Data Monitoring Committee Initiative A PROPOSED APPRENTICESHIP MODEL FOR PREPARING NEW CANDIDATES FOR DMC SERVICE

Transcription

1 Data Monitoring Committee Initiative A PROPOSED APPRENTICESHIP MODEL FOR PREPARING NEW CANDIDATES FOR DMC SERVICE

2 A PROPOSED APPRENTICESHIP MODEL FOR PREPARING NEW CANDIDATES FOR DMC SERVICE OBJECTIVE: Facilitate novice DMC members in securing on-the-job training with experienced DMC Member support. The proposed apprenticeship model is intended to help train clinical research professionals with little or no prior DMC experience, who are interested in serving on a DMC, by affording them the opportunity to experience the interim data monitoring process firsthand and the chance to discuss this experience and the questions arising from it with a more experienced DMC member or members. The Apprenticeship model outlined describes a particular model through which the candidate would obtain on the job training working on an actual DMC and is intended to complement and not replace other apprenticeship models, self-study materials, education or instructor-led training that could provide DMC candidates with valuable training and education. 2

3 DEFINITIONS: MENTOR: A Mentor in this proposed model would be an individual with prior DMC experience who has a solid understanding of the unique interpretive challenges in evaluating accruing clinical trial data, and who would be willing to work with an apprentice to build that individual s capability to independently serve on a DMC. APPRENTICE: An Apprentice in this proposed model would be a clinical research professional with little or no experience serving on a DMC, who would agree to a sponsor approved mentoring relationship with an experienced DMC member and to participation on a DMC under the guidance of that Mentor. APPRENTICESHIP SCOPE: The specific scope of the proposed Apprenticeship is not prescribed and is left for the Mentor and Apprentice to determine and agree upon. The learning through the Apprenticeship will come primarily through regular conversations between the Mentor and Apprentice, including sharing examples of best practices and through common participation on a DMC. One should anticipate that at least several DMC meetings will be required in order to deliver a sufficiently comprehensive experience that one could reasonably consider the apprenticeship as complete. 3

4 APPRENTICESHIP MODEL FRAMEWORK: The proposed steps describe how the proposed apprenticeship model might be implemented in practice: 1. DMC Apprentice Registration Individuals interested in a DMC Apprenticeship may elect to enter their information into a DMC Registry and indicate their interest in an Apprenticeship. This would help DMC organizers identify Apprentices, though suitable candidates may be identified through other channels as well. (Note: Indicating an interest in an Apprenticeship on the DMC Registry would not guarantee that one would be arranged within a specific timeframe, nor does it preclude a candidate from being offered to serve on a DMC as a full, voting member from the outset. In this latter case, other just-in-time training materials could be leveraged by the candidate.) 2. DMC Mentor Recruitment Clinical trial sponsors electing to include an Apprentice on their DMC would first identify a candidate to serve as a Mentor, from among the experienced members of the proposed DMC. Individuals interested in serving as a Mentor also have the opportunity to flag that interest within the DMC Registry. 3. DMC Apprentice Recruitment The DMC organizer identifies a suitable candidate for an apprenticeship. The DMC Registry could be helpful in that regard, but the candidate could be identified through other means as well. For instance, a potential Mentor may him or herself wish to suggest an individual interested in a DMC Apprenticeship. 4. Formalize Apprenticeship The sponsor and the Mentor would agree on the feasibility of the Apprenticeship, and the Apprentice would then be assigned to the Mentor. 5. Apprenticeship Agreement The specific scope of an apprenticeship is not prescribed by this proposed model and would be left for the mentor and the apprentice to determine and agree upon (see APPRENTICESHIP SCOPE ). Although the specific nature of the apprentice-mentor interactions is left for them to decide, agreement from the research sponsor will be required in accordance with their own organizational DMC processes. Each stakeholder involved in the apprenticeship relationship should agree upon and approve at the outset the specific commitment and requirements of the apprenticeship. 6. Apprenticeship Close Out The Apprenticeship would be considered complete once the agreed-upon commitments and defined requirements have been met. If the apprentice was identified within the context of the DMC Registry, upon completion of the Apprenticeship, the Apprentice should update the apprenticeship field to indicate this status. Depending upon their interest in broadening their DMC experiences, candidates can pursue additional Apprenticeship opportunities, or they may indicate that they are no longer interested in subsequent Apprenticeship opportunities. 4

5 POINTS TO CONSIDER If either a Mentor or Apprentice happens to be identified from a source other than the DMC registry, they would be encouraged to sign up to the proposed DMC registry. The Apprentice may be asked to serve in the capacity of a voting or non-voting member, at the discretion of the sponsor. The Apprentice would need to understand and agree to required and approved terms and conditions that allow him or her to participate on the DMC. A candidate who indicates interest in an Apprenticeship within the DMC Registry cannot typically be guaranteed to be offered such an opportunity within a certain timeframe, nor does indicating their interest preclude the candidate from being asked to serve as a voting member on a DMC from the outset.»» Where suitable DMC candidates are scarce or limited, even someone who would prefer an Apprenticeship initially may be asked to serve on a DMC without the benefit of an Apprenticeship. In such cases, other forms of just-in-time training may be leveraged.»» The DMC Registry may offer links to helpful online training materials, specially selected to familiarize someone new to the interim data monitoring process with core concepts and practical insights. They could also include regulatory guidance documents, commentaries on roles and responsibilities of DMC members, summaries of best practices, and case studies. Sponsors may wish to gauge the interest of experienced multi-disciplinary clinical/ medical and Statistical DMC members in serving as Mentors as part of their DMC member recruitment process. Mentors should have significant experience in serving on DMCs and be able to articulate the roles and responsibilities of different DMC members as well as all key principles required for maintaining data integrity/ reliability of trial results, patient safety and human subject protections. Addressing the multi-disciplinary needs of a DMC should include the concepts of statistical analysis, approaches to data review, interpretation of interim data and its impact on ongoing safety/efficacy analysis within the context of a DMC. Mentors should ensure that Apprentices are exposed to these concepts at a depth commensurate with their anticipated role on a DMC. The establishment of a Mentor/Apprentice relationship in the context of a particular DMC should not preclude the Apprentice from interacting with and learning from other DMC members. In fact, to ensure the most comprehensive learning experience the Apprentice should be encouraged to gain as much insight as possible about the various multidisciplinary roles of all DMC members. At no point should the Apprenticeship impact any requirements of the conduct of the clinical trial being monitored. The proposed elements for consideration outlined in this document are suggested as a minimum in this process and are not intended to be binding or all inclusive. 5