May 17, 2020

Sanofi to go public with clinical trial data, supporting data sharing and EHR

Admin
3 min
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Written by Alyssa Clark Following suit with other large pharma companies, Sanofi has jumped onto the data sharing bandwagon— the corporation has...

Written by Alyssa Clark

 

Following suit with other large pharma companies, Sanofi has jumped onto the data sharing bandwagon— the corporation has recently stated that it plans to release clinical trial data in an effort to enable a website where researchers can easily and readily request study information. First pioneered by GlaxoSmithKline last year, it seems as if this recent trend to support research and data sharing is a suit for everyone to follow in the upcoming year. Whether the gesture will satisfy industry critics remains to be seen. Sanofi will make available trial data and related documents, including clinical study reports, for studies in human that were submitted to US and European regulators and the product must have been approved by both agencies – on or after January 1, 2014.

Industry trade groups in the US and Europe have pushed for this decision for quite some time now, with their proposed plans of data sharing which are currently being considered by the European Medicines Agency. Critics have generated a lot of discussion concerning the past lack of access to research data and statistics from corresponding studies, and whether or not Sanofi’s move to join the new wave of sharing-friendly pharma companies will satisfy public uneasiness is still too new to determine.

“Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers,” says Sanofi ceo Chris Viehbacher, who is also president of the European Federation of Pharmaceutical Industries and Associations, in a statement.

This new public information will silence the long-standing criticism of the credibility of the statistics generated by pharma giants in terms of how they market their products and the consequential success of the specific product. Drugmakers’ excuse of clinical trial data being “proprietary” has officially run out in the public’s opinion, and now forcing companies to be responsible for the raw numbers of their respective drugs will hopefully reinstate some truth to an industry long-buried in dirty money secrets. After seeing scandals like Glaxo and Johnson & Johnson, in which the companies were cited nearly $3 billion in settlements for withholding information about side effects, the demand for honest and reliable numbers is at an all-time-high.

For the most part, drugmakers have resisted any change, although since Glaxo launched its web site to provide patient-level data to researchers, upon request, several others have now agreed to participate, including Roche, Boerhinger Ingelheim, ViiV Healthcare – a joint venture between Glaxo, Pfizer and Shionogi to develop HIV medicines.

Though impossible to predict the future behaviors of the pharma industry, bringing clinical trial data to the public eye is a small victory for the everyday patient and those researchers working on behalf of public health to provide us with the truth about the healthcare that’s available to us. 

 

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Jul 25, 2021

Getting ready for cloud data-driven healthcare

Data
healthcare
CloudComputing
Technology
 Joe Gaska
4 min
Getting ready for cloud data-driven healthcare
 Joe Gaska, CEO of GRAX, tells us how healthcare providers can become cloud-based and data-driven organisations

As healthcare continues to recognise the value of data and digital transformation, many organisations are relying on the cloud to make their future-forward and data-centric thinking a reality. In fact, the global healthcare cloud computing market was valued at approximately $18 billion and is expected to generate around $61 billion USD by 2025. 

At the forefront of these changes is the rapid adoption of cloud-based, or software-as-a-service (SaaS), applications. These apps can be used to handle patient interactions, track prescriptions, care, billing and more, and the insights derived from this important data can vastly improve operations, procurement and courses of treatment. However, before healthcare organisations can begin to dream about a true data-driven future, they have to deal with a data-driven dilemma: compliance. 

Meeting regulation requirements

It’s no secret that healthcare is a highly regulated industry when it comes to data and privacy – and rightfully so. Patient records contain extremely sensitive data that, if changed or erased, could cost someone their life. This is why healthcare systems rely on legacy technologies, like Cerner and Epic EHRs, to manage patient information – the industry knows the vendors put an emphasis on making them as secure as possible.

Yet when SaaS applications are introduced and data starts being moved into them, compliance gets complicated. For example, every time a new application is introduced into an organisation, that organisation must have the vendor complete a BAA (Business Associate Agreement). This agreement essentially puts the responsibility for the safety of patients’ information — maintaining appropriate safeguards and complying with regulations — on the vendor.

However, even with these agreements in place, healthcare systems still are at risk of failing to meet compliance requirements. To comply with HIPAA, U.S. Food and Drug Administration 21 CFR Part 11 and other regulations that stipulate the need to exercise best practices to keep electronic patient data safe, healthcare organisations must maintain comprehensive audit trails – something that gets increasingly difficult when data sits in an application that resides in the vendor’s infrastructure.

Additionally, data often does not stay in the applications – instead healthcare users download, save and copy it into other business intelligence tools, creating data sprawl across the organisation and exposing patient privacy to greater risk. 

With so many of these tools that are meant to spur growth and more effective care creating compliance challenges, it begs the question: how can healthcare organisations take advantage of the data they have without risking non-compliance?

Data ownership

Yes, healthcare organisations can adhere to regulations while also getting valuable insights from the wealth of data they have available. However, to help do this, organisations must own their data. This means data must be backed up and stored in an environment that they have control over, rather than in the SaaS vendors’ applications.

Backing up historical SaaS application data directly from an app into an organisation’s own secure cloud infrastructure, such as AWS or Microsoft Azure, makes it easier, and less costly, to maintain a digital chain of custody – or a trail of the different touchpoints of data. This not only increases the visibility and auditability of that data, but organisations can then set appropriate controls around who can access the data.

Likewise, having data from these apps located in one central, easily accessible location can decrease the number of copies floating around an organisation, reducing the surface area of exposure while also making it easier for organisations to securely pull data into business intelligence tools. 

When healthcare providers have unfettered access to all their historical data, the possibilities for growth and insights are endless. For example, having ownership and ready access to authorised data can help organisations further implement and support outcome-based care. Insights enabled by this data will help inform diagnoses, prescriptions, treatment plans and more, which benefits not only the patient, but the healthcare ecosystem as a whole. 

To keep optimising and improving care, healthcare systems must take advantage of new tools like SaaS applications. By backing up and owning their historical SaaS application data, they can do so while minimising the risk to patient privacy or compliance requirements. Having this ownership and access can propel healthcare organisations to be more data-driven – creating better outcomes for everyone. 

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