Author Archive
15th Annual Scientific Meeting Posters
Wednesday, December 5th, 2018Poster PDFs and abstracts are in alphabetical order by author.
Speakers’ Corner – 2019 Autumn Conference – Includes joint day with ECNP
Wednesday, December 5th, 2018Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 2019 Autumn Conference. This page contains all the links you will need for submitting information to the ISCTM, as well as information we hope you find helpful for your planning.
Dates/Location
5-7 September 2019
AC Hotel Bella Sky
Copenhagen, Denmark
(Housing to be booked through ISCTM during registration process. Do not contact the hotel directly.
Details below)
STEP 1: Complete the Online Confirmation and Agreement
STEP 2: Please Email Biographical Paragraph and Photo
2500 characters max (including spaces)
STEP 3: Register for the Meeting
Registration is now open. Select link below. From the drop down, selecting Speaker will direct you to the fee waived registration path. You will have the opportunity to book your housing during the registration process. Do not contact the hotel.
REGISTRATION LINK
STEP 4: Please Email Abstract
Individual talk abstracts, for inclusion in the program book, should be submitted after the first session development call with chairs, but no later than Thursday, 1 August 2019. Abstract should be in paragraph form, < 300 words and contain no tables.
STEP 5: Presentation Submission Schedule
— Draft: Chairs will advise according to each segment’s agenda development telecon schedule.
— Final: Bring flash drive to onsite registration desk the morning of your session, no later than 30 minutes prior to the start of the meeting day. If you have video or any other special needs regarding your presentation, please advise the Secretariat at least one week in advance of the meeting to arrange an appointment with the AV onsite PRIOR to the day of the presentation.
STEP 6: Chairs/Co-Chairs – Publication Information
To facilitate dissemination of information discussed during ISCTM meetings, we encourage publications from ISCTM sessions. Chairs will discuss publication plans during the session development calls. Please inform Secretariat of any publication plans. PUBLICATION GUIDELINES
Travel Arrangements:
We ask speakers who will request reimbursement to book flights enough ahead of travel dates to take advantage of the lower fares. In order to meet ISCTM’s fiscal responsibilities, the Society endeavors to operate its meetings as close to break even as possible, hopefully in the black. The Executive does not wish to raise additional revenue through increasing registration fees, so we must keep a close watch on expenses. (ISCTM Speaker Reimbursement Policy)
Preliminary Agenda:
| Day 1: Thursday, 5 September | |
| 17:30-19:00 | Welcome reception |
| Day 2: Friday, 6 September – Joint sessions with EC |
|
| 8:15 | Presidential Welcome |
| 8:30-10:15 | Clinical trials for treatment resistant neuropsychiatric conditions |
| 10:30-12:15 | Neurocognitive challenges in treatment trials in epilepsy and multiple sclerosis |
| 12:15-13:45 | Lunch |
| 13:45-17:30 | Drug development for Autism Spectrum Disorder: Challenges and opportunities |
| 17:30-19:00 | Poster Session/Reception |
| Day 3: Saturday, 7 September |
|
| 7:00 am | Registration opens |
| 8:30-13:00 | Developing pharmacological treatments for the rapid reduction of suicidal ideation in depression |
| 13:00 | Meeting adjourns |
| 13:00-15:00 | TBD Working Group Sessions |
ISCTM Contact Information
Philip Harvey – Chair, Scientific Program Committee (2019-2021)
Carlotta McKee – Executive Director, ISCTM
Mary Bea Harding – Associate Director, ISCTM
Linda Hutchinson – Project Coordinator, ISCTM
Phone: +1.615.383.7688
2019 Autumn Online Confirmation and Agreement
Wednesday, December 5th, 2018Innovative Technologies for Clinical Trials
Tuesday, November 27th, 2018Chairs: Richard Keefe, PhD; Michael Davis, MD, PhD
Recent Deliverables:
Publication: Current and Emerging Technologies to Address the Placebo Response Challenge in CNS Clinical Trials: Promise, Pitfalls, and Pathways Forward, Innovations in Clinical Neuroscience (open access)
Publication: Innovative Technologies in CNS Trials – Promises and Pitfalls for Recruitment, Retention and Representativeness, Innovations in Clinical Neuroscience (open access)
Recent Activity:
Working Group Session – 18th Annual Scientific Meeting – view slides – 23-25 February 2022, Washington DC
Working Group Session – 2021 Autumn Conference includes joint day with ECNP – view summary. The WG reviewed the status on the three sections of the manuscript that is in development on the use of innovative technologies to address key issues in clinical trials: patient recruitment; placebo response mitigation; and assessing clinically meaningful response.
Working Group Session, 17th Annual Scientific Meeting, 8 April 2021
Hot Topic: Regulatory viewpoints from EMA and FDA on contemporary challenges and strategies for conducting and analyzing clinical trials in the COVID-19 era, 2020 Autumn Conference
Webinar: 15 May Adapting Trials (In a Hurry) for Remote Assessment Call 3- EMA Perspectives: Link to View Video
Webinar: 17 April Adapting Trials (In a Hurry) for Remote Assessment WG Call 2 – FDA Perspectives: Link to View Video and Questions Discussed
Webinar: 3 April Adapting Trials (In a Hurry) for Remote Assessment WG Call 1: Link to View Video and Call Notes
Working Group session, 16th Annual Scientific Meeting, 21 February 2020, Washington DC
Working Group Session, 7 September 2019, AC Bella Sky Hotel, Copenhagen Denmark View Summary
The Innovative Technologies Working Group is in the early stages of developing a document outlining how innovative technologies may address key challenges in CNS clinical trials as well as the scientific and regulatory issues that need to be considered.
Working Group Session – 15th Annual Scientific Meeting– 21 February 2019, Washington DC
This working group was developed based upon the all-day session of the same name at the Autumn 2018 meeting co-chaired by Phil Harvey, Rich Keefe, Mike Davis and Tiffany Farchione. The emphasis of this working group will be on an ongoing non-commercial discussion of strategies for providing developing and implementing need-based technologies to help solve current challenges in CNS clinical trials. Conceptual, practical, measurement, statistical, and regulatory issues will be considered in this working group.Regulatory input will be essential to this discussion. The inaugural meeting of this working group will take place at the 15th Annual Scientific Meeting, 19-21 February 2019.
Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs
Tuesday, November 27th, 2018Chairs: Christian Yavorsky, PhD; Jan Sedway, PhD
Most Recent Activity: Working Group Session, 20th Annual Scientific Meeting – view summary, 21-23 February 2024, Washington DC – view slides
Working Group Session, 19th Annual Scientific Meeting – view summary, 15-17 February 2023, Washington DC
Working Group Session, 18th Annual Scientific Meeting, 23-25 February 2022, Washington DC
Working Group Session, 17th Annual Scientific Meeting, 7 April 2021
Working Group Session – 2020 Autumn Conference – 26 October 2020, View Summary. View video invitation.
Working Group Session, 16th Annual Scientific Meeting, 21 February 2020, Washington DC – View Summary
Working Group Session, 7 September 2019, AC Bella Sky Hotel, Copenhagen, Denmark (Chairs: Elizabeth Ballard/Christian Yavorsky) View Summary
Group reviewed results of survey of clinicians assessing rapid acting ADs and followed up on items from 15th Annual meeting (see summary below).
Inaugural Working Group Session – 15th Annual Scientific Meeting-view summary – 19 February 2019, Washington DC
This working group will be focused on evaluating the validity and reliability of current and prospective future methods of assessment of efficacy, effectiveness of the “next wave” of treatments in mood disorders, utilizing the rapid acting antidepressants (RAADs) as a model. Do the instruments developed to evaluate the efficacy of older generations of treatments (e.g. MAOIs, TCAs, SSRIs) meet the needs of this new class of treatments? How well do they capture (a) speed of effect, (b) phenomenology, (c) patient experience, and (d) meaningful change? The inaugural working group meeting will take place at the 15th Annual Scientific meeting (19-21 February 2019) with a focus on developing and refining applicable domains to help evaluate the utility of different endpoints/instruments for this new class of treatments. Strengths and weakness of standard and novel assessment methods will be compiled with the goal of holding a session to present current evidence on this topic at a future ISCTM meeting.
Thank You!
Tuesday, November 20th, 2018Thank you for completing the evaluation and for joining us at the meeting!
15th Annual Meeting Working Group Session Descriptions
Thursday, November 8th, 2018There will be two working group session times, so half of the groups will be offered at one time, the others at the alternate time. When registering you will be asked to provide your first and second choices. We will make best effort to schedule groups to avoid as many conflicts as possible.
Algorithms/Flags (Rabinowitz/Schooler)
The group is currently working on the PSP scale. The first round of draft flags was reviewed at the October meeting in Marina Del Ray. This meeting will be an opportunity to consider updates to the initial draft and examine initial data analyses that have applied the flags to several data sets. Discussion of further steps to complete work on this scale should result in a final plan for publication.
Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs (Opler/Ballard)
This working group will be focused on evaluating the validity and reliability of current and prospective future methods of assessment of efficacy, effectiveness of the “next wave” of treatments in mood disorders, utilizing the rapid acting antidepressants (RAADs) as a model. Do the instruments developed to evaluate the efficacy of older generations of treatments (e.g. MAOIs, TCAs, SSRIs) meet the needs of this new class of treatments? How well do they capture (a) speed of effect, (b) phenomenology, (c) patient experience, and (d) meaningful change? The initial working group meeting will focus on developing and refining applicable domains to help evaluate the utility of different endpoints/instruments for this new class of treatments. Strengths and weakness of standard and novel assessment methods will be compiled with the goal of holding a session to present current evidence on this topic at a future ISCTM meeting.
Autism Spectrum Disorder (Mantua, Farchione, Arango)
The chairs will summarize the work carried out so far and outline the ISCTM/ECNP session to be held in Copenhagen, 5 September 2019. The WG activities will then focus on the preparation of articles for a special issue of European Neuropsychopharmachology, a series of opinion papers on issues relevant for improving clinical trial methodology in ASD, addressing initiatives in the field to foster drug development.
Behavioral and Psychiatric Symptoms in Dementia (BPSD)
Apathy Subgroup (Lanctot, Miller)
The working group will discuss progress on apathy diagnostic criteria for neurocognitive disorders and continue working on the apathy review paper and plan next steps for the group.
Behavioral and Psychiatric Symptoms in Dementia (BPSD)
Agitation Subgroup (O’Gorman, Rosenberg)
The Alzheimer’s Disease Agitation Working Group of the BPSD working group will meet to discuss their progress in the development of a white paper to help inform clinical trial design and methodology in the area of AD agitation. Items for discussion will include: –Wider ISCTM endorsement including regulatory opinion –Publication timelines –Developments in drug development in the indication since last meeting –Next steps
Cognitive Trajectories in Schizophrenia (Harvey, Granger)
This working group will be focusing on whether the baseline severity of cognitive impairments in schizophrenia affects the likelihood of cognitive improvements with treatment. In so doing, we will re-analyze previous studies with both pharmacological and cognitive training approaches. The next meeting will have some of those results ready and we will review those and plan for subsequent analyses before the next meeting. A white paper, with regulatory input, will be the eventual plan for dissemination.
Innovative Technologies for Clinical Trials (Keefe, Davis)
This working group was developed based upon the all-day session of the same name at the Autumn 2018 meeting co-chaired by Phil Harvey, Rich Keefe, Mike Davis and Tiffany Farchione. The emphasis of this working group will be on an ongoing non-commercial discussion of strategies for providing developing and implementing need-based technologies to help solve current challenges in CNS clinical trials. Conceptual, practical, measurement, statistical, and regulatory issues will be considered in this working group.Regulatory input will be essential to this discussion.
Estimands and Missing Data (Lim, Polverejan)
The draft ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” introduced a trial planning framework in which clear trial objectives are to “be translated into key scientific questions of interest by defining suitable estimands “. It was recognized that “the construction of the estimand(s) in any given clinical trial is a multi-disciplinary undertaking including clinicians, statisticians and other disciplines involved in clinical trial design and conduct”. The ISCTM Estimands and Missing Data Working Group consists of both clinicians and statisticians from FDA and industry. This working group has been applying the recommended estimand framework on specific CNS studies, starting with Major Depressive Disorder (MDD), as an entry point to devising a process to be used by clinical teams. This process can be generalized and applicable to most clinical trials, including outside of CNS treatments. In this session, the WG will share and discuss with the participants points to consider in the process of defining estimands for clinical trials. Estimand definitions for MDD will be used as examples.
Late-Onset Depression: A distinct indication? (Capaccione, DeBoer)
The Late Onset Depression (LOD) working group will continue to explore the definition, description, and pathophysiology of this distinct type of depression. Of particular interest are the unique challenges in design and conduct of the clinical trials and the optimal methods to select the population for inclusion. The group will also consider the appropriateness of an indication in LOD and the regulatory path to obtain approval in this indication. The output of the group decisions will be captured in a Whitepaper.
Orphan Diseases (Busner, Anand)
Patient Centricity: Group will review goals and prioritize potential deliverables including publications and a potential half-day session at a future ISCTM meeting.
Instructive Case Examples: Group will review collected cases, decide upon editing/characterization, review strategies for ensuring submitter and sponsor-blinding, and generate ideas for soliciting additional cases across relevant stakeholders.
Prevention Trials in Alzheimer’s Disease (Posner, Harvey)
The WG focus will be revising a well developed draft of paper currently entitled: Options and Considerations for Alzheimer’s Prevention Trials. Draft will be circulated to all registered attendees prior to the meeting.
2019 Executive Committee Election
Tuesday, November 6th, 2018VOTING IS NOW CLOSED. RESULTS TO BE ANNOUNCED AT ANNUAL BUSINESS MEETING, 20 February, 2019, The Fairmont Washington DC.
Call for Nominations Letter
(Includes criteria for service on the Executive Committee)
To complete this form you will need:
1) If nominating someone other than yourself, your endorsement alone is sufficient, UNLESS the nominee is someone from within your organization, then a second endorsement from someone outside of your organization is required. One person may fill out on behalf of both people in this instance.
2) If you are self-nominating, you will need endorsement from two people, not from the same group.
3) Short bio of nominee
Submission deadline: Wednesday, 12 December 2018 (more…)
15th Annual Scientific Meeting – Speakers’ Corner
Tuesday, November 6th, 2018Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 15th Annual Scientific Meeting. This page contains all the links you will need for submitting information to the ISCTM, as well as information we hope you find helpful for your planning.
Dates/Location
19-21 February 2019
The Fairmont
Washington DC, USA
(Housing to be booked through ISCTM during registration process. Do not contact the hotel directly.
Details below)
STEP 1: Complete the Online Confirmation and Agreement
STEP 2: Please Email Biographical Paragraph and Photo
2500 characters max (including spaces)
STEP 3: Register for the Meeting
Registration announcements will be sent via email week of 12 November. Selecting Register from that email will direct you to the fee-waived Speaker Registration path. You will have the opportunity to book your housing during the registration process. Do not contact the hotel. To have the email resent please email the Secretariat.
STEP 4: Please Email Abstract
Abstract, for inclusion in the program book, should be submitted after the first session development call with chairs, but no later than 8 January 2019. Abstract should be in paragraph form,
< 300 words and contain no tables.
STEP 5: Presentation Submission Schedule
— Draft: Chairs will advise according to your session’s agenda development telecon schedule.
— Final: Bring flash drive to onsite registration desk the morning of your session, no later than 30 minutes prior to the start of the meeting day. REMINDER: Disclosures must be included in slide presentation.
STEP 6: Chairs/Co-Chairs – Publication Information
To facilitate dissemination of information discussed during ISCTM meetings, we encourage publications from ISCTM sessions. Chairs will discuss during the session development calls. (Output category specifications)
Travel Arrangements:
In order to meet ISCTM’s fiscal responsibilities, the Society endeavors to operate its meetings as close to break even as possible, hopefully in the black. The Executive does not wish to raise additional revenue through increasing registration fees, so we must keep a close watch on expenses. Therefore, we ask speakers requesting reimbursement to keep this in mind when arranging travel, specifically, to book flights enough ahead of travel dates to take advantage of the lower fares. (ISCTM Speaker Reimbursement Policy)
Preliminary Agenda:
| Day 1: Tuesday, 19 February 2019 | |
| 10:30-6:00 | Onsite Registration Open |
| 1:00-4:10 | Unresolved Problems in Neuroscience Drug Development – Point/Counterpoint |
| 4:25-6:00 | Working Groups – Session A |
| 6:00-7:00 | Welcome Reception |
| Day 2: Wednesday, 20 February 2019 | |
| 7:15 | Registration opens/Continental Breakfast |
| 8:15-Noon | Parallel Sessions A. Strategies for generating meaningful data for payers B. Methodological issues associated with the new Alzheimer’s draft Guidance |
| Noon-1:30 | ISCTM Annual Business Meeting/Luncheon |
| 1:45-5:30 | Finding the signal: Strategies for participant-centric trials in the face of participant-introduced validity challenges |
| 5:45-7:30 | Poster Session/Reception |
| Day 3: Thursday, 21 February 2019 | |
| 7:00 | Registration opens |
| 7:15-9:15 | Working Groups – Session B – Breakfast |
| 9:30-1:15 | Untangling the regulatory and statistical challenges when designing trials for disease modification |
| 1:15 | Meeting Adjourns |
ISCTM Contact Information
George Haig – Chair, Scientific Program Committee
Carlotta McKee – Executive Director, ISCTM
Mary Bea Harding – Associate Director, ISCTM
Phone: +1.615.383.7688
Thank You
Monday, October 15th, 2018Thank you for completing the evaluation and joining us at the course!