The National Academies Press

Currently Skimming:

Appendix A: Study Approach
Pages 179-202

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.

From page 179... ... release in January 2014 of a document presenting a framework for discussion, which invited public feedback on a set of issues relevant to this report and is described in greater detail in the section below; (3) reviews of the scientific literature and commissioning of two papers on special topics, including de-identification of clinical trial data (see Appendix B) Read the entire page →
From page 180... ... The committee invited comments on a set of specific topics for public feedback on difficult issues that were likely to be complex and on which the public and stakeholders were likely to have differing perspectives. In addition to the public release of the Framework, several medical journals wrote editorials on the committee's work and encouraged their readership to send comments. Read the entire page →
From page 181... ... • "Resource constraints" or "Resource limitations" • "Implementation" • "Incentives" or "Disincentives" and "Academic"/or "Outcome research" or • "Changing norms" • "Protection of human subjects" "/or" "/" • "Patient privacy" or "Patient confidentiality" or Privacy • "Intellectual property" • Legal or Jurisprudence or "Legal issues" or "Legal aspects" or Law • "Scientific standards" or "Rogue analyses" • "Data quality" or "Quality control" • "Informed consent" • "Competition law" or "Antitrust" • "Liability" • "Data exclusivity" • "Infrastructure" • "Governance" • "Resource poor setting" • "Public health" • "Risks" • "Benefits" • "Challenges" 2 Note that "information dissemination" is the MeSH (Medical Subject Headings) term for data sharing. Read the entire page →
From page 182... ... OPEN SESSION (2:30 PM-4:45 PM) OPEN Session Objectives • Review statement of task with sponsors • Receive testimony from invited speakers and the public on attributes of responsible data sharing activities National Academy of Sciences Building, NAS 125 2101 Constitution Avenue, Washington, DC 2:30 PM Welcome and Introductory Remarks (begin open session) Read the entire page →
From page 183... ... Bernard Lo, Committee Chair 8:15-8:45 AM Clinical Trial Data and Challenges to Data Sharing Robert Califf, Duke University (by WebEx) Discussion 8:45-9:15 AM Preparing for Responsible Sharing of Clinical Trial Data Michelle Mello, Harvard University Discussion SESSION 1: CLINICAL TRIAL DATA TYPES AND SHARING ACTIVITIES Objectives: Characterize the spectrum of "data" generated in the conduct of clinical trials and review existing and proposed data sharing activities. Read the entire page →
From page 184... ... • Adam Asare, Immune Tolerance Network Trial Share • Hans-Georg Eichler, European Medicines Agency • Charles Hugh-Jones, Project Data Sphere • Frank Rockhold, GlaxoSmithKline • Joseph Ross, Yale University Open Data Access Project Moderator: Joanne Waldstreicher, Johnson & Johnson 12:00-1:00 PM Lunch SESSION 2: PRINCIPLES FOR RESPONSIBLE SHARING OF CLINICAL TRIAL DATA Objectives: Explore the perspectives of those conducting, sponsoring, or participating in clinical trials and those disseminating and using clinical trial data. Identify interests, values, and concerns to consider in the development of guiding principles for sharing clinical trial data. Read the entire page →
From page 185... ... • Discuss the elements and activities of data sharing outlined in the discussion framework document, and review the completeness of the set of selected models as a heuristic framework for the commit tee's analytic process to be undertaken as part of the study. Read the entire page →
From page 186... ... • Discuss incentives for data sharing and challenges in the imple mentation and ongoing conduct of data sharing activities. • Seek public comment on potential strategies and approaches to facilitate responsible data sharing. Read the entire page →
From page 187... ... Moderator: Steve Goodman, Stanford University School of Medicine 3:25-3:40 PM BREAK 3:40-4:45 PM Guiding Principles for Clinical Trial Data Sharing: Invited discussants to consider the suggested guiding principles for data sharing. Discuss how the principles can be operationalized to balance the benefits and risks of data sharing. Read the entire page →
From page 188... ... Bernard Lo, Committee Chair SESSION 2: LEGAL, REGULATORY, AND POLICY CONTEXT Objectives: Discuss the landscape of laws, regulations, and policies under which data sharing occurs, focusing on protection of clinical trial research participants and competition and intellectual property laws. Legal, Regulatory, and Policy Context: Protection of Research Participants 9:05-9:35 AM International Legal and Policy Context Mark Barnes, Ropes & Gray LLP and Harvard Multi Regional Clinical Trials (MRCT) Read the entire page →
From page 189... ... • Mark Barnes, Ropes & Gray LLP • Barbara Evans, University of Houston Law School • obert Gellman, Privacy and Information Policy R Consultant • Bradley Malin, Vanderbilt University Moderator: Deven McGraw, Manatt, Phelps & Phillips, LLP 11:45 AM- LUNCH 12:30 PM SESSION 3: INCENTIVES FOR SHARING AND IMPLEMENTATION OF DATA SHARING ACTIVITIES Objectives: Discuss how recognition and promotion structures and processes can provide incentives or disincentives to share data. Identify these incentives and norms in academia, industry, government, and other sectors as relevant. Read the entire page →
From page 190... ... Glasner, Georgetown University • Benjamin Roin, Petrie-Flom Center, Harvard Law School Moderator: Arti Rai, Duke University School of Law 2:15-3:00 PM Discussion Panel: Cultural and Financial Incentives for Data Sharing -- Recognition and Promotion: Recognition and promotion norms in academia -- including academic promotion/tenure structures; approaches to academic credit for clinical trialists -- and their impact on incentives to share data. Industry staffing/promotion structures; cultural issues relating to data sharing. Read the entire page →
From page 191... ... Suggest strategies and practical approaches to facilitate responsible data sharing. 4:00-4:45 PM Discussion Panel: Cross-Cutting Proposed Guiding Principles and Discussion Framework Questions Panelists to discuss: − Because most large clinical trials are global in nature, how can clinical trial data be shared in that global conext? Read the entire page →
From page 192... ... − What might be the advantages and disadvantages to various stakeholders of sharing different types of data sets, at different points in time after the comple tion of a clinical trial? − Should programs or approaches calling for or requir ing new data sharing apply only to new trials under taken from the date of a new program forward, or retroactively apply to clinical trials started before the data sharing program was initiated? Read the entire page →
From page 193... ... − What would be appropriate outcome measures to assess the usefulness of different models of clinical trial data sharing, and how can they be used to guide improvements in data sharing practices? • Susan Bull, The Ethox Centre, University of Oxford • John Ioannidis, Stanford University School of Medicine • Ira Shoulson, Georgetown University Moderator: Bernard Lo, Committee Chair 4:45 PM Public Comment Period 5:15 PM Closing Comments (end open session) Read the entire page →
From page 194... ... • Discuss incentives and disincentives in the global clinical trial landscape, particularly within research institutions, including uni versities, organizations that carry out data sharing, funders, jour nals, and other organizations involved in clinical trials. • Discuss guiding principles and characteristics for the optimal infra structure and governance for sharing clinical trial data. Read the entire page →
From page 195... ... , Chief Executive Officer, Accelerated Cure Project for MS Moderator: Sharon Terry, Committee Member 11:15 AM BREAK SESSION 2: STRATEGIES AND PRACTICAL APPROACHES FOR INCENTIVIZING RESPONSIBLE SHARING OF CLINICAL TRIAL DATA: PERSPECTIVES OF INVESTIGATORS AND LEADERS OF ACADEMIC MEDICAL CENTERS Objectives: Understand current norms and attitudes toward clinical trial data sharing. Identify new and current incentives that might facilitate clinical trial data sharing and practical steps within the broad clinical trial enterprise (including major research fields, international and limited-resource settings, data coordinating centers) Read the entire page →
From page 196... ... , Vice Dean for P Research, University of Texas Health Science Center San Antonio Moderator: Bernard Lo, Committee Chair 12:30 PM LUNCH SESSION 3: STRATEGIES AND PRACTICAL APPROACHES FOR RESPONSIBLE SHARING OF CLINICAL TRIAL DATA: GOVERNANCE AND INFRASTRUCTURE Objectives: Identify guiding principles and characteristics for the optimal infrastructure and governance for responsible sharing of clinical trial data. Discuss optimal and practical governance models that account for the global nature of clinical trials, in which relevant laws, policies and practices vary by jurisdiction. Read the entire page →
From page 197... ... , B Director, Centre of Genomics and Policy, McGill University Moderator: Tim Coetzee, Committee Member 3:00-4:30 PM Discussion Panel: Characteristics for the Optimal Infrastructure of Data Sharing • hilip E Bourne, Ph.D. Read the entire page →
From page 198... ... based in the Department of Public Health at the University of Oxford (confirmed) Data Sharing Public Comments and Contributions Contributors Name Organization Alves, Teresa Health Action International Europe, International Society of Drug Bulletins, Medicines in Europe Forum, and Transatlantic Consumer Dialogue Aquino, John Bloomberg BNA Azoulay, Daniel AP-HP Hôpitaux Universitaires Henri Mondor Barnes, Mark Harvard MRCT (Multi-Regional Clinical Trials) Read the entire page →
From page 199... ... Unknown Johnson, Lorraine Consumers United for Evidence-Based Healthcare Jureidini, Jon University of Adelaide Kalamegham, Rasika American Association for Cancer Research Kush, Rebecca Clinical Data Interchange Standards Consortium Lehman, Dale Alaska Pacific University Levett, Paul George Washington University Levit, Laura ASCO (American Society of Clinical Oncology Read the entire page →
From page 200... ... National Institutes of Health Radecki, Ryan University of Texas Medical School Rivas, Maria AbbVie Rosenblatt, Michael Merck and Co., Inc. Rouse, Dwight NIH funded clinical trialist Sanjuan, Judit Rius Médecins Sans Frontières/Doctors Without Borders (MSF) Read the entire page →
From page 201... ... How can differ ent national regulations for research participants' privacy protec tions; approval of drugs and devices; data exclusivity; and intel lectual property laws, resources, and health priorities be taken into account? • How might strategies and approaches regarding data sharing take into account clinical trials conducted in resource-poor settings, trials designed by citizen-scientists using data they contribute directly, and trials designed through participatory research? Read the entire page →
From page 202... ... For those with experience in data sharing, what is the burden of providing such support to help others understand and use the provided information? Measuring Impact • What would be appropriate outcome measures to assess the useful ness of different models of clinical trial data sharing, and how can they be used to guide improvements in data sharing practices? Read the entire page →

From page 179...

... release in January 2014 of a document presenting a framework for discussion, which invited public feedback on a set of issues relevant to this report and is described in greater detail in the section below; (3) reviews of the scientific literature and commissioning of two papers on special topics, including de-identification of clinical trial data (see Appendix B)

Appendix A: Study Approach Pages 179-202

Appendix A: Study Approach
Pages 179-202