Clinical trials or clinical research studies are trials and experiments carried out on patients or volunteers to test the new medication, treatment or a newly invented medical equipment.
Clinical trials are carried out in four phases.
- Phase I studies- analyses the safety of the drug and the device. It does not require more than 20-100 volunteers. It tests how the medicine is absorbed and excreted. Side-effects are also observed. Most drugs pass this phase. This phase can take a few months to complete.
- Phase II studies- assesses the efficacy of the drug. It involves about a hundred volunteers. This is more of a blind, comparative study where neither the volunteers nor the researches know which volunteers are given regular medicine and experimental medicine. This comparative study helps getting a clearer picture on the effectiveness of the drug. One-third of the drugs pass this test. This phase can take several months to a year.
- Phase III studies- provides thorough understanding on the effectiveness. The benefits and side-effects are also ruled out. It involves up to thousand patients. 70%-90% of the drugs pass this test. With the end of this phase, the pharmaceutical companies can officially request FDA for the approval of the marketing of these drugs.
- Phase IV studies- also known as, Post Marketing Surveillance Trials, follows after the completion of the third phase. It keeps a track of the effectiveness of the medicine and the influence on the consumer’s life. This finally leads to the decision of keeping the medicine in the market or not. Restrictions and precautions are provided if necessary.
Some find it scary and do not participate in it. This is a huge misconception. People hesitate in volunteering for clinical trials. They are worried about the side-effects and further complications. The reality is quite the opposite. It is a safe procedure. These clinical trials are carried out after years of research and tests done on mice and rats. The following reasons will clear your doubts and help you see clinical trials as safe researches and not mere “experiments”-
- You will be aware of your condition. There will definitely be a better and clearer understanding of your medical condition.
- You are basically getting rid of or treating your medical ailment for free. The chances of a drug not working out are slim. It is a great opportunity to getting a free treatment.
- The research is carried out by a team of doctors, nurses and other health-care professionals. There is no way you or your situation won’t be handled safely.
- You will be informed about the procedure, the benefits and the side-effects prior to the research. You are free to opt out of the research anytime.
- You just might earn some money. Some pharmaceutical companies which are doing a research on a large-scale basis, pay some amount of money to the volunteers.
It is to be noted that there is no treatment or trial in the world that is considered 100% safe. Clinical Research & Clinical Trials are handled with a lot of precautions. Once you volunteer, the doctors and healthcare professionals are responsible for the side-effects or complications if there are any. As mentioned formerly, the tests are carried out after years of research.