Insights into Challenges and Perspectives on COVID-19 Treatment Trials
Survey results and feedback from stakeholders involved in COVID-19 treatment master protocol trials reveal key challenges in setting up study sites, including staffing, contracting, IRB issues, and feasibility concerns. Stakeholder perspectives from clinical investigators, academia, pharma, government, biotech, CROs, and others offer valuable insights for improving the efficiency of COVID-19 treatment trials.
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Presentation Transcript
January 13, 2021 Survey to inform: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies
CTTI Request for Experiences Inform meeting topics CTTI collected feedback Dec. 28, 2020 to Jan. 13, 2021 Survey distributed via: Email to CTTI member organizations and public contacts Posts on Twitter and LinkedIn Encouraged trade, media, and other organizations to share 25 Target respondents individuals executing COVID- 19 treatment master protocol trials in the U.S.
What best represents your stakeholder perspective? (n=22) Clinical Investigator/ Site 2 Academia 2 Pharma 7 Government 4 Biotech 1 Other 1 CRO 5 Not represented: device/IRB/Legal/Patient/Healthcare Delivery
Challenges Setting Up COVID Treatment Study Sites
What are your biggest challenges to setting up new COVID treatment master protocol trial sites? (n=18) Staffing 10 Contracting 10 Perceived feasibility 8 Institutional Review Board (IRB) 6 Other 5 Trial budget not adequate 2 Human Research Protection training 0 0 2 4 6 8 10 12 Allowed to choose 3
Contracting Challenges Indemnification, Indemnification, Indemnification Other (7) Review/negotiation timelines U.S. longer than non-U.S. Different and duplicative layers of approval at each site Additional government specific steps that are not part of typical commercial subcontracts Finding the correct contracting vehicle Additional sites not network If no master agreement available
IRB Challenges Timely review 4 First time sIRB 2 0 1 2 3 4 5
Feasibility Challenges Abiliy to recruit patients 6 Competing trials 6 Study Design 4 0 2 4 6 8
Additional Start Up Challenges Supplies and resources are limited Evolving environment and Standard of Care We are a VA site. There is often inadequate understanding of VA procedures for conduct of non-VA protocols. An adequately staffed office able to handle all aspects of integration of VA and non-VA agencies for master protocol implementation is needed. There is an over reliance on networks of sites assumed to be self directed and self managed with little to no direction. Central IRBs should be recommended but NOT mandated. It is not faster when all of the paperwork to cede to a central IRB is required for academic site Patients are declining participation because one of the three agents being tested is not yet approved for use. Drugs could be grouped to avoid having one drug impede trial progress.
Strategies to Successfully Start Up Sites (n=16) FEASIBILITY STAFFING Streamline Protocol Reallocate Supplement Single point of contact site management CONTRACTING IRB Training Being flexible Expedited TRIAL BUDGET Take it or leave it Select sites based on timely review Increase Budgets Leverage existing contracts
What are your biggest challenges to enrolling participants into COVID treatment master protocol trials? (n=10) Competition for same patients 9 Study activity burden on staff too high 6 Other 3 Burden on patient too high 2 Co-enrollment in multiple trials not allowed 2 Obtaining participant consent 1 0 2 4 6 8 10 Allowed to choose 3
Additional detail: Participant consent is challenging E-consent logistics VA cannot incorporate HIPAA into electronic consent Other Challenges Testing to confirm COVID-19 infection in a timely manner. Patients were enrolling into our outpatient trial later in their disease/infection Shortage of staff on the trial as they are involved with large vaccine trials Inc/Exc criteria
Strategies to Successfully Enroll Participants (n=9)nAllppt.com PROTOCOL DESIGN CO-ENROLLMENT SITES Amendments Streamline protocol Communication CONSENT New sites Domestically Non-US Simplify
