Comparison between industry-sponsored and investigator-initiated clinical trials

 Principal Investigator (PI)-initiatedIndustry-Initiated
AccountingAccount set-up via ORAAccount set-up via ORA
Authorized Administrative OfficeInvestigator-Initiated Clinical Trials are processed and negotiated by the OCR.Industry-Initiated Clinical Trials are processed and negotiated by the OCR.
Dataa) The company receives a summary report of the trial results and may receive case report forms, as appropriate. The report may be used by the company for any purpose, subject to the University’s intellectual property and publication rights.
b) Since the company funding the trial is not the regulatory “sponsor” as the term is defined in the Code of Federal Regulations 21CFR50, the company may not access medical records or other patient identifying information unless a revised authorization specific to the study and which complies with CMIA requirements is obtained from the subject.
a) The industry sponsor owns the completed case report forms, the compiled data that is developed under the trial, and any deliverables required under the protocol. However, the University retains the right to use the case report forms and results for publication, education, and research.
b) The industry sponsor may receive and use de-identified clinical trial specimens (blood samples, x-rays, etc.).
c) The University retains ownership and unrestricted use of original “raw” data including clinical trial specimens. The industry sponsor may have access to raw data for FDA inspection/monitoring.
d) The industry sponsor may access, but not copy, subjects’ medical records containing individual identifiable patient information for the limited purposes of auditing data quality and monitoring the study as required under FDA regulations. The disclosure is allowed under HIPAA; however, such disclosure is not allowed under CMIA without subject’s authorization.
FDA PhaseIn general, Investigator-Initiated Clinical Trials are either Phase I or Phase II Trials and may be multi-site studies.In general, Industry-Initiated Clinical Trials may include Phase I through IV and are usually multi-site studies.
Funding/Supportyesyes
IDC30% Clinical Trial IDC (assessed on all costs)30% Clinical Trial IDC (assessed on all costs)
Intellectual PropertyThe University retains all rights to inventions developed under the study. If the funding source for the Clinical Trial is a for-profit entity, the entity will be granted the first right to negotiate for a license to commercialize such invention. If funding source is a non-profit entity, the non-profit entity will be granted certain non-commercial rights to the invention.In general, the industry sponsor will own any patentable inventions developed in the direct performance of the protocol.
Investigational New Drug (IND)/ Investigation Device Exemption (IDE)Submitted to FDA by facultySubmitted to FDA by Sponsor
PaymentAlthough the actual payment schedule is subject to negotiation with the company, the Principal Investigator and departmental administrators should develop a suggested payment schedule that is based upon the spending pattern anticipated for the study. The initial payment should include non-refundable start-up costs, as appropriate. Subsequent payments may be due quarterly, or based on subject enrollment. The University may not underwrite expenses for the company, and reimbursement should remain current with expenditures throughout the life of the study.Although the actual payment schedule is subject to negotiation with the sponsor, the Principal Investigator and departmental administrators should develop a suggested payment schedule that is based upon the spending pattern anticipated for the study. The initial payment should include non-refundable start-up costs as appropriate. Subsequent payments may be due quarterly, or based on subject enrollment. The University should not underwrite expenses for the sponsor, and reimbursement should remain current with expenditures throughout the life of the study.
Protocola) Protocol authored by an IU Investigator within the course and scope of his/her University employment; or
b) An IU Investigator within the course and scope of his/her University employment jointly with an employee of another entity (e.g. an employee of another non-profit institution or/and employee of the company funding the study)
a) Protocol is authored by a non-IU employee (i.e. the company’s employee or an employee of an outside university or institution), or
b) A University investigator under a personal consulting agreement and without use of University facilities in accordance with IU Policies
Publicationa) The University retains the right to publish the results of the Clinical Trial consistent with University policy.
b) The Principal Investigator is responsible for registering the trial for publication.
a) The University retains the right to publish the results of the Clinical Trial consistent with University policy.
b) The Principal Investigator coordinates with the industry sponsor to determine who will assume responsibility for registering the trial so the results may be published.
Required Formsa) Request for Extramural Support (RES Form)
b) 700-U Conflict of Interest Form completed for the PI and Co-PI
c) Statement of Work (i.e. protocol)
d) Budget 27% (Total Direct Costs) IDC. The budget includes any sub sites participating in the study.
a) Clinical Trial Agreement Request
b) 700-U Conflict of Interest Form completed for the PI and Co-PI
c) Budget 27% (Total Direct Costs) IDC. The budget includes any sub sites participating in the study.
d) HIPAA Authorization
e) Application for Institutional Research Bulk Account
f) Clinical Trial Agreement Request Addendum
Subject InjuryExcept for injury attributable to the manufacturer of the study drug, the University assumes responsibility for any injury directly resulting from the subject’s participation. The University will provide medical treatment for any such injuries. It is unacceptable to require billing of 3rd party insurance companies in lieu of recovery of such costs. Neither is it appropriate to restrict participation of subjects based on medical insurance coverage status or the subject’s ability to pay.The industry sponsor is responsible for any injury directly resulting from a subject’s participation in the trial, or injuries resulting from the study drug, or the placebo, or protocol procedures. The industry sponsor will reimburse the University for the costs of medical treatment for such injuries. It is unacceptable to require billing of 3rd party insurance companies in lieu of recovery of such costs. Neither is it appropriate to restrict participation of subjects based on medical insurance coverage status or the subject’s ability to pay.