What is the Patient’s Role in Clinical Trials?

Safety precautions take during clinical trials are certainly the most important aspect. There are two groups which have scientific oversight: the sponsor and the physical investigator (doctor).

Additionally, the FDA reviews them along with independent review boards.

There is also “Informed Consent”. A patient consents to all the trial rules before the trial begins. Thus, the patient sees a written document with expectations of all parties spelled out, and knows what to expect once the trial is underway.

Another important factor in clinical trials is “GCP” or “Good Clinical Practice” which are clinical trial rules that all countries agree to follow. All procedures are disclosed in it.

Lastly, a patient can protect themselves by knowing what they are doing. They ask questions, inquire as to the drug being tested and request updates. Keep informed of all that is being done. Question it. Ask the clinical trial people. If not satisfied. then ask someone else. Don’t ever assume.

Drug Lifecycle Tracking Application maps the end-to-end drug approval process. It offers a one stop shop to manage Drug Lifecycle and Regulatory Review process. Call us at (240) 753-8282.