Patients participate in clinical research for a variety of reasons. Some participate to help advance the medical field for the benefit of others and to help researchers and physicians learn more about diseases and treatment options. Others participate to gain direct access to new medications and medical care for their disease or illness that may have few or even no other treatment option.

Government agencies, medical institutions, foundations, medical institutions and pharmaceutical companies can sponsor clinical research. Typically, these organizations have a new medical product that they want to advance to achieve FDA approval.

Each specific clinical study or trial defines who can participate in it. These specific definitions are called the eligibility criteria and only those patients matching the specific criteria can participate in that study. Depending on the study and the treatment, patients may be healthy volunteers or they may be required to have a particular diagnosis. For example, a new diabetes medication may need to be tested first on newly diagnosed diabetic patients who are not currently taking any diabetic medication. However, later in the product’s development, the medication may need to be tested on patients with more advanced stage diabetes and are currently prescribed insulins.

Participation in a clinical study is completely voluntary, so only enroll if you want to. If you choose to participate in a clinical study, consider the time commitment. Each study varies in length and requires different visit schedules and procedures. Some clinical studies are relatively short (8 to 16 weeks), while others are much longer (1 to 3 years). In general, patients are asked to routinely come into the clinic for visits and exams. Depending on the protocol, these encounters could be weekly, monthly or as infrequently as every 6 months. Patients also should consider the study medication and what known side effects it may have. Study patients are asked to adhere to the study medication guidelines and need to be compliant in taking the study medication to remain enrolled. Before a patient agrees to participate in a clinical study, our Clinical Research staff will go over everything in the study with them and address any questions they may have. We want to ensure that the patient has a clear understanding of the study time commitment, what they can expect at each study visit, and who they should call if they have any questions of concerns.