Looking back to our last post in the Ins and Outs series on Confidentiality, you’ll see there’s an obvious disconnect and therefore potential conflict in relation to publication rights between a sponsor and the principal investigator (PI)/institution.
Onerous restrictions on publication rights could be counterproductive and unlikely to be accepted by the institution and PI. For a start, it could potentially sour the goodwill and alliance established between the institution, PI and sponsor prior to commencing the clinical trial. Further, sponsors understand that for many institutions and PIs, in addition to facilitating the development of new medicines, conducting clinical trials has the allure of professional recognition and development.
Undertaking clinical trials are an exciting way in which the institutions and PIs may remain at the cutting edge of their specific therapeutic areas and develop their skills and interests further. Through their involvement and their ability to publish and present the outcome of their clinical work, they have the prospect of being recognised as thought leaders in their therapeutic niche.
Publication rights include all public disclosures, including academic presentations, peer-review journals and professional meetings.
Given the wide definition of publication, and to balance the interests of all the parties involved, the sponsor will typically allow publications by the institution and PI but would want prior review of the proposed publication (lasting around 60 days) to redact confidential information. They would also want to ensure that any publication of clinical trial data is limited to a summary form or some other restricted form and/or delay the proposed publication or presentation to let the sponsor obtain patent protection.
What the sponsor permits
When it comes to the clinical trial results, the sponsor will typically permit the institution and/or PI to publish or present the results based on the following occurrences:
- After publication of multi-site data. If a site is part of a multi-site clinical trial, the sponsor will request that the results from all of the clinical trial sites be included in a single publication to ensure that publication or presentation of the clinical trial results aren’t based on a particular sub-set of data. This only permits publications by individual sites following a multi-site publication.
- After sponsor indicates it won’t publish multi-site data.
- After completion or abandonment of clinical trial at all sites.
In the event of any of the above occurrences, the sponsor will usually allow such publication following an 18 month delay, which is the industry standard.
Even though publication can be seen as a contentious issue, timely publication has many benefits for sponsors. In particular, publication can draw attention to the sponsor’s expertise and investment in tackling certain types of diseases and potential drug therapies they have in their pipeline, and this in turn helps attract future investments and creates a stronger marketing authorisation application to the regulatory authorities.
This post was written by Sharmela Thevarajaha, Associate, Intellectual Property & Life Sciences, JAG Shaw Baker.