Collaborative Community Charter
The Alliance is acting as a facilitator to establish a collaborative community in the field of digital pathology/ML/AI.
The Pathology Innovation Collaborative Community (PIcc) is a regulatory science initiative that aims to facilitate innovations in pathology as well as advance safety and effectiveness evaluation, and to harmonize approaches to speed delivery to patients using collaborative, pre-competitive approaches. The collaborative community (PIcc) is open to all stakeholders, public or private, including, but not limited to, academia, industry, health care providers, patients and advocacy groups.
FINAL VERSION OF THE CHARTER
In summary, creating a collaborative community in the field of digital pathology is an exciting approach for the field (“us”) to engage formally with the regulatory (FDA). The collaborative community will be (by design) inclusive, open to the public, designed to enable all stakeholders the ability to directly provide input and contribute into creating or updating regulatory frameworks.
WHY THE NAME CHANGE
The term collaborative community has a specific meaning in the FDA context. In July 2019, Michelle Tarver introduced us to the framework for collaborative communities with the FDA. We are now actively pursuing this goal and hope to be formally recognized by the FDA as a collaborative community. As we progress towards this goal, we need to collectively generate a charter that reflects our values and priorities (see below). During the drafting sessions, it was felt that the information gleaned from the name (i.e., “The Alliance”) was insufficient. We agreed that Pathology Innovation Collaborative Community (PIcc) better reflects what we are passionate about.
BACKGROUND
In the medical device ecosystem in the USA, the terms “collaborative communities” is used in a specific context (=specific definitional requirements by the FDA). A collaborative community can bring together stakeholders to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Collaborative communities can contribute to improvements in various regulatory areas. Notably, creation and participation in collaborative communities is a central component in the FDA’s strategies priorities – outlined in the Digital Health Innovation Action Plan.
APPROACH
In general, collaborative communities may develop for a number of reasons, including when:
Challenges are ill-defined or there is no consensus on the definition of the challenges
Challenges and outcomes are complex
Partners are interrelated
Incremental or unilateral efforts to address the challenge have been ineffective
Partners seek to optimize efforts, including preventing duplication of efforts
Better outcomes could be achieved with integrating different perspectives, experiences, resources, and expertise
AIMS FOR DIGITAL PATHOLOGY
The key aim of the collaborative community is to accelerate the development and delivery of regulatory science initiatives in the pre-competitive space that advance the field of digital pathology, including but not limited to machine-learning and artificial intelligence. This may be accomplished through collaborative initiatives using various health technologies, leveraging real-world data, and innovative research.
VISION
The key deliverable is a clinical, interoperable, modularized, integrated solution for digital pathology implementation, from tissue acquisition to diagnostic algorithm.
SOME OF THE REQUIREMENTS
(See FDA toolkit for details)
All meetings will be open to the public.
The collaborative community encourages that applicable content, after confirmation with the author(s), will be made publicly available.
The collaborative community needs a charter
FDA cannot guide (see Federal advisory act)
We need a convener; currently MDIC has been proposed and we are actively working with MDIC leadership on this (not finalized); for definition of “convener” (see toolkit)
The Alliance is currently acting (alongside DPA, DPAF, and others) as the facilitator (see toolkit)
The charter will outline deliverables
Status (October 2020): As originally stated in the first Alliance meeting (July 2019) – creating a collaborative community is one of the overarching strategic deliverables of the Alliance. A presentation outlining an update (status October 2020) was provided at the Alliance Visions 2020 meeting; the presentation is also available here. The presentation provides a status update and concrete tasks for finalizing the current draft charter.
Click here to view presentation.
KEY ELEMENTS
Key aim is to establish the collaborative community and start delivering
A copy of the current state of the charter can be found here - Version 10
The final version can be found here - Version 25
Two charter drafting sessions (open to public) took place on:
11/10 at 3pm ET
11/13 at 10am ET
Register for one or both drafting sessions here
If you are unable to attend a drafting session and wish to contribute feedback, please send your comments to: digipathalliance@gmail.com
In preparation for the charter drafting session we suggest you prepare by:
Reading the FDA toolkit
Reviewing Michelle Tarver’s presentation
Studying existing collaborative communities with CDRH participation
EVOLUTION OF THE CHARTER
A copy of the current state of the charter can be found here - Version 10
November 11, 2020: We had a successful and productive charter drafting session on Nov. 10th, 2020, with more than 25 attendees who all contributed to editing the charter. General comments included the naming of the Collaborative Community to the “Pathology Innovation Collaborative Community” or PIcc. In addition, many stakeholders pushed for simplification of the charter to allow for continued growth and evolution of the PIcc – this simplification led to a streamlining of the charter and included more open language for potential growth. Please review the latest version of the charter HERE (Version 16), and join us for the next drafting session, scheduled for Nov. 13th, 2020 at 10:00 AM EST.
November 12, 2020: An updated version can be found here - Version 18
November 13, 2020: Our second charter drafting session on Nov. 13th, 2020 had more than 18 participants who contributed to editing the latest version of the charter that was streamlined to five pages following recommendations in the first drafting session (11/10/2020) and in the steering committee meeting (11/11/2020).
The conversation included fine-tuning of the mission and vision, defining the roles of membership and voting, and delineating next steps for identifying signatories. Please review the latest version of the charter HERE (Version 19).
November 13, 2020: A few highly motivated members from the East and West Coast spontaneously jumped on another call to do a bit more wordsmithing and moved the charter to version 20 - HERE.
We have reached a stage of the charter where this round of input should be considered 'final changes'. We aim to finalize the charter over the next few days. Please consider whether you would like to sign the charter (act as a signatory) and email your decision and/or final suggestions and comments to digipathalliance@gmail.com
November 18, 2020: An updated version can be found here - Version 22
November 19, 2020: Version 23 and Version 24
November 20, 2020: The final review session was attended by 18 members who had the opportunity to provide input on the latest draft of the charter. During the session we reviewed the name change to PIcc, the importance of including an aspect of patient centricity to our initiative, and the final steps. At this point, a number of folks have signed in support of the charter. If you support the initiative and would like to continue involvement, please download, sign and return (to digipathalliance@gmail.com) the most up to date version of the charter. The next steps involve finalizing the charter in coordination with MDIC followed by formal submission to FDA. Thank you all for your contributions!