With the evolving requirements and expectations for the pharmaceutical industry to increase its transparency related to clinical trial data, medical publication practices and financial disclosure, the need exists for ISMPP members to stay apprised of recent developments and current best practices for adoption by their companies.
The ISMPP Global Transparency Committee, which was newly formed for 2016-17 and broadens the scope of the former Sunshine Act Task Force, will help serve this purpose by addressing both data and financial transparency globally, as well as greater transparency of medical publication practices. The Committee aims to develop pragmatic resources related to data and financial transparency for ISMPP members to apply in real-world situations facing their organizations. Further, working in collaboration with the ISMPP Advocacy & Outreach Committee and under the auspices of the ISMPP Board of Trustees, the Committee plans to develop focused publications that provide greater visibility into established best practices that support ethical medical publishing within pharmaceutical organizations. More information on goals and upcoming resources will be shared at upcoming ISMPP meetings.
In the near term, the Committee will focus on three primary deliverables:
- Survey and Report of Company Financial Transparency Practices – In the years since the passage of the Sunshine Provision of the US Patient Protection and Affordable Care Act as well as the voluntary EFPIA Disclosure Code, companies have determined how to potentially disclose transfers of value related to developing medical publications to authors. The Committee endeavors to research current practices and report anonymously on trends to inform members and organizations.
- Transparency Publication Plan – In recent months, there has been scrutiny around medical publishing practices, often questioning the ethics behind established best practices regularly employed by publication professionals. The Committee will plan a publication or series of publications to provide greater clarity on some of the more common practices that are regularly employed by organizations to decide on appropriate authorship selection, prevent commercial bias in publishing, engage journals, etc. Utilizing a more proactive approach in this regard is expected to reduce criticism of our profession and ultimately elevate the critical importance of medical publication professionals in the development of peer review publications.
- Educational Series – As data and financial transparency regulations evolve globally, the job of the medical publication professional is becoming more complex. Indeed, there is a gap in succinct educational materials that summarize common terminology such as transparency, disclosure, etc., as well as a need for locally specific summaries of transparency laws, regulations, and voluntary commitments. To address these gaps, the Committee will 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.
The Global Transparency Committee plans to share information about its efforts during the Poster Reception at the 13th Annual Meeting of ISMPP, in National Harbor, Maryland, USA, on May 1-3, 2017. This session will enable bi-directional engagement with ISMPP members, and provide the opportunity to learn directly about member needs related to transparency.
“The initiation of the Global Transparency Committee represents the next step in ISMPP’s response to our evolving profession with a growing emphasis on transparency. This Committee is driven to deliver practical resources that will help members bring value to their organizations.” –Rob Matheis, Chair
The Committee is chaired by Rob Matheis, and consists of the following volunteer members: Bhakti Kshatriya, Karen Mittleman, Terry Peña, Kalyan Pulipaka, Sonia Schweers, Brian Sharkey, Kanaka Sridharan, Christine Vanderlinden, Susan Wieting, Julie Vanderkerckhove, Kevin Sharkey, and Eric Yu.
Thank you to Rob and all the members of the Global Transparency Committee for their dedicated efforts to address the evolving transparency issues in the medical publications profession!