Investigator-Initiated Trials Application Overview
Thank you for your interest in psychedelic research! The MAPS Public Benefit Corporation (MAPS PBC) investigator-initiated trial (IIT) program is designed to create an ever-growing network of qualified clinicians whose passion and innovative questioning help to inspire new possibilities within the path to expanding patient access and the conditions that MDMA-assisted therapy may be possible in treating.
Investigator-initiated trials (IITs) by design are unique clinical trials sponsored and implemented by clinicians to investigate a specific research question they have interest in furthering within their field. The U.S. Food and Drug Administration (FDA) defines an investigator as “an individual who both initiates and conducts a clinical trial, and under whose immediate direction the investigational drug is administered.” The clinician has the responsibility to comply with federal regulations applicable to both the sponsor and the investigator.
To understand your roles and responsibilities as a sponsor-investigator (S-I) in an investigator-initiated trial, please refer to the U.S. Food and Drug Administration (FDA) guidelines here.
MAPS PBC does advise but does not prescribe on IIT study designs and can only accept novel study designs which are not replicas of prior MAPS-sponsored work. Priority is given to projects that address organizational strategic indications, questions of patient access, and geographic regions of interest. As part of your IIT submission, please provide as much detail about your research concept as possible in order to ensure effective evaluation. Please note MAPS PBC is only accepting IIT submissions for the compound MDMA at this time.
IIT concepts submitted to MAPS PBC are evaluated on the following criteria:
- Concept relevance to program strategic objectives, indications, and initiatives
- Scientific merit of study design – including FDA-approved and appropriate clinical outcome assessments (COAs), rigorous control, adequate sample size
Investigators wishing to submit a concept for review will be prioritized based on the following qualifications:
- Proven track record of submitting and implementing IND clinical trials
- Experience with clinical trials involving scheduled substance
- Expertise in the proposed indication
- Experienced team to support study implementation
See below for an overview of the MAPS PBC IIT collaboration process, from idea conception to study close-out.
Click on the diagram to expand.
MAPS Public Benefit Corporation Requirements for IITs
Selection and Qualification of Sponsor-Investigators for IITs
MAPS PBC will only support IIT collaborations with third-party sponsor-investigators that can demonstrate evidence of high ethical and scientific standards as related to clinical research in human subjects as per the International Conference of Harmonization (ICH) Efficacy Guidelines E6 – GCP.
As part of an IIT submission, MAPS PBC will require the following documentation:
- Recent certification or evidence (within the previous three years) of the potential sponsor-investigator being trained in GCP (such as CITI or other WCGIRB-compliant courses of study).
- Evidence of a current license to practice clinical therapy, medicine, or psychiatry (if applicable to S-I) and evidence of good medical standing (no evidence of restrictions by a regulatory/government body to practice or partake in clinical research)
- Curriculum Vitae (CV)
MAPS PBC IIT staff will ensure validity of all the above documentation and requirements.
While MAPS PBC may undertake an IIT collaboration with an investigator with limited prior experience with clinical trials or scheduled substances, priority will be given to submissions by investigators with prior experience with clinical trials and scheduled substances.
MAPS PBC, as a small public benefit corporation reliant entirely on MAPS’ private donations, is not generally able to provide funding for IITs. As such, it is the expectation by MAPS PBC that sponsor-investigators will arrange for their own funding for their trial(s).
IIT collaborations will only be undertaken with submissions that demonstrate access to funding or a fundraising plan.
Before considering an IIT, it is important that a potential sponsor-investigator arranges access to all necessary infrastructure to support clinical trial procedures.
Necessary infrastructure to ensure the successful conduct of an IIT includes the following:
- A qualified team of researchers including a safety physician, statistician, co-therapists, database and systems programmer, and regulatory support
- Administrative support such as a research assistant or study coordinator (an often-overlooked asset to the early development of a clinical trial)
- Access to compliant systems for collecting and storing data, and recording, storing, and transmitting video for therapy supervision
- A relationship with an ethics board (e.g., Institutional Review Board/IRB, Ethics Committee/EC, Research Ethics Board/REB)
- Access to treatment rooms, a laboratory, imaging equipment, and other software or hardware that may be needed for the research procedures
MDMA Therapy Training
To receive access to the investigational medicinal product (IMP), MDMA, MAPS PBC requires that investigators and study therapists receive training in MDMA-assisted therapy through the MAPS MDMA Therapy Training Program. While sponsor-investigators are expected to arrange for training and drug costs, limited scholarships may be available. Learn more about the MDMA Therapy Training Program by visiting mapspublicbenefit.com/training.
Adherence to the MAPS PBC IIT Process
MAPS PBC provides scientific review and oversight at three stages in an IIT project: concept, proposal, and protocol. Following approval of a protocol, the IIT team provides technical assistance to support the S-I at all stages of the clinical trial activation process, including regulatory applications and study drug shipment. MAPS PBC reserves the right to discontinue collaboration on projects with sponsor-investigators if they are unable to adhere to the milestones listed below.
Proposal Development Stage
Upon acceptance of concept, MAPS PBC may provide reference documents and templates to help with developing a proposal. Proposal development should take about 3 months. Concepts accepted for proposal development will be expected to adhere to the following proposal milestones:
- Supporting documentation sign-off within one week of notification of acceptance:
- Confidential Disclosure Agreement
- Psychedelic-Assisted Psychotherapy Code of Ethics Statement
- Acknowledgment of the Sponsor-Investigator Guide for IITs
- Receipt of a proposal draft in 30 days
- Evidence of a planned budget in 60 days for feasibility review only, MAPS PBC does not provide funding
- Finalization of proposal in 90 days
Protocol Development Stage
Upon finalization of proposal, MAPS PBC may provide reference documents and templates for help with developing a protocol. Protocol examples and templates provided are examples only. Templates should be adapted to fit the logistics, economics, staffing, and set-up of individual sites and studies. Protocol development should take about 3 to 6 months. Proposals accepted for protocol development will be expected to adhere to the following protocol milestones:
- Receipt of a protocol draft in 30 days
- Finalization of protocol in no later than 180 days from proposal acceptance
MAPS PBC requires sign-off on the final protocol document before initiation of the contracts stage or any regulatory/ethics submissions to ensure that the protocol meets current safety and drug standards consistent with our Phase 3 development program. Attempting to submit to ethics or regulatory boards before receiving MAPS PBC approval could result in delays of your anticipated study start.
Approved protocols will also be required to register with appropriate government registries, such as clinicaltrials.gov
The Clinical Trial Agreement
MAPS PBC will provide a contract template to sponsor-investigators following approval of a final protocol, covering safety and outcome data sharing, an open science policy, provision of drug, and milestones. Note that data exclusivity is generally not granted by MAPS PBC.
Full execution of contracts is required to initiate all other site activation procedures.
FDA / Regulatory Approval
As the sponsor-investigator for the study, the investigator must file for their own Investigational New Drug (IND)/equivalent application. As access may be needed to CMC (Chemistry Manufacturing and Controls) information in the main MAPS IND for MDMA, MAPS PBC can facilitate a letter of authorization to access this information on your behalf, once the CTA has been signed.
To learn more about the IND process, see the resources provided here.
Ethics Board Approval
As the sponsor-investigator for the study, the investigator must file for their own ethics board approval. If affiliated with a major institution, you may already have access to your own IRB/EC/REB. Large institutions can take up to three months to approve new research.
Otherwise, the IRB utilized by MAPS PBC for sponsored studies in the United States is WCGIRB. Visit the WCGIRB website for more information and a schedule of fees: wcgirb.com
The sponsor-investigator is required to provide the final approved informed consent form and ethics outcome letter to MAPS PBC.
DEA / Scheduled Substance Application and Licensure
MDMA is currently a U.S. Schedule I substance. As the sponsor-investigator for the study, the investigator must apply for their own scheduled substance license. The U.S. Drug Enforcement Administration (DEA) or equivalent scheduled substance licensure typically involves a background check for the applicant and any authorized users listed on the application, a physical inspection of site storage facility, and a site security plan detailing how secure storage of the scheduled substance at the study facility will be ensured.
From application to receipt of a license can take up to five months.
The sponsor-investigator is required to submit the scheduled substance license to MAPS PBC upon receipt.
Initiation of Drug Shipment
Initiation of the drug shipment process by MAPS PBC may or may not include import and export permits and/or establishment of a recipient depot. It is the sponsor-investigator’s responsibility to determine this and to execute import and export permit application processes. It is also the sponsor-investigator’s responsibility to provide local regulatory labeling requirements to the MAPS PBC CMC department.
Drug shipment paperwork and process on the MAPS PBC authorized distributor side can take one to three months depending on particularities and location of shipment.
In addition to a final, approved protocol and signed clinical trial agreement, MAPS PBC requires sites to provide the following essential regulatory documentation prior to site activation:
- CVs for all study personnel
- Medical licenses for all site license holders
- IRB approval
- Approved Financial Disclosure form
- FDA or regulatory authority approval
- DEA Schedule I License or equivalent scheduled drug licensure
- Permits for drug shipment
Once MAPS PBC has confirmed receipt of all the above documents, MAPS PBC will notify the sponsor-investigator in writing that all criteria to begin enrolling participants have been met. Please note that there may be additional local requirements.
MAPS PBC requires the sponsor-investigator to provide the following items to MAPS PBC as part of essential document maintenance once a study is active:
- Annual submission of ethics renewal
- IND annual reports
- Scheduled substance license renewals
- Quarterly submission of safety and primary outcome data – with the exception of Severe Adverse Events (SAEs) which require expedited reporting within 24 hours and Suspected Unexpected Severe Adverse Reactions (SUSARs)
MAPS PBC requires the sponsor investigator to provide the following to MAPS PBC at the time of study close-out:
- Final clinical study report
- Primary manuscript (for review only)