12.10:
Clinical Trials
Clinical trials are prospective studies conducted on humans to determine the safety and effectiveness of a newly developed treatment, drug, diet, or medical device.
Clinical trials are conducted in different phases. Some early-stage trials may examine the drug's effectiveness and side effects. In later stages, tests are conducted to find out whether the new treatment is better than the existing one.
Traditionally, clinical trials are conducted in four phases.
Phase I trials involve healthy volunteers to get early data on new treatment methods in human pharmacology and decide the dose or range of doses.
Phase II trials involve patients with a disease to explore the safety and efficacy of the new treatment.
Phase III trials are therapeutic confirmation studies involving several thousand patients over a short time. Following the completion of phase III trials, the sponsor submits a report to regulatory agencies for marketing approval.
Phase IV studies explore therapeutic use after a drug has been approved and marketed to populations with several other conditions, such as patients with compromised liver functions and taking several concomitant medications.
12.10:
Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one study establishes the basic pharmacology profile, such as absorption, distribution, metabolism, and elimination of drugs. In phase two, studies demonstrate the safety profile and efficacy of the drug. During the third phase, several hundred to several thousand patients are involved over a short period to establish the drug dose, dosage, and efficacy. As soon as the phase three trial is completed, the results are submitted to regulatory agencies such as the FDA for approval to market the drug, as long as the drug meets all the requirements and is marketed for regular use. Post-marketing surveillance is the fourth phase of clinical trials. Researchers examine the drug's therapeutic potential in diverse populations with various clinical conditions and taking multiple medications.