THREE PILLARS OF CLINICAL TRIAL: SPONSOR, INVESTIGATOR AND SUBJECT

Clinical trial is an essential platform for testing efficacy and safety of any medicinal product, device or agents in human for the purpose of marketing in future. Any medicine should go through different phases of clinical trial before getting approval from regulatory authority for marketing by using healthy as well as targeted diseased human subject as volunteers. 

Development of a drug from any of potential compound detected on laboratory is a complex process which requires series of investigations, testing and trial by considering regulatory and ethical aspects. Total estimated timing new drug development is 12 to 15 years and estimated costs of 3.5 billion USD. here we discuss three major  and participating aspects as three pillars of clinical trial, which are sponsor investigator and subjects. 

1. sponsor:                                                                                                      Sponsor can be any person, organization or manufacturing company itself who initiates trial by selecting potential investigating site and investigator based upon area of expertise, quality controls by routine monitoring and auditing, owns all financial aspects through the process and acts as point of contact in case demanded by higher authority. 
2. investigator :                                                                                                      Investigators are doctors by profession who directly conduct study in human by taking medical decision of trial subject, giving intervention or investigational product, recording all clinical and laboratory evidences, management of any emergency situations and maintaining all record. In short, investigator is responsible for every activity within trial site. Investigators are selected by sponsor 

1. subjects:                                                                                                                      Subjects are those individuals who participate in clinical trials voluntarily by signing on informed consent form. Voluntariness of participants after being informed foreseeable risks and benefits is the key factor before initiating any interventions and should not be compromised. Institutional ethics committee is that body which takes responsibilities of protection of right, safety and well beings of human subjects, which gives approval/favorable opinions to conduct study after going in detail through protocol, investigator’s brochure, curriculum vitae of investigators, other documents related to data entry and analysis  for more information related to this topics with different prospective, go through following links .https://www.jstor.org/stable/pdf/25386081.pdf   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2028034/