Author Archive
13th Annual Working Group Dinner Session Descriptions
Tuesday, October 18th, 2016Abuse Liability: A lethal combination: Clinical trial design considerations to evaluate the nature of opioid and benzodiazepine interactions (Setnik, Sokolowska, Klein)
During this session, study methodologies will be discussed to further evaluate and characterize opioid-benzodiazepine and other drug interactions with CNS drugs that may pose serious safety concerns. Furthermore, such studies may also evaluate the potential of new analgesics or sedatives that may have decreased risk of respiratory depression. Considerable variability exists between studies in terms of the criteria for defining respiratory depression.
Furthermore, a discussion of defining clinically meaningful respiratory depression in the context of a clinical trial will be held. This session will introduce non-invasive methods to evaluate respiratory depression in a clinical setting evaluating the safety risks associated with drug-drug interactions in healthy volunteers.
Behavioral and Psychiatric Symptoms in Dementia (Ereshefsky, Miller, Pani)
1. Collaboration between ISTAART, NPS PIA and ISCTM BPSD WG
Co-Chairs – Krista Lanctôt, Joanne Bell PIA
• Report on joint NPA PIA and BPSD ISCTM activities including featured research symposium submitted February 1st to AAIC
• Other activities related to ongoing collaborations, including ISCTM involvement in the PIA Day and Paris ISCTM meeting
2. Discussion with drug sponsors providing insights:
• Agitation/Psychosis/BPSD (lessons learned, update on drug development strategies)
3. Apathy
• How do lessons learned from sponsor-regulatory experiences guide our development of a strategy to facilitate tx of apathy in dementia?
Pseudospecificity, diagnosis, assessment, primary and secondary endpoints, effects of the progression of illness
• To assess the feasibility/desirability for ISCTM to support a consensus group.
–Identify necessary steps (workshops and ISCTM programming).
–Activities required beyond meetings and conference calls
• Identify opportunities and pathways for collaboration with the Biomarkers Consortium even though the FNIH Endpoints Working Group was not funded
4. Neurocircuitry/Biomarker strategies
• How do reward and hedonic pathways relate to apathy studies in AD?
• Discussion on role of MBI (mild brain injury) in apathy, neurocircuitry/biomarker studies, differentiation with depression?
5. Deliverables:
• FRS proposal in collaboration with ISTAART PIA submitted by February 2017 -Done
Final adjustments to the program for ISCTM Paris 2017
• Identification of additional ISCTM supported activities to move towards a consensus group on treatment of Apathy in AD
Prevention Trials of Alzheimer’s Disease – Ongoing Optimization and the Roles of Biomarkers and Cognitive, Performance, and Functional Assessments (Posner, Harvey)
This working group has recently been focusing on prevention trials and our previous two publications concentrated on optimal trials design and performance/cognitive outcome measures. In the execution of clinical development for new compounds, however, there has been a movement toward the rapid assessment of treatment strategies centering on biomarkers. In this next meeting we will compare and contrast biomarkers versus performance based and cognitive outcome measure for both subject selection and outcome measures.
Cognitive Dysfunction (Parker, Fava)
Background: There is increasing evindence supporting that cognitive dysfunction in psychiatric disorders is not limited to Dementia or Schizophrenia but may also play a key role in additional disorders, including those such as mood disorders that are episodic in nature. Cognitive dysfunction has been recognized as an important feature of bipolar disorders, and a recent Institute of Medicine panel convened to discuss the role of cognitive dysfunction in Major Depressive Disorder (MDD). Addtionally, at a recent Advisory Committee, FDA endorsed the idea of Cognitive Dysfunction as a legitimate target for drug development. Further evaluation of approaches for rigorous evaluation of cognitive dysfunction in the context of psychopharmacological studies appears warranted.
Objective: To further advance the understanding of cognitive dysfunction in psychiatric disorders and, with a diverse group of stakeholders, provide guidance on potential development pathways for future therapeutics.
Methodological Challenges in International CNS Clinical Trials (Kalali, Pappadopulos)
While great progress has been made with expert and regulatory guidelines for the cross-cultural adaptation of patient reported outcomes (PROs), similar guidance for ClinROs have yet to be established. At the spring session, the working group members will continue their work refining, gathering input and gaining consensus on the draft guidelines for Clinician Rated Outcomes (ClinROs). To date, the working group has reviewed the literature and developed a draft position on ClinRO translation and adaptation for international clinical trials. These guidelines will not revisit well-established standards for technical translation/adaption, but rather focus uniquely on CNS measures with the goal of maintaining measure integrity and validation while balancing the ideal/desirable versus what is possible/realistic in the current CNS drug development environment. As we are reaching our objectives with the current project, we will also conduct a survey and gather recommendations for the future goals and deliverables
Missing Data (Lim, Samad)
In the 2014 concept paper for the ICH E9 (Revision 1) “Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trial”, the authors emphasized the need for a “golden thread” linking clear trial objectives with selection and prioritization of endpoints and hypotheses for statistical testing or targets for estimation. The authors make the case that this “golden thread” could be provided by a clear description of what was to be estimated by the analysis – the “estimand” of the analysis, and also noted the ‘Absence of a framework for conducting and interpreting sensitivity analyses.’ These problems could lead to inconsistencies in inference and decision making within and between regulatory regions. Consequently, an ICH E9(R1) Expert Working Group has been formed to provide recommendations on these problems, with a draft Addendum expected to be released in the second half of 2017.
During the Feb 21st ISCTM Missing Data Working Group meeting, the framework (to be recommended by the future ICH E9 Addendum) for setting objectives and estimands for a clinical trial will be discussed in the context of different clinical decisions and perspectives, as well as disease and treatment considerations. CNS clinical trial examples will be used in the discussion. This framework will create the foundation for the selection of the design, primary and sensitivity analyses for a clinical trial in the presence of missing data and other treatment confounders.
Negative Symptoms (Marder, Daniel)
Schizophrenia clinical trials utilizing negative symptom endpoints remain challenged by issues such as high placebo response, measurement error, secondary effects from improvement in positive symptoms and potential different pharmacological responses of different negative symptom domains. This may explain – in part – the confusing results from recent trials. At the most recent meeting of the ISCTM Negative Symptom Workgroup it was decided to reconvene when new information from trials is available. With this in mind, the group will discuss the new results and when available, data mining of recent negative symptom trials with the aim of informing future methodology. An update on the performance of negative symptom endpoints such as the BNSS will be presented as well.
Mitigating Nonadherence (Shiovitz, McCann)
Nonadherence is a substantial problem in clinical trials and contributes to study failure. This working group has published its recommendations on ways to mitigate the effects of nonadherence in clinical trials (Shiovitz et al., J Clin Pharmacol 56: 1151, 2016). Such recommendations, however, can only be effective if stakeholders are made aware of them in a way that facilitates their implementation. At the February, 2017 ISCTM meeting, the nonadherence working group will continue to discuss ways to promote awareness of the recommendations. The group will also discuss a new ISCTM initiative on obtaining sponsor data to answer key methodological questions (e.g. relationship of study size and other factors to study success, effects of nonadherence and nonadherence mitigation strategies). What questions should be addressed? What data should be obtained from sponsors? Is this initiative feasible?
13th Annual Meeting – Speaker Online Confirmation and Agreement
Thursday, October 6th, 201613th Annual Scientific Meeting – Speakers’ Corner
Thursday, October 6th, 2016Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 13th 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
21-23 February 2017
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
2500 characters max (including spaces)
STEP 3: Register for the Meeting
Registration will open mid-November. You will receive an email announcement. 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.
STEP 4: Please Email Abstract
Abstract, for inclusion in the program book, should be submitted after the first session development call with chairs. 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.
STEP 6: Chairs/Co-Chairs – Publication Information
To facilitate dissemination of information discussed during ISCTM meetings, we encourage publications from ISCTM sessions. Please advise the Secretariat of your plans, and communicate your plans with speakers 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 who will request 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, 21 February 2017
11:00-5:30 Onsite Registration Open
1:00 Session 1: Advantages and Challenges of Adaptive CNS Trials: Real World Lessons (Kando/Marcus)
5:45-6:30 Welcome Reception
6:45-8:30 Session 2: Working Group Dinners
Day 2: Wednesday, 22 February 2017
7:15 Registration Opens / Continental Breakfast
8:15 Session 3: Optimizing Use of Big Data for Patient Identification and Disease Management (Wilcox/deJong)
Noon – 1:30 ISCTM Annual Business Meeting / Lunch
1:45 Session 3 continues
6:00-8:00 Poster Session/Reception
Day 3: Thursday, 23 February 2017
7:15 Registration Opens / Continental Breakfast
8:15 Session 4: Silver Linings Playbook: The Positive Side of Negative Trials (Keefe/Romano)
12:15 Meeting Adjourns
ISCTM Contact Information
Thomas Laughren – Chair, Scientific Program Committee
Carlotta McKee – Executive Director, ISCTM
Mary Bea Harding – Executive Assistant, ISCTM
Lori Bales – Administrative Assistant, ISCTM
Phone: +1.615.383.7688
13th Annual Scientific Meeting Poster Submission Form
Wednesday, October 5th, 2016ISCTM 13th Annual Scientific Meeting
21-23 February 2017
The Fairmont
Washington DC
IT IS IMPORTANT THAT YOU REVIEW GUIDELINES. Revised December 2016.
The ISCTM Poster Committee is calling for Abstracts with content pertaining to significant CNS methodological problems-solutions relevant to the meeting program topics or previous ISCTM topics. ABSTRACTS AND POSTERS MUST BE FREE OF COMMERCIAL BIAS OR PROMOTION. (Please see Guidelines)
Submission Process: You may submit your Abstract online by filling out the form provided below or by EMAIL. If submitting by email, please be sure to include all requested information. You will receive a confirmation of receipt.
Submission Deadlines: Abstracts should be submitted no later than Monday, 9 January 2017, for review by the ISCTM Poster Committee.
Notification: You will be notified of the committee’s decision on or before Tuesday, 17 January 2017.
Meeting Dates: 21-23 February 2017
Formal poster session: Wednesday, 22 February 2017, 6:00-7:30 PM
Presenter must register for the meeting and attend the formal session. Poster session is part of the Scientific Program. ISCTM recommends that the poster be presented by the first author. If that is not possible, please designate which author will be present at the session to discuss the work with attendees.
Poster set up: Wednesday, 22 February during lunch break. Poster order (board number) will be included in the Poster Abstract section of the Meeting Program booklet. Numbers will not be distributed prior to the meeting.
Poster removal: Posters should be removed at the conclusion of the formal Poster Session.
Location: The Fairmont, Washington DC
Poster Review: Certificates of Recognition will be awarded. In order to facilitate judging, please forward .pdf of poster to Secretariat for review by judging committee by Tuesday, 14 February.
Poster Dimensions: Up to 4’ (122 cm) by 6’ (183 cm) Landscape orientation
As the poster session is small, it is not necessary to include the presentation number on your poster.
(Refer to Guidelines link above for additional formatting information)
Shipping Information:
The Fairmont, Washington DC
2401 M Street, NW
Washington, DC 20037
Attention: Guest- Receiver’s Name
Guest’s arrival date at hotel
ABSTRACT SUBMISSION FORM
Submission should contain:
- Title, all authors, author affiliations
- Methodological Question being addressed
- Abstract content should be formatted into sections as outlined in the Guidelines, with word count up to 500 exclusive of title, authors, affiliations.
- Please review Guidelines before submitting abstract.
If you are submitting abstract on behalf of author, please be sure to enter your name and email under Submitter. Thank you.
Protected: Adaptive Design Webinar 2 Viewing
Friday, September 16th, 2016Autumn 2016 Posters
Thursday, August 18th, 2016Posters and Abstracts are listed alphabetically by author.
Mitigating Nonadherence Autumn 2016 Workshop
Thursday, June 2nd, 2016Co-Chairs: Thomas Shiovitz, MD / David McCann, PhD
Objective: To review findings of the working group and audience comments from the Spring 2016 ISCTM panel.
Work plan for the session:
- To discuss whether a new working group on “Size vs Success in Phase 2/3 trials” should be created.
- To discuss how to get the recommendations of the Mitigating Nonadherence Working Group in front of stakeholders and implemented in front of future studies.
Deliverable:
- Elucidate three steps to implement working group recommendations
- If a working group on Size vs Success is agreed upon, submit co-chairs and recommendations to the ISCTM scientific committee.
Protected: Adaptive Design Webinar 1 Viewing
Friday, May 20th, 2016Addressing Methodological Challenges in International CNS Clinical Trials Autumn 2016 Workshop
Monday, May 16th, 2016Co-chairs: Amir Kalali, MD / Elizabeth Pappadopulos, PhD
The International clinical trials workgroup has been focused on their product which is a Guidance for clinician rated outcome measures and their cultural adaptability. This should be finalized by the 2017 Annual meeting.
At our last meeting we discussed the next focus of the group with a deliverable. The group members were enthusiastic about focusing on one of the many topics that could be addressed with several proposed.
At this workshop, we will determine which topic to move forward.
Deliverable: Based on topic of focus chosen
Cognitive and Functional Assessment in Clinical Trials of Alzheimer’s Disease and Its Precursors 2016 Autumn Workshop
Friday, May 13th, 2016Co-chairs: Holly Posner, MD / Philip Harvey, PhD
Objective: Continue and fine-tune our discussion on the ideal prevention trial design by having several additional key experts attend: Dorene Rentz, Marwan Sabbagh, and Jeff Kaye. They will provide expertise in performance to biomarker convergence in preclinical AD, assessment and prevention of AD in individuals with Down’s Syndrome, and innovative naturalistic outcomes assessments in early prevention trials, respectively.
This meeting will add on to the information presented in our previous two documents, now in review at ICNS:
—Outcomes Assessment in Clinical Trials of Alzheimer’s disease and Its Precursors: Readying for Short-term
—Long-term Clinical Trial Needs and Performance-Based and Observational Assessments in Clinical Trials Across the Alzheimer’s Disease Spectrum
Autumn workshop deliverable: Paper with content derived from the 2016 February Working group dinner and Autumn 2016 Workshop.