Developing a new medicine is a sophisticated and complex task which initially begins with the understanding of disease or condition as thoroughly as possible. At first, the researchers conduct studies in cells, tissues and animal models to determine whether the disease or condition can be influenced by new molecule. After that clinical trials establishes new molecule (IND) as a drug and also provide information that how drug acts on underlying diseases.
Clinical trials are potential biomedical or behavioural research studies on healthy human volunteer as well as patient that are intended to respond particular questions about experimental medicine or functional interventions like new vaccines, drugs or dietary supplements. The clinical trials are conducted only when the appropriate information is submitted to government health authority/ethical committee and their approval is granted,. There are three primary groups involved in the conduct of clinical trials: sponsors, clinical investigators and IRBs. Beside, human subjects and regulatory agencies also involved in clinical trials.
For conducting clinical trial, there is a proper protocol which describes aim and objectives of the study. Every clinical trial has its own terms and conditions, i.e who will take part and who won’t. Clinical trials either need volunteer who have the disease in question, or a healthy volunteer. There are Ethical Codes like ICH GCP Guideline, Good Clinical Practice (GCP) which is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data generated is credible.
Clinical trials are important for every drug development process because they intensify our understanding of human physiology, pathophysiology and translate fundamental research into medical care. Clinical trials are led by a principal investigator, who is usually a medical doctor, and a research team of nurses and other paramedical staff. There are different phases of clinical trials: Phase I: testing of drug in a small group of people (nearly 20-80) to estimate the safety, evaluate appropriate dosage and detecting side effects. Phase II: testing on larger group (nearly 100-300) to estimate effectiveness and safety of drugs. Phase III: testing on large groups (nearly 1,000-3,000) to assure efficacy, monitoring of side effects and collection of data which will allow it to be used safely. Phase IV: deals with post marketing studies which includes adverse drug event, risk & benefits, optimal use of therapy.
If the results of all required clinical trials phases show that the investigational new drug is safe and effective, the company submits a New Drug Application or Biologics License Application to the regulatory authority. This application, which includes reams of data from all the stages of testing, is a request for regulatory approval to market the new medicine. Scientists at the regulatory authority carefully review all the data from all of the studies on the investigational drug and, after weighing the benefits and risks of the potential medicine, they approve the drug for marketing. These medical/clinical trials or researches accomplish the results of clinical investigations through proper regulatory channels without compromising the health of trial subjects or patients.