A sponsor is a company, an institution, or an individual who is responsible for the design, development, management, and financing of a clinical trial from start to finish. While a sponsor may delegate certain tasks or activities to the study team, they are generally responsible for the overall quality of the study.
Some examples of clinical trial sponsors include government agencies, such as the National Health Service; health care institutions, such as academic medical centers and health maintenance organizations (HMOs); pharmaceutical, biotechnology, and medical devices companies; and private individuals, organizations, or companies.
Clinical trial sponsors play instrumental roles in ensuring the success of a study. They are actively involved throughout the stages of a trial. Some of their responsibilities include;
Before The Trial
Before the study commences, clinical trial sponsors select the appropriate investigator(s) who would spearhead the research. If necessary, they also select a contract research organization (CRO) – an organization hired to conduct the research on behalf of the sponsor.
They then proceed to draft the necessary contract detailing the activities and responsibilities of the investigator, before obtaining the ethics committee’s review report which confirms whether the trial can go on or not. Finally, they set up a data and safety monitoring committee to supervise patient safety and treatment progress while the trial is ongoing.
During The Trial
As the trial progresses, sponsors have to submit an annual status report to the recognized regulatory agency, which in this case is the Food and Drug Administration (FDA).
They also ensure the implementation of appropriate Quality Control systems to ensure the validity of trial data and make sure the investigation is conducted in compliance with the general investigational plan and protocols contained in the Investigational New Drug (IND).
They keep the FDA and all participating investigators abreast of significant events or risks concerning the drug that could potentially impact the conduct of the trial, participant safety, or impact the ethics committee’s approval and ensure the discontinuation of studies that pose an unreasonable and significant risk to the health of subjects.
After The Trial
After the completion of the trial, the sponsor is mandated to make the results of a clinical study public. Should a trial be discontinued, they must submit a summary report to the FDA which would contain information like:
- A brief description of the study
- Number of participants exposed to the drug
- Dose and duration of exposure
- Details of adverse drug reactions, if any, and;
- The reason for discontinuation of the study.
Finally, they would ensure the appropriate archival of study-related documents as well as disposal of any left-over Investigational Product.
Thinking about sponsoring a clinical trial? Choose CCR. Here’s why
At Carolina Clinical Research, we specialize in conducting clinical trials for infectious diseases. We have the facilities and expertise necessary to conduct clinical trials safely and effectively.
We have a proven track record in conducting timely, affordable, and effective clinical trials for many pharmaceutical companies and research facilities. When you choose Carolina Clinical Research, you can be assured that you will receive accurate study results with an attention to detail not found with larger clinical trial facilities. We would love to hear from you regarding your trial or study needs and will work with you to meet your needs. To get more information, click here.