18 February 2013 Strategic Thinking Session Summary
Overview: The half-day session addressed issues about the future direction of the society. While there has been general sentiment that the society is thriving, we paused to consider refinements in how we think about the society and what we would like the society to look like over the next 3-5 years.
It was largely agreed that the core of the society is interaction among members and those involved in the greater community of CNS clinical trials. Historically, we have viewed this interaction primarily as our participation in our Annual and Autumn meetings. However, there was considerable support for an increased emphasis in the society for our activities outside our meetings. The future core of ISCTM will include interactions such as working groups, publications, responses to guidance documents, and collaborative activities with other societies, including our participation in their meetings.
Our society is a community organizing the field of all those involved in CNS trial methodology. We provide opportunity to learn from others (members and guests), and our work emanates forward to the benefit of all those involved in CNS research and clinical care.
Details on each of the five breakout groups are provided below.
Communication of ISCTM Work – Phil Harvey, Rick Hartman, Judy Dunn
The overriding sentiment of the group was that there is an excellent set of processes in place for communication of ISCTM work, but the challenge has been to get busy people to devote the considerable amount of time needed to derive products. The primary suggestion was for the generation of reports and publications to be front and center during the entire course of planning a session, workgroup, or other activity, including even responses to guidance documents.
– Process:
– Upfront planning – define communication goal before session
• Prioritize sessions as to communication potential
• Publication issues should be raised during session planning at Scientific Program
Committee meetings
– Content and structure to be defined before session; create outline of paper
– PROPOSAL: Engage junior academics to join in publication process –
• Leader of WG or Chairs of session should be experienced to mentor future leader
during publication development process.
• Junior member gets authorship of paper.
• PC has progressed with this proposal and will present it to the EC, perhaps in May
– Where?
– Innovations in Clinical Neuroscience
• As this has cost associated, better to target other journals when appropriate
– Targeted journals for specific topics
• White paper
• Full manuscript
– Website
• RECOMMENDATION open access to archived meeting materials. (Full EC 15
March 2013: Recommendation reviewed and approved beginning with February 2013
Annual meeting).
• Tools for collaboration
• Bios should contain information on current involvement – papers,
research, as opposed to traditional – could be useful as a connection tool
• Visual content
•Podcasts
•A Presidential blog was recommended. The question is whether this will
have an impact – for instance there has been very little feedback on
other Presidential communications. Is anyone reading them?
– Leverage collaboration potential to develop new original outputs
– Contribute money to run studies answering a specific question
– Contribute data for data mining exercise
– These suggestions are completely aligned with strong recommendation that
ISCTM is not just a meeting society but a society that has a variety of products
Involvement in Activities Outside of ISCTM Meetings – Rob Lasser, Michelle Stewart, Adam Butler
-Be PROACTIVE
– Develop capacity to proactively scan environment to see where there are opportunities
for ISCTM to drive the field forward rather than just reacting (e.g. to guidances)
• Example: ISCTM organize a meeting that produces a deliverable such as publication
on issues that reflect state-of-art methods that are not necessarily consensus-based;
publications from these efforts could offer roadmaps but stop short of being
“guidances.”
– Consider holding meetings outside the regular ones as satellite meetings where
we partner w/another group to focus on methodological issues of common interest – e.g.,
would be inviting Autism Speaks to partner on daylong meeting focusing on outcome
measures.
– Evangelize our expertise and focus to more therapeutically oriented groups – taking ISCTM
methodology focus to their meeting as with AAIC
– Key points to ensure success:
1. Target therapeutic areas that are ready to partner with us (a good example is a focus
on AD when several large studies read out);
2. Identify ISCTM members with expertise/interest in that therapeutic area;
3. Target scientific organizations with research focus
– Goal to have at least 3 of these joint meetings.
•Possible groups to reach out to: ECTRIMS, ADAA for PTSD, Movement
Disorders Society, pain groups, possibly NIH or NIMH, NIDA, traumatic
brain injury
– Align ourselves with complementary societies that may have less methodological focus, but
that need to hear about and consider methodological issues
– Possible groups to reach out to: ACNP, ECNP, Society of Biological Psychiatry,
CNS Summit, ASENT
– Develop strategy for outreach
– Compile list of other organizations that ISCTM members are currently members of
– Submit ISCTM-focused sessions at other meetings
– Meet with leadership of other societies to explore potential for collaborative activities
International Impact and Presence – Carla Canuso, Jill Rasmussen, A Kalali
ISCTM is an international society. Most of our members work for organizations that have
global impact and global presence. The methodological issues that we address have an
impact on clinical trials in all parts of the world. Increasingly, clinical trials are conducted
across various countries and cultures, and ISCTM can help address the challenges
associated with the internationalization of clinical trials. This is not an expansion of our
mission; it is an integral component of our core mission.
– What is ISCTM’s current value to International members?
– Opportunity to exchange views
– Connecting Science and Regulatory
– Value of knowing FDA and EMA thinking
•Engage FDA and EMA members to assure ongoing participation and attendance
– Fostering working relationships across regions and cultures
– How best to involve active members outside US in our Meetings?
– Relevant scientific content
– Enduring material e.g. Society journal including summaries of sessions
– Include webinars with scientific / regulatory content
– International scientific / regulatory discussion
– The Brussels meeting lost revenue, but the society has changed and it is a different
time, so we need to approach internationalization of ISCTM with fresh vigor
– We could have stand-alone meeting outside US or interact with existing meeting
(e.g. ECNP)
– The form of interaction may differ from our Annual and Autumn meetings, which
may gain attention from members
– How best to involve active members outside US in our Committees?
– Consider Barriers
•Commitments
•Time zones
•Costs
– Convene an ISCTM Workgroup to address International clinical trials issues such as harmonization of outcomes
– What efforts should be made to have meetings outside of the US?
– Limitations of sharing same meeting
•Time zones
– Webinars
•Materials on website
•Regulators can participate
– Challenges:
•How to engage one-time participants further in ISCTM
•Language for engaging Japan
– Impact on current ISCTM members
Innovation – Gary Sachs, Mike Detke, Michael Hufford
This group addressed a series of crucial questions regarding the role of innovative strategies in CNS Clinical Trials:
– What is the role of methodology in the current stagnation in CNS clinical trials?
– How can ISCTM help address this stagnation with innovative methods?
– What challenges and opportunities for innovative strategies have been provided by recent
changes in health care?
– There have been huge apparent improvements in efficiency and quality in many research
areas, with the cost and efficiency of innovative products increasing dramatically over time.
However, the opposite trend is evident in drug development over the past 50 years, with a
decline in the number of approved drugs, and an increase in the cost per approved drug.
– Key Questions
– What innovations can decrease costs?
– What innovations help to decrease risk?
– What innovations can help to improve signal detection?
– Innovation Across the Drug Development Spectrum
– Should ISCTM focus more on methodological issues that arise earlier in the sequence of
drug development programs?
•Phase 1.5 designs
•Pivot from P2b to P3
•Connection to C-path PRO consortium
– Post-approval issues
•Mining clinical practice (e.g., Patients Like Me)
•Standard measures integrated into clinical care
– Other innovative strategies
•Statistical approaches to subgroup analyses
•Biomarkers
•Learn from other fields, e.g. oncology
•Epidemiology
– Recommendation: Establish an Innovation Working Group will be established to address
these important issues
Sustainability – Ramy Mahmoud, Tony Loebel, Barry Lebowitz
– The role of this group was to:
•Review our current financial plan
•Outline potential strategies to ensure regular membership growth and long-term
sustainability of the society
•Develop strategies for broadening membership participation without increasing
leadership fatigue, and optimize our strategy for collaborating with other societies.
Specifically, the group addressed how we can maintain / broaden industry support, whether there are areas of CNS clinical trials methods that we have not emphasized sufficiently such as pain and neurology, and whether there are service offerings we can provide that add value to the society beyond financial benefit.
The group noted our current heavy dependence on corporate dues and contributions. Individual dues are a small proportion of overall income. While total society assets and investment income are growing, there is a need to attract non-corporate contributions to augment corporate and there is a shortfall in the society balance sheet if corporate contributions are excluded from operating income.
One proposal forwarded was the development of a separate Foundation or Endowment Fund the would allow a portion of the corporate contributions to be tax deductible, which may increase the willingness of some companies to contribute to the broader activities of the society, such as society-sponsored research. This segment of ISCTM would be similar to the NIH Foundation. We could approach major charitable foundations interested in scientific issues, but would need to clearly articulate society value to create a basis for an endowment.
This group also emphasized the need for us to engage CNS issues outside of psychiatry and to attract members other than psychiatrists, such as epidemiologists and neurologists.
Mechanisms for increasing revenue:
– Overall our dues structure was viewed as within the acceptable range.
– Revenue could be generated from workgroup products such as journal
subscriptions/publications
– Materials could be marketed, (but this may be at odds with efforts to
broaden the impact of the society)
•A successful marketing campaign with our materials could generate
attention to the society and revenue at the same time.
– Soliciting funds from payers was broached.
