Author Archive
Kick-Starting the Brain: Methodological Challenges of Emerging Technologies
Thursday, April 21st, 2016Co-Chairs: Jill Rasmussen, MD / Dawn Velligan, PhD
Increasingly researchers are exploring the application of novel brain therapeutics to improve outcomes in psychiatric and neurological disorders. This session will give the background to these new approaches and discuss the methodological and regulatory challenges they present. Data from recent trials with ECT have given new insights into methodologies for dosing, type of application, frequency of administration and safety evaluation. Somewhat similar challenges are faced in the design of trials with IV ketamine and transcranial stimulation. The similarities and differences regarding methodological challenges and learning from each of these modalities will be compared and contrasted.
Should the Randomized Withdrawal Design for Relapse Prevention Studies in Mood Disorders Be Updated?
Thursday, April 21st, 2016Co-chairs: Atul Mahableshwarkar, MD / Gary Sachs, MD
Medications to treat mood disorders are most commonly first approved for treatment of acute episodes. This is followed by study/studies that treat acutely ill patients in an open-label manner till they reach remission, followed by a variable period of continued open-label treatment. Total duration of open-label treatment has ranged from 6-26 weeks for approved agents. This is followed by a placebo-controlled, double-blind randomized withdrawal period during which rates of relapse are compared between the drug and placebo groups.
This is a powerful design which has consistently demonstrated sensitivity in separating drug from placebo when the acute studies have shown efficacy. Even when acute efficacy was not replicated, benefit in preventing relapses was evident which lead to approval of lamotrigine. However the following issues with this design and advances in the field should be considered and updates to it may be considered: 1) The definition of a relapse in these trials often requires the patient to be hospitalized or have a rather significant clinical worsening. In routine clinical care treatments are often adjusted earlier in a clinical course without waiting for dramatic worsening of clinical status. This clinical reality is not reflected in the current design; 2) Since the inception of this design the field has advanced to include the concepts of “roughening” as smaller worsening of clinical status which could lead to relapses and “necessary clinical adjustments” which was studied as a novel end point in patients with bipolar disorder in the LiTMUS trial; 3) Inclusion of patient evaluation of their clinical status such as using the QIDS or use of multiple assessments in determining relapse.
The proposed session will consist of 4 presentations, one outlining the issues, the second discussing the approaches from the LiTMUS study followed by presentations utilizing data from two separate recently concluded industry sponsored relapse prevention trials followed by regulatory discussions.
Missing Data in Neuroscience Clinical Trials: Truth or Consequences
Wednesday, April 20th, 2016Co-Chairs: Pilar Lim, PhD / George Haig, PharmD
When conducting clinical trials, one is searching for the Truth. Unfortunately, when there is substantial missing data, the truth may be unknown and the statistician and clinician must deal with the Consequences (all of the different methods and sensitivity analyses).
It is widely known in neuroscience clinical trials that a fair amount of missing data can be present. Missing data occur when not all patient visits are completed, for whatever reason, resulting in omitted data at scheduled time points. In trials concerning depression and schizophrenia, for example, it is not unusual to have at least a third of the key data missing. This creates a problem for statistical inference in the primary analysis and interpretation of the trial results. As a commonly seen approach, the primary analysis is based on the MAR (missing-at-random) assumption that only observed data explain dropouts, followed by a few sensitivity analyses based on the MNAR (missing-not-at-random) assumption that unobserved data also explain dropouts. This session will present recent biopharmaceutical, academic, and regulatory perspectives concerning approaches for the primary and sensitivity analysis. This topic will also be discussed in light of recent debates concerning the primary estimand (the main clinical quantity of interest to be estimated in a study) and corresponding analysis methods. Varied examples in the neuroscience therapeutic area will be presented. The session will also discuss end-to-end procedures that could be put in place in a clinical development program to prevent or minimize missing data. Examples will also be provided.
Update from IOM meeting “Neuroscience Trials of the Future”
Tuesday, April 19th, 2016Co-Chairs: Richard Keefe, PhD / Atul Pande, MD
This session highlights the key talks from the Institute of Medicine’s Neuroscience Trials of the Future 2016 workshop. The specific topics will address new methodologies on recruitment networks, study designs that address placebo effects in CNS conditions, the use of wearables in clinical trials, biomarker strategies, and precision medicine approaches. Examples will be presented from oncology, cardiovascular disease, neurology, economics, and technology.
Biomarkers 2016 Autumn Workshop Description
Tuesday, April 19th, 2016Co-Chairs: Steven Potkin, MD / Donald Goff, MD
During the development of the ISCTM Workshop publication “Biomarkers for Drug Development in Early Psychosis: Current Issues and Promising Directions” a crucial gap in the literature was identified. Very few studies compare multiple biomarkers and the methodology used across studies is rarely comparable; as a consequence, meaningful comparisons are not currently possible. The consensus was that another hundred studies of biomarkers in schizophrenia without addressing these deficiencies will be of limited value.
Workshop Objective:
The workshop will consider feasibility of designing and funding a prospective study to remedy these deficiencies with an ADNI-like study of early psychosis/schizophrenia. ADNI is a successful longitudinal study of mild cognitive impairment supported by academia, industry federal and foundation support. What lessons can we learn from ADNI in designing, forming and funding such a partnership?
Deliverable:
The Biomarkers committee will investigate potential designs and logistics for such a study.
Algorithms/Flags 2016 Autumn Workshop Description
Tuesday, April 19th, 2016Co-Chairs: Jonathan Rabinowitz, PhD / Nina R Schooler, PhD
Workshop Objective:
Complete consistency flags for the MADRS.
Workshop work plan:
Revised draft of flags based on previous meeting will be reviewed and data on prevalence of flags from NEWMEDS data set will be presented. Group will also consider other available data sets to evaluate for prevalence as well as presentation and publication plans.
Deliverable:
Completed draft of consistency flags for the MADRS.
ISCTM 2017 New Investigator Award Application
Thursday, April 14th, 2016The ISCTM Awards Committee is calling for New Investigator Award applications.
ISCTM has created a program to recognize promising new investigators across the broad range of methodological, regulatory and substantive programmatic interests of the Society.
View Guidelines: Includes details of the program, eligibility criteria, and required materials for completing application.
Submission Process: You must submit your application online by filling out the form provided below. You will receive a confirmation of receipt.
Submission Deadline: Applications should be submitted no later than Midnight, EST 1 November 2016 for review by the ISCTM Award Committee.
Notification: You will be notified of the committee’s decision on or before 12 December 2016.
Meeting Details:
21-23 February 2017
The Fairmont, Washington DC
Poster session will take place Wednesday, 22 February 2017.
APPLICATION
(all fields are required)
The application must be completed in one session, so do not start application until you have all the necessary documents available for upload. Thank you.
2016 Autumn Conference – Poster Submission Details and Guidelines
Thursday, March 17th, 2016ISCTM 2016 Autumn Conference
26-27 September 2016
Loews Philadelphia Hotel
Philadelphia, PA USA
IT IS IMPORTANT THAT YOU REVIEW GUIDELINES.
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 Wednesday 17 August for review by the ISCTM Poster Committee.
Notification: You will be notified of the committee’s decision on or before Friday, 26 August 2016.
Meeting Dates: 26-27 September 2016
Formal poster session: Tuesday 27 September – DURING LUNCHEON
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: Tuesday morning, 8:00-10:00. Reminder session is being held during lunch which begins at 11:45. 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 Loew’s Philadelphia Hotel, 33rd floor, Howe, Lescaze and Terrace.
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 no later than Monday, 19 September. Posters of awardees will be published on the ISCTM website.
Poster Dimensions: Poster boards are Horizontal. Posters should not exceed 4’ (122 cm) Vertical by 6’ (183 cm) Horizontal. 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:
Loews Philadelphia Hotel
1200 Market Street
Philadelphia, PA 19107
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.
2016 Autumn Meeting Poster Submission Form
Thursday, March 17th, 20162016 Autumn Conference – Speakers’ Corner
Wednesday, March 9th, 2016Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 2016 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
26-27 September 2016
Philadelphia Loews Hotel
Philadelphia, PA 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-June. 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 session development call with chairs (no later than Monday 29 August). 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: Monday, 26 September 2016
11:00-5:30 Onsite Registration Open
1:00 Session 1:
Missing Data in Neuroscience Clinical Trials: Truth or Consequences
(Lim/Haig)
5:30-6:45 Welcome Reception/Dinner
6:45 Workshop Sessions
Day 2: Tuesday, 27 September 2016
7:15 Registration Opens / Continental Breakfast
8:00-11:45 Parallel Sessions
Session A Update from IOM Meeting “Neuroscience Trials of the Future”
(Keefe/Pande)
Session B Should the Randomized Withdrawal Design for Relapse Prevention Studies in Mood Disorders be Updated?
(Mahableshwarkar/Sachs)
11:45-1:45 Poster Session/Lunch
1:45-5:25 Kick-starting the Brain: Methodological Challenges of Emerging Technologies
5:30 Meeting Adjourns
ISCTM Contact Information
Thomas Laughren – Chair, Scientific Program Committee
Carlotta McKee – Executive Director, ISCTM
Mary Bea Harding – Executive Assistant, ISCTM
Phone: +1.615.383.7688