Let’s learn more about what Clinical Research Actually Is……
In brief, clinical research is a branch of health and medical research which is intended to produce valuable knowledge and insight of all kinds of human diseases. There is a massive service rendered towards mankind in disease prevention and treatment promoting good health by clinical research. Thus, investing in a career in clinical research earns you not just a stable and viable career but you also render a great service to the world.
Clinical research embraces an array of studies which involve the interaction with patients, diagnostic clinical materials and medical data in the categories of disease mechanisms, translational research, clinical knowledge, detection, and therapeutic interventions including development of drugs, biologics, devices, and instruments as well as community-based and managed care-based trials.
Some of the main components of the clinical research includes:
Sponsors: This includes both private and public sector funding organizations such as the National Institutes of Health, pharmaceutical companies, medical device manufacturers, biotechnology firms, universities, private foundations, and national societies. Sponsors in the public sector includes the National Institutes of Health (NIH), which is the largest clinical research sponsor.
Research Organisations: This includes academic health centers, private research institutes, as well as contract research organizations.
Investigators: These are the scientists and clinicians performing clinical research from varied disciplines with a range of academic qualifications. At a clinical trial site, the principal investigator is responsible for the conduct of the clinical trial. The sub-investigators are delegated by the principal investigator to help with the clinical trial conduct.
Participants: These are the subjects or participants who are volunteers willing to participate in a clinical trial. The participants may have various health conditions for which they are taking part in the clinical trial and they offer their consent through an informed consent process.
Oversight entities: The oversight entities include the Institutional Review Boards, Food and Drug Administration, Department of Health and Human Services, National Committee for Quality Assurance, and other national regulatory agencies which independently give oversight to clinical trial conduct.
Stakeholders: For the success of the clinical trial being conducted, the clinical trial has to be conducted with the participation of many stakeholders. These include the clinical trial site staff who are the internal stakeholders. The clinical research coordinators are the backbone of clinical trial conduct. They help with the coordination of day to day activities at the trial site and are assisted by a clinical research assistant. The clinical research staff who are delegated to perform clinical trial activities should be GCP certified. The other stakeholders include the healthcare systems and patient advocacy groups.
The drug development process does not happen overnight, it is a process which takes some years to come into light, starting with pre-clinical trials, the actual trial process and post-approvals. The sponsor submits a New Drug Application with FDA to obtain the approval once all the phases of the clinical trial are complete. Thus, clinical research is a long journey which has a huge positive impact in our lives.