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4th Annual Scientific Meeting – Dinner Debate
Wednesday, June 4th, 2014ISCTM
4th Annual Scientific Meeting
25-27 February 2008
Washington, DC
Summary of Dinner Debate, Monday, February 25th, 2008: Views on the Evolving Relationship Between Journal Editors and Authors: Is a Two-Tiered Approach for Industry and Academic Authors Beneficial?
I. Will Carpenter: Position for a Two-tiered Review System for Publication of Research Manuscripts:
Dr. William Carpenter began his comments by clarifying that the debate issue was whether journals should have a two-tier system of review in order to provide special scrutiny to manuscripts submitted from the for-profit sector. In taking up the position for a two-tiered system, Dr. Carpenter stated that his comments were based on the assumption that they applied most directly to reports of studies of marketed drugs. He stated that these points were made on the following assumption: that they related to common [not ubiquitous] issues with industry sponsored studies which were substantially less common [not absent] in academic studies with sponsorship from non-profit entities.
Points relevant to the debate, as summarized by Dr. Carpenter, are listed below:
1. A key problem for editors concerns manuscripts that can influence clinical practice and/or have financial implications for the study sponsor.
2. The field needs to face squarely the implications of systematic bias in manuscripts from industry relating to marketed drugs. How else to explain the “our drug beats your drug” publication bias. An explanation offered at the debate discussion was that it was natural for authors to focus on the things that interest them most. To an editor, this is just a way of explaining how the bias works. Company A is not likely to be most interested in reporting how Company B’s drug is superior.
3. Any author may be subject to bias based on prestige, ego, or the hope for fame and fortune. But the fact that anyone could be biased does not negate the obligation to address an area of systematic bias that contributes to the erosion of public trust. Consider some fundamental differences between a pharmaceutical company’s sponsored post-marketing clinical trial and an NIH sponsored post-marketing clinical trial:
In one case the sponsor knows the desired outcome
- • In one case the sponsor may control release of the report
- • In one case the hypotheses, analytic strategy, and primary end points have been recorded in advance and peer reviewed
- • In one case the sponsor is likely to limit access to the data, while in the other the sponsor may encourage or require public release of the data
- • In one case commercial third parties may be hired to prepare manuscripts and organize reviews.
- • In one case an academic leader may be offered authorship on manuscripts where their role in the study is minimal or absent.
- • In one case the authors may worry about personal implications of publishing a report which hurts the market value of their employers’ product; in the other case the authors may worry about adverse consequences of not publishing study results in future grant applications.
4. Erosion of public trust in pharmaceutical and academic science is a critical issue. Damage to the prestige of our scientific field is partly based on widely held views that data mining, selective reporting, bias in interpreting results, and conduct of clinical trials for marketing rather than scientific or clinical reasons are frequent.
5. There are no absolutes in this area, and there is potential for witting or unwitting bias in any study and with any investigator. But the public [and perhaps most reasonable people] would believe that prestige and ego of authors without dollars is trumped by prestige, ego and dollars. The financial conflicts are always there for industry studies, and only sometimes for studies sponsored by public sources.
6. There should be a high standard in review of all manuscripts, but any reader of journals will appreciate the inadequacy of the review process. How else to explain the numerous publications from industry that favor the sponsor’s drug and run counter to reports from public science?
7. A “second tier” approach can be aggressive, such as JAMA’s requirement for independent academic statistical analysis of data being reported. However, a more modest approach which might increase sensitivity of authors, editors and reviewers [and maybe sponsors] might evolve along the following lines:
- • Clearly identify whether the sponsor or the authors have a financial stake in the study results.
- • State whether the hypothesis, analytic strategy and end points are predefined in a public access format.
- • State whether authors have sole responsibility for the report, or whether the study sponsor has the authority to control release of the report.
- • State plan for making the data publicly available or reasons why not.
The answers would not serve to disqualify a manuscript, but would serve to focus attention on key issues. It would apply to academic authors who receive large funds from the sponsor, or have intellectual property rights related to the study.
Dr. Carpenter concluded his remarks by stating that, if a plan evolved along these lines, it would apply to all manuscript submissions. It would, in fact, be a one-tier system with statements that would alert editors and reviewers to potential issues that might require special attention in the review process.
[In comments forwarded following the debate, Dr. Carpenter noted that this topic had received significant attention in a JAMA editorial entitled: Impugning the Integrity of Medical Science—The Adverse Effects of Industry Influence. The DeAngelis and Fontanarosa editorial contained specific recommendations related to the debate issue. The same April 16, 2008 issue of JAMA contained two articles illustrating how commercial interest may be influencing the reporting of clinical trial data.]
II. Alan Breier: Position against a Two-tiered Review System for Publication of Research Manuscripts:
Alan Breier opened his comments by highlighting the fact that public confidence in medical data has been shaken. He cited the withdrawal of Vioxx as a recent example of the challenges of properly presenting the full picture with regards to medical information, and underscored that the blame for the public’s sense of misrepresentation of data and risk was shared between Industry, the FDA and academia. Following these opening comments, Dr. Breier clearly stated that he was against a two-tiered publication standard for academic and industry authors, acknowledging that there were powerful potential conflicts of interest for members of both industry and academia (the former relating to the business of selling pharmaceuticals, the latter relating to issues such as the need to support academic promotion and grant funding). He underscored the point that managing conflict of interest was critical for all authors, regardless of professional affiliation.
Besides the most obvious area of concern, that of conflict of interest, Dr. Breier listed several other issues. They included the selective reporting of data (“cherry picking”), the failure to disclose results of negative studies (“file drawer phenomenon”), fraud or data fabrication, and ghost authoring. He then went on to describe four key elements to address with regards to conflict of interest, including the need for transparency, the requirement for codes of conduct and formal publication policies, compliance measures and, lastly, the need for cultural change.
Dr. Breier then briefly discussed some additional considerations for enhancing publication requirements. These included providing additional complementary materials with any submitted manuscript, including study protocol, protocol amendments, and the statistical analytic plan; ensuring registration of all trials on clintrials.gov; providing access to study data and analytic programs with each submitted manuscript; disclosing journal reviewers’ comments; and external auditing for compliance.
Dr. Breier ended his presentation with an overview of Eli Lilly’s publication policy.
III. John Kane: Summary Comments
In comments following Drs. Carpenter and Breier’s viewpoints, Dr. John Kane discussed his view on the evolving relationship between journal editors and authors
Dr. Kane commented that the advancement of science depends upon the collection, analysis and publication of data in an objective, complete and unbiased fashion. An important reevaluation of potential bias has occurred in recent years; however, the attention has largely focused on conflicts of interest and bias in relation to the publication (or lack there of) of industry-sponsored clinical trial data. There is considerable evidence, Dr. Kane continued, that publication bias or selective reporting of clinical trial results has occurred, though it is not always clear whether and when this results from failure on the part of the authors and/or sponsors to submit reports, from recommendations by reviewers and decisions by editors not to publish, or both.
Additionally, the scope and potential impact of financial conflicts of interest in biomedical research have received considerable attention. Dr. Kane stated that there was no doubt that our failure to acknowledge and manage these risks has enormous implications for scientific progress, clinical practice, patient outcomes and healthcare costs.
Dr. Kane commented that both Drs. Carpenter and Breier made important points in discussing this issue. Dr. Carpenter emphasized the high stakes involved in influencing prescriber practice when bias influences the design, conduct and reporting of trials, and contrasted the difference between public and private sponsorship in a number of ways. However, the contrasts, in Dr. Kane’s opinion, minimized the bias and conflicts of interest that occur everyday in academia, though these may be less obvious and less easily identified. For example, though there may be more absolute dollars riding on industry sponsored results, the motivating “rewards” (fame, promotion, influence and renumeration) to academic investigators cannot be underestimated in both their scope and impact on behavior (not just in their own work, but in their review of competitors grants and papers). In many ways, this is far more insidious because it is far harder to detect. There is no FDA policing data collection, data analyses and the “marketing” of results in academia. Dr. Kane stated that he was aware of many non-industry supported and NIH supported research that did not get published or adequately published, adding that though it is currently very difficult for industry sponsors to withhold data, this has only recently become an issue (still largely untested) for NIH sponsored studies.
Dr. Kane then asked, are academic investigators more rigorous in recording and publishing a priori hypotheses, end points, data analytic plans etc? Unfortunately not, he concluded. If anything, the drug approval process requires far more advance documentation. Dr. Kane agreed with Dr. Breier’s suggestion that both industry and academic authors offer the study protocol with every clinical trial submitted for publication, adding that all trials should be registered in clinicaltrials.gov and quality review should be built into the research enterprise system-wide.
Dr. Kane emphasized that numerous reports (e.g. Bekelman et al 2003; Perlis et al 2005; Heres et al 2006; Turner et al 2008) have focused on industry publication bias and potential industry–academia conflicts of interest. He stated that these data make a compelling argument for better management of these potential risks.
Dr. Kane noted that Dr. Breier had emphasized what Lilly is doing to address these challenges. Clearly progress is being made, but more remains to be done across the biomedical research enterprise. It would be valuable if similar reviews (to those cited above) could examine relevant risks in non-industry-supported research. If one could overcome the impediments to accurately analyzing this issue (which is not easy, he added), it might be more embarrassing than we care to imagine.
The debate that fostered theses remarks asked if a two tiered approach for reviewing and publishing papers from industry and academia would be appropriate. One could argue, Dr. Kane continued, that we already have a two tiered approach in that industry sponsored studies undergo a different type of scrutiny because their sponsorship is obvious. Journals need to address the concern that negative results are less likely to be submitted for publication or published than positive results in both industry and academia.
Dr. Kane ended his comments by stating that it was not convincing to him whether a two tier publication system would solve the problems summarized above.
The following references were provided by Dr. Kane in support of his comments:
Bekelman JE. Li Y. Gross CP. Scope and impact of financial conflicts of interest in
biomedical research: a systematic review JAMA. 289(4):454-65, 2003
Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. Am J Psychiatry. 2006 Feb;163(2):185-94.
Perlis RH, Perlis CS. Wu Y. Hwang C. Joseph M. Nierenberg AA. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. American Journal of Psychiatry. 162(10):1957-60, 2005
Turner EH. Matthews AM. Linardatos E. Tell RA. Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. New England Journal of Medicine. 358(3):252-60, 2008
ISCTM Poster Guidelines
Tuesday, June 3rd, 2014ISCTM Guidelines for submission and preparation of POSTERS
*Important- Download Poster Abstract Template below
The goals of the ISCTM, which emphasize methodological analyses, strategies, and applications in clinical trials in CNS disorders, result in challenges and some differences in priorities from those commonly occurring in most scientific organizations which include CNS disorders in their organizational aims. Within the structure of the ISCTM, our policies, listed below, are intended to ensure that posters are of strong scientific merit and that they are not product promotional in nature.
The focus and content of posters should be methodology. This may involve novel study designs, novel analytical approaches, novel assessment approaches, or other methods involved in the planning, conduct, or analysis of data arising from CNS clinical trials. The desired content of acceptable posters is easiest to illustrate with examples:
1) Description of a novel study design along with explanations of the advantages and disadvantages of such a design, whether or not the planned study has actually been conducted. What would not be acceptable would be the description of a routine trial that has no novel features.
2) Analytic methods applied to data arising out of a clinical trial, even if that trial is a fairly routine trial. It would not be acceptable to present the results of a routine clinical trial using routine analytical methods.
3) In recent years, various groups have developed methodologies intended to improve the precision and conduct of clinical trials, e.g., novel designs, improved patient selection, detection of non-adherence to assigned treatment in trials, detection of fraudulent patients, improved assessment instruments and techniques, improved monitoring of the administration of standard assessment instruments, and novel analytical methods. These groups typically operate independently of pharmaceutical companies, and have as one of their goals the marketing of these approaches to pharmaceutical companies. Posters illustrating the application of such methodologies, especially if they involve actual data showing the potential advantage of such approaches are acceptable, providing they go beyond simply extolling the potential virtues of such methods with actual data, or can in some other way stimulate useful discussion at a poster session. An unacceptable poster is one that simply promotes a particular approach for enhancing trial conduct but has no data, simulations, or other substance that could be the subject of discussion at the poster session. It would also not be acceptable for such a group to present a poster describing an existing regulatory guidance and promoting itself an expert in the application of such regulatory advice.
4) Methodology abstracts on trial designs for which data is not yet available are acceptable providing the following, a) The trial has commenced and is ongoing, and an adequate sample size is expected to be obtained on or before the poster session, b) Authors must include within the abstract a clear description of the hypothesized results and all appropriate data that will be used to support any conclusion they wish to make; these data must include expected sample size, c) Authors must clearly outline the statistical methodology that will be used to analyze the data, and d) The abstract follows the methodological guidelines outlined above. Abstracts failing to include such projected sample size will not be considered for presentation unless it is clear from the description that hard numerical evidence of sample size cannot be expected (e.g. when presenting an innovative concept or new technology).
It is understood that the application of these criteria is not always straight-forward and will often involve discretion and judgment. The ISCTM Poster Committee is the body charged by ISCTM with making these judgments and will be the final authority in decisions about the acceptance or rejection of a particular poster.
We request that at least one author of the poster be present during the poster session and be qualified to answer questions about the contents. Further we ask presenters to refrain from going beyond the contents of the poster by explicitly soliciting buyers if the contents present data that suggest an advantage to a product or method.
TITLE: The title of a presentation and or abstract should be free of commercial information. The number of characters, inclusive of spaces, should not exceed 130.
LOGOS and ACADEMIC SEALS: Logos and seals should be limited to ones which are not intended for, or could be interpreted as promoting commercial interests. The size of logos should not be dominant, and logos may only appear at the bottom of the poster. QR codes leading to company websites are not permissible.
AUTHORS AND AFFILIATIONS: List authors names without degrees. Include initials without periods (e.g. Abrams, BC). Affiliations of authors should be noted by superscripts in author lines, and detailed in smaller font below the author lines.
Qualifications for authorship: Those listed as authors must have contributed to one of these areas: Conception and design, data analysis and interpretation, drafting or revision of the poster. In addition, each author must approve the final version of the poster. For clinical studies, this policy will generally result in authorship both by investigators not affiliated with a sponsor as well as scientific personnel of the sponsoring organization(s).
FORMAT AND LENGTH:
*Download Poster Abstract Template here
Abstract
-Organize the abstract with the following sections:
• The Methodological Issue Being Addressed
• Introduction (Aims)
• Methods
• Results
• Conclusions
• Disclosures* if applicable
-Word limit, exclusive of title, authors and references sections, should be less than 500 words. We recommend no references or figures for abstracts. However short tables and up to 2 references, sufficient to locate the article, may be included.
Poster
-Posters are Landscape orientation: Not to exceed 48″ (121 cm) Vertical by 72″ (182 cm) Horizontal.
-To insure easy viewing of the poster, please use font size of 16 or greater for all sections except references, Table/Figure legends and superscripts for references (which may be smaller font size but should still be easily viewable).
-Narratives in all sections of the poster should refrain from statements that could be perceived as promotional or seeking commercial advantage. As example, “Treatment X represents a new efficacious and well tolerated first line treatment for early Alzheimer’s disease” would go beyond the conclusions possible from a single clinical trial. Additionally, words or phrases which have been patented should be avoided.
-QR Code linking to electronic version of poster is permissible. Promotional QR codes are not permissible.
*Disclosures: A concluding Acknowledgment should be made regarding source of support and any individuals or organizations who aided a body of work. Along with this statement each poster shall include one of the following statements along the bottom of the poster. If the second option is applicable, then disclosure must be included as part of the abstract.
1. “The authors report no conflicts of interest for this work” or
2. “One or more authors report potential conflicts which are described in the program”
The Scientific Program Committee appreciates very much your cooperation in complying with these guidelines.
(Version: 07/2024)
2014 Autumn Conference – Poster Submission Details and Guidelines
Tuesday, June 3rd, 2014ISCTM 2014 Autumn Conference
6-8 October 2014
Boston Park Plaza
Boston, MA
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 Monday, 25 August 2014 for review by the ISCTM Poster Committee.
Notification: You will be notified of the committee’s decision on or before Friday, 5 September 2014.
Meeting Dates: 6 – 8 October 2014
Formal poster session: Tuesday, 7 October, 6:00-8:00 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: Tuesday, 7 October 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 Boston Park Plaza, Terrace Room (Lower lobby)
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 Friday, 26 September. Posters of awardees will be published on the ISCTM website.
Poster Dimensions: Posters are Horizontal, not to 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:
Boston Park Plaza
50 Park Plaza at Arlington Street
Boston, MA 02116
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.
2017 Autumn Conference – Chairs/Presenters Abstract Submission
Tuesday, June 3rd, 2014Autumn 2014 Workshop: Biomarkers in Schizophrenia
Monday, June 2nd, 2014Chairs: Steven Potkin, MD; Don Goff, MD
This workshop will discuss non-imaging biomarkers in schizophrenia. The workshop is to review and develop strategies for publication. We will discuss the application of the imaging biomarker template to non-imaging biomarkers. The discussion may include:
1. Biomarkers that have been replicated
2. Biomarkers that differ between schizophrenia patients and healthy controls
3. Biomarkers that predict treatment response
4. Peripheral biomarkers that significantly correlate with CSF concentrations or other more direct CNS findings.
Autumn 2014 Workshop: Adaptive Design
Monday, June 2nd, 2014Chairs: Ron Marcus, MD; Judy Kando, PharmD, BCPP
The ISCTM Adaptive Design Working Group will continue with the adaptation design of a single Phase IIIB/IV comparative effectiveness study in schizophrenia that was discussed at the February 2014 Annual Meeting. This study utilized a large electronic medical record database to compare a novel treatment versus treatment as usual. A co-primary outcome was explored that included hospitalization versus treatment failure. In addition, differences in effectiveness amongst subgroups (young vs older; substance abuse vs no substance abuse) were explored. The group will revisit the assumptions and discuss different ways to handle the composite endpoint. The likelihood of success using traditional design versus adaptation will be explored.
Autumn 2014 Workshop: Negative Symptoms
Monday, June 2nd, 2014Chairs: Stephen Marder, MD; David Daniel, MD
In previous meetings the Negative Symptom Work Group discussed guidelines for clinical trials of agents targeting negative symptoms. Since the last meeting, large Phase 2 and 3 have reported results. Data and experiences from these trials will be reviewed and prior decisions regarding inclusion criteria, study design, study implementation, and trial endpoints will be reconsidered.
Autumn 2014 Workshop: Algorithms/Rules to Identify Clinical Inconsistency in the use of Rating Scales in CNS RCTs
Monday, June 2nd, 2014Chairs: Jonathan Rabinowitz, PhD; Nina R. Schooler, PhD
Objective- To create consistency and plausibility rules and checks for use of ratings scales by identifying patterns of ratings that are clinically implausible or at least unlikely. Inconsistent ratings can contribute to measurement error, extreme variability and generate incomprehensible ratings. We will develop consistency algorithms for widely used rating scales. This work will add to the armamentarium of tools to improve measurement. Our first focus will be the PANSS.
Autumn 2014 Workshop: Implementing Innovations in CNS Trials Working Group
Monday, June 2nd, 2014Chair: Gary Sachs, MD; Michael Detke, MD, PhD
The working group aims to deliver a paper with recommendations to help those seeking to implement innovation in CNS drug development – both content and process issues. Members have worked to establish a common knowledge-base regarding innovation from other fields and offering feedback to those engaged in innovative initiatives. We have identified opportunities and challenges to implementing innovation in CNS trials. The primary goals for this session will be to review a first draft of the group’s paper and to finalize a work plan for completing the paper.