Let's Get Real About Clinical Trial Participation

Let's Get Real About Clinical Trial Participation

11.26.12 | By

As one of the founders of a global clinical research organization (CRO) and as current Chair of ACRO, the trade association for CROs, I can assure you that the pharmaceutical, biotechnology and CRO industries are dedicated to the protection, safety, privacy and rights of the volunteers who participate in the studies that allow new medications to be developed for the improvement of health and the quality of life.

As professionals in the biopharmaceutical industry, we all understand that without clinical trials, and the people who voluntarily participate in them, there would simply be no new medicines. We all want new safe and effective treatments for chronic and life threatening diseases, ranging from cancer to diabetes to Alzheimer's. And we want them sooner. This is what we all gain from clinical trials.

For instance, the United States has recently confronted a new outbreak of West Nile virus, for which there is no vaccine. Without clinical trials, no vaccine can be developed.

But the importance of clinical trials, and the vital role that patients and healthy volunteers play in the drug development process, seems to be lost on many in the media and entertainment industries. ACRO has been fighting against the recent flurry of disparaging images of research participants in the media. Study participants are not "guinea pigs" or "test monkeys" and we categorically reject the use of these terms.

Rather, we like to borrow a phrase from our friends at the Center for the Information and Study of Clinical Research Participation (CISCRP) and refer to these individuals as Medical Heroes, for that is what they are. Their often unselfish contributions to science make them nothing less.

Here is a dose of reality and why it is so important to encourage clinical trial participation and promote a positive image of clinical research. In the United States, only about 4 percent of the population participates in clinical trials. Yet, approximately half of all clinical trials worldwide are conducted in the US. This model is not sustainable. The math simply does not work.

Access to patients is one reason why more and more clinical trials are being conducted - using the same standards of patient safety and ethics - in other regions, including Europe, Asia and Latin America. Why would we limit ourselves to the US population of 315 million when the world has a population of seven billion? Diseases such as cancer and diabetes have no boundaries. So we conduct clinical trials around the world to access patients, trained investigators and new markets. If a drug is one day to be sold in China, or Russia, or Brazil, for example, for the benefit of patients there, it would be valuable to have clinical trial data from these populations.

Nevertheless, we can never stop encouraging participation in the United States if the US is going to continue to be the hub of medical innovation.

Ultimately, what we want is a fair and realistic portrayal of clinical trials in the media. Certainly clinical trials do not always produce miracle cures - though in some cases they may - but the people whose participation is so valuable deserve to be treated with respect.

Jeff McMullen is the current Chairman of the Association of Clinical Research Organizations, one of the founders of PharmaNet/i3 - the clinical segment of inVentiv Health, and Vice Chairman, inVentiv Health.

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