What are the phases of the Clinical Trials?
Clinical trials have four phases
In phase I studies, a new drug is tested for safety, side effects and how the drug is administered. A small number of the patients are usually admitted to Phase I trials. If the Phase I study shows safety a Phase II study begins.
Involves a larger number of patients and continue to evaluate the safety of the new drug and any less common side effects.
These trials compare the new drug to the standard therapy. Phase III participants are randomly chosen to receive either the new drug or the standard treatment, or a combination of both.
Phase IV trials continue to evaluate the safety, benefits and optimal use of a therapy already approved and available to the public.
What are the potential risks and benefits of participating in a clinical trial?
Participating in a clinical trial has benefits but there also may be risks. The Clinical trial participants may experience some have side effects, which are sometimes serious, from study medication. Study treatment and evaluation may require more time than standard therapy.
Also, there is no guarantee the study medication will work.
The clinical trial participants may be able to gain access to a research treatment that is otherwise unavailable, and may help others by participating in medical research. Clinical trial participants may also have access to study medication, medical care, and laboratory services, all at no cost.
How are the Clinical Trial participants protected?
There are a number of processes designed to regulate clinical trials and to help protect trial participants. Institutional Review Board, Peer reviews, independent monitoring and the Informed Consent process help protect the rights of the clinical trial patients.
An Institutional Review Board (IRB) monitors actions and documentation in the clinical trial process. The board consists of Medical specialists, nurses, medical ethicists, patient advocates, social workers and clergy, to view the research studies from social, medical and ethical perspectives.
Peer Review is conducted by experts, chosen by a study sponsor, to gauge the merit, safety and ethical issues of a trial.
Informed Consent is the process of making sure the clinical trial participant has all the necessary information about the trial before deciding to participate or not. If you decide you are interested in the trial, you will first meet with a member of the research team. You will find out about the trial and receive the written information about the trial. This written information is called the Informed Consent document.
It’s important to understand the facts about the trial before making the decision. This is the time to ask your contact person any questions.
If you decided to join the trial, you will be asked to sign the document. Keep a copy for the reference. And remember that you are free to leave the trial anytime.
How do I know if participating in the Trial is right for me?
Choosing to participate in a clinical trial is an important personal decision. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
You need to talk with your doctor and your loved ones about any decisions concerning your participation in a trial. If you find a trial, take the time to ask questions and to understand if participating may be right for me.
Patients volunteering the research studies are the medical heroes partnering in drug and device discovery.