As reported in January 2017 in The MAP newsletter, one of the goals of the ISMPP Global Transparency Committee was to “develop an educational series designed to educate members and provide them with real-world resources to inform their worldwide approaches to data and financial transparency.”
Ongoing efforts by health authorities (US Food and Drug Administration, European Union, and other regions) worldwide, as well as initiatives led by governments, the World Health Organization, and other global organizations, have resulted in additional regulations and calls for transparency related to data disclosure and data sharing, including patient-level data. Although results disclosure and commitments to publishing are currently in place, the disclosure of patient-level data has not been fully mandated. Efforts by regulatory bodies to ensure compliance, as well as voluntary requirements, including the International Committee of Medical Journal Editors (ICMJE) framework for data sharing as a prerequisite for publication, will help to uphold ethical standards of research conducted or funded by sponsors.
In addition to clinical trial data transparency, in the US, the advent of the Affordable Care Act (ACA), which includes a provision known as the “Physician Payments Sunshine Act,” has made it mandatory for pharmaceutical companies to disclose details of financial payments made to healthcare professionals. Information about these financial payments is available via the open payments database (https://openpaymentsdata.cms.gov/), and is accessible to the public. Disclosure of financial ties by pharmaceutical companies is now a global effort with ex-US regions, including Europe, Canada, and Australia, adopting policies to disclose financial fees.
Both data and financial transparency are critical. Data disclosure and data sharing, as well as transparency with financial ties, will help strengthen the integrity of the research, create evidence-based medicine, and restore trust in the pharma sector.
This educational series was developed by the members of the ISMPP Global Transparency Committee, with the objective to:
- Increase awareness among publication professionals on the various guidances/policies that exist surrounding this topic
- Provide an overview of the different regulations in place in various countries
- Provide insight into the ethical and compliant way of conducting and reporting clinical trial and other publications
To learn more, join the ISMPP U webinar on September 20, 2017, which will highlight the various components of the transparency educational series. The full educational slide deck will be accessible to ISMPP members on the Society’s website by end of September.
ISMPP U Webinar
Educational Series on Data and Financial Transparency –
A Project of the Global Transparency Committee
Wednesday, September 20, 2017
11 am EDT / 4 pm GMT
The contents contained in the module will serve as a reference guide and NOT in any way represent or replace individual company policies on data and financial transparency.