CORE Kidney

Information on Clinical Trials

Clinical trials

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.

Phases of a Clinical Trial

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:

  • Early Phase 1 (Formerly listed as "Phase 0"): Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies)
  • Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.
  • Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance, called a placebo, or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
  • Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
  • Phase 4: Studies occurring after FDA has approved a drug for marketing. These including post market requirement and commitment studies that are required of or agreed to by the study sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Participating in a clinical trial

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 the 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).

Read the Bill of Rights (your rights as a participant in a clinical trial)