MTPA IRP Process
Phase I: Submission of a Concept Overview
In order to submit a Concept Overview, Applicants must first complete the registration and submit current curriculum vitae (CV). This may be done via the Mitsubishi Tanabe Pharma America (MTPA) online Independent Research Portal (IRP) application portal:
Next, Applicants must fill out the Concept Overview page. The general information provided during the registration process will be used to pre-populate certain fields in the Concept Overview page. Applicants are required to provide the following information related to the proposed Concept Overview:
- Title of proposal
- Type of support requested (financial, drug, or both) including estimate of amount and/or name of drug (if applicable)
- Study design
- Study rationale and explanation of unmet medical need
- Study hypothesis
- Study population
- Feasibility of enrolling proposed population
- Description of the unique or novel feature of the Study
- Study Budget
All Concept Overviews must be submitted via the MTPA online IRP application portal. Hard copies will not be accepted.
Review and Approval of Concept Overview
Concept Overviews will be reviewed on a bi-annual basis (typically, Feb and Aug).
The MTPA Independent Research Review Committee will review all Concept Overviews for scientific merit, innovation, clinical importance/potential impact on patients, and compliance with company policy and requirements. The Review Committee will extend contingent approval* to certain Applicants to proceed to the second step of the process, which is submission of a detailed Proposal. Applicants will be notified of the Review Committee's decision via email and the status will also be available on the portal.
Phase II: Submission of Independent Research Proposal
Once Applicants have been granted contingent approval of the Concept Overview, Applicants may submit their Proposal. All Proposals must be submitted via the MTPA online IRP application portal within 6 weeks of approval of the Concept Overview. Hard copies will not be accepted. Proposals are reviewed on a monthly basis.
All expenses associated with the independent research must be identified in the detailed study budget of the application. The amount of all expenses must not exceed fair market value of the expenses associated with the research. Fair market value includes, among other things, consideration of the relevant market and geographic region. Expenses shall only be requested for research-related goods and services that are legitimate, reasonable and necessary in order to conduct research and that are actually utilized in conducting the research. All payments must be milestone-based and not based on final results. In addition, payment shall not be made in one lump sum prior to the start of research. Instead, payment will be spread out based on milestones achieved.
Permissible direct study costs include:
- Subject-related costs
- Non-MTPA drugs and clinical supplies, while MTPA does provide funding for placebo, it does not supply the placebo, nor does MTPA provide blinded study drug.
- Study-related personnel costs (for personnel dedicated to the Study full-time), but may not include the cost of any fringe benefits for the personnel
- Diagnostic fees and services
- Data management expenses
- Statistical services - this cost should be limited to $2,500, absent special circumstances that are documented and approved in advance by MTPA
- Institutional overhead - in general, the amount of institutional overhead is limited to 25% of the total research budget.
Permissible indirect study costs may include:
- Publication costs (e.g., medical writing to prepare manuscript, manuscript submission fee, etc.) - this cost should be limited to $2,500, absent special circumstances which must be documented and approved in advance by MTPA
- IRB review fees - this cost may include initial IRB submission fee and all applicable renewal fees
- Costs of reasonable travel, lodging, congress registration (if required to make presentation) and related expenses of the Independent Research Requestor for the express purpose of presenting the study results at one scientific congress or meeting.
Costs that shall not be included in any IR Proposal include, but are not limited to:
- Start-up funds to establish new clinical research programs or to expand an existing program
- Purchase of capital equipment or software
- Hiring of staff who are not dedicated to the Study full-time
- Costs of travel, lodging, or related expenses of the Applicant for purposes other than presenting Study results at a scientific congress or meeting
- Expenses relating to the Independent Research Requestor's normal business operations (e.g., electricity, phone, employee fringe benefits)
- Any "permissible" expenses which exceed fair market value
Development of Full Proposal Documentations
The MTPA Independent Research Review Committee will review contingently approved proposal documentations including but not limited to full study protocol, budget and patient consent/assent if applicable with the 2 months of the contingent approval.
Independent Research Agreement
Applicants whose Proposal is contingently approved, will be sent an Independent Research Agreement which will set forth the obligations with respect to the study. Applicants will have four weeks from the date the Agreement is sent/emailed/uploaded to review, sign and return the Independent Research Agreement. If the Independent Research Agreement is not returned within four weeks, the contingent approval may be withdrawn. Some of the topics addressed in the Independent Research Agreement include:
- Funding: amount and payment schedule (if applicable)
- Drug - amount (if applicable)
- Adverse Event Reporting
- Requirement to submit Quarterly Reports to MTPA
- Intellectual Property rights
- Publication requirement
MTPA requires Independent Research Recipient(s) to comply with all applicable laws, rules, regulations and industry codes related to clinical and/or non-clinical research. Independent Research Recipient(s) may be required by law to file an IND for the Study. Independent Research Recipients are solely responsible for compliance with all applicable laws, rules, regulations and industry codes, including for example, making the IND determination and filing for the IND.
For those Studies that require IRB/IACUC approval and/or an IND, Independent Research Recipient(s) must submit a copy of the approved IRB/IACUC and/or IND via the MTPA IRP online portal.
*Please note: All IRB approvals must be received within four months of when MTPA executes the Independent Research Agreement. If this deadline is not met, MTPA reserves the right to rescind approval of the Independent Research study.
Clinical Trial Registration
Independent Research Recipient(s) are required to comply with all applicable laws, rules, regulations and industry codes governing registration of protocols and posting of results such as on FDA's ClinicalTrials.gov database or another trial registry website. Independent Research Recipient(s) should be identified as the "sponsor" on such registrations and postings, not MTPA. Independent Research Recipient(s)
Independent Research Applicants may request that MTPA provide marketed or investigational drugs for Studies. Once an Independent Research Agreement has been fully executed, the drug approved for the Study may be requested via the MTPA IRP online portal. Requests for Study Drug require a minimum lead time of ten (10) business days.
It is the responsibility of the Independent Research Recipient to maintain the Study Drug and supplies in the appropriate storage and handling conditions and to account for all Study Drug and supplies, including its receipt, usage, destruction or return. Independent Research Recipient(s) should contact the Independent Research Coordinator for questions regarding Study Drug, including information on how to return Study Drug.
Adverse Event Reporting
Independent Research Recipient(s) are responsible for complying with all applicable laws, rules, regulations and industry codes concerning adverse event reporting. The Independent Research Agreement will include information on how to submit an adverse event to MTPA.
In order to ensure the appropriate progress of research, MTPA requires that Independent Research Recipient(s) submit an update on the study on a monthly basis. Monthly status reports are due the first business day of each month. These monthly status reports must be submitted via the IRP online portal. Milestone payments will not be made if a monthly status report has not been submitted for the most recent month.
All Investigators must provide MTPA with a detailed Final Report which outlines the research findings.
MTPA expects the results of ISTs to be published or presented, whether the results are positive or negative. Publications must take the form of either (1) a manuscript submitted to a peer-reviewed journal, or (2) an abstract submitted to a scientific or medical congress. All publications must be sent to MTPA in advance of submission, according to the timeframe set forth in the Independent Research Agreement. All publications should comply with recognized ethical standards concerning publications, authorship and disclosure of funding, including without limitation the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, www.icmje.org, established by the International Committee of Medical Journal Editors.