Why Should I Volunteer?

Clinical trials offer alternate treatment options and continuous, in-depth medical observation by healthcare experts.

In addition, some clinical trials may offer continued use of the treatment medication after the study has concluded. In cases where the therapy drug may cost thousands of dollars out of pocket, patient compassionate care is provided without financial hardship.

Volunteering in a clinical trial contributes to the advancement of medical knowledge in specific indications and/or therapies. The knowledge acquired from these trials may provide healthcare professionals and patients alike alternate treatment options.

Safety

According to the U.S. Food and Drug Administration (FDA), the FDA “is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” U.S. Food and Drug Administration. (2013, September 19).

Find out more at http://www.fda.gov/aboutfda/whatwedo

Clinical trial volunteers are protected by regulations set forth by the FDA and the global International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practices (ICH GCP).

During enrollment in a clinical trial, the health and safety of the volunteer is monitored by healthcare professionals, which include but are not limited to: a qualified healthcare provider and research site staff; medical monitors who review the safety data; and a centralized Independent Ethics Committees and Institutional Review Boards whose role is the protection of Human rights and safety of clinical trial volunteers.

Benefits/Risks

While all clinical trials are different, volunteers could potentially benefit from receiving medical care and therapy for their specific indication and also be actively involved in their health status.

Common risks may include known and unknown side effects of drugs. In certain studies that incorporate a placebo, there is the potential that the volunteer would not receive the experimental therapy. While this may sound scary, the patient is monitored throughout the study and may choose to discontinue participation at any time. The physician conducting the study may also decide to discontinue the patient’s enrollment if their health status declines at any point. The patient’s safety is always of primary concern.

Additional risks would also depend on the type of clinical trial. Some clinical trials may require additional tests to be performed, which may include blood samples, tissue samples, X-rays, and additional invasive & non-invasive procedures.

Additional information can be found at:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ucm129557.htm   (Volunteering info)

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm (GCP info)

Palmtree Clinical Research, Inc. conducts clinical studies, which include interventional, observational and prevention trials.

In Interventional Studies, also known as Clinical Trials, patients receive interventional care, which may involve the use of a medication or the use of a medical device for a specific health indication. Interventional studies may also include a procedure or a change in the patient’s normal habits, such as a change in exercise and/or diet.

In Observational Studies, patients will receive no interventional therapy such as medication, medical device, or procedures. The patient will only be observed to assess health status as part of the standard of care.

Prevention trials test new approaches such as medicines or vaccines that researches believe may lower the risk of the onset of a disease.