Real-world evidence (RWE) study publications and clinical trial data disclosure were two major topics of discussion at the 14th Annual Meeting of The International Publication Planning Association (TIPPA), with both keynote sessions being led by Oxford PharmaGenesis. The meeting, held in San Diego on 9–10 February 2015, was attended by an approximately even mix of pharmaceutical company publications managers and communications agencies, with several major publishing groups also exhibiting.
On the first afternoon, Commercial Director Dr Richard White delivered a keynote presentation on the issues surrounding the publication of RWE, which is increasingly required by regulators, payers and clinicians to demonstrate the value of new healthcare interventions. Drawing on Oxford PharmaGenesis’s extensive experience in the design and publication of RWE studies, Richard gave a brief overview of the spectrum of RWE, using analogies to demonstrate in simple terms the pitfalls and potential solutions for publishing RWE. The session was very well received, and Richard has been asked by the International Society for Medical Publication Professionals (ISMPP) whether his talk can be submitted to their educational committee as a possible ISMPP-U educational event later in the year.
In the next session, Executive Vice-President Gordon Muir-Jones teamed up with consultant Lisa DeTora to consider the issues surrounding uniform disclosure of clinical trial data by pharmaceutical companies. Gordon gave a highly engaging presentation on the pros and cons of full data disclosure, during which he managed the unusual feat of quoting Ben Goldacre, the Dalai Lama and Yoda in quick succession. The ensuing debate revealed the interesting fact that the majority of requests to pharmaceutical companies for clinical trial data access come from competitor companies and from lawyers, with academics, clinicians and patients appearing well down the list.
Further sessions and discussion panels at TIPPA covered subjects ranging from ongoing experiences with the Sunshine Act, to the potential contribution of publications managers to clinical study design and protocol development, and the role of social media in raising awareness of key publications. The involvement of patients in the journal peer review process proved to be the most hotly debated topic, with opinion polarized as to whether a typical patient has sufficient understanding to contribute meaningfully to review of a scientific paper. Oxford PharmaGenesis is currently exploring effective communication of the patient viewpoint in journal publications, a possible topic for presentation at TIPPA in 2016. Watch this space …
