Most of us hear the term clinical trial on drug advertisements since that’s the compulsory progress a medicine must go through before entering the market. Yet, not many people know the people standing behind the process. In this article, we are going to uncover the pipeline and reveal the four big guys in a clinical trial.
Sponsors are basically entities who want to conduct a clinical study. These can be the government with a hope of developing a new drug to fight a national plague, or private agencies such as pharmaceutical companies, medical centers, non-governmental organizations and individuals with business purposes. Since sponsors are covering the cost of the entire study, they will gain benefits once the new drug is approved for mass production.
Thus, sponsors have the full control over the course of the trial. Sponsor staff work closely with investigators to tackle problems and minimize mistakes, for example directly participating and having a say in any modifications made along the way in the case of an adaptive clinical trial model.
Normally, all pharmaceutical companies have clinical trial departments who are in charge of conducting trials for new drugs. However, ever since the start of the 21st century, the trend has been outsourcing to contract research organizations (CROs). Proof of this trend is the flourish of CRO companies such as Parexel, Quintiles, and Covance, together with the dynamic and robust merger and acquisition (M&A) activities in the CRO market.
These CROs are the actual conductors of the trial. Although sponsors can choose to outsource partially or completely, more and more research is being entirely carried out by CRO. Services vary among companies, but with regards to clinical trials, CRO can offer an A-to-Z service package: from writing the protocol to recruiting personnel such as investigators, clinical research coordinator (CRC) and clinical research associate (CRA), to contacting sites and recruiting patients, to analyzing the dataset and reporting to FDA.
A regulatory agency is the authorized entity that governs clinical trials in general. In other words, it sets out standards and regulations for trials to comply with and makes the final decision on whether the treatment is eligible for mass production. Note that the regulatory agency not only checks up after the trial has been done, but results after each phase must be submitted for review before the CRO gets permission to conduct the next phase. This is because only a minority of drugs make it to Phase IV; the rest have failed from earlier phases.
Each country has their own regulatory department, such as the Chinese Food and Drug Administration (CFDA), U.S Food and Drug Administration (FDA), Korean Food and Drug Administration (KFDA). In Europe, the authorized entity is called European Medicines Agency (EMA). Despite having different names, these agencies all serve to regulate the activity of clinical trials and protect the rights of patients.
Third-party vendors in clinical trial
Not in the straight chain of the clinical trial process, these third-party vendors come into view as outsourcing entities for CROs. The term can mean a variety of organizations, from hospitals which act as sites to technology companies which provide clinical data management solutions. Rather than complicating the procedure, these vendors contribute to the smoothness of the trial and at the same time release pressure for CROs.
When deciding to conduct a trial, sponsors can suggest vendors for the study themselves, or rely on CROs to make that choice. However, the Good Clinical Data Management Practices (GCDMP) suggests that sponsor delegates that have expertise in the field being outsourced should take part in vendor evaluation. This is to make sure that the company chosen offers services that comply with FDA standards and regulations as well as standard operating procedures (SOP).
Thanks to these four players in the industry, the clinical trial process has been smooth enough to produce new drugs every year to improve healthcare all over the world. With the growing trend of the pharmaceutical market in general and clinical trial market in particular, we should be able to see more companies entering the game as well as existing companies expanding.