Enrolling patients in clinical trials is one of the biggest barriers in cancer research. Only 3% to 5% of adult cancer patients enroll in clinical trials. And despite efforts to improve the experience for patients, the number of participants hasn’t grown over the last decade. Some studies never enroll enough participants to complete the project. Patients cite the complex requirements of some studies, lack of insurance coverage or just lack of awareness for not enrolling in trials.
That may be changing, thanks to advances in molecular medicine, according to the author of a commentary published Wednesday in the journal Science Translational Medicine. Molecular medicine is the study of disease at the level of cells and molecules. It offers the potential for matching particular drug therapies to patients based on individual genetic or molecular characteristics. A good example is the drug Herceptin. It is prescribed for women who have a mutation in the HER2 gene.
As the number of clinical trials involving molecular medicine grows, it may be easier to persuade people to participate in the research, said Dr. Richard L. Schilsky, a cancer expert at the University of Chicago Medical Center and author of the commentary. Because of strides in molecular medicine, studies will be based on some knowledge of which people are most likely to benefit. Even early-phase trials are expected to yield some information on how well the therapy might work. Moreover, many molecular therapies don’t carry the harsh side effects of traditional cancer therapies, such as chemotherapy.
Overall, people will be more willing to participate in trials when they believe they may benefit or, at least, won’t be harmed.
The way researchers are going about recruiting patients for clinical trials is evolving too, Schilsky said. He provides the example of the Love/Avon Army of Women project, which has enrolled 337,000 women online who may be interested in entering a trial. (The women are all breast-cancer patients or at risk for breast cancer.) Researchers fill out an application for a study that is reviewed by an outside panel of experts. If the application is approved, the organization issues an e-mail to everyone in the registry to let them know it’s open for enrollment.
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