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25 June 2015Americas

Life Sciences Law Forum: social media and clinical trials

The Life Sciences Law Forum opened today, June 25, with a lively panel on the implications of online technology for innovative companies in the sector, including the knock on effect for intellectual property rights.

Rhianon Ebsworth, senior corporate counsel at pharmaceutical company Novo Nordisk, and Helen Roberts, a life sciences solicitor, discussed how clinical trial practice might evolve online, raising questions about data collection, disclosure and its effect on a company’s IP protection.

The pair were speaking during a panel discussion at the event, currently taking place in London.

Ebsworth referred to a 2009 survey by Canada’s Pharmaceutical Advertising Advisory Board which found that 70% of Canadians look to the internet for medical information as a starting point to make a case for companies engaging more online, not just for building engagement, but also in a more practical sense, to improve the quality and efficiency of their clinical trials.

The panel then went on to discuss so-called ‘e-trials’ which it said could have enormous implications, not least because being able to obtain informed consent from participants remotely (on video or through online forms) widens the potential pool of suitable subjects by potentially removing the need for geographical proximity to the trial.

E-trials may also help companies identify suitable patients to participate in trials by engaging with existing patient groups online and increasing the visibility of a given study through online outreach.

Of course, such trials raise issues, not least around data security and the different requirements for consent and transparency in different jurisdictions.

Different stakeholders, notably US patient organisations, may have different views on who owns the data generated through such trials.

The wider question of data transparency affects IP too, the panel said.

Ebsworth highlighted the difficulty of knowing exactly what counts as commercially confidential information when meeting the European Medicines Agency’s (EMA) transparency requirements for data.

Indeed, the panel said it may be the case that patent applications could be threatened  by the lack of clarity in this area, since it is not clear whether the EMA considers unpublished patent applications as potentially public or not.

The Life Sciences Law Forum ends today.

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