A public health need: informing and engaging stakeholders on the periphery of the clinical research enterprise.

Although most Americans believe that clinical research is important for advancing medical knowledge, very few know where to find information about relevant clinical trials. There is a need for greater public awareness in the clinical research enterprise. It is important that the public, prospective volunteers, health professionals, policymakers, and the media all be informed and engaged in this process. This article will review the ways the public and prospective volunteers learn about clinical research and will discuss recent regulatory and self-regulating measures to increase information transparency and disclosure. Since advocacy and outreach programs are critical to realizing the benefits of biomedical research, these programs also will be discussed.

Key words: education, recruitment, retention, study volunteers

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A troubling inverse relationship exists between the resources devoted to patient recruitment activity and volunteer involvement in clinical trials. As research sponsors and investigative sites commit more capital and personnel to recruit volunteers, study enrollment and retention rates become worse. Something is fundamentally wrong with this picture.

Since the mid-1980s, for example, spending on patient recruitment programs by investigative sites and research sponsors has grown by 16% annually, reaching more than $500 million in 2003. (1) During that same period, volunteer randomization rates declined steadily. According to reports from several hundred investigative sites and analyses of study completion records, nearly 45% of volunteers were enrolled in clinical trials in 1984. In 2003, randomization rates declined to less than 25%. (2) And whereas one out of every six enrollees dropped out of clinical trials in 1984, an average of 27% dropped out of clinical trials in 2003. (3)

In 2003, investigative sites reported that more than 90% of all clinical trials had to extend their original study timelines to enroll the requisite number of volunteers. (4) Sites attributed these enrollment delays both to the unrealistic timelines set by research sponsors and to the high level of difficulty in recruiting and retaining study volunteers. Government and industry-funded research sponsors now expect significant project delays as they seek approximately 2.6 million study volunteers to complete their studies each year. (5) Ultimately, these delays hinder medical innovation that may benefit overall public health.

In my 20 years as an observer of the clinical research enterprise, through my involvement at CenterWatch and now at the Tufts Center for the Study of Drug Development, I have had the opportunity to collect, review, and analyze a growing body of knowledge about public attitudes and study volunteer perceptions and experience with clinical research. The data clearly indicate that the public and volunteer communities know virtually nothing about clinical research and the important role that each party plays in the process. These stakeholders and others on the periphery of the clinical research enterprise--including health care providers, the media, and policymakers--have limited to no context with which to understand and to easily access quality information about clinical research. And they are not engaged as partners in the process.

Recent survey …