Investigational New Drug Applications
All clinical research involving investigational drugs and devices, or other products regulated by the Food and Drug Administration (FDA) must comply with all applicable FDA requirements. Claremont McKenna College requires IRB and Keck Science Department approval before such research can take place.
An Investigational New Drug (IND) application is submitted to the FDA if a drug not previously authorized for marketing in the United States is intended to be used for the purposes of clinical investigation.
A clinical investigation is defined by the FDA as “an experiment in which a drug is administred or dispensed to, or used involving, one or more human subjects. Such an experiment is any use of a drug (whether approved or unapproved) except for the use of a marketed drug in the course of medical practice.”
The Sponsor of an IND application is the party who submits the application to the FDA. In the absence of any other sponsor (e.g. pharmaceutical company), the investigator conducting the proposed clinical investigation is the sponsor of the IND application.
When developing new drugs and devices in pre-clinical research to the point where they transition to investigations clinical applications, FDA approval is required and the PI for the research serves as the sponsor of the IND unless or until the further development and/or commercialization of the new drug or device is undertaken by a third party.
The Principal Investigator for the project under which a new drug may become the subject of a clinical investigation and who is responsible for the initiation and conduct of the clinical investigation shall be responsible for developing the IND application to be submitted to the FDA and will be a “sponsor-investigator” in accordance with 21CFR 312.53. Usually, the intent of the research in such a clinical investigation is to gain scientific knowledge without seeking market approval for the drug or device. This responsibility is generally part of the PI’s research duties when it takes place in the course of sponsored or institute-funded research. The sponsor-investigator is the source of the information for the relevant FDA filings and reports and is responsible for their content.
The sponsor-investigator’s responsibilities include:
- Selecting clinical investigators. Clinical investigations must be conducted in appropriate clinical settings under the direction of a physician (or dentist, when appropriate) qualified by training and experience as appropriate experts to investigate the drug who should be listed as a sub-investigator for the trial and should be responsible for all trial-related medical (or dental) decisions. Clinical investigations will generally be conducted pursuant to an appropriate contract or subcontract with a Clinical Research Organizatiom (CRO), most often an academic medical center, with the sub-investigator serving as its PI. The negotiation and awarding of the contract or subcontract will follow all applicable institute policies, guidelines, and applicable regulations.
- Selecting a Contract Manufactoring Organizationn (CMO) or other source to provide the drug for use in the study in compliance with applicable FDA requirements. The negotiation and awarding of the contract with the CMO or supplier will follow all applicable institute policies, guidelines, and applicable regulations.
- Informing and qualifying investigators by obtaining their commitment to supervise the study, follow the protocol, and obtain consent.
- Monitoring the conduct of the study by auditing documentation and conducting site visits.
- Completing regulatory filings related to the IND or IDE, adverse events, amendments or revisions, progress reports, withdrawal of IRB approval, and final reports.
- Controlling the distribution, tracking, and dispensation of the regulated products.
Sub-invetigator (PI for Clinical Contract or Clinical Subcontract)
- Ensuring IRB approval for the study is obtained before any subjects are enrolled.
- Ensuring that informed consent is obtained in accordance with FDA regulations.
- Ensuring that the investigation is conducted according to the ivnestigational plan and applicalbe regulations.
- Administering the drug or using the device only in subjects under the investigator’s supervision or under the supervision of a recognized sub-investigator.
- Maintaining adequate records of the dispensation of the drug or device.
- Returning unused materials at the end of the trial.
- Preparing and maintaining adequate case histories and signed informed consent documents.
- Maintaining correspondence with the IRB and the sponsor to make sure that both have reviewed protocol amendments, recruitment materials, investigator brochures.
- Retaining records in accordance with regulations.
- Providing progress, safety, final and financial disclosure forms.
- Notifying the sponsor if IRB approval is withdrawn.
- Complying with International Conference on Harmonisation (ICH) guidelines, if applicable.
- Inspections and Audits
- Ensuring computer systems comply with 21 CFR Par 11.