subject: What Are Clinical Trials? [print this page] Clinical trials are studies which are conducted in a scientific and regulated environment to evaluate the safety and the efficacy of a molecule which warrants therapeutic benefits.
It is done to ensure whether a particular drug is safe for consumption and ready to market. Conducted worldwide by Pharmaceutical companies, these trials are conducted through an in-house Research and Development center or outsourced to a Contract Research Organization (CRO). A panel of Investigators headed by a Principal Investigator work in conjunction with CRO team at carefully selected trial sites.
Different types of clinical trials (Phase I to Phase IV) have different approaches and regulations in place. Some trials are conducted to diagnose a disease in a better manner and some to find a better treatment for a particular medical illness. Then there are few other trials undertaken to prevent the growth or occurrence of a particular disease in some people or to prevent re-occurrence.
Ready to Volunteer
Depending upon the phase, the trials are conducted on either healthy volunteers or patients with specific disease. In all cases the study participants commonly known as subjects are well informed about the study procedures (commonly known as the Informed Consent Form or ICF), the risks and the benefits of the drug that is being evaluated and any other queries they may have in their mind for the same. These are carefully conducted research studies undertaken and led by clinicians in the field of science and medicine. This process is commonly known as the Informed Consent Process which forms the basis of todays clinical trials across the globe. The medical team is well equipped to ensure that any side effects and/or adverse reactions are well taken care of and controlled.
Clinical Trial The Agenda
Every clinical trial has a study design and a study protocol, a how-to-proceed list. This explains as to what will be done in the study, who are the people who can participate, how to go about with the trial and why each part of the study is necessary. Trials are phased out in Preclinical and Clinical Stage. After confirmation of the safety and efficacy of the drug in the in-vitro stage they are then moved into human clinical trials (in-vivo) which are conducted in different phases namely from Phase I- Phase IV.
Clinical trials have come a long way since the time they were looked upon with negativity and conjuring images of unethical treatment meted out to subjects who are treated with little or no respect. However, the awareness that has spread bringing to light the ethical framework of Clinical trials and the protection of Subject rights have all led to countries collaborating to bring to the world safer and effective healthcare at affordable costs.
