Author Archive
12th Annual Scientific Meeting Details
Thursday, February 11th, 2016Host Hotel:
The Fairmont – Washington DC
2401 M Street NW
Washington DC 20037
202-429-2400
Hotel changes must be made in writing to the Secretariat: isctm_secretariat@isctm.org
Onsite registration opens:
10:30 Tuesday 16 February 2016
The Fairmont Ballroom Foyer
Sessions begin:
1:00 PM Tuesday 16 February 2016
ISCTM Activity Update
Friday, November 13th, 2015Publications
Congratulations to the SI/SB Consensus Meeting Steering Committee and all those who invested in the months of work which laid the groundwork for the SI/SB Consensus Meeting. Report of that meeting is now published in Journal of Clinical Psychiatry Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting J Clin Psychiatry 2017;78(6):e638–e647 (Open Access supported by ISCTM). Visit the ISCTM Publications page to find this newest additions to the library and perhaps find other papers of interest utilizing the ‘Search Publications’ tool.
Working groups are an excellent vehicle for delving deeper into subjects than can be done at our semi-annual meetings. To view activity of ISCTM working groups or if you are interested in bringing forward a working group topic, please contact the Secretariat. WORKING GROUP PAGE
2016 Executive Committee Nomination
Monday, October 26th, 2015Call 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 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
NOMINATIONS CLOSED
Drug repositioning in CNS
Wednesday, October 21st, 2015Chairs: M Davidson, C Canuso
While the research to design original, novel drugs based on the understanding of the pathophysiology of mental illnesses continues, a parallel line of investigation tests drugs designed for non-mental illnesses indications, to treat mental illnesses. The idea behind repositioning and repurposing is that a) drugs with similar chemical structure might have similar biological effects b) diseases with similar pathophysiology or similar molecular basis might respond to similar drugs c) most drugs affect more than one target (pathophysiological process, receptor). The impetus for repurposing derives on one hand from the lack of molecular and pathophysiologic understanding of this disease and on the other hand from the need to de-risk drug development.
Traditionally – in medicine in general and in psychiatry in particular – repositioning was the result of serendipitous but astute clinical observation of an unexpected benefit or expected or unexpected adverse effects. Also epidemiological associations of a drug exposure with an unexpected benefit has occasionally let to successful reposition. More recently, repositioning has become systemic (not serendipitous) taking advantages of the latest technologies often blurring the distinction between it and “de-novo” drug development. Systematic computational analyses of transcriptomic (gene expression), GWAS large libraries of compounds are such examples. Candidates for repurposing can be drugs in preclinical development or active phases of clinical development (phase I-IV) or which are currently or have been on the markets.
In an attempt to facilitate the repositioning process collaborations have been established between governments the pharmaceutical industry (NCATS in the US and the New-Meds in Europe), not-for-profit foundations (Stanley Medical Research, NARSAD), for-profit (Biovista) and professional organizations (ECNP-Medication Chest). Annual conferences (www.drugrepositioningconference.com) and journals (www.liebertpub.com/overview/drug-repurposing)have joined the effort.
Mitigating the effects of nonadherence in clinical trials
Thursday, October 15th, 2015Chairs: T Shiovitz, E Bain
At this session we will present findings of the ISCTM Nonadherence Workgroup in advance of (or in close proximity to) publication of the ISCTM white paper. At the conclusion of the conference, attendees will be able to identify types of nonadherence (NA), how nonadherence can adversely affect study outcome (including effects on sample and effect sizes), where/how to take action in order to ameliorate the negative effects of nonadherence on study success as well as regulatory issues related to eliminating or censoring non-adherent subjects.
Novel developments to address methodological issues in Autism Spectrum Disorder
Thursday, October 15th, 2015Chairs: L Gault, G Pandina, L Alphs
Despite the relatively high prevalence and lifetime impact of autism spectrum disorder (ASD), wide gaps remain in consistent diagnosis, and identification of meaningful clinical endpoints. This session will clarify the outstanding issues from the perspective of the clinician, the clinical trialist, regulators and advocacy organizations. The goals of this session are to: Discuss heterogeneity of clinical presentation of ASD and the challenges of identifying a suitable population for clinical trials; Identify gaps in identifying meaningful endpoints that adequately track clinically important symptoms and outcomes in persons with autism-spectrum disorder when including them in clinical trials; Identification of regulatory considerations related to clinical trials for autism-spectrum disorder and Identification of opportunities for stakeholders to partner to advance research in ASD
Improving Transparency of Clinical Trial Data
Thursday, October 15th, 2015Chairs: M Weiser, A Kalali
Progress in developing drugs is often plagued by publication bias of several sorts, including non-publication of negative studies. Non-publication is damaging for the field, as compounds which have already been tested with no results published might be tested again, leading to unnecessary exposure of patients to study procedures/placebo and to a waste of funds that might otherwise be used to test innovative compounds. Additionally, investigators sometimes report the results of studies improperly, neglecting to differentiate between primary and secondary outcome measures, and/or presenting post hoc and sub-group analyses as primary outcomes. This symposium will present an overview of this issue, and show rates of publications of studies of some of the major agencies which fund trials in psychiatry.
12th Annual Working Group Dinner Session Descriptions
Thursday, October 15th, 2015Adaptive Design (Kando, Marcus)
The Adaptive Design Working Group (ADWG) will develop a plan for a series of webinars to be executed over the ensuing months. The group will discuss number of sessions, topics, possible presenters, timing and execution.
Addressing Methodological Challenges in International CNS Clinical Trials (Keefe, Kalali)
We will continue to work on the paper we are submitting on recommended processes for translating, culturally adapting, and implementing clinician reported outcomes (ClinROs) in international trials. The workgroup time will be utilized to get input from the paper authors and to get feedback from working group participants.
Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs (Rabinowitz, Schooler)
The working group will commence its work on developing consistency flags for the MADRS after having successfully completed a set of flags for the PANSS. The group is seeking to include additional members with relevant MADRS experience.
Biomarkers in Schizophrenia (Potkin, Goff)
Group will receive update on manuscript and develop objectives for next phase of working group.
Behavioral and Psychiatric Symptoms and Dementia (Ereshefsky, Miller, Pani)
The Working Group at our second meeting at ISCTM Amsterdam had a robust discussion on next steps forward and on WG priorities. There was substantive agreement (though not completely so) with the results of our survey findings (sent out to WG participants following our inaugural meeting in Washington DC in February 2015.) These survey results and follow-on discussions form the basis for next steps to be considered at the February 2016 meeting.
Summary of key BPSD Working Group Survey Results:
- We had 19 responses out of 37 survey recipients (51%). The Working Group participants in Amsterdam supported the survey results to focus our efforts on Alzheimer’s disease and AD spectrum i.e., pre-clinical/MCI (18 top rank votes), rather than on all Dementia and Neurodegenerative disorders (2 top rank votes).
- The top three neuropsychiatric symptoms or symptom clusters receiving the most support to focus our effort on were: Agitation/Aggression; Depression/Affective disturbances, Apathy/Amotivation/Anhedonia.
- 90% of respondents agree with the following statement from the EMA workshop on BPSD:
In order to be considered as a stand-alone indication it is expected that the mechanism of action of the medicinal product would be relevant and specific for the treated neuropsychiatric symptoms. This requires reliable and valid measurement tools for the studied patient population in the specific stages of the disease…”
- The highest endorsement for a specific element of the EMA Workshop Paper (November 2014) was: An indication “requires reliable and valid measurement tools for the studied patient population”.
- In a question ranking potential priorities for the WG, both the greatest number in support (n=9) and strongly disagree (n=10) were associated with the statement: “Assess the current state of the BPSD drug development literature and review current study methodologies for BPSD indications in order to identify experimental medicine strategies and ‘fit for purpose’ designs suitable for a clinical development plan (IND-Phase I-III)”
Cognitive Assessment in CTs of AD and its Precursors (Posner, Harvey)
The next version of the Cognition in Alzheimer’s Disease working group will focus on a single highly important topic:
Drawing from the insights from prior meetings and the previous two white papers produced by the working group, the February 2016 session will discuss and debate the merits and risks of various possible Alzheimer’s prevention trial designs.
There are several critical topics contained in this discussion, which include brief presentations and extensive discussion by the working group members.
These include:
- What is the treatment population and how would they be identified and selected?
- What are the key inclusion criteria?
- Is there a need or place for a longitudinal low risk comparison group?
- What are the outcomes assessments?
- How long should the trial last?
- How often should the assessments performed?
- Is it possible to compare different drugs or even different doses of drugs in a study such as this.
These are complex questions and will require careful consideration. By their very nature, prevention trials are high risk and uncertain in their formulations and this working group will start toward consensus on optimal research designs.
Identifying and Analyzing Adverse Events Related to Abuse and Dependence Potential in CTs (Setnick, Sokolowska, Klein)
The purpose of this session is to discuss the varying lists of adverse event terms related to abuse and dependence that have been utilized across CNS clinical drug development programs, compare these to the recommendations in the FDA guidance and discuss which terms may be routinely examined. Recommendations regarding abuse related adverse event collection and presentation will be reviewed with specific case examples discussed. Additional data sources in clinical trials (e.g. drug accountability, withdrawal scales) that may be relevant to abuse and dependence potential will also be reviewed.
Network meta-analysis: Integrating results of direct and indirect treatment comparisons
Thursday, October 15th, 2015Chairs: N Schooler, G Haynes, M Stewart
Meta-analysis is a statistical technique widely used to integrate results of studies comparing the same treatments in order to obtain the best estimate of effect size. Network meta-analysis extends this methodology to comparisons of treatments that are not included in the same studies, i.e., have not been directly compared to each other. This potentially allows a wider range of comparisons to be considered in estimates of effect size; and may also be particularly useful as the results of trials with new interventions must be integrated with results of earlier comparisons. This session will present an overview of the statistical concepts used in network meta-analysis, and examples based on antipsychotics in schizophrenia and mood stabilizers in bipolar disorder will be used. Commentaries by academic and industry clinical trialists, a statistician, and a representative from the payer community, will address the strengths and limitations of this new approach and how it is viewed by the field.