Who initiates clinical trials – Sponsors, NIH or PI?

08 Oct Who initiates clinical trials – Sponsors, NIH or PI?

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A frequently asked question : Who initiates clinical trials – Sponsors, NIH or PI?

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In general, there are two main types of clinical trials:

  • Sponsor initiated trials

  • Principal Investigator (PI) initiated trials

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Sponsor-initiated trials are by their nature, large scaled-multi-site trials mostly characterized in different phases – I, II, III, IV.  The sponsor owns the protocol and the drug or device; trial is mostly patient-based research; trials are done in strict adherence to FDA, IRB/IEC, and ICH GCP.

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Sponsor-initiated trials begin with field representatives (the CRAs) of a medical company making contacts with hospital or research institutes for a possible clinical trial. The sponsor provides the funding, the project resources, investigator, coordinator and the data monitoring system. It is mandatory that the Sponsor is available for an emergency.

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Because sponsor-initiated trials are large and done in multi-site, the use of local IRB is mostly never needed. Data Safety Monitoring Board (DSMBs) with relevant expertise are used to review accumulating data by coded treatment group across the sites to detect early signals relevant to safety/toxicity, feasibility, and efficacy. Most Sponsor-initiated clinical trials go through IND/NDA process and for that reason all SAE must be reported to Sponsor/manufacturer, IRB/IEC, and FDA promptly (See FDA reporting guidelines)

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trial-initiation

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PI-initiated clinical trials are done on a small scale. They are initiated by a  scientist pursuing own research who becomes the PI. The PI performs the monitoring function as part of the general oversight and scientific leadership of the study. With such trials, the PI secures funding for the trials, provides his own database manager, Biostatistician, and Laboratory scientist. In case of an emergency, the PI/designee must be available.

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Because PI-initiated trials are mostly limited to a single site, local IRB is used to evaluate and determine compliance issues. PI-initiated trials are mostly Non-IND and for that reason all SAE are reported directly to the FDA med-watch program.

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The National Institutes of Health (NIH) is a biomedical research facility and is an agency of the United States Department of Health and Human Services. It is the primary agency of the United States government responsible for biomedical and health-related research. The NIH both conducts its own scientific research through its Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program.

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The organization leans on both the side of the PI in its Intramural Research capacity and on the side of the Sponsor on its Extramural Research capacity. In other words NIH could fill a PI-initiated or Sponsor-initiated capacity in clinical trials. The only difference in terms of being a PI- is the finance aspect of the clinical trial, instead of securing funds as in normal PI-initiated clinical trials; they fund both Intramural and Extramural clinical trial researches.

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 Hosanna Gerizim, HGCR consultants