Rare disease biopharma Shire has kick-started a new mandatory open-access program for research manuscripts to journals it has funded.
Christopher Rains, head of global medical affairs and medical shared services at Shire, told FierceCRO that Shire “is one of, if not the only, biotech company to implement a publication policy requiring the submission of all company-supported research manuscripts to journals that offer public availability via OA [open access].”
What this does is remove the barrier of subscription journals, a move Shire sees as “allowing the public to obtain free, unrestricted online access to Shire's research promptly following publication.” The policy covers preclinical, clinical and postmarketing data.
The open-access policy went into effect on Jan. 2 this year, but the company said it’s been in the works for the last 12 months.
Rains said: “This policy helps allow others to build on and learn from our research promptly following publication. Increasing transparency can encourage collaboration and drive medical innovation, with a goal of helping to bring innovative treatments to patients more rapidly. Shire has been encouraging OA for several years […] The drive toward a mandatory OA policy began in January last year, following the first meeting of Open Pharma.”
Rains explained that the plan is for all Shire-supported research manuscripts to be made available to the public on journal websites that offer an open-access policy to all audiences.
“In addition, Shire will look into whether it is possible to provide links via ShireTrials.com,” he said.
This policy includes all journal submissions going forward, including submissions about data from studies or research conducted prior to Jan. 2, 2018.
Rains said that it has also “started discussions with relevant publishers and are looking in to if this is possible and feasible for our historical publications.”
This comes amid a growing trial transparency campaign, notably in Europe, with the European Medicines Agency driving for better use of clinical study reports (CSRs) to be published or made available, and the 2013 launch of AllTrials, a Dr. Ben Goldacre, BMJ and Sense About Science lobby group. AllTrials aims to keep the pressure up on the industry and academia to publish all clinical trial data for public consumption.
“AllTrials is great campaign, as it too encourages transparency for all.” He added that Shire was “the only company (academic or corporate) to have posted the results of all the trials it had conducted according to an analysis by AllTrials.”
Shire has not committed to signing the AllTrials register, as GlaxoSmithKline has done, to further open up its data, but Rains said: “Shire is completely committed to transparency for clinical trial data. Since 2015, Shire has had teams and systems in place that have enabled the company to consistently register and report all studies per regulations in a timely fashion."
“In addition to disclosing study results on regulatory sites including clintrials.gov, Shire also hosts shiretrials.com which contains links not only to ongoing studies and completed study results,” he added.
Rains said that clinical trials results in a format of redacted synopses of CSRs are posted on Shire’s clinical trials disclosure website, which date back to 2014.