Investigator Initiated Trial Requests

Potential IIT Investigators must be qualified to conduct the intended research and have applicable experience, training, and capacity to execute the proposed study.  The Investigator and affiliated institution must adhere to the relevant patient safety and privacy laws and good clinical practices and must have documented processes in place to ensure proper reporting of adverse events or product complaints.

For clinical research conducted in humans, the investigator and site personnel are responsible for completing recent GCP training.  Additionally, Phathom requires documentation that demonstrates recent evidence (within the previous 3 years) of the investigator’s experience in undertaking clinical research.

Phathom assesses IIT proposals for scientific merit, feasibility, sound study design, and potential to advance medical and scientific knowledge in Phathom’s pre-defined areas of interest.  IITs should be intended to generate data that does not currently exist or, if previously studied, generate data that have the potential to expand the knowledge of the current area.  IITs must never be a pretense to promote Phathom products.

Phathom will consider grant support for research intended to advance medical and scientific knowledge aligned to our areas of clinical interest in certain gastrointestinal disorders, such as Gastroesophageal Reflux Disease (GERD), inclusive of Erosive Esophagitis (EE) and Non-Erosive GERD.  These areas of interest are highlighted on the “Our Science” portion of our company website and will change along with the GI landscape and Phathom’s areas of focus.

A Concept Proposal requires a brief overview of the study design, patient population, and estimated cost, as well as justification of the scientific merit of the study.

A Full Proposal requires a detailed description of the study design, rationale, schedule of activities, statistical plan, enrollment plan, publication plan, study management plan, and a detailed budget.  In addition, the Investigator must submit an updated CV including an overview of their research experience.

A full checklist of required study elements can be downloaded by clicking here.

IIT proposals can be submitted at any time.  Phathom reviews proposals once per month.  Depending on the timing of submission, please allow at least 12 weeks for review and rendering of a decision after submission of your Full Proposal.

Phathom follows a stepwise process for review of IIT proposals. Once you have registered and submitted all the required information, your concept proposal will be reviewed by  Phathom’s IIT Review Committee.  The IIT Review Committee meets once a month to review IIT submissions.

Therefore, please allow 6-8 weeks for a decision post submission of your Concept Proposal.  Incomplete submissions and/or requests for additional information may extend these timelines.

Please allow at least 12 weeks for a decision post submission of your Full Proposal. Incomplete submissions and/or requests for additional information may extend these timelines.

All contact is made via email to the address submitted with the proposal though the Grants mailbox (Grants@phathompharma.com).   Note that you may be informed that your IIT proposal has been approved, denied, or more information is needed to render a decision.

Following final approval of your IIT by Phathom, we will work with you to collect all required Regulatory documents and initiate the Investigator-Initiated Trial Agreement (“Agreement”).    If the Agreement is fully executed and all required documentation is on file, the first payment will be initiated following receipt of an invoice. Grant payments are generally milestone-based and are required to be outlined and agreed to by both parties in the Agreement prior to execution of study start.

The following expenses will not be covered.  Please note this list is not all-inclusive:

• Purchase of capital equipment, including but not limited to computers, cell phones, tablets, machinery, appliances, and camera equipment
• Support for research that has already been conducted
• General operational support, education and training activities
• Support for ongoing activities and clinical programs that are part of an organization’s routine operations
• Construction of funds to build new facilities
• Hiring of staff that are not dedicated to the study

Phathom does not provide operational support (e.g., authorship of a protocol, statistical analysis, study report, publication, site monitoring) for an IIT. Operational support for IIT research is the responsibility of the sponsor-investigator. Publication support should be external to Phathom and should be included in the IIT budget only if using external resources.

Support for an IIT is awarded strictly based on research merit criteria which is aligned with the areas of corporate scientific focus.

Phathom requests the right to a budget reconciliation of the IIT grant, as well as any documentation related to the conduct of the IIT as stated in the approved IIT application and signed Investigator- Initiated Trial Agreement.  This review can be triggered by missed milestones or other standard operating procedures.

Phathom fully supports the Investigator-Sponsor to publish the results of the study regardless of the outcome.  A publication plan must be submitted with the IIT application.  Phathom reserves the right to review proposed publications or other public disclosures of the results of the IIT prior to publication in order to prevent inadvertent disclosure of Phathom’s proprietary information, as well as the right to request a short delay in publication in order to protect intellectual property.

All relevant studies, if necessary under applicable law, must be registered on www.clinicaltrials.gov and the results must be reported.

Periodic reports detailing the general progress of the study should be provided to Phathom at least semi-annually and more often depending on the agreed frequency in the Investigator- Initiated Trial Agreement.  Additionally, study payments will generally be based on the achievement of pre-specified milestones outlined in the Agreement.  Documentation that those milestones have been met will be required to initiate study payments.

Upon notification that the study has been completed (i.e., last patient, last visit) we will work with you to collect closeout documentation, including:

• Study results in a format suitable for publication or in such other form as may be agreed upon in the Investigator- Initiated Trial Agreement
• Confirmation of completion of all milestones defined in the research contract
• Reconciliation of grant funds
• Documentation of drug destruction

The study investigator must submit the results in a format suitable for publication within 6 months following conclusion of the study or in such other form or time period as may be agreed upon in the Investigator- Initiated Trial Agreement, at which time, Phathom will issue the final study payment to the research site.

Yes, subject to specific terms set forth in the Investigator- Initiated Trial Agreement, generally either party may terminate the study at any time by mutual written consent.  Phathom reserves the right to terminate an IIT for reasonable cause including but not limited to misconduct, futility, or in the event of product withdrawal from the market.  Phathom is not allowed to terminate an IIT based on anticipated study outcomes.