Who Are Clinical Trial Sponsors?

Clinical trial sponsors play an important role in determining the viability of a clinical study. They oversee the overall study design, facilitate funding sources and develop beneficial procedures to help guide the study towards a successful outcome.

Sponsors are responsible for overseeing the study’s continued progress.

Clinical study sponsors may either be an individual or a pharmaceutical company, charged with overseeing various tasks that are critical to the success of the study.

Some of the responsibilities of a sponsor may include:

1. Designing the study to address key research or medical questions
2. Finding and hiring qualified study investigators
3. Ensuring investigators are briefed on all data pertinent to the clinical study
4. Monitoring the clinical study and verifying the trial is compliant with the protocol identified in the Investigational New Drug (IND) application
5. Keeping the FDA, ethics boards or regulatory agencies abreast of any identified side effects, safety concerns or benefits of the investigational drug
6. Lastly, ensuring budget adherence, managing investor expectations and communicating issues to stakeholders

A variety of organizations may sponsor a clinical trial.

According to the U.S. National Library of Medicine, clinical trial sponsors may include:

• Government agencies; such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA)
• Private individuals, companies or organizations
• Pharmaceutical, biotechnology and medical devices companies
• Health care institutions, such as academic medical centers and health maintenance organizations (HMOs)

Funding sources may range depending on the study scope.

Sponsors help secure the budget necessary for a clinical trial by facilitating grants and soliciting investor contributions. The costs associated with a given trial may range depending on the following information:

1. Volume of participants
2. Staff size needed for study completion
3. Manufacturing of research materials needed
4. Amount of patient compensation,
5. Length of clinical study
6. Approval status of the investigational drug.

According to Wikipedia, “the cost of a study depends on many factors, especially the number of sites conducting the study, the number of patients required, and whether the study treatment is already approved for medical use. “

Learn more about clinical trials.

OCRC sponsors and Contract research organizations, like Covalence, work hard to streamline our regulatory process, volunteer recruitment and data management capabilities. Our website explains the full nature of their specific contributions and responsibilities.

Would you like to learn more about clinical trials? We are happy to offer tours for volunteers who meet study criteria at our state-of-the-art clinic. Please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.