Imagine having a drug that makes you unhealthy and later revealing that the drug was incompetent to cure your disease and could become the reason for some side effects. It can be fatal for the public at large who are consuming that drug. Therefore, clinical trials are essential before allowing such new drugs to distribute. The Central Drug Standard Control Organization (CDSCO) is India's national regulatory authority (NRA) responsible for Clinical Trial Approval in India. CDSCO also gives a quality check to the imported drugs and sets standards. CDSCO (Central Drugs Standard Control Organization) coordinates with the State Drug Control Organization and helps them with expert advice and training to maintain uniformity in implementing the Drugs and Cosmetics Act. The primary role of CDSCO is to give permits for the license of certain specialized types of critical drugs.
What is a Clinical Trial?
The Clinical Trial definition describes that a clinical trial is a structured investigation involving human subjects to study a new or investigational new drug. Its purpose is to collect data on the drug's clinical effects, pharmacology, pharmacodynamics and pharmacokinetics, and adverse effects. The main objective is to evaluate the drug's safety, efficacy, and tolerance.
Academic Clinical Trial refers to a clinical trial of a drug already approved for a specific claim that is initiated by any investigator, academic, or research institution for a new indication, new route of administration, new dose, or new dosage form, and the results of which are used only for academic or research purposes and not for seeking approval from the Central Licensing Authority or regulatory authority of any country for marketing or commercial purposes.
Why Clinical Trials Are Executed?
Clinical trials are an essential research technique for furthering medical knowledge and improving patient care. Doctors conduct clinical research when unsure whether a novel strategy is effective and safe in humans and which therapies or tactics are appropriate for specific illnesses or groups. Clinical trials are critical for discovering novel disease treatments and new techniques to detect, diagnose, and prevent disease development. Clinical trials can demonstrate to researchers what works and doesn't work in people, which isn't possible to discover in the lab or with animals. Clinical trials can assist doctors in determining if the risks of a new treatment are acceptable compared to the possible benefits. The outcomes of clinical trials are unknown to researchers.
Public Participation in Clinical Trials
Because of this uncertainty, patients may find it difficult to determine whether or not to participate in a clinical trial. While patient volunteers rarely get harmed by a clinical trial's therapy or procedure, millions of patients have benefited because others before them volunteered to participate in a trial that resulted in a new, more effective treatment. While clinical trials are vital, the decision to participate in one is personal and based on your specific circumstances. When presented with a clinical study, you and your doctor must assess the advantages against the dangers and decide what is best for you.