What is a clinical study? Why do we have them, and what does a clinical study accomplish? Medical research studies are an important part of clinical drug development. A clinical study is also a crucial step in developing new treatments and interventions for diseases and injury. Read on to learn all the facts about clinical trials and what they do for us.
What Clinical Studies Do
A clinical study gives doctors and researchers the opportunity to test a new drug or treatment in a controlled way that verifies whether the new medical intervention is doing any good. It also lets them see possible side effects and determine if side effects, which all drugs and treatments have, are worth the benefits. Clinical studies are also a way for patients to get access to cutting-edge techniques and treatments that are not yet available to the general public, or which would be prohibitively expensive otherwise.
Understanding Their Effectiveness
Outcomes for a clinical study are measured with a p-value, which helps to decide how likely it is that the results of a clinical study could be due to chance rather than to a difference in treatments. For example, a p-value of 0.05 is considered important because this means the likely outcomes were due to chance are less than 5%.
Why Studies Are Essential
Clinical studies are a crucial step in finding out whether any treatment is safe, effective, and useful. Before entering clinical trials and being used on any human beings, any treatment must first go through a lot of rigorous testing. This testing must give researchers and the FDA strong confidence that the treatment or drug is reasonably safe. When asked, almost 50% of those surveyed believe that taking part in a medical research trial is just as essential to medicine and healthcare system as giving blood.
Informed Consent is Always Needed
No clinical study goes on unless everyone involved is clear about the possible risks and benefits of the treatments involved. It is so essential that participants be able to give informed consent to participation that it was made a part of the 9th revision of the ethical code of the American Psychological Association. For participants under the age of 18, informed consent must be obtained from parents or legal guardians before the children can take part in any clinical study.
Studies Ramp up Slowly and Carefully
From the Phase 1 clinical trial all the way to Phase 4, these studies are designed to protect people while also finding out crucial information about treatments. In Phase 1, only a very small group is tested, primarily to measure safety and find out about side effects. In Phase II, a larger group of people is involved, this time to find out more about the treatment’s effectiveness as well as safety. Should that go well, Phase III trials are made using a large group and actively comparing the new treatment to standard treatments, both for effectiveness and safety. Only after Phase IV is a new drug or treatment approved to go on the market, and only about one per year is approved by the FDA.
A clinical study is a vital way of testing new drugs and new treatments, and of finding breakthroughs in medicine that can improve quality of life and even extend life. Taking part can be a way of getting access to experimental treatment; but, more importantly, it’s also an important way of benefiting the cause of health care and medicine for all.