Clinical Research Industry – Stakeholders/ KeyPlayers
Clinical Research industry is a dynamic and interdependent industry. The industry works in collaboration with various organizations. The stakeholders of clinical research industry are subjects, sponsor, investigator and team, government agencies, Regulatory authorities, monitor, Institutional review board, Contract research organization, Independent ethics committee, Academic institutions, public and private sectors whose contribution significantly influence the clinical research process.
All Stakeholders are bounded by three basic responsibilities – Ethical, Scientific and Administrative Responsibilities.
Sponsors are primary stakeholders who intiates, organizes, finances clinical research. Sponsors can be an individual or company or an organization. Usually, Sponsors are pharmaceutical company, biotechnology companies, Academic Institutions.
Investigator and investigator team is appointed/hired by sponsor. The Investigator team is constituted by co-investigator, sub-investigator, clinical research coordinator, study nurse, pharmacist, laboratory personnel, research assistant and subject recruiter. All team members should be qualified, experienced and trained to conduct assigned clinical research duties under supervision of principal investigator. Clinical Research should be conducted in accordance with ethical principles that have their origin in declaration of Helsinki and consistent with good clinical practice, standard operating procedures and Applicable Regulatory Requirements.
Regulatory Authorities are the stakeholders responsible for giving permission to conduct clinical research in the country. The sponsor submits the investigational new drug application or new drug application to the regulatory authorities for review and approval. Once the sponsor obtains approval to initiate and continue the research, regulatory authorities conduct audits and inspection upon serious non compliance, major violations. Regulatory Authorities are also responsible for ensuring protection of public health by safeguarding rights, safety and wellbeing of trial subjects
Institutional review board or independent ethics committee is stakeholder at the clinical research site. Trial should be initiated at the site only after approval from the ethics committee. Ethics committee is responsible for protecting rights safety and well being of trial subjects, Review of ongoing clinical trials, compensation and payments to trial subjects.