Trial Sponsor

Key facts

Defined in

21 CFR 312.3

Obligations

21 CFR 312.50 to 312.59

Can delegate to

A contract research organization, in writing (21 CFR 312.52)

ClinicalTrials.gov fields

Lead sponsor, collaborators and responsible party

What is a trial sponsor?

FDA regulations define a sponsor as a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or a pharmaceutical company, governmental agency, academic institution, private organization or other organization. The sponsor does not conduct the study itself unless it is a sponsor-investigator.

The sponsor is usually, but not always, the funder. A company may fund an investigator-initiated trial that an academic center sponsors, and agencies such as NIH sponsor or fund large studies. For an FDA-regulated drug trial, the sponsor typically holds the Investigational New Drug Application (IND).

What a sponsor is responsible for

Sponsor obligations under 21 CFR Part 312, Subpart D include:

• Selecting qualified investigators and giving them the information they need to conduct the study properly.
• Ensuring proper monitoring and that the investigation follows the IND and the protocol.
• Keeping FDA and all participating investigators informed of significant new adverse effects and risks.
• Controlling the investigational drug supply and maintaining required records.

Sponsors on ClinicalTrials.gov

ClinicalTrials.gov records list a lead sponsor and any collaborators, along with a responsible party who must register the trial and report results. Under 42 CFR Part 11, the responsible party is the sponsor unless the sponsor designates a qualifying principal investigator.

Sponsor names are entered as free text, so one company can appear under several spellings, subsidiary names or pre-merger names.

Why the trial sponsor matters

Sponsor is the primary field for pipeline and competitive analysis: it shows which organizations are developing therapies in a disease area and how their programs compare by phase. Business development teams look for small sponsors with promising mid-stage programs, contract research organizations and site networks use sponsor history to find prospects, and transparency researchers measure results reporting by sponsor.

Licensing deals and acquisitions change who owns a program, so the sponsor on an older record may no longer be the company developing the drug.