the Drug Information Association's 42nd Annual Meeting in Philadelphia, PA (2006).

19. "The FDA's Reputation with the General Public is under Assault," Harris Interactive (2006), http://www.harrisinteractive.com/news/printerfriend/index/asp?NewsID=1060 (accessed June 11, 2006).

20. "Knowledge is Power," Coalition of Cancer Cooperative Groups (2006): http://www.cancertrialshelp.org/pdfs/KnowledgeIsPower.pdf (accessed July 20, 2006).

21. B. Hughes and N. Wong, "Most Physicians Do Not Participate in Clinical Trials Because of Lack of Opportunity, Time, Personnel Support and Resources," Harris Interactive (2004): http://www.harrisinteractive.com/news/printerfriend/index.asp?NewsID=811 (accessed July 2, 2006).

22. N. Wong, "The Many Reasons Why People Do (and Would) Participate in Clinical Trials, According to a National Harris Interactive Survey," Harris Interactive (2003): http://www.harrisinteractive.com/news/printerfriend/index.asp?NewsID=632 (accessed June 17, 2006).

Joseph Mudd is a lead CRA for TAP Pharmaceutical Products, Inc., and a graduate of George Washington University Medical Center's MSHS program in clinical research administration, email: muddjr@gmail.com