Before participating in a clinical trial, it’s important to get any questions you have answered by the research team. Some individuals take notes, videotape their meetings with the treatment team or even bring a partner with them to help them remember the responses they’re given. Read on to learn everything you need to know before participating in a clinical study.
What Is a Clinical Study?
Clinical trials refer to a sort of study that analyses the impact of innovative tests and procedures on human healthcare outcomes. Clinical trials are used to evaluate medical interventions such as medications, tissues, and other pharmaceutical drugs, surgical operations, radiological procedures, equipment, behavioral therapies and preventative care.
How Does a Clinical Study Work?
Clinical trials must be authorized before they can begin, as they must be properly prepared, evaluated and finished. Clinical trials for breakthrough medicines are separated into stages, which are referred to as phases.
Early phase studies may examine whether or not a medicine is safe, as well as the adverse effects it creates. Later-stage studies are designed to see whether a new therapy is superior to established therapies. Clinical trials are divided into three phases: phase 1, phase 2 and phase 3.
Phase 1
Phase 1’s goal is to make sure the medication is safe for people and to see how and where it spreads throughout the body. This kind of testing is usually done with a small sample of healthy participants.
The trial sponsor keeps an eye out for any “severe adverse events,” which are any poisonous, unpleasant or unwanted effects that result in death or harm to one’s health.
Phase 2
Phase 2 is used to evaluate the appropriate dose and efficacy in treating a specific ailment. This kind of testing is usually done with a larger sample of participants who have the illness.
A trial sponsor might run their study in a variety of ways, but most plans include allocating participants to various treatment groups, with each group receiving varying dosages of the drug.
Phase 3
Phase 3 comprises a considerably bigger group of participants and is designed to see whether the treatment is effective and safe for a broad range of individuals. Participants are usually divided into treatment and control groups as part of the strategy.
Who Is Responsible for Conducting Clinical Studies?
Every clinical trial is overseen by the main investigator, who is almost always a medical practitioner with extensive experience in the field. The lead investigator is usually accompanied by a research team, which may consist of physicians, nurses, counselors, and other members of the healthcare profession.
In addition to the federal government, clinical research may be sponsored or financially supported by pharmaceutical corporations, universities, medical institutes, voluntary organizations and other non-profit organizations.
What Are the Advantages of Participating in a Clinical Trial?
- You may be the first to get a new therapy for an illness before it is made accessible to the general public.
- You can take a more active role in the management of your health.
- You have the opportunity to help others receive better treatments for their health concerns.