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Full Disclosure: Meet the Clinical Trial Disclosure Community
The DIA Clinical Trial Disclosure (CTD) Community provides a forum for discussing and sharing clinical trial disclosure and transparency information in the US, Europe and Canada. The CTD Community began in 2006 as a Clinical Trial Register/Results Working Group under the GCP/QA Special Interest Activity Group (SIAC), and quickly grew in number; today, it is a standalone Community. The current Core Team consists of Marla Brickman (Pfizer, Inc.), Merete Jørgensen (Novo Nordisk A/S, Denmark), Erik Lakes (Takeda Pharmaceuticals, Inc.), Community Chair Robert Paarlberg (Paarlberg & Associates, LLC), Pat Teden (Teden Consulting, LLC), and Matthias Zerm (Merz Pharmaceuticals GmbH, Germany).
The CTD Community covers the entire global clinical trial disclosure and data transparency environment from protocol through the reporting of clinical trial results and data sharing. Members discuss and share operational best practices, new clinical trial disclosure/transparency requirements along with medical, scientific, and regulatory information related to registry and results disclosure activities. Beyond legal requirements, we discuss a variety of industry and organizational disclosure policies (e.g., WHO. ICMJE, PhRMA, EFPIA). Our neutral forum also allows industry, research organizations, academia, patient advocacy organizations and regulators to “cross the aisle” in dialogue on these topics.
Community members come from clinical development, regulatory affairs, medical writing, publications, corporate communications, biostatistics, project management, legal departments as well as patient advocacy organizations. Consequently, our Community has cross-functional ties with the Medical Writing, Medical Communications, Regulatory Affairs, Statistics, Legal Affairs, and Patient Engagement Communities.
The CTD Community holds calls the second Tuesday of every month with ongoing participation from the National Library of Medicine (ClinicalTrials.gov) and the European Medicines Agency (EMA), as well as guest speakers representing other agencies/databases. These monthly calls provide an excellent forum for members to share information as well as interact with National Library of Medicine and EMA staff on new procedures and policies.
CTD Working Groups (WG) are established on an as-needed basis. We currently have the following active Working Groups: Final Rule WG, Plain Language Summary WG and Policy 0070 WG. Deliverables from the Working Groups vary depending upon the focus of the specific working group.
The Final Rule Working Group is led by Francine Lane (Trialscope) and focuses on implementing the requirements for submitting registration and summary results information for specified clinical trials of drug products (including biological products) and device products to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). The Working Group was established in September 2016 when the NIH issued the Final Rule for Clinical Trials Registration and Results Information Submission that clarifies and expands the regulatory requirements and procedures for submitting registration and summary results information of clinical trials on ClinicalTrials.gov. The Working Group has created an Final Rule Q&A Excel Spreadsheet which contains questions and answers on the implementation of the Final Rule including input from ClinicalTrials.gov. The Working Group periodically updates the Excel spreadsheet with new questions from the Community and responses by the ClinicalTrials.gov staff.
The Plain Language Summary Working Group (PLSWG) is led by consultant Renee Entzminger. As the global regulations on lay summaries are still being refined, the PLSWG provides a forum for members to collaborate and learn together. Current work streams within the PLSWG include Changing Regulations and Updates; Endpoints; Lay Summaries for Complex Trial Design; and Process-Related.
The Policy 0070 Working Group is led by Shalini Dwivedi (Kinapse Ltd., India). The Policy 0070 Working Group was formed to share learning, experiences and suggest solutions to challenges being encountered with document submissions to the European Medicines Agency (EMA). EMA Policy 0070 is a new development towards improved trial transparency. Currently, the pharmaceutical industry is gaining experience with EMA’s implementation process while submitting their clinical trial documents. Current work streams within the Policy 0070 Working Group include: Policy 0070 External Guidance; Anonymization Techniques; Risk Assessment; Other Related Policies/Regulations (e.g. Policy 0043; EU Data Protection Regulation); and Policy 0070 Phase 2.
Previous Working Groups established by the CTD Community include:
EU Clinical Trial Regulation Working Group was co-chaired by Merete Jørgensen and Matthias Zerm and focused on the clinical trial disclosure aspects of the EU Clinical Trial Regulation. The Working Group created a document which assesses the disclosure/transparency requirements of the Clinical Trial Regulation.
NPRM Clinical Trials Registration and Results Submission Working Group was chaired by Scott Patton and created an interpretation document of the Notice of Proposed Rulemaking (NPRM) published in the Federal Register on 21 November 2014. The NPRM was provided for in the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded the reporting requirements in ClinicalTrials.gov.
For the last several years, the CTD Community has been organizing yearly clinical trial disclosure/transparency conferences alternating between the United States and Europe as well as chairing disclosure and transparency sessions at the DIA Global Annual Meeting. In September, the CTD Community will be conducting a Clinical Trial Disclosure and Data Transparency Conference in Rockville, MD. This conference will provide critical and timely information relating to clinical trial disclosure and data transparency from those on the front lines. It will highlight major recent regulatory changes and other related hot topics to clinical trial disclosure information transparency, including implementation of the US Final Rule, EMA Policy 0070, EMA policy 0043, data sharing, and lay language summaries. Speakers will provide expert insight into how study sponsors from industry, academia, and government are addressing these changes and putting them into practice.
The conference will also feature half-day short courses: Disclosures 101, designed for professionals new to clinical trial disclosure operations; and 2) Preparing Documents for Disclosure and Public Sharing, designed for medical writers and other professionals who prepare documents for disclosure. We will also conduct a Clinical Data Publication Evolving from Policy 0070 Conference on 6-7 December in London, UK. This conference will focus on Policy 0070 and provide lessons learned, updates from EMA,insights on how sponsors are preparing documents for EMA submission, and the impact of the new Data Privacy Regulation on Policy 0070 documents.
The Clinical Trial Disclosure Community is open to all active DIA members. If you are interested in engaging in meaningful and constructive dialog with your peers as well as regulators, or in advancing your knowledge and skills within the expanding clinical trial disclosure and transparency environment, this Community is for you!
This article originally appeared in the August 2017 Global Forum.