The first step in creating a new medication is to gain as much knowledge as you can about the illness or condition. Basic research offers hints about prospective treatment approaches for illnesses, including addressing their symptoms or underlying causes. Equipped with a concept, scientists endeavor to comprehend the biological targets for a prospective medication. A protein, RNA, DNA, or other molecule that is connected to the disease in any way can be considered a "drug target." Next, they search for a lead compound, which is a promising molecule with the potential to affect the target and eventually develop into a medication. Investigators carry out investigations on animal models, tissues, and cells to ascertain whether a medication can affect the target, also known as pre-clinical tests. The process of discovery and development, which starts with basic research and ends with the release of novel medications that can save or improve lives, begins with this. But before the release of the novel medication into the health market, the US FDA does not make a determination about the safety and efficacy of a pharmaceutical until several phases of clinical studies have been completed for a larger patient group.[1]
Clinical trials (CT) are a type of clinical research that specifically tests the safety and effectiveness of new or existing medical interventions according to a plan called as Protocol defining the type of patient who may enter the study, Schedule of test & procedure, drug involved, dosage of the drug, length of the study & what is the outcome of the study. CT involves cross functional team of scientist, doctors, nurses & volunteers/participants who must agree to the rules and terms outlined in the protocol. CT provides another option for validation of new intervention when the standard therapy has failed.[3]
BioPharma R&D's, the contract research organizations (CRO's) and regulated (FDA approved) hospitals who plan the CT should strictly follow the Good clinical practices GCP guideline, this became essential since in the past a number of high-profile clinical trials failed, resulting in serious harm to trial subjects. International GCP standards were created by the ICH and initially released in 1996. The GCP guidelines were first published and have subsequently undergone multiple revisions. ICH GCP E6 (R3), the latest recent revision, was released in 2021. Clinical trial conduct is now standardized globally using GCP. It is in use in more than 100 nations worldwide.
The GCP guidelines address many different subjects, such as:
a) The obligations and rights of sponsors, investigators, trial subjects, and other trial staff
b) The planning and execution of clinical trial design
c) The gathering, logging, and reporting of data from clinical trials
d) Clinical trial quality assurance and control
Clinical trials benefit from GCP since it helps to guarantee that:
a) Trial participants are safeguarded from danger.
b) Data from clinical trials are precise and trustworthy.
c) Results of clinical trials are shared in an equitable and open way.
According to the GCP criteria, clinical trials:
a) Trial participants must provide informed permission after being made aware of the advantages and disadvantages of taking part in the study.
b) Throughout the experiment, trial participants must have access to medical treatment.
c) Trial data must be gathered, carefully recorded, and comprehensively maintained.
d) Trial findings ought to be communicated as soon as possible.
e) Trial sponsors are required to possess the financial means to sustain the trial.
Every clinical study carried out in a nation under FDA regulation must adhere to GCP. In order to guarantee that clinical trials carried out in nations not subject to FDA regulation follow global standards, GCP compliance is equally crucial. All things considered, the GCP principles offer a framework for carrying out clinical trials in a way that is secure, moral, and rigorously adheres to science. Ensuring the validity of clinical trial data and safeguarding the rights and welfare of trial participants depend on GCP ...
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