Different Stakeholders in Clinical Research and Drug Development

harmaceutical and Biotech Companies are organizations or companies that fund and oversee (or “sponsor”) clinical trials.

Patients and Participants are individuals who volunteer to participate in clinical trials, providing data and samples for research.

• Patient Advocacy Groups represent the interests and concerns of patients who may be affected by specific diseases or treatments.
• Ethics Committees/Institutional Review Boards (IRBs) ensure the ethical conduct of clinical trials and the protection of participants’ rights.

Regulatory Authorities regulate and approve new drugs and ensure their safety and efficacy through reviewing clinical trial data in their jurisdiction (i.e., US FDA in US, EMA in the EU, TGA in Australia, etc.).

Investment and Funding Entities such as venture capitalists provide funding to biotech companies in the early stages of drug development. Philanthropic organizations and foundations often fund clinical trials for specific diseases (e.g., Alzheimer’s), and government grants and other government agencies may fund certain types of research.

Healthcare Professionals including principal investigators (physicians who lead clinical trials), clinical research coordinators, and other clinicians or healthcare providers oversee or treat patients at research sites.

Clinical Trial Sites are hospitals, clinics, and private practices that host and conduct clinical trials.

Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs)

Full-service CROs provide outsourced research services to pharmaceutical companies, from patient recruitment and trial management through data analysis; specialized CROs focus on clinical trial monitoring, regulatory affairs, data management, or other specific functions/service.

Manufacturers of Active Pharmaceutical Ingredients provide the raw materials from which CMOs produce the drug products for clinical trials, while other clinical trial suppliers provide the medical and other equipment for clinical trials.

Health Insurance Providers can help identify patients for clinical trials and shape drug treatment costs and reimbursement policies.

Types of Partnerships in Clinical Research and Drug Development

Large-scale multinational partnerships involve multiple stakeholders from different countries or continents to address global health challenges and often focus on infectious diseases that affect populations across the globe (e.g., HIV, malaria) or cancer research.

Drug development start-up companies often form partnerships with venture capital firms to raise the funds (and refine strategies) needed to bring a drug candidate through early-phase clinical trials. Larger investors or private equity firms often provide significant financial backing to fund late-stage drug development or commercialization efforts.

Two partners can agree to collaborate to mutually develop a drug (i.e., one partner conducts research, the other conducts commercialization) through a co-development agreement; two partners can also establish a separate entity as a joint venture to jointly develop and commercialize a drug.

A smaller pharmaceutical or biotech company may enter into a licensing agreement to license its drug candidate or technology to a larger pharmaceutical company for further development and commercialization.

Public-private partnerships bring government agencies, academic institutions, and private companies together to work on specific areas of drug development, such as vaccines or a treatment for a rare disease.

Government agencies such as the US National Institutes of Health or nongovernmental organizations like the Bill & Melinda Gates Foundation often provide public funding or grants for drug development projects in areas with unmet medical needs (e.g., rare, tropical, or neglected diseases).

Pharmaceutical companies often engage in research partnerships to fund universities or academic institutions conducting basic or early-stage research, often in innovative discoveries that pharmaceutical companies can advance in clinical development. Research sites often engage in clinical trial site partnerships with sponsors for executing that company’s clinical trials.

Pharmaceutical and biotech companies often engage in outsourcing agreements with CROs to outsource clinical trial management services, which allow these companies to focus on drug discovery and development. Some companies enter into full-service partnerships with CROs to manage every aspect of their trials; they may also partner with CMOs for the manufacturing of drugs during clinical trials.

Pharmaceutical companies often work with patient advocacy groups through advisory or consulting partnerships to ensure that clinical trial designs and outcomes prioritize patient needs. Pharmaceutical companies and patient advocacy groups may also partner in joint advocacy initiatives to promote funding or policy changes to support certain diseases or conditions.

Pharmaceutical companies often collaborate through data science partnerships with technology companies to collect, manage, and analyze the large volumes of data generated during clinical trials. Electronic health record (EHR) partnerships allow pharmaceutical companies to partner with hospitals or health systems to access deidentified EHR patient data for observational or post-marketing surveillance studies.