All over the world people use medicines for innumerable diseases and ailments. How safe they are – how efficient they are – and how they should be marketed and prescribed to patients? In order to find out the right answers for these vital questions, the Medical World consistently puts the new drugs, vaccines, and microbicides under stringent Clinical Trial Process.
This Process involves various stages checking the medicine step-by-step, before certifying its safety and efficacy, when given to human beings.
- At the very outset, Pre-clinical Testing is conducted to find out if there is any potential benefit in the medicine and also about its overall safety. This testing is conducted at the Lab on animals mostly. It may take from three to four years.
- An Application should be filed with appropriate Health Authorities, along with a detailed Report of the Pre-clinical Testing results, and also defining how future studies on the new drug are going to be conducted.
- Phase I Clinical Trial is conducted to assess the safety of the drug when applied to humans, and possible side-effects if any. The dosage to be used in future trials and also the fact of how the human body reacts is specified. This testing is conducted on a small group of volunteers (with HIV negative) of about 20 to 100 persons. This first phase takes months and up to 1 year to get completed. About 70% of drugs pass this testing.
- The next Phase II Testing is for ascertaining the effectiveness and safety of the drug, by applying to more number of people – from 100 to 300 persons. The participants of the study are divided into two groups – one group receiving the exact experimental drug and the other group (the “control” group) receives only standard medical care or placebo. Testing may last up to 2 years. Normally only 30% of the experimental drug successfully pass Phase I and II Testing. Comparative information about the safety as well as the effectiveness of the experimental drug is recorded in this Phase.
- In Phase II Large Scale Testing, the study is conducted on a number of people from 1000 to 3000. By this extensive study, the concerned drug manufacturers can ascertain everything related to the effectiveness of the drug, safety, benefits accruing, possible adverse reactions and their full details, as also the comparison with the standard drugs or methods in vogue. This Phase of testing lasts for several years. Almost 70 to 90% of the drugs, vaccines, and microbicides successfully complete the test. After this successful completion of this Phase III Testing, a manufacturing company can apply for approval of Health Authorities, for marketing the drug to the public.
- The manufacturing companies are required to file a New Drug Application (NDA) as also a Biological License Application. In these Applications, all the details about the Research conducted in the 3 Phases of Clinical Trial Process are to be recorded accurately. The Health Authority may take about 6 months for granting approval, and sometimes it may extend up to 2 years depending on circumstances.
- Once the approval is given by the Health Authority, the concerned drug, vaccine or microbicides will be made available to health care providers for a prescription. However, even though the drug is approved, the monitoring of reviews continues to ensure the safety and efficacy of the drug. If any adverse effects are found, they are reported promptly for quality control checks. The Health Authority can also order for post-marketing studies, so as to evaluate the long-term effects of the drugs.
- Sometimes Accelerated Approval of some drugs may be necessitated. In cases of serious diseases like AIDs for a newly invented drug or treatment strategy, quick approval from the authorities is required. Yet there will be no compromising on the quality of the drug, in respect of efficacy and adverse effects.
- Post Marketing Studies are called Phase IV of the Clinical Trial Process. These Studies are conducted to determine the long-term effects, as also the impact of the person’s quality of life after using the drug. Often time, these Studies are conducted on a different population of participants like children and the elderly. In some Studies, the cost-effectiveness of the drug or therapy is also ascertained when compared to other conventional or new therapies.
Global PharmaTek provides an extensive range of specific clinical research services to help the life science companies in bringing in new and fresh drugs and devices to the markets effectively and efficiently.