Improve public knowledge and trust through communication

Clear info about benefits needed

In these days of negative headlines about research and the pharmaceutical industry, it’s essential that clinical trials offices, IRBs, and research institutions join together to improve public education and trust about how research is conducted and the benefits it brings to society, several experts say.

Bad news is cyclical, and it appears the research industry is entering another period of increasing public distrust. Consider these recent events:

  • After Merck & Co. recalled its best-selling painkiller Vioxx (rofecoxib) because of cardiac risks, newspapers reported a safety reviewer at the FDA had warned the pill was too risky. The Lancet reported in early November that a cumulative meta-analysis of rofecoxib studies demonstrates it was evident in 2000 that the drug had unacceptable cardiovascular risks.
  • There have been a number of books recently published that are critical of the pharmaceutical industry: For example, Marcia Angell, who worked at The New England Journal of Medicine for two decades, wrote a book titled The Truth About the Drug Companies: How They Deceive Us and What to Do About It, published by Random House in August. Another book that finds fault with the pharmaceutical industry is The $800 Million Pill: The Truth Behind the Cost of New Drugs, written by Merrill Goozner, and published this year by the University of California Press.
  • The Washington Post reported Oct. 30 that the Environmental Protection Agency (EPA) has accepted $2 million from the American Chemistry Council to help fund the Children’s Environmental Exposure Research Study (CHEERS) to investigate the impact of household pesticide exposure on 60 infants and toddlers in Duval County, FL. According to the newspaper, some EPA officials are concerned about the ethics of the study since it essentially will pay families $970 plus children’s clothing and a camcorder to purposely expose their young children to pesticides, which may have no potential benefit for the subjects. EPA officials defend the study, saying that while it’s acknowledged that pesticide exposure has been linked to neurological problems, birth defects, and lung damage, the impact of how the bodies of young children absorb harmful chemicals is little known.

• The CDC announced in October that there would be a shortage of doses of influenza vaccine this year because the Chiron Corp. announced that none of its product would be available this flu season. News reports claimed this would cut the expected supply in half and make the United States one of the only industrialized nations to have fewer than the number of necessary doses. Some reports blamed the FDA’s regulations regarding vaccine trials and the approval process and vaccine manufacturers’ fear of lawsuits for the conditions that led to a shortage.

Every few years, there are media reports of a research project that has failed in some way or may have betrayed public trust; these can affect how the research community is perceived by the public. When this happens, it puts more pressure on researchers to educate the public about their work, experts say.

Statistics measuring public trust of information received from clinical research professionals show a trend in the wrong direction, says Roni Thaler, president of the Center for Information & Study on Clinical Research Participation in Boston.

"Over the last six years, the public’s trust of information from the research community has decreased dramatically," Thaler says. "There also has been a lot of negative press about clinical research and public health issues like Vioxx and the flu vaccine."

The research community has done too little to counter the negative publicity, Thaler and others say.

"What continues to happen is that researchers come into a community, wanting something from that community, but they aren’t interested in a dialogue with that community," says Deborah Collyar, president of Patient Advocates in Research in Danville, CA.

Some researchers have done a good job of connecting with communities, including the African American community, by visiting with churches and identifying community leaders and health advisors, she notes.

"They need to identify those people and engage them in dialogue so they can tell researchers what are the needs of that community," Collyar suggests.

Research institutions and IRBs should employ this type of strategy and others even when it’s not for the purpose of recruiting subjects among a certain community, the experts note.

"What we believe is it’s important to increase awareness about clinical research and the role it plays in our national health, as well as to educate and inform the public and patients, so when they are given the option of taking part in a trial, they’re more informed and educated about the process and can make the best decisions for themselves, along with their physician," Thaler says.

Groundwork needs to be laid to better inform the public because the old methods of simply worrying about education during the informed consent process do not work very well, she says.

"What we have seen is the education part seems to take place during the informed consent process when data show 45% of people either don’t read it or understand it," Thaler notes. "Many times, people are asked to sign the informed consent document when they are ill, and it’s a difficult time to achieve a general awareness of the process."

Meantime, statistics show that when people are asked why they don’t participate in clinical research, 41% say it’s because information about research is difficult to access or is not available, and another three in four people say they have no real knowledge of the clinical research process, she adds.

"So we want to close this gap through education and outreach to the public," Thaler says.

Another good reason for educating the public about research has to do with subject recruitment, which has slowed the clinical trials process in recent years, others say.

"By some measures there are claims that virtually every kind of clinical trial has some sort of time delay directly related to patient recruitment," says Jeffrey Trunzo, RPh, MBA, CIP, vice president of Chesapeake Research Review Inc. of Columbia, MD. "These involve two sets of realities: Are expectations set by sponsors realistic to begin with and, secondly, is the public willing to participate?"

Get investigators to go public

The research community has not honed its message well enough, Trunzo notes.

"Part of the message the public is missing is that there’s a safety net in terms of what sponsors do to formulate studies and what regulators do to oversee them and what the IRB does to mitigate risk," he says. "I think there’s not enough information out there, laying out the system of human research protection in the United States."

For example, clinical trials staff and researchers could speak before public groups about how clinical trials have changed and how there’s an important emphasis on prevention, quality of life issues, screening subjects, and, ideally, to identify better treatments for people who have a disease, Collyar notes.

"I really think with the public the only way they’re going to be receptive and get used to clinical trials is to let them know there’s a spectrum of clinical trials, and these are helping to get better answers more quickly," she says.