The development of new vaccines, drugs, dietary supplements, and medical devices is a long process. Years of research and development are followed by clinical trials. Clinical trails are medical research studies carried out in clinical settings, involving volunteers and patients. They can last over a period of years and produce important information about new drugs and treatments. Many people believe that taking part in clinical trials is as important for the functioning of the healthcare system as donating blood.
How clinical trials are set up
Clinical trails can begin only when the project has been approved by health authorities in the country and the relevant ethics committee. Participants in clinical trials can be volunteers or patients. The approval process involves calculating the risks versus the benefits of the drug or treatment. Approval at this stage pertains to the trials and not to the drugs, treatments or devices themselves.
Trails begin with small group pilot studies and then progress to larger groups and comparative studies. They can be a carried out in a single or multiple locations and facilities, and even in several different countries.
The phases of clinical trials
Clinical trails are carried out by large organizations like government facilities or pharmaceutical, biotechnology or medical device companies. Monitoring and lab work may be down by outside
research organizations or laboratories.
- In Phase 1 clinical trials typically test experimental drugs or treatments on small groups of 20 to 80 people. At this stage, the goal is to evaluate safety and to discover any side effects.
- Phase II trials of a clinical study use larger groups, of 100 to 300 people. At this point, both safety and effectiveness are being evaluated.
- In Phase III of clinical trials, expand the test groups to 1,000 to 3,000. The focus is on effectiveness, side effects, and comparisons with existing standard or equivalent treatments. All of this information is used to ensure that the drug or treatment can be used safely.
- Phase IV happens after the drug or treatment is on the market. It is concerned with the effects of the drug on large populations and with identifying any side effects due to long term use.
Ethical issues in clinical trials
Biomedical or behavioral research on human subjects must be done under ethical safeguards. Clinical trails must be approved by an Institutional Review Board (IRB) which makes sure that the study is ethical, that it protects all participants, and that the risks involved in the study are reasonable in relation to benefits.
If children under the age of 18 are to participate in a study, researchers must obtain written permission from a parent or guardian.
Clinical drug development is a complex process that takes a long time to complete. It is estimated that while 5,000-10,000 drugs annually enter R and D, only five make it to clinical trials, and of these, only one gains FDA approval. This process is necessary in order to move medical research and treatment forward.