Volunteering For Clinical Research Studies
Clinical research studies are vital to improving the quality of care for those with chronic conditions. Patients who volunteer at AMCRI contribute to the discovery of new therapies to treat and possibly cure their illness. You are an important link to cutting-edge research that can benefit people long before a medication or device becomes available in the healthcare marketplace.
Each study has specific requirements such as age, sex, and a current diagnosis of the medical condition under study. A physician reviews the medical history of anyone interested in participating All volunteers will be given details on the study procedures, risks and benefits as part of the required informed consent process. This process allows volunteers to ask pertinent questions of the clinical study team and to be regularly informed about all aspects of the study they are involved with.
Frequently Asked Questions
If you are enrolled in a clinical research trial, all costs associated with the clinical research trial will be available at no cost to the participant. You may be compensated for your time and participation in the clinical research trial. Click on our current studies page to learn more details.
Clinical research trials have eligibility criteria outlining who can participate. Click on the current studies page to see if you qualify for any of our enrolling studies.
Phase I
Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 30 patients. The drug may help patients, but Phase I trials are to test a drug’s safety. If a drug is found to be safe enough, it can be tested in a phase II clinical trial.
Phase II
Phase II trials further assess safety as well as if a drug works. The drug is often tested among patients with a specific type of illness or disease. Phase II trials are done in larger groups of patients compared to Phase I trials. Often, new combinations of drugs are tested. Patients are closely watched to see if the drug works. However, the new drug is rarely compared to the current (standard-of-care) drug that is used. If a drug is found to work, it can be tested in a phase III clinical trial.
Phase III
Phase III trials compare a new drug to the standard-of-care drug. These trials assess the side effects of each drug and which drug works better. Phase III trials enroll 100 or more patients.
Often, these trials are randomized. This means that patients are put into a treatment group, called trial arms, by chance. Randomization is needed to make sure that the people in all trial arms are alike. This lets scientists know that the results of the clinical trial are due to the treatment and not differences between the groups. A computer program is often used to randomly assign people to the trial arms.
There can be more than two treatment groups in phase III trials. The control group gets the standard-of-care treatment. The other groups get a new treatment. Neither you nor your doctor can choose your group. You will also not know which group you’re in until the trial is over.
Every patient in a phase III study is watched closely. The study will be stopped early if the side effects of the new drug are too severe or if one group has much better results. Phase III clinical trials are often needed before the FDA will approve the use of a new drug for the general public.
Phase IV
Phase IV trials test new drugs approved by the FDA. The drug is tested in several hundreds or thousands of patients. This allows for better research on short-lived and long-lasting side effects and safety. For instance, some rare side effects may only be found in large groups of people. Doctors can also learn more about how well the drug works and if it’s helpful when used with other treatments.
- You may get an investigational new treatment for a disease before it is available to everyone.
- You play a more active role in your own health care.
- Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
- You may have the chance to help others get a better treatment for their health problems in the future.
It is important for clinical research trials to have participants of different ages, sexes, races, and ethnicities. When research involves a group of people who are similar, the findings may not apply to or benefit everyone. When clinical research trials include diverse participants, the study results may have a much wider applicability.
Researchers need the participation of older people in their clinical research trials so that scientists can learn more about how the new drugs, therapies, medical devices, surgical procedures, or tests will work for older people. Many older people have special health needs that are different from those of younger people. For example, as people age, their bodies may react differently to drugs. Older adults may need different dosages (or amounts) of a drug to have the right result. Also, some drugs may have different side effects in older people than younger people. Having seniors enrolled in drug trials helps researchers get the information they need to develop the right treatment for older people.
To find out more information about clinical research trials, visit www.clinicaltrials.gov.