PharmaWrite at the 12th Annual Meeting of ISMPP
DATA SHARING, DATA TRANSPARENCY AND DISCLOSURE: A Changing EnvironmentCompiled for you by PharmaWrite.
The use, sharing and disclosure of clinical trial data is entering a new and exciting environment as requirements and demands for this vital information continue to evolve and expand. This growing transparency brings new challenges – and new opportunities – for our industry.
Recently, at the 12th annual meeting of the International Society of Medical Publication Professionals (ISMPP), this subject of data sharing, data transparency and disclosure was one of the more significant trends that surfaced for discussion.
The New Proposal
Specifically, there was a great deal of debate around the new ICMJE member data-sharing proposal. This proposal recommends that, in order for a manuscript to be considered for publication in any ICMJE member journal, the authors must:
- Share de-identified individual patient data (IPD) supporting the results presented in the manuscript within six months of publication.
- Include a data-sharing plan as a component of clinical trial registration, including specific information about where data will be housed and how it can be accessed.
Most of the ISMPP attendees agreed that increased data transparency would be beneficial for replication and verification of research. However, some were concerned that these requirements would needlessly delay publication and result in apprehensions over privacy. Comments on the ICMJE proposal from the ISMPP discussions are available as well as a summary of the feedback received.
New Disclosure Codes in Europe
In Europe, concerns over disclosure transparency resulted in the passing of the new European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code.
Similar to the US Sunshine Act, the EFPIA Disclosure Code would require pharmaceutical companies across Europe to disclose transfers of value (TOV) made to healthcare professionals (HCPs). Examples of TOV that could be covered are speaker fees, speaker training, medical writing, data analysis, and development of educational materials.
As discussed at the meeting session, publication professionals who work with international authors should be aware of the new requirements to ensure that they are compliant.
Other New Initiatives
There have also been new initiatives to help authors comply with transparency requirements relating to conflict of interest. Convey, a new user-controlled, online global disclosure system developed by the Association of American Medical Colleges (AAMC) was introduced at the ISMPP meeting. It aims to serve as a central repository of all the conflict of interest (COI) financial disclosure information for a given author so this information can be easily accessed during the manuscript submission process. By standardizing COI information, the AAMC hopes Convey will increase efficiency and disclosure transparency for HCPs, journals, and those working in medical communications and publications.
For your convenience, and for your reference, the PharmaWrite staff has compiled a detailed meeting summary of the ISMPP event, including session descriptions, key takeaways, and valuable speaker comments and quotes. Fill out the form below to request this comprehensive summary.