Every day, medical professionals worldwide engage in clinical research to push the boundaries of medicine. Clinical trials, a significant category of clinical investigations, are vital in developing new medications. Clinical research involves investigating medical treatments and procedures involving human participation. Some research undergoes extensive study, often spanning numerous years or even decades.
Preclinical research provides fundamental insights into a drug's safety, but cannot replace investigations into how the drug will interact with the human body. However, clinical research involves the human body. As developers plan a clinical trial, they will carefully define their goals for each clinical research process and initiate the Investigational New Drug process (IND) beforehand, a mandatory step before beginning clinical research.
In the first phase, the drug or device undergoes initial testing and evaluation on human subjects for the first time. It is administered to healthy humans. Scientists aim to evaluate and establish the therapy's safety during this early testing phase across multiple months. A limited group of fit people, typically 20 to 100 individuals, receive the treatment, and their response is meticulously observed.
This phase in the clinical research process aims to determine if the outcomes observed in animal studies will translate to humans, including the presence and severity of any side effects, and identify the appropriate dosage levels. The researchers aim to investigate how the medication interacts with the human body, assess its absorption, metabolism, and elimination, identify its side effects, and determine correct dosages.
In the next process, the researchers give the medication to a group of individuals with a specific illness or ailment that the medication is intended to treat to ascertain its efficacy. Usually, with only a few hundred participants, this research process lacks the size necessary to determine if the medication will provide any advantages.
This research stage provides researchers with supplementary safety information. The researchers use this data to fine-tune their inquiries, formulate research techniques, and craft fresh blueprints for the following process. Also, randomized experiments are conducted during this phase, assigning individuals to either a "control group" or a "placebo group." People are closely observed, and any adverse reactions are documented.
During this process, the researcher assesses the efficacy and safety of a new treatment compared to established treatments. Research activities may go on for years, commonly conducted without bias or randomly, and include hundreds to thousands of individuals.
This phase provides the majority of safety information. Previous research might have missed identifying common side effects. Due to these studies' larger scale and longer duration, they are more inclined to reveal uncommon or enduring side effects. Also, conducting extensive tests at a large scale gives researchers a comprehensive grasp of the treatment's efficacy, long-term advantages, and potential adverse effects.
During the clinical research process, it is vital to undergo evaluation by the local institutional review board (IRB) within the medical facilities where the trial is conducted. Without approval of the clinical trial's content, the trial cannot proceed.
In addition to medical professionals like doctors, nurses, and pharmacists, the IRB also includes individuals from outside healthcare institutions, such as university faculty and professionals in welfare-related fields. Having people with varied backgrounds helps ensure the impartiality of the review process.
