Scope of Key Function Committees


Quality Assurance and Ethics

The Quality and Ethics Committee will review site reports annually to ensure that VTEU personnel are up to date with the relevant certifications and trainings and report the findings to the SOGC. These evaluation processes will strengthen our sites and ensure that all personnel have the required competencies so that they are able to perform the highest quality research. Specific planned activities include the intent to:

  • Ensure the master template for QMP is modified to encompass DDE.
  • Establish correct governance and plan for quality management.
  • Provide guidance on implementation of sIRB.
  • Provide guidance on how IRB review will be conducted for international sites, in particular for multi-site international.
  • Provide guidance on IRB review for single site study (if appropriate).
  • Discuss use of IRBs (sIRB vs site) for international studies.
  • Discuss fiscal responsibility for Lab QA/QC.
  • Develop template consent document.


Performance Evaluation

Through the Performance Evaluation Committee, the SOGC establishes standards of performance for the LOC, the COU, the LOU including LG laboratories, the SDSU; and the VTEUs and other protocol-specific Clinical Research Sites (CRSs). Staff of the COU will work with the LOC Performance Committee to monitor study metrics and data completeness at each site and to develop metrics for site performance.  It is anticipated that these metrics will include local regulatory approval times, study enrollment, study startup time, data completeness, compliance with protocol requirements, data quality, protocol deviations, demographics of study enrollees, lost to follow-up rates, study closeout intervals, and any other items or metrics decided by the COU leadership and the LOC. Diversity and inclusion need to be part of measurement and feedback. Having baseline metrics is important in measuring this, and some of the measurements may have to be geographically specific.

There’s overlap between QA and performance evaluations, the latter being more high-level oversight rather than individual metrics. Performance Evaluation Committee activities are intended to include:

  • Meaningful reporting with feedback.
  • Timely reporting of lab evaluation results.
  • Site-specific staff training evaluation
  • Site-specific report cards with rankings (opportunity to improve), particularly on studies conducted across the entire VTEU network (in which evaluations can be standardized).
  • Multidisciplinary evaluation teams.
  • Annual PI/coordinators meeting rotating at VTEU sites.


Mentoring and Career Development

The LOC through the Mentoring and Career Development Committee (MCDC) will foster the development of junior investigators in clinical and translational infectious diseases research. This is a vital component of the application since the success of research leading to new vaccines and therapeutics depends on a vibrant well-trained cadre of young investigators. A multifaceted training approach is critical to create a pipeline of “new generation investigators” with a comprehensive knowledge about the path from discovery to development and deployment of vaccines and therapeutics. Young clinical trialists must now be equipped to incorporate genomics, proteomics, innovative modeling and analytical tools to explore, create, innovate and implement the vaccine and therapeutic programs of the future. The MCDC seeks to support this generation of well-trained investigators.  Teaching the next generation of vaccinologists is a priority. 

The Committee will consider a comprehensive career development program that ranges from “soup to nuts”.  Ideas include opportunities for fellows focused on sections of certain studies, perhaps a 3rd year of fellowship could be focused on a single protocol, empowering junior faculty to be part of protocol development and provide publication opportunities. Senior faculty may be encouraged to support junior faculty in roles that facilitate their being first authors on papers. It will be the role of the Committee to create a structure to encourage people at the sites to have a dedicated commitment to mentor the junior faculty. Diversity and Inclusion is also a priority in developing the workforce in infectious diseases.  The priorities here include encouraging a diversity of investigators – starting at the trainee level and a diversity of research participants – community engagement, other partners. Unconscious bias training will be incorporated into management training


Collaborations and Publications

All manuscripts covering primary research conducted by the IDCRC must be submitted to the Collaborations and Publications Committee (CPC) of the SOGC for review and clearance prior to submission to a journal.  The CPC will share the manuscript with all CPC members and send it to the Chair of the appropriate Expert Working Group for primary review.  That individual will either review the manuscript or select someone within the EWG to perform the primary review.  Reviews will then be returned to the lead author from the submitting writing group within 10 business days with any requested revisions.  If the review requires changes, the primary authors will be given 30 days to make the changes and resubmit to the CPC.   Both the CPC and the primary reviewer will evaluate the revised draft. If approved, the manuscript will be forwarded to the SOGC and NIAID for parallel review and clearance that should be completed electronically within 10 working days.  Changes requested by SOGC and/or NIAID will be sent to the lead author, who will take responsibility for subsequent revisions.  Once those changes are made, the manuscript will be forwarded to the SOGC and NIAID for final approval.  If approved, the primary author will be advised to submit the manuscript to the agreed upon journal.  If the journal requires substantial revisions prior to publication, the author may be required to resubmit to the CPC/SOGC and NIAID or clearance.  Modified SOPs will be developed for secondary and tertiary analyses and for abstracts that may require shortened timelines for submission to scientific meetings. The CPC and SOGC will have an expedited process for manuscripts of time-sensitive public health importance, for example during a pandemic when information is needed to guide decision-making.

Following acceptance by a journal or scientific meeting, the primary author will share the accepted manuscript/abstract with the members of the writing group, the IDCRCLG and NIAID, prior to publication/presentation.  The CPC, in consultation with the lead author SOGC and NIAID, will decide if there should be press releases associated with the publication or abstract presentation.  If so, LOC Communications and the CPC will work with NIAID and the lead author’s institution in developing the press releases. The publication policies and timelines will be evaluated and modified as needed annually.

With regard to collaborations, one focus will be on high level collaborations by the LG. VTEU collaborations also bring significant value.  The LG can reach out to major collaborators (PHARMA, Gates, Global groups) to increase recognition of this new resource.  The Committee will also help develop LG policies to encourage internal collaboration within the IDCRC, such as the role of concept submitters in implantation.

The CPC committee should have 2-3 VTEU members, 1 NIAID, and 2-3 LG, with rotating terms.


Innovations

Laboratory innovations are also a key component of the IDCRCLG and will be incorporated in all aspects of trial design and prioritization. As is outlined in the LOU section, the revolution in areas of systems immunology including single-cell multi ‘omics platforms are leading to breakthroughs in how we understand the human immune response. We envision a seamless integration of the LOC Innovations Committee, with Dr. Paul Spearman as the Chair, and the LOU leadership, so that the latest in laboratory advances are included in trial planning and design, and appropriate internal or external investigators are engaged at early stages. We envision the studies designed and conducted by the IDCRC as the premier testing ground for innovative ideas and assays relevant to infectious diseases and vaccine evaluation, engaging the brightest minds in the field in collaborative science. 

These are examples of new approaches to connectivity, vaccine development and therapeutics and concepts in clinical trials design and laboratory innovations that enhance sensitivity and integrate new information for the advancement of scientific knowledge and clinical practice. The LOC Innovations Committee will identify and evaluate additional new approaches (e.g. new instrumentation, public-private models) that can shift infectious diseases clinical research paradigms. The committee will also focus on biomedical innovation in infectious diseases, entrepreneurship-utilization of NIAID’s small business program, the identification and development of areas of frontier research such as computational biology, immune-engineering and interfaces with the for-profit biomedical sector (biotechnology, pharmaceutical, information technology) and the non-profit sector both locally and nationally and will connect to innovation ecosystems developing globally. The committee will also address new approaches to intellectual property issues, data sharing and IDCRC reciprocity agreements.  Some innovation ideas already under discussion include:

  • Potential to create an umbrella screening protocol to allow expedited screening and enrollment for urgent trials in emerging infections area.
  • Adaptive or iterative study design to allow Phase I studies to shift into Phase II studies.
  • Find ways to publish more quickly – remove barriers to publication and other communications with the scientific community in general, such as: don’t limit all reports to after the final CSR, allow earlier data queries and locking of database. This is felt to be essential to achieve high impact from any innovation in our clinical trials.
  • Operational innovations are needed: protocol development can be greatly streamlined; face-to-face meetings emphasized; direct data entry should be the norm.
  • Find ways to prioritize or optimize moving the best products through to Phase I studies and potentially interfacing with other groups. The discussion centered on integrating our efforts by having VTEU representatives in other areas: emerging infections, flu centers, others.
  • Using big data to find the high-risk patients that would be best candidates for hard to enroll studies. Google, Amazon cited as examples.


Laboratory Sciences

The laboratory research activities will be overseen by the Key Function Laboratory Science Committee (KFLSC), chaired by Dr. Rafi Ahmed. Activities of the Committee will include:

  • Protocol Standardization across sites.
  • Defining pathogen and vaccine specifics.
  • Universal SOP for specimen handling, shipping.
  • Engaging working groups to define assays as a priority.  
  • SOP’s regarding biobanking.
  • Building a quantitative lab approach, bringing in innovative ‘omics.
  • Samples in international sites - standardizing issues of shipping or setting up regional labs to help standardize - identify the key areas where we will be working and want to have linkages with extended sites.
  • Quarterly IQA is important – look at how it can be made less burdensome.


Training and Education

The Training and Education Committee will develop best clinical research practices to enhance quality and efficiency of the IDCRC clinical research. While training and education activities are embedded activities of the COU, LOU, and SDSU, the overall LG oversight will be under the Training and Education Committee. This oversight would include Personnel Proficiency & Training, Oversight of Training, Review of COIs prior to each protocol initiation and issues such as cross-training for continuation of essential activities in the event of illness or other staff unavailability. Related are the development of Standard Operating Procedures for training, proficiency testing and for example oversight site pharmacists for more efficient management of experimental drugs. The committee will also engage the next generation of infectious diseases researchers, coordinators and staff.  

Training and education must be ensured at every level.  Several training opportunities already exist, and the Committee will facilitate sharing information about these opportunities for training across sites, i.e. through a blog or regular calls to communicate successes and share best practices.  The Committee will leverage existing programs at the institutions, the VTEU’s and at DMID.  Training models also exist in the ACTG that might serve as models for the LG.  This Committee will be charged to ensure the competence of the workforce, performing LG oversight of all participants regarding documentation of appropriate training & certification and monitoring the number of trainings conducted at sites.

Leadership