Climbing the mountain of compliance
As CEO or VP Clinical and regulatory, do you see social networking as an opportunity or as a threat for your medical device clinical trials ?
From a cyber security and privacy perspective, an immediate reaction might be to focus on threats to privacy and intellectual property and answer no to the above question, but social networking is so part of our lives today, it is impossible to ignore. Your patients and your site coordinators are on Instagram whether you like it or not.
The challenge of privacy, GDPR and HIPAA Security Rule compliance for medical device clinical trials is no longer a problem to be solved by lawyers. The value and advantage of ePRO, connected medical devices, eSource and cloud EDC make these technologies a must for medical device clinical trials.
While privacy regulation are obvious constraints, there is a tremendous opportunity for social media and private social networking technologies to accelerate the patient recruitment process, support patient engagement and enrich the medical device clinical operations team with better information regarding patient compliance in medical device clinical trials.
For home-use and chronic disease medical device – the objectives of high levels of patient compliance are top priority for every medical device CEO.
The value of high levels of patient compliance to the clinical protocol are clear to medical device CEOs who embrace online and modern cloud technologies. But the importance of patient compliance in clinical trials appears less clear for big pharma who are reluctant adopters of private social networking and social media in general..
… So why do big pharma have a problem with social?
Big pharma are online with a wealth of information as a public service. Medical devices, esthetics and food supplements have run their business online for years.
While big pharmaceutical companies are not major social networking players – they do know how a lot about online marketing. Let’s talk about work that Sanofi-Aventis has been doing online since 2009.
Sanofi Aventis portfolio includes research and development and manufacturing of new medications. They cover 7 major therapeutically areas: cardio, thrombosis, oncology, diabetes, CNS, internal medicine and vaccines. The site has loads of information concerning the company such as: Press releases, material targeted to draw the attention of possible investors, access to the Research and development section where you can learn about the newest medications as well as their future plans and their clinical trails plus guests can apply for the different clinical research experiments.
On the other hand – it’s easy to try out social media and see if you get traction. The energy barrier is so low and the leverage on Youtube is so high, it’s an irresistible force pushing on a very heavy object like this:
Behind the science
Sanofi Aventis and AstraZeneca Launch YouTube Sites – Social media has been a buzzword in the pharmaceutical industry for the past few years (see ePharma Summit), but few companies have crossed the line into the world of social networking or conducting two-way conversations with patients online.Feb 18, 2009
The Sanofi channel is part of its integrated GoInsulin campaign, an unbranded health education program designed to give people more information about diabetes and serve as a launching pad to the Sanofi homepage. It features an array of patient videos and a link to an off-site, online game that separates the myths about insulin from reality. The channel has no branded drug material, but lists the company’s name below the top banner.
Although social media like Twitter is dominantly about personal opinions and experiences, social software such as blogs, micro-blogs and file sharing have important collaborative applications.
For example – like how to integrate all the information and care of a patient with multiple issues and care-givers (a typical MSA patient will have a GP, neurologist, speech therapist, physiotherapist, nutritionist and primary care giver at home who is usually the husband or wife of the patient with problems of their own. Speaking before a conference of the Case Management Society of America in October 2007, Tim Rothwell from Sanofi Aventis discussed their commitment to help resolve problems of collaborative care
The issues and challenges of poor transitions of care, said Rothwell, are critically important to him personally and to Sanofi-Aventis as a company. ‘The problem, of course, is a healthcare system that, for many – particularly those who get bounced around within it – is fragmented and sometimes even frightening,’ Rothwell observed. ‘For those who have family members or friends who have experienced repeated encounters with the healthcare system, the only consistent thing they believe it delivers is confusion and, sometimes, flawed outcomes.’
If you want to learn more about how to integrate your connected medical device, or if you are interested in helping with the project, give us a buzz and ask Batya or Danny for a demo.
Thanks for reading!