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Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP

The Research, Development, and Regulatory Roundtable (R3) is a neutral forum wherein policymakers, legal counsel, academicians, industry representatives, and global regulators may present, discuss, and deliberate pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

R3 meetings are open to organizations that sponsor R3 and occur three times per year.  The meeting locations will rotate among the Ropes & Gray LLP offices in Boston, New York City, Chicago, San Francisco, and Washington, D.C. Each R3 meeting focuses on one or two timely discussion topics related to the domestic and global impact of new legislation, regulations, guidance, and policies on research community stakeholders. At the end of each R3 meeting, we will consider whether the topic warrants further discussion or development as a publication, position paper, case study analysis, or commentary.

In order to promote open dialogue, the meetings are run by ‘Chatham House Rule,’ by which commentary will not be attributed to any individual nor to their institutional affiliation. R3 meetings are open to organizations that sponsor the R3. Please contact mrct@bwh.harvard.edu if you are interested in sponsoring the R3.

The MRCT Center and Ropes & Gray LLP are grateful to the following R3 sponsors:

  • Advarra
  • Baim Institute for Clinical Research
  • Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Johnson & Johnson
  • Novartis
  • Pfizer, Inc.
  • Sanofi
  • Takeda Pharmaceuticals International, Inc.
  • Washington University in St. Louis

Current status: Active

Impact: Non-partisan forum for discussing the impact of laws, regulations, policies, and guidance on drug and device development and regulatory oversight of clinical trials

Objectives:

  • To engender open and collaborative discussion of non-proprietary issues in research and development
  • To promote a deeper understanding of the laws and regulations that influence therapeutic innovation, product approval, and the protection of human research participants on the global stage

Upcoming:

  • Fourth meeting of the R3: Legal and Ethical Issues in the Enrollment of a Company of Institution’s Own Employees and/or Students in Research Studies

Key Milestones:

Date and TopicTopic SummaryOutput/ Next Steps
Mar 2019,
Secondary Uses of
Health Care Data for
Clinical Recruitment:
Legal and Regulatory
Ambiguities
The use for clinical trial recruitment purposes of data
that were originally collected for another business
purpose raises several legal and regulatory questions,
including whether the companies have authority to use
healthcare data for these secondary purposes; whether
health care providers may receive payment for
permitting secondary uses of their data or for the
results of these secondary uses; the extent to which
third-party payors, or agents of those payors, may
be involved in research recruitment; and which
contact patients directly to discuss possible enrollment
in a clinical trial. During this session, we discussed each
of these issues from a legal and regulatory
perspective, noting the many issues for which there is
legal ambiguity.
In development
Third Meeting
Nov 2018,
Expanded Access:
Practical, Legal, and
Regulatory Considerations
Attendees discussed the advantages and drawbacks of
the two pathways by which patients may now request
access to investigational therapies. Among other
things, we considered the impact of each avenue on
long-term drug development, the resources necessary
for handling requests in a timely and consistent
manner, and the optimal contents of organizational
policies, considering the perspectives of both pharmaceutical companies and large academic healthcare
facilities.
In development

Second Meeting
Jul 2018,
Application of General
Data Protection Regulations
to Research: Legal,
Practical,and Strategic Implications
Convening representatives from academia, industry,
and government, this conference explored the impact
of the EU GDPR on human subjects research,
highlighting the challenges posed by the GDPR to
clinical research, biobanking and databanking, and big
data research, particularly in light of the limited
guidance available to date from EU and EU member
state authorities.
Initiated workgroup
to draft a
Code of Conduct
for the EU GDPR
Inaugural Meeting

Project Leadership: Mark Barnes (Ropes & Gray LLP), Barbara Bierer (MRCT Center)

Contact information: mrct@bwh.harvard.edu