VIRTUAL LEGAL ROUNDTABLE – 2019 EFS MASTER CLINICAL TRIAL AGREEMENT Liliana Rincon-Gonzalez, PhD Program Director, Clinical Science Medical Device Innovation Consortium Jaime Walkowiak, JD Chief Operating Officer, Baylor Scott & White Research Institute SVP, Baylor Scott & White Health
Objectives • Provide a brief recap of 2018 Legal Roundtable and current initiative - 2019 Virtual Legal Roundtable. • Provide a overview of the feedback received during current MCTA review • Discuss the substantive changes to the MCTA • Elaborate on next steps to finalization of MCTA, Version 2 2
RECAP OF 2018 ROUNDTABLE AND PILOT USE OF MCTA 3
EFS – Contracting Development of EFS MCTA – Version 1 Reconciliation MDIC Language Conception Legal Distribution and of Legal Roundtable Working Libraries Development and use of Roundtable Group of MCTA and MCTA supplements template 4
EFS – Contracting Conception of Legal Roundtable • Goal - Develop an EFS-specific Master Clinical Trial Agreement (MCTA) to facilitate efficiencies in the EFS contracting process which provides: • balance between site and sponsor concerns, serving as a starting point for contract negotiations with a priori agreement of 90% or greater, and • allowing both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation • BSWRI took the lead on drafting a MCTA template using the provisions from the Language Library developed by MDIC Working Group • Draft MCTA circulated for review to the Legal Roundtable participants prior to the meeting • Legal Roundtable was hosted by Baylor Scott & White Research Institute (BSWRI) on February 8-9, 2018. 5
EFS – Contracting 2018 LEGAL ROUNTABLE AGENDA The roundtable agenda focused on frequent key choke points in EFS contract negotiations: • Indemnification • Subject Injury • Intellectual Property • Third Party Payer • Confidentiality • Publication • Audit 6
EFS – Contracting Post Roundtable Discussion - Reconciliation and Development of MCTA and Industry and Sponsor-specific supplements • Second review of the MCTA draft resulted in better understanding of organization's variances from the template and led roundtable participants to the conclusion that MCTA alone would not resolve all concerns and that supplemental information would be necessary • Written summaries of variances along with narrative explanation serve as a supplement to the MCTA that equips people to efficiently make decisions on which institutions and sponsors to approach – reduces timeline to establish - eliminates meaningless negotiations 7
Current Initiative 2019 Virtual Legal Roundtable • Explore use of MCTA by a broader audience • Obtain additional feedback received from 2018 Legal Roundtable participants as well as new participants. • Discuss pertinent items during today’s webinar • Finalize, distribute, and publish, EFS CTA, Version 2 8
EFS MCTA REVIEW – VERSION 2 9
EFS MCTA Version 2 Review • Conceptually minor edits • Typo correction / reformatting of select provisions • Clarifying language • Proposed Substantive Edits • Section 9 - Study Device • Section 10 - Disclaimer • Section 11.5 - Record Retention • Section 15.3 - Inventions • Section 16.1 – Confidentiality • Section 20.3 – Reimbursement of Medical Expenses • Any proposed changes that have not been incorporated, but required per institution/company requirements should be added to the Institution/Company Specific Terms document. 10
Proposed Modifications Section 9 – Study Device 11
Proposed Modifications Section 10 - Disclaimer 12
Proposed Modifications Section 11.5 – Record Retention 13
Proposed Modifications Section 15.3 - Inventions
Proposed Modifications Section 16.1 – Exceptions to Confidentiality 15
Proposed Modifications Section 20.3 – Reimbursement for Medical Expenses 16
EFS MCTA, Version 2 - Closing • Feedback received from today’s webinar will be considered along with the redlines/comment received previously via email. • Typed comments from today’s webinar will be retained and analyzed during the finalization of the Version 2 template. • Updated copies of the Version 2 template will be distributed to all participants once all feedback evaluated and any further edits have been made. • We are evaluating multiple means to communicate to all participants and obtain feedback on this work including in-person meetings, additional webinars, seminars, or other means. 17
Jaime Walkowiak Chief Operating Officer Jaime.Walkowiak@BSWHealth.org
@MDIConline www.mdic.org 202-828-1600 Pamela Goldberg Liliana Rincon-Gonzalez President and CEO Program Director, Clinical pgoldberg@mdic.org Science lrincon-gonzalez@mdic.org
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