Clinical trials are research studies that involve human participants to explore new medical and surgical treatments or devices, cells and other biological products, preventative methods, and radiological procedures that are beneficial, effective and safe for human use. Their aim is to provide relevant and reliable data to the healthcare professionals which will help them in decision making. These research studies adhere to strict ethical and scientific standards to protect the patients.
A clinical trial has many steps that it has to go through before it can be regarded as a valid one. Each clinical trial starts after years of experience with the new product in basic science labs and animal studies. Once the studies show promising results in these experiments (which make take years to complete), the greenlight to start clinical trials with the new medication is granted. A clinical trial goes through 5 different phases. Food and Drug Administration (FDA) has described these phases as follows:
Each clinical trial determines the eligibility criteria for the study and therefore to be a part of a clinical trial one has to satisfy the eligibility criteria. Some trials look for people affected by specific conditions or disease states whereas some clinical trials look for healthy participants.
Safety of participants in clinical trials is considered as the highest priority for clinical researchers. There are scientific oversight committees/organizations that ensure that the standards for safety of participants are never compromised. Some of the organizations that work towards this goal are the Institutional Review Board (IRB), Food and Drug Administration (FDA), Data Safety Monitoring Board (DSMB) and Office for Human Research Protections (OHRP).