For Clinical Research Patients & Caregivers

Clinical research patients help advance healthcare innovation

Through the power of clinical research, life spans are 10 years longer. Fewer deaths from heart disease give us nearly 4.2 million more hearts to share every year. And eight out of ten children beat cancer so they can get out of the hospital and into the backyard so they can just be kids.

Clinical studies follow strict rules to help protect the safety of clinical research participants. The goal of these studies is to learn whether a potential new medication, treatment or medical device is safe and effective in treating a particular disease or condition.

Clinical study basics: Information for potential clinical research patients

Clinical studies involve an evaluation process, when study doctors determine if you are eligible to participate in the study. Studies have different requirements and they're broken into phases:

• Phase I studies determine basic drug safety and how the drug affects the body. The studies are performed on a relatively small group of healthy volunteers and typically lasts a few weeks to a few months.
• Phase II studies look at the drug's effectiveness and dosing in about 100 to 200 people who suffer from the disease or condition. Phase II studies may last one to two years.
• Phase IIIa studies verify drug effectiveness and safety on a larger scale -- several hundred to several thousand people -- and may last two to three years.
• Phase IIIb studies are conducted on large numbers of patients and seek to determine cost effectiveness and effectiveness relative to existing drugs used to treat the same disease.
• Phase IV studies begin after the drug is available on the market. These studies prove safety in a wider group of patients and effectiveness in new uses, dosage strengths and formulations (e.g., a sustained release capsule or a flavored solution for children).