What is a clinical trial and what are the steps involved?
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.
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).
What are my rights?
Well this question falls under the Bill of Rights. What is the Bill of Rights? California Law requires any person taking part in research which involves medical investigations (clinical trial) to receive a list of rights which you obtain during your time in the clinical trial. This can also be received in your native language if it is not English. This document will be given to you alongside the informed consent form (ICF). It is not needed for you to sign the document but you can do so if you want to.
The Health Insurance Portability and Accountability Act of 1996 contains provisions to protect your confidentiality and security of personally-identifiable information that arises in the course of providing health care and after it has concluded. This includes your name, SSN, Medical Record number, geographic subdivisions (ie. house address), any element of dates that are linked to you (ie. Birth date), pictures and any kind of identifiable information to name a few. These are all examples of Protected Health Information (PHI).
A covered entity is the organization that has to comply with HIPAA. The University of California is a Hybrid Covered Entity because, in addition to providing health care at its medical facilities, it also has other organizational activities such as education and research.
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.
If you are interested in participating in a clinical trial then you should contact the study coordinator to set up a meeting to see if you are a candidate and fulfill the required criteria. Your study coordinator is the person you will have contact with throughout the life of the study. Your study coordinator is there to make sure that the trial is following all the necessary protocols. Your study coordinator is responsible for making sure all of the information including test results, vitals, medication to name a few, are correctly logged into the computer and are all up to date. Study coordinators will inform and update the principal investigator(s) of your progress in the trial. She/he is highly trained to conduct clinical trials using good clinical practice (GCP).