ISMPP is pleased to offer the recently updated Clinical Data and Financial Transparency Resource, an educational primer and reference for data and financial transparency globally. ISMPP members have free access to this updated resource. Non-members can access it for a fee of $49 or join ISMPP to access all the member benefits.
The objectives of this resource are to:
- Increase awareness among medical publication professionals of the various guidance/policies that exist surrounding this topic.
- Provide a high-level overview of the regulations that ensure financial transparency in publications, with links to additional sources and information.
- Outline ethical and compliant ways of conducting and reporting clinical trial and other publications.
Are you familiar with the laws, regulations, and guidelines that apply to data and financial transparency in your country, region, and worldwide? The Clinical Data and Financial Transparency Resource provides an informative overview to learn about about essential laws, regulations, and guidelines, like:
•US Physician Payment Sunshine Act (Sunshine Act)
•EU General Data Protection Regulations
•EU Requirements for Medical Device – EUDAMED
•EFPIA/PhRMA Principles for Clinical Trial Data Sharing for Pharmaceutical Companies
•ICMJE Data Sharing Statements and Requirements
•US NIH Data Sharing Policy
•Vivli: Center for Global Clinical Research Data
•Yale University Open Data Access (YODA) Project
The resource has been divided into four parts, each available separately below:
Current Transparency Landscape: Impact on Publication Professionals
- Publication professionals must maintain awareness of current guidance regarding data and financial transparency and keep up to date with advances in medical communications ethics and best practices [1,2] to ensure that authors and sponsors are aware of their obligations, including disclosure and potential conflict of interest.
- There are many statements and guidance documents available from different sectors, including government regulatory agencies and professional associations of biopharmaceutical industry and editors.
- Each company's compliance and legal teams differently interpret the laws and devise recommendations to be followed by employees, including publication professionals.
- Different practices apply in different countries - not all countries in the emerging markets have laws for data and financial transparency.
- Global transparency guidelines may not necessarily be aligned with local guidelines.
2. DeTora LM, Toroser D, Sykes A, et al. Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Ann Intern Med. 30 August 2022. doi:10.7326/M22-1460
Acknowledgement
ISMPP thanks the members of the ISMPP Global Transparency & Trends Committee who contributed to this slide deck (2023): Kim Buscemi, Allison Galway, Sandi Harris, Bhakti Kshatriya, Sonia Schweers, Shannon Stahl, Amanda Steele
License Notice & Agreement
ISMPP will grant limited permission to use the ISMPP Clinical Data and Financial Transparency for personal, noncommercial use. Such use is permitted only if you accept the terms and conditions contained in this nonexclusive, nontransferable, limited license agreement.
By using the ISMPP Clinical Data and Financial Transparency series, you hereby accept and agree that: use of the ISMPP Global Transparency Educational Series, and its content, shall be for individual, personal, and noncommercial reference and use only; and the ISMPP Clinical Data and Financial Transparency series shall be used only pursuant to the terms of this license agreement. The Clinical Data and Financial Transparency series and its contents are proprietary information of ISMPP. The contents may not, in whole or in part, be reproduced, copied, disseminated, or otherwise utilized, in any form or manner or by any means, except for individual, personal, and noncommercial reference and use.
Updated October 2023