Improving communication about clinical trials

This week's ACRP Wire highlights an article from the American Journal of Public Health which examines the problems with communication about clinical trials. Misinformation and miscommunication about the nature and the risks of clinical trials, specifically HIV vaccine trials, is inhibiting enrollment in these trials. In order for these trials to succeed, it is important to have the support and participation of high-risk groups and communities. But to get their participation, researchers have to improve how they communicate with community members and stakeholders. Improved communication will facilitate greater trust of the clinical research professionals, as the community will be able to see that they are working towards the same goal - improved health for the entire community.

Managing anxiety when talking about clinical research

I am looking forward to presenting later this month on the topic of communication and informed consent at the Association of Clinical Research Professionals Global Conference. I am going to be presenting on several different communication behaviors and theories, but I think one aspect of my presentation that may initially be surprising, though I hope will resonate, is the idea of Anxiety-Uncertainty Management. Anxiety-Uncertainty Management is actually an intercultural communication theory that examines communication between members of a given cultural group, and a "stranger" to that culture. Anxiety-Uncertainty Management contends that communication is effective when someone is able to effectively interpret the words and actions of the other person. But when a person is a stranger to the culture, they may not understand the words and actions of the other person, and thus may become anxious and unable to process the new information that they are receiving. A little bit of anxiety can be OK, and it may in fact be helpful. But when anxiety becomes overwhelming, communication suffers. It is pretty easy to see how this might play out in clinical research encounters. A potential research participant, who is new to the world of clinical research, may not be able to interpret the words and actions of the research coordinator, and because they do not understand what is going on, they may become so anxious, they are unable to process new information, such as an informed consent discussion. So what can research coordinators do? In order to create an environment where effective communication can take place, coordinators should help potential research participants manage their anxiety. They can do that by explaining who people are, what their jobs are, and what's going to happen. Take the mystery out of the clinical research experience. Because if they are able to manage their anxiety about the situation, then they will be able to have an effective conversation about participating in research.

Therapeutic misconception and participation in clinical research

In her column this week, Dr. Pauline Chen touches on a serious concern for clinical researchers: therapeutic misconception. Clinical research is dependent on the voluntary, informed participation of research participants. Researchers, coordinators and institutional review boards, put a great deal of time and effort into making sure that potentially participants are fully informed about the nature of their participation in research, including the fact that they themselves may not directly benefit from participating in the trial. But when potential participants face serious, life-threatening illnesses, they may view participation in the trial as their only hope, even if the researcher tells them there is only a small chance they will benefit. Dr. Chen's column ultimately explores the ethics of hope. Is it OK for researchers to enroll participants who are enrolling with unrealistic expectations, despite the researcher's best efforts at informed consent? Is there any way to prevent unrealistic expectations? Should we prevent unrealistic expectations if they give hope?

Finding the right metaphor

The ACRP Wire, the newsletter of the Association of Clinical Research Professionals, had an interesting article today on a study which looked at how language affects research participant understanding. The metaphors research coordinators use make a difference in participant understanding of concepts such as randomization. A metaphor that described randomization as similar to the flipping of a coin evoked the idea of winning or losing, while comparing randomization to the chance an expectant mother may have a boy or a girl was better understood.

The study points to the importance of effective communication, targeted to the literacy and health literacy of the potential research participants involved.

The other revolution started by "The Pill"

This article is a week old, but I still wanted to point it out. Last week was the 50th anniversary of FDA approval of the birth control pill. Approval of the birth control pill is credited being one of the events that led to the "sexual revolution." But as this article points out, the approval of the pill started another revolution, a revolution at the FDA. At the time of the pill's approval, the FDA started to take a strong role in post-market surveillance, that is, continued observation and research of drugs after they have been approved. With the pill, we also saw the beginning of the FDA's direct communication with patients, rather than communication from the FDA to patients via physicians. The approval of the pill also followed the expansion of the process of clinical trials to show safety and efficacy of a drug, procedures that are now commonplace. It's an interesting piece of research history and shows how we came to the regulations researchers now face today.

Seeking help for a rare illness by going where the researchers are

Along with an article about an FDA orphan drug conference last month, The Wall Street Journal also explored how one mom is using the conference as a chance to seek treatment for her daughters by going where the researchers are and talking with them face-to-face. The purpose of the conference is to encourage researchers to pursue funding and research for orphan drugs, that is drugs for very rare diseases. The FDA has set aside substantial money for orphan drugs, but few researchers pursue it. So the FDA has hosted conferences to encourage researchers to seek the funding and help them with the application process.

But the conference isn't just attracting researchers. It has also attracted one persistent mom, who visited the conference to pursue research to find a treatment for a rare illness affecting her twin daughters. The conference helped "demystify the process" for this mom and the researchers, but also showed what can happen by actually meeting and talking to each other.

Review board steps aside approving a fake study

The Wall Street Journal Health blog had an article today about Coast IRB, a for-profit Institutional Review Board that approved a fake study posed by the Government Accountability Office. The GAO conducted the sting operation to see if for-profit IRBs adequately review and supervise medical trials and the interest of research subjects. The approved study had a fake company, falsified records and an unapproved product. The company failed to ensure that risks to subjects were minimized and whether the research would be conducted under acceptable legal and professional guidelines. As such, the company has agreed to stop reviewing new FDA-regulated studies and halt enrollment to previously approved studies. The company itself will undergo complete restructuring, with a new board, new standards of practice and frequent internal audits.

The case shows the importance of institutional review of clinical research studies and the importance of knowing that the reviewers are capable of doing their jobs.