Clinical Trials: What Patients and Volunteers Need to Know

There's a lot to know about the hugely important clinical trials of drugs that aim to ease or cure the most vexing diseases— from a trial's medical and ethical oversight to the source of funding, the qualifications of the investigators, possible conflicts of interest, and risks. For anyone considering entering a clinical trial, it's worth bearing with the dry, dense delivery here (aided by case studies) because of the rich information. Speid, a 30-year veteran of the pharmaceutical industry, wades into the labyrinth of the drug development process, the complexities of trials involving children, the elderly, and the disabled; the special safety issues in experimental approaches, like gene transfer; and the importance of grilling the doctor running the research to get a full understanding of the trial. Still, the most powerful message is the simple wisdom of not going it alone: advocates should be enlisted from a hospital, church, law firm, or family to represent the participant's interests. Also useful, though ploddingly redundant, are questions Speid provides for each trial step, and Web links for exploring a process so fraught with hope for its participants—and all those who may benefit from its results. (Aug.)