Investigator-Initiated Trials

About Our IIT Program

Ironshore is committed to improving the lives of patients and caregivers. As part of this commitment, our Investigator-Initiated Trial (IIT) program provides support for research, designed and conducted by independent clinicians and scientists, that addresses important medical and scientific questions related to our drug products and disease areas of interest.

IIT concepts that address Ironshore’s areas of interest are reviewed according to the schedule below. Experienced researchers who place the safety and welfare of patients as their highest priority can request Ironshore-marketed product and/or financial support to be used in well-designed studies. Note that study budgets cannot exceed $500,000 inclusive of overhead, and overhead costs cannot exceed 20% of the total budget. Based on unsolicited requests for support of an IIT, Ironshore may provide funding, drug product and/or authorization to reference Ironshore’s NDA or other regulatory submissions (e.g., IND). Ironshore does not provide input in the design of an IIT or participate in the conduct of an IIT.

For researchers intending to request Ironshore drug product only, and obtain financial support from other sources, Ironshore highly recommends submitting your request to Ironshore for review before submitting funding requests elsewhere.

FREQUENTLY ASKED QUESTIONS

Information for Applicants

Ironshore’s IIT program accepts submissions from applicants with varied education and training backgrounds, including MDs, DOs, PhDs, PAs, PharmDs, NPs, and RNs.

The following types of research are considered:

Interventional

Observational

Monitoring; surveillance

Use of registry data

Historical chart review

Secondary research or meta-analysis

Patient-reported outcomes

Ironshore expects study results to be published, per the registration and publication requirements set forth by the International Committee of Medical Journal Editors (http://www.icmje.org) and the Good Publication Practice guidelines (https://doi.org/10.7326/m22-1460).

Submission Deadlines

2024 Submission Deadline

Proposal Submissions
Decision Date
Submission Window: January 1 – March 31, 2024

April 15, 2024

Concept Submissions will be reviewed on a rolling basis. If a Concept Submission is accepted by the Ironshore IIT Committee, Full Proposals must be submitted by the dates listed above.

IIT Areas of Interest

Delayed-Release and Extended-Release Methylphenidate (DR/ER-MPH)

Research that further informs the appropriate clinical use of DR/ER-MPH in ADHD, including use in special populations

Research with a focus on the abuse deterrent potential of DR/ER-MPH

Research that investigates the use of DR/ER-MPH in non-ADHD therapeutic areas

IIT Submission Process

IIT concept submissions are carefully reviewed by the Ironshore IIT Committee, which consists of a cross-functional team of medical and scientific representatives. Submissions that are accepted must meet standards set by the Committee with respect to potential patient benefit and safety, scientific merit, feasibility, legal and regulatory compliance, budgetary guidelines, and alignment with Ironshore’s areas of interest.

Requests must be submitted via the Concept Application Form by the Principal Investigator

Full proposals might be requested after the initial review has been completed by the Ironshore IIT Committee

Request for a full proposal does not guarantee that a submission will be accepted

FREQUENTLY ASKED QUESTIONS
EMAIL IIT COORDINATOR

Frequently Asked Questions

Concept Submission

What is a Concept Submission?

A concept submission is a brief, high-level outline of the proposed study. It is not intended to be a full proposal. An estimated study budget will be requested in the concept submission.

Please note that you will need to verify your email address in order to access the Concept Application Form.

How will I know if my submission was received?

E-mail notifications will be sent to the Principal Investigator throughout the process to acknowledge receipt of submission, to convey the Ironshore IIT Committee's decision, and to request study progress updates for approved studies. 

What if I do not receive e-mail notifications?

Check Spam and/or Junk e-mail folders. Once located, if you are using Outlook, right-click on the e-mail and select the option under "Junk E-mail Options" to add IIT@ironshorepharma.com to the "Safe Senders List."

Alternatively, you can also manually add IIT@ironshorepharma.com to the safe senders list in your email account. If using Outlook, complete the following steps to add as a safe sender:

Click on Actions, then locate the "Junk E-mail Options"

Click on the tab for "Safe Senders"

Click "Add", type in IIT@ironshorepharma.com and click "OK"

Does acceptance of a Concept Submission guarantee acceptance of a Full Proposal?

No, each request submitted to Ironshore will be considered based on its individual merit, as well as the amount of overall funding still available in a particular calendar year. Please do not consider any request approved until a research agreement has been signed by all parties. 

If a Concept Submission is accepted, what are the next steps?

If a Concept Submission is accepted, the next step is to submit a Full Proposal, including a protocol and line-item study budget. The Full Proposal Form will be made available to you once your Concept Submission has been accepted.

Full Proposal Submission

When is a Full Proposal submitted?

A Full Proposal is submitted after your Concept Submission is accepted by the Ironshore IIT Committee. 

A proposal is significantly more detailed and well-developed than a concept submission. Request for a full proposal does not guarantee that the study will be approved.

How are study budgets evaluated?

All budgets will be reviewed for accuracy, inclusion of covered costs, and alignment with fair market value.

Acceptable budget items include direct costs (e.g., procedural costs, supplies, and personnel costs) and indirect costs (e.g., overhead, Institutional Review Board (IRB) review, pharmacy fees, etc.).

Funds may not be used for any expenses unrelated to the research project, including equipment, office supplies, tuition, fees, dues, subscriptions, and salary or travel expenses related to other projects.

Please note that study budgets cannot exceed $500,000 inclusive of overhead, and overhead costs cannot exceed 20% of the total budget.

What are the next steps after a full proposal has been approved?

Once a study has been approved by the Ironshore IIT Committee, Ironshore will work with the legal department or contracts office at the investigator’s institution to negotiate a research agreement.

Studies may not be initiated until a mutually acceptable agreement has been executed.

Study Conduct

Are there study initiation requirements?

Prior to study initiation, Ironshore requires documentation of IRB approval or waiver (if applicable), a copy of the IRB-approved final protocol, confirmation of health authority approval (if applicable), and a fully executed research agreement.

What are the investigators’ regulatory responsibilities?

The Principal Investigator must ensure that the study is conducted in accordance with all applicable regulatory requirements, including adherence to International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. These regulatory responsibilities include but are not limited to, IRB approvals, FDA approvals, and any associated reporting obligations to IRBs and FDA.

If the IIT uses an Ironshore product, the sponsor will be required to follow Ironshore’s safety reporting requirements. All safety reporting requirements will also be set forth in the research agreement between Ironshore and the Principal Investigator’s institution.

Investigators, or their institutions, are responsible for posting applicable studies to the FDA’s ClinicalTrials.gov database. (www.ClinicalTrials.gov).

How is drug product provided, if requested?

Terms of Ironshore’s provision of drug product will be outlined in the research agreement.

How is funding provided?

Payments are linked to study milestones as outlined in the research agreement.

Funding provided through an IIT may be subject to reporting to the Centers for Medicare and Medicaid Services (CMS) as part of the Sunshine Act. In compliance with the Sunshine Act or other applicable laws, Ironshore will report annually on payment and other transfers of value made to covered recipients.

A final financial report is due 90 days after the end of the funding period reconciling the proposed budget with the actual expenditure. In the event that unexpended funds remain at the end of the funding period, these funds must be returned to Ironshore.

What study updates are investigators expected to provide?

All investigators are required to submit study progress updates. Updates include the current status of the study, proposed amendments, planned publications, and IRB renewals, as outlined in the research agreement.

How are study protocol changes handled?

Study protocol changes must be submitted when there is a significant change in the design and/or implementation of the study as compared to the original submission. Requests for a protocol change will be considered on a case-by-case basis, but approval is not guaranteed. Please submit a study amendment request with the following information:

Anticipated changes to the study design, if applicable

Anticipated changes to the study implementation, if applicable

Anticipated changes to the personnel involved with the study, if applicable

If it is determined that Ironshore no longer wishes to support the study based on the changes, Ironshore may cancel the request post-funding.

What closeout requirements does Ironshore stipulate?

Ironshore requires a final written report, or manuscript, documenting study results at the conclusion of each IIT as well as a financial reconciliation of funds provided and documentation of the destruction of any remaining drug product.

Ironshore expects the publication of all study results. As such, Ironshore expects investigators to comply with the registration and publication requirements set forth by the International Committee of Medical Journal Editors http://www.icmje.org and the Good Publication Practice guidelines (https://doi.org/10.7326/m22-1460).

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Ironshore Therapeutics has been acquired by Collegium Pharmaceutical, Inc.

(Nasdaq: COLL)

For additional information, please reach out to IISProgram@collegiumpharma.com