The Process Of Clinical Trials
Clinical trials are the tests conducted on human subjects after the laboratory and animal tests have been done. It involves the testing of a chemical, drug, medical equipment or a dietary supplement. These are conducted to find new methods for the treatment of diseases, and improving the living standards all over the word.
There are fifteen to fifty people in the initial phase of testing. Phase 1 has two main objectives: –
- To find out the best way to give the new treatment.
This implicates that whether the drug developed, will be injected by a syringe or given in the form of a tablet. The most effective method is found out by conducting this test.
- To determine the dosage that can be given to the patient.
Inferences can be drawn from the tests about the amount of a drug or the concentration of a chemical that can be administered to the patient without casing side effects.
All the tests are done by trained and experienced professionals. They monitor the test results and after a strenuous verification, the trials progress towards Phase 2.
After determining the dosage to be given and the method of giving it, the testing subject( drug, chemical or supplement) is tested for its effectiveness. This is also the primary aim as without knowing the effectiveness of a certain medicine, one cannot take the treatment ahead.
There are usually fifty to one hundred people involved in a Phase 2 trial. In which researchers aim to find out the benefits of the medicine, for instance, if the tumor size has reduced, increased or remains the same. There can be some other significant observations like if the drug is improving the strength of the body, or if the survival time of the terminal illness has increased.
If the benefits obtained in Phase 2 of the clinical trials are desirable and effectiveness of the treatment is acceptable, the trials go into the third phase. In this phase, masking is introduced, in which the patients are more than 100 and none of them has any idea, as to which drug is being tested on them. Neither the researchers know about it. This test is also referred to as the double binded tests. This randomization brings out more meaningful results as it eliminates the psychological hindrances that are caused by preconceived mindset and notions.
Drug administrations agencies are responsible for assigning new treatments and set standards for human safety. Therefore, certification from these agencies is essential before the induction of any clinical trial into the final stage.
In the final stage, there are close to a thousand test volunteers. Such a large number is necessary to validate the results for a larger variety of people. In clinical trials It is common to see a medicine treating a disease effectively for one person and doing no good at all to another person. Therefore, this stage is crucial to find out if a larger population can be benefited from the breakthrough. Also, a keen focus is given on the probable and observable side effects of the drug on different people.
Clinical trials are conducted to bring out a new treatment to an ailment, that is more effective and has less side effects. While volunteering for clinical trials can be highly rewarding, precautions and detailed knowledge of the process is considered necessary.