Industry-Initiated Studies

1. Definition: These are research studies sponsored and often funded by pharmaceutical companies, biotechnology firms, or medical device manufacturers.
2. Purpose: The primary goal is typically to test new drugs, devices, or treatment strategies developed by the industry. These studies are often aimed at obtaining regulatory approval and eventually marketing the product.
3. Design and Conduct:
   
   • Design: The industry sponsor designs the study protocol, including the research questions, methodology, and endpoints.
   • Funding: The sponsor provides the financial resources needed to conduct the study, including costs for recruitment, data collection, and analysis.
   • Oversight: The sponsor often has significant control over the study's conduct and may employ contract research organizations (CROs) to manage various aspects of the trial.
4. Advantages:  
   • Resources: Industry-initiated studies often have more financial resources and access to advanced technologies.
   • Speed: These studies can sometimes be conducted more quickly due to dedicated funding and resources.
5. Considerations: 
   • Bias: There may be concerns about potential bias, as the sponsor has a vested interest in the outcome. However, regulatory bodies and ethical review boards work to ensure the integrity of the research.

Investigator-Initiated Studies

1. Definition: These are research studies initiated and designed by individual researchers or academic institutions rather than industry sponsors.
2. Purpose: The focus can be on a wide range of research questions, including exploring new uses for existing treatments, testing novel hypotheses, or addressing clinical questions not covered by industry-sponsored research.
3. Design and Conduct:
   • Design: The investigator or research team develops the study protocol based on their research interests and expertise.
   • Funding: Funding may come from grants provided by government agencies (like NIH), non-profit organizations, or institutional funds. In some cases, industry may provide partial funding or resources, but the research is led by the investigator.
   • Oversight: Investigators have control over the study design and conduct, although they must still adhere to regulatory requirements and ethical guidelines.
4. Advantages:
   • Independence: Investigators have the freedom to explore research questions without industry constraints.
   • Innovation: These studies can lead to novel discoveries and new areas of research that might not be pursued by industry due to commercial considerations.
5. Considerations:
   • Resources: Investigator-initiated studies may have fewer resources compared to industry-sponsored trials, potentially impacting the scale and speed of research.

Summary

• Industry-Initiated: Funded and conducted by pharmaceutical or medical device companies with a focus on their products, often with more resources but potentially more conflicts of interest.
• Investigator-Initiated: Led by researchers or academic institutions with independent research goals, potentially with less funding but greater freedom in research focus.

Both types of studies play crucial roles in advancing medical knowledge and improving patient care.

If you have any questions about next steps to set-up a clinical research project, contact your pre-award Fund Manager or Christine Moran at clmoran@health.ucsd.edu