2014 Autumn Conference
Wednesday, October 15th, 2014
Poster Awardees: |
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| All Poster Abstracts are available at the end of the second day |
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Day 1 (6 October 2014) |
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Concurrent Workshop Sessions |
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| Adaptive Design | R Marcus J Kando Report Back |
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| Addressing Methodological Challenges in International CNS Trials | R Keefe A Kalali Workshop  slidesReport Back |
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| Algorithms/Rules to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs | J Rabinowitz N Schooler Report Back |
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| Biomarkers in Schizophrenia | S Potkin D Goff Report Back |
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| Cognitive and Functional Assesssment in Clinical Trials in AD and its Precursors: Readying for Short Term and Long Term Needs | H Posner P Harvey Report Back |
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| Identifying/Reducing Effects of Non-Adherence | T Shiovitz E Bain Report Back Nonadherence: A bitter pill for drug trials (Science 17 Oct 2014, Vol 346 #6207) |
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| Implementing Innovation in CNS Clinical Trials | G Sachs M Detke Report Back |
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| Negative Symptoms | S Marder D Daniel Report Back |
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Day 2 (7 October 2014) |
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| Presidential Welcome | S Romano slides video |
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| TARGETING COGNITIVE IMPAIRMENT ACROSS CNS DISORDERS |
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| Methods, Measures and Medications – Lessons Learned from Schizophrenia |
Chairs: N Schooler I Lombardo |
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| Introduction | N Schooler* video |
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| History: What We Did Right, Unanticipated Problems and Solutions | S Marder slides video |
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| Methodology Lessons Learned and Recommendations from Positive and Negative CIAS Studies | G Haig slides video |
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| Perspective on Methodological Challenges: How Phase 2 Studies Influence Design and Conduct of Phase 3 | I Lombardo slides video |
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| Future Directions in Cognitive Impairment Associated with Schizophrenia: Social Cognition | M Green slides video |
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| Bringing Cognitive Neuroscience to Bear on Drug Development: Behavioral Tasks and Imaging Biomarkers from CNTRICS and CNTRACS for Use in Clinical Trials and Experimental Medicine Studies | C Carter slides video |
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| Panel/Audience Discussion | G Haig I Lombardo S Marder N Schooler video |
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| Report from the ISCTM Consensus Meeting on Clinical Assessment of Response to Treatment of Cognitive Impairment in Schizophrenia | R Keefe slides video |
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| Targeting Cognitive Impairment in Major Depressive Disorder | Chairs: T Laughren A Mahableshwarkar |
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| Introduction | A Mahableshwarkar slides video |
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| Cognitive Impairment in Depression: Unmet Need and Biology | A Nierenberg slides video |
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| Strategies for the Assessment of Cognitive Performance in Treatment Studies in Depression | P Harvey slides video |
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| An Industry Perspective on Targeting Cognitive Impairment in MDD | C Kurre Olsen** |
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| Regulatory Issues | K Broich slides video T Laughren slides video |
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| Panel/Audience Discussion | K Broich P Harvey T Laughren A Mahableshwarkar A Nierenberg C Kurre Olsen video |
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| Poster Session / Reception | Poster Abstracts | |
Day 3 (8 October 2014) |
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| Special Challenges: Bipolar and Epilepsy |
Chairs: G Sachs S Frangou |
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| Defining the Problem and Session Overview | G Sachs slides video |
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| Overview of the Issues for Designing Trials that Address CI Associated with Bipolar Disorder | S Frangou slides video |
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| Assessing Cognitive Function in Bipolar Disorder: Challenges and Recommendations for Clinical Trial Design | K Burdick slides video |
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| Methodological Challenges Developing Treatment for CI Associated with Epilepsy | K Meador slides video |
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| Industry Perspective Discussant: Challenges in Study Design – What Needs to be Done to Move Things Along | A Loebel slides video |
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| Panel Discussion/ Summary | K Burdick S Frangou R Goldman A Loebel K Meador G Sachs video |
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| Closing Comments/Meeting Adjourns | S Romano* video |
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| * No slides presented ** Slides and video not released
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2015 Autumn Conference
Wednesday, June 18th, 2014
Poster Awardees: |
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Bipolar Depression: Acute Stable Response to Medication as a Predictor of Long-term Treatment Response (Iosifescu) Quantifying Myelin Kinetics in Healthy Subjects Using Deuterium Labeling (Kanhai) |
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All Poster PDFs and Abstracts are available at the end of the second day. |
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27 August 2015 |
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| Welcome Reception | ||
28 August 2015 (Includes Joint Sessions with ECNP) |
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| Welcome from the Presidents | R Keefe for S Romano slides G Goodwin slides video |
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| Session 1: Challenges in Utilizing Outcome Measures Across Regions and Cultures | Chairs: ISCTM Chair, R Keefe ECNP Chair, S Leucht |
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| Cultural issues in psychiatric outcomes for global trials | S Leucht slides video |
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| Challenges of multinational European schizophrenia studies | W Fleischhacker slides video |
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| Multi-national clinical trial outcomes in international studies of bipolar disorder | E Vieta slides video |
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| Workgroup on International clinical trials update: Translation and adaptation of clinician rated outcomes | A Kalali slides video |
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| Regulatory comments | V Mantua** K Broich* video |
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| Panel and Audience Discussion | All Speakers video |
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| Session 2: Cognitive Impairment in Major Depressive Disorder as a Target for Drug Development | ECNP Chair, C Harmer ISCTM Chair, T Laughren |
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| Introduction | C Harmer* video |
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| Overview of CI in MDD as an unmet need | M Fava slides video |
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| Objective measures of cognitive impairment in depression | G Goodwin slides video |
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| Targeting cognitive impairment in major depressive disorder- industry perspective | C Kurre Olsen slides video |
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| Regulatory challenges in targeting cognitive impairment in depression | K Broich slides video T Laughren slides video |
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| Panel and Audience Discussion | All Speakers video |
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| Session 3: An Update on Critical Issues for Alzheimer’s Disease | ISCTM Chair, R Anand ECNP Chair, G Knudsen |
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| Welcome and introduction | G Knudsen slides video |
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| Critical issues in Alzheimer’s Disease and outlook for the future | R Anand slides** |
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| Amyloid pathways and disease-modifying treatments for AD: What changes are necessary in new trials? | J Hardy slides video |
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| 50 ways to improve your trial in AD | P Scheltens slides |
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| Evidence from amyloid – modifying treatments: Are we learning anything about the treatment of AD? | R Doody** | |
| How can the new diagnostic criteria improve patient selection for DM therapy trials | B Dubois slides |
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| Is there a need for new symptomatic therapies for Alzheimer’s Disease and what have we learned from past trials of symptomatic therapies? | G Grossberg slides |
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| Regulatory efforts to streamline the pathway for developing novel treatments for AD | K Broich slides |
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| Roundtable Discussion | R Anand G Knudsen |
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| Adjourn Joint Meeting | R Keefe for S Romano |
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| ISCTM Poster Session / Reception | Poster Abstracts and PDFs | |
29 August 2015 |
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| Session 4: Continued Challenges with Placebo Response in CNS Trials: What Has Changed and What Have We Learned in Mood Disorders, Schizophrenia and Pain | Chairs: R Keefe for S Romano G Groeneveld |
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| Introduction | R Keefe for S Romano* |
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| The neurobiology of placebo and its implications for clinical trials | F Benedetti** | |
| Placebo response in MDD/Bipolar studies | E Vieta slides |
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| Placebo effect in schizophrenia studies | M Davidson slides |
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| The placebo conundrum | A Dahan** | |
| Dogma, myths, silos, and assumptions: Can we do better? | A Kalali** | |
| Panel Discussion | All Speakers |
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| Meeting Adjourns | R Keefe for S Romano | |
| * No slides presented ** Slides not currently released
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2005 Midsummer Conference
Thursday, June 5th, 2014
Assessment of Cognitive Dysfunction in Schizophrenia: Conceptual and Methodological Issues |
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Day 1 (22 August 2005) |
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| Session I: Cognitive Deficits in Schizophrenia | Co-chairs: B. Gallhofer, J. van Os |
| Presentation: Schizophrenia and Cognition | R. Bilder |
| Summary: Schizophrenia and Cognition | R. Bilder |
| Presentation: Assesment of Cognition in Schizophrenia | R. Keefe |
| Session II: MATRICS Challenge (panel) | Co-chairs: S. Marder, L. Alphs |
| Presentation: Industry Challenges for Assessing Cognition in Schizophrenia Industry Challenges for Assessing Cognition in Schizophrenia | L. Alphs |
| Presentation: Academic Challenges for Assessing Cognition in Schizophrenia | S. Marder |
| Presentation: Matrics Mandate | W. Fenton |
| Presentation: Cognitive Battery | K. Nuechterlein |
| Presentation: Co-primary | M. Green |
| Presentation: Study Design | R. Buchanan |
| Discussion Points | R. Mohs, P. Harvey |
Day 2 (23 August 2005) |
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| Session III: “Conceptual and Practical Difficulties in the Assessment of Cognition in Schizophrenia: Possible Implications for the Proposed Design” | Co-chairs: R. Anand R. Keefe |
| Presentation: Conceptual and Practical Difficulties | R. Anand R. Keefe |
| Presentation: Selection of a Cognitive Assessment Battery | R. Bilder |
| Presentation: Practical Issues in the Assessment of Cognition | T. Sharma |
| Presentation: Design of a prospective randomized long-term trial to assess treatment effects on cognition in schizophrenia: challenges and results: experience from a 12-month treatment trial | G. Garabaldi |
| Session IV: Functioning and Cognition | Co-chairs: N. Schooler A. G. Awad |
| Presentation: What is functioning in Schizophrenia? | N. Schooler |
| Presentation: Review of instruments | P. Harvey |
| Presentation: Impact of Cognition on Functioning Community versus Long-Term Trials | T. Patterson |
| Discussion Points | J. Addington |
| Session V: Statistical and Data Management Challenges | Chair: J. Christie |
| Presentation: Psychometric Analyses | S. Millis |
| Summary: Psychometric Analyses | S. Millis |
| Presentation: Statistical Approaches for Trials Assessing Cognition | A. Leon |
2005 Inaugural Meeting
Wednesday, May 21st, 2014
Day 1 (22 February 2005) |
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| Related Publications: | |
| AC Leon, CH Mallinckrodt, C Chuang-Stein, DG Archibald, GE Archer, K Chartier Randomized Controlled Clinical Trials: Methodological Issues in Psychopharmacology  Biological Psychiatry, 2006; 59:1001-1005. PMID: 16503329 |
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| Welcome and state of ISCTM | A.G. Awad, President ISCTM |
| Organizational Structure and Functioning of Society | O. Ray |
| Topic I: Difficulties in Establishing Long-Term Efficacy for Psychotropic Drugs: Common Methodological Issues – To assure themselves that medications are effective in the long-term treatment of psychiatric disorders, clinicians desire evidence that medications maintain effects that have been established during acute treatment for exacerbations of an underlying major psychiatric disorder. To demonstrate efficacy in long-term treatment, the design currently preferred by some regulators is that patients be stabilized for 6 months on study medication and then randomized to placebo or active treatment. Relapse prevention paradigms address whether the time to relapse is delayed should that medication be discontinued. This session will examine the questions being addressed and the most effective ways to answer them. | R. Anand M. Rapaport |
| Introduction | R. Anand |
| Clinical Requirements, Current Practice | M. Rapaport |
| Industry Perspective: Goals and Hurdles | G. Gharabawi |
| Industry Perspective: Goals and Hurdles | L. Alphs |
| Audience Discussion | |
| Basis for Current Regulatory Requirements: Need for Change? | C. Sampaio |
| Panel Discussion: Directions for the Future | M. Thase R. Bullock |
| TOPIC 2: DATA BLITZ (during dinner) Attendees are encouraged to present during this session. Interesting issues, new methodological approaches, new ways of interpreting data, and new trial designs should be presented. Each presentation will be limited to a maximum of 4 minutes and 4 slides and will be followed by 5 minutes audience discussion. | |
Day 2 (23 February 2005) |
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| TOPIC 3: Impact of Attrition on Outcome – Methodological and Statistical Approaches – Attrition from clinical trials often affects interpretation of safety and efficacy results. This session will present various techniques of dealing with missing data (e.g. Hot Deck Imputation, carried forward methods, mixed model approaches, and multiple imputation) and the use of retrieved dropouts. Issues to consider when determining a reasonable approach to deal with missing data and strengths and weakness of analyses that use imputations and alternative paradigms to address these issues will be discussed. | |
| Introduction | C. Chuang-Stein |
| Lecture: Impact Of Attrition On Outcome – Methodological And Statistical Approaches | A. Leon |
| TOPIC 4: Long-Term Treatment Trials in MCI/ AD – Developing medications for MCI presents a number of clinical and regulatory challenges. Prevention or delaying the transition from pre-diagnostic dementia states to fully expressed disease would be a boon to millions of persons. However, performing clinical trials in patients with MCI present many challenges, including diagnostic accuracy, establishing clinically valid endpoints, developing clinically feasible and ethically justifiable study designs that would also meet regulatory needs. | Moderator: M. Farlow |
| Introduction | R. Anand |
| The Case for MCI | M. Farlow |
| Critical Review of Results from MCI Studies | L. Schneider |
| MCI Conundrums: A Regulator’s Perspective | S. Ferris |
| Audience Discussion | |
| MCI: A Critique of the Concept and Proposed Methodologies | R. Krishnan |
| Panel Discussion and Summary | R. Bullock C. Sampaio |
| TOPIC 5: Publication of Study Results – Positive. Negative. Or Failed: Damned if You Do and Damned if You Can’t | R. Baldessarini |
| Industry Perspective: Where We Are Now and How We Got Here? | R. Mahmoud |
| Industry Perspective: A View to the Future Roundtable: Perspective from Invited Journalists and Editors (See Selected Slides to the Right) |
A. Pande J. Coyle D. Jeste H. Nasrallah B. R. Olsen A. Picard P. Neighmond |
| Roundtable: Perspective from Invited Journalists and Editors | |
| TOPIC 1: Difficulties in Establishing Long-Term Efficacy for Psychotropic Drugs: Common Issues: Position Paper | M. Rapaport |
Day 3 (24 February 2005) |
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| TOPIC 6: Use of Biological Markers as Endpoints in Clinical Trials of Psychiatric and Neurological Indications | Moderators: R. Krishnan S. Potkin |
| Introduction | R. Krishnan |
| Use of FDG PET as an Outcome Variable In Schizophrenia Trials | S. Potkin |
| Measures Of Neuronal Activity In Psychiatric Disease | P. Renshaw |
| Measures Of Neuronal Activity In Psychiatric Disease | P. Renshaw |
| Audience Discussion | |
| Structural Neuroimaging as an Outcome Variable in MCI and AD Clinical Trials | M. Weiner |
| Role of PET Imaging in Different Phases Of Drug Development: Account of a Substance P Antagonist | S. Reines |
| Panel Discussion | C. Sampaio P. Renshaw M. Weiner P.J. Snyder |
| TOPIC 4: Plenary Session; Long-Term Treatment Trials in MCI/AD: Position Paper | M. Farlow |
| Adjournment | |
NIMH/ISCTM Satellite Meeting
Wednesday, May 21st, 2014Satellite Meeting on the NIMH Initiative Regarding Treatment Development for Negative Symptoms
Day 1 (23 February 2006) |
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| Welcome | G Awad |
| Objectives of Meeting and Outline of Prior Work on NIMH Initiative This presentation will provide a brief background on the NIMH initiative regarding treatment development for negative symptoms, its conceptual objectives and implementation to date. |
W Fenton |
| Defining Negative Symptoms This presentation will provide a working definition for negative symptoms, their differential diagnosis, and will outline confounding issues such as their relationship to cognitive and depressive symptoms. In addition, the presentation will address the question “Why have negative symptoms become the new focus for treatment target?” This will include an understanding of clinically meaningful improvements in negative symptoms and what would constitute a meaningful step forward in treatment effect (i.e. effect size). |
S Marder |
| Open Discussion | S. Leucht & R. Anand |
| Epidemiology and Long-Term Course of Negative Symptoms This presentation will provide an epidemiological survey of the prevalence and incidence of negative symptoms in the schizophrenic population. The impact of these symptoms on quality of life and outcome will be discussed. In so doing, target populations for negative symptom treatments will be identified and trial design issues that arise from the long-term course of negative symptoms will be presented. |
D Miller |
| Open Discussion | |
| Overview of Scales to Assess Negative Symptoms In this presentation negative symptom scales that are in common use will be reviewed. Data supporting their strengths as well as their weaknesses will be discussed. |
B Kirkpatrick |
| Open Discussion | |
| Subdomains of Negative Symptoms This presentation will provide the evidence for the existence for negative symptom subdomains. The source of this evidence, its strength and its significance will be discussed. In particular the theoretical and clinical importance of these subdomains for prognosis and treatment of negative symptoms will be considered. |
J Blanchard |
| Open Discussion | |
| The Neurobiology of Negative Symptom The most prevalent neuroanatomical models of faulty circuitry in patients with predominantly negative symptoms involve consideration of dorsal-ventral prefrontal system dysfunction, monoamine dysregulation especially in the dopaminergic and serotonergic pathways, and a focus on imbalance in the input-output functions of supragranular and infragranular layers of prefrontal and temporal cortices. Another set of faulty prefrontal system throughput, especially in negative symptom patients, may also be inferred from the circuitry which factors in glutaminergic (and noradrenergic) inputs to layers III and IV may be result in reduced and asymmetric drive in competing cortico-subcortical loops of prefrontal systems. |
J Fallon |
| Open Discussion | |
| Negative Symptoms as a Clinical Target: European Regulatory Perspective In this session a representative from the European regulatory authority will present a European perspective on the regulatory issues that must be addressed to obtain an indication for the treatment of negative symptoms. Commentary will be provided on the regulatory position on some of the issues raised during this meeting. |
C Sampaio |
| Open Discussion | |
Day 2 (24 February 2006) |
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| Process for Developing NIMH Scale for Negative Symptoms This presentation will briefly summarize the objectives and process that has occurred to date for developing the NIMH Scale for Negative Symptoms. |
B Kirkpatrick |
| A New Assessment for the Measurement of Expressivity in Schizophrenia This presentation will briefly summarize the objectives and process that has occurred to date during the development of the expressivity items for the NIMH Scale for Negative Symptoms. Specific items selected for inclusion and their operational use will be described. Issues of reliability, validity, sensitivity to change, cultural sensitivity and facility for training will be discussed. |
R Gur |
| Open Discussion | |
| A New Assessment for the Measurement of Anhedonia/Asociality in Schizophrenia This presentation will briefly summarize the objectives and process that has occurred to date during the development of the anhedonia/asociality items for the NIMH Scale for Negative Symptoms. Specific items selected for inclusion and their operational use will be described. Issues of reliability, validity, sensitivity to change, cultural sensitivity and facility for training will be discussed. |
A Kring |
| Open Discussion | |
| Design Of Clinical Trials For Negative Symptoms: A clinical/academic perspective This presentation will provide a clinical view on the objectives of clinical trials for treatment of negative symptoms and translation of these objectives to an operative trial. This will include identifying the issues relevant for broad spectrum and adjunctive treatment and concerns about pseudospecificity. |
R Buchanan |
| Design Of Clinical Trials For Negative Symptoms: A clinical/academic perspective This presentation will provide a clinical view on the objectives of clinical trials for treatment of negative symptoms and translation of these objectives to an operative trial. This will include identifying the issues relevant for broad spectrum and adjunctive treatment and concerns about pseudospecificity. |
L Alphs/ G Gharabawi |
| Open Discussion | |
| Identification and Management of Statistical Issues in Negative Symptom Trials This presentation will address statistical issues that must be managed when designing, conducting and analyzing clinical trials of negative symptoms of schizophrenia. Issues of effects of attrition will be discussed, as will analytic paradigms and generalizability of results. In addition, issues related to long-term effects and maintenance of effect will be considered. |
C Chuang-Stein |
| Open Discussion | |
| Negative Symptoms as a Clinical Target: US FDA perspective In this session a representative from the FDA will present a US perspective on the regulatory issues that must be addressed to obtain an indication for the treatment of negative symptoms. Commentary will be provided on the regulatory position on some of the issues raised during this meeting. |
T Laughren |
| Summary of Meeting In this summary session key outcomes of the meeting will be provided and next steps and directions for the future identified. |
R Anand |
| Adjourn | G Awad / S Marder |
Presentation at FDA
Wednesday, May 21st, 2014ISCTM Position on Maintenance of Effect Data (PDF)
2nd Annual Congress
Wednesday, May 21st, 2014
Day 1 (21 February 2006) |
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| Welcome and state of ISCTM | A.G. Awad President, ISCTM |
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| Current concepts of long-term efficacy in psychiatric disorders: problems and opportunities | R. Baldessarini | |
| Session I: Treatment Resistance: New designs and regulatory opportunities | Co-chairs: G. Awad, M. Rapaport |
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| Treatment Resistance in psychiatry Study methodology and design issues Statistical issues US Regulatory perspective EU Regulatory perspective |
J. Davis R. Anand W. Olson R. Levin C. Sampaio |
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| Summary and discussion | M. Rapaport | |
Day 2 (22 February 2006) |
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| Session II: Drug Development for Parkinson’s Disease: Beyond Motor Control | Co-chairs: J. Friedman, R. Anand |
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| Treatment of motor symptoms of PD – state of the art and unresolved issues Behavioral disturbances in PD Cognition in PD Regulatory perspective of treatment of non motor syndromes in PD |
W. Olanow J. Friedman J. Kulisevsky C. Sampaio |
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| Session III: “Defining dose for psychopharmacological agents in early development” | S. Potkin L. Alphs |
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| Objectives, issues and evolving strategies Prediction of dose for Phase I in humans: – Extrapolation of pharmacological data – Extrapolation of toxicological results Defining dose for Phase 2 efficacy and safety studies: – Pharmacokinetics, tolerability and experimental data |
S. Potkin W. Potter L. Ereshefsky |
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| Summary and discussion | L. Alphs | |
| Thorny issues in CNS methodology | A. Mahableshwarkar | |
| Session IV: “Defining dose for psychopharmacological agents – Phase III and beyond” | Co-Chairs: L. Ereshefsky W. Olson |
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| Analyses to define therapeutic dose range Post marketing assessment of dose response Statistical issues EU regulatory assessment of dose response US regulatory assessment of dose response |
R. Anand R. Mahmoud J. Weaver C. Sampaio |
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| Discussion | ||
MJFF / ISCTM Satellite Meeting
Wednesday, May 21st, 2014The Michael J. Fox Foundation/The International Society for CNS Clinical Trials and Methodology (ISCTM)
Day 1 (21 February 2007) |
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| Welcome and Meeting Goals | K Kieburtz R Anand |
| What is Parkinson’s Disease? | JW Langston |
| Background on Parkinson’s Disease and Neuroprotective Treatment | A Lang |
| Neuroprotection Trial Designs and Underlying Assumptions – When Can They Best Be Applied to Effectively Measure NeuroprotectionThe Mystique of Neuroprotection for Parkinson’s Disease | W Olanow J Shoulson |
| The Selection of Patient Groups for Neuroprotective Trials | W Poewe |
| Identifying Endpoints For Effectively Measuring Neuroprotection | C Tanner |
Non-Clinical Endpoints to Assess Disease Progression
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J Perlmutter B Ravina |
Day 2 (22 February 2007) |
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| Introduction | K Kieburtz |
| Statistical Issues in Early Phase Studies | B Levin |
| An Industry Perspective on Neuroprotective Trials | B Musch |
Neurodegenerative Disorder Therapeutics – Process and Product Amid Complexity
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M Walton |
| European Regulatory Perspective on the Concept of Disease Modification in Parkinson’s Disease | J Ferreira |
| Summary & Next Steps | K Kieburtz |
2006 Midsummer Conference
Wednesday, May 21st, 2014
Day 1 (7 July 2006) |
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| Welcome and state of ISCTM | A.G. Awad, President ISCTM |
| Current concepts of long-term efficacy in psychiatric disorders: problems and opportunities | R Baldessarini |
| Session I: New approaches and trial designs for drugs in long-term treatment | S. Leucht & R. Anand |
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S Leucht M. Trivedi R Anand T Laughren M Davidson |
Day 2 (8 July 2006) |
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| Session II: Long-term trials in Bipolar Disorders | R Baldessarini & E Vieta |
| Problems in establishing long-term efficacy in BPDs: Where are we and what is needed? | R. Baldessarini |
| Mood-stabilization: Clinical needs and study designs for long-term trials in BPDs | E Vieta |
| Bipolar depression: Clinical needs and study designs to test for long-term efficacy | J Calabrese |
| Industry challenges & innovative trials designs | M Tohen |
| Regulatory perspective: Comments | T. Laughren |
| Discussant | C Bowden |
| Session III: Long-term evaluation of psychotropic drugs in major psychiatric disorders: outcome measures, study-designs and statistical approaches | G. Gharabawi & A. Leon |
| Introductory comments Investigator & patient based outcomes Overview: trials designs & analyses Industry perspective Regulatory perspective: Comments Discussant |
G Garabaldi J Endicott A Leon L Alphs T Laughren D Meltzer |
| Conclusions and update on next meeting | R. Baldessarini |
3rd Annual Congress
Wednesday, May 21st, 2014
Day 1 (February 20, 2007) |
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| Related Publications: | |
| AC Leon, H Demirtas, D Hedeker
Bias Reduction With an Adjustment for Participants’ Intent to Dropout of a Randomized Controlled Clinical Trial |
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| Session I: Conducting CNS Clinical Trials in the Developing World | Co-chairs:
L Alphs JP Lindenmayer |
| Welcome | G Awad |
| Introduction and Objectives of Meeting | L Alphs |
| The Challenges and Opportunities for Global Clinical Development – An Industry Perspective | M Page |
| Multi-National Trials in the Developing World: Conceptualizing the Trials—An Academic Perspective | A Kiev |
| Multi-National Trials in the Developing World: Conceptualizing the Trials—An Industry Perspective | R Anand |
| Setting Up and Implementing Protocols in the Developing World: Special Issues When Conducting Multi-National Trials with Centers in the Developing World and Their Solution–A CRO Perspective | A Kalali |
| Reviewing the Protocol Submissions: A Developing Country Perspective on Issues to Be Considered in Approving a Global Trial-An Indian Regulatory Perspective | S Khanna |
| Conducting CNS Trials in Developing Countries
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JK Trivedi
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| A Case Study: Evaluating Cognition In Multi-National in Developing World Trials | T Sharma
R Mohs |
| Reviewing Data from Multi-National Trials in the Developing World: FDA Perspective | NA Khin |
| Reviewing Data from Multi-National Trials in the Developing World: European Regulatory Perspective | G Pons |
| Multi-National Trials in the Developing World: Ethics Roundtable and Discussion | Co-Chairs:
G Gharabawi S Khanna Participants: R Mahmoud A Gilman JP Lindenmayer |
| Summary of Session | JP Lindenmayer |
| Dinner with Thorny Topics | |
Day 2 (February 21, 2007) |
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| Session II: Methodological Challenges in Randomized Effectiveness Trials in Psychiatry | Chairs:
P Wang A Leon |
| DEDICATION TO THE MEMORY OF WAYNE FENTON | R. Heinssen |
| Introduction: Objectives of Session | J Rasmussen |
| Objectives of Effectiveness Trials and Prior Experience with Them in the Psychiatry | P Wang |
| Study Designs (Future Studies) | S Murphy |
| Statistical Challenges Of Randomized Effectiveness Trials | D Hedeker
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| Results of Randomized Effectiveness Trials: Translation to Clinical Practice | A Grogg |
| Summary of Session | A Leon |