Tag Archive | Safety

Social Media, Literature Search, Sponsor Websites – A Safety Source Data Integration Approach

I haven been part of my fair share of discussions on Drug Safety and Social Media. In fact, I have even written a blog post about how these two are being forced into an “arranged marriage”, which could be a good thing :-). While processing data from social media is very complex and often unreliable, there is increased push to process it anyway. Understandably, Marketing teams are the first to adopt social media channels in pharmaceutical organizations, now the drug safety teams are being forced to act as these channels could end up generating adverse events and they are obligated to register, review and report.

As mentioned, processing of data from social media could be complex and may yield very few cases (0.2% according to a Nielsen’s Online survey of health-related social media content) the high level process is very similar to Literature Scanning. The later is something that is already being handled by organizations. I think that the Social Media content search and analysis can becoming an extension to this process. Now lets look at both the processes.

Literature Search:

Literature Search is used by BioPharmaceutical organizations to identify Adverse Events related to their medicinal products in medical and scientific journals published worldwide. This process was adopted as a result of multiple serious adverse events and the ensuing regulations and increased safety concerns. Many sponsor organizations have successfully built automated systems to speed up the overall process. These systems typically scan sources (Journals, Abstract Libraries and Reference Libraries) based on certain keywords, product names, Boolean expressions etc. and capture the mentions into a local database. These entries are then screened by trained professionals to either accept or reject them based on the required data elements to qualify as an adverse event. If additional details are required, the journals are purchased and reviewed to qualify the “hit” as an adverse event. Once identified, this becomes a case that will then be transferred manually or electronically (e.g. E2B) to an Adverse Event Management System and will follow the life cycle till it is reported as an expedited or periodic report to regulatory authorities.

Social Media:

This process can be very similar to Literature Search except that the source of data is much more diverse and also the data is far less structured. Depending on the source system, a manual or automated process can be adopted to monitor and record the “hits”. If the source system is a “blog” or “Twitter” or “Facebook”, a tool can be build to continuously poll certain blogs, tweets or Facebook pages to scan for keywords, products/brands etc. The resulting “hits” can be processed to filter and aggregate the “trends”. These trends can then be reviewed by trained professionals to make a decision on whether they qualify as “Safety Cases” that will then be processed per the AE case management process.

Enterprise Websites, Response Centers etc.:

The third variety that may be considered as source systems for safety cases are Brand Websites and other portals setup to increase the brand awareness or assist the patients to receive medicine faster or address any questions and concerns. This may even include response centers setup for patients, pharmacists and physicians to reach the sponsors for information and advice. Depending on the nature of inquiries, these could be potential sources of Adverse Events. This data, once screened and qualified, can also be fed into the AE Management System for subsequent review and reporting purposes.

Source Data Integration:

From a technology standpoint the architecture and design for aggregation and analysis of data may differ for each of the datasets. However, an integrated approach to collecting, aggregating, analyzing and reporting of Adverse Event data needs to adopted by the sponsor IT organizations. The diagram below depicts:

  1. Multiple Source Categories and Systems (Literature, Social Media, Enterprise Websites)
  2. Multiple Interfaces  (Manual, XML, Text, API, RSS, Web Services etc.)
  3. Simple, High Level process to screen, record, review and report the case
Literature Scanning, Social Media & Enterprise Websites  - Safety Source Data Integration

Social Media Safety Source Data Integration

(To Be Continued…)

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Clinical Information Super Highway and Integration

Generic Industry Challenges:

Expiring patents, drying pipelines, increasing budgets, stringent regulations and cost pressures are some of the challenges faced by the Life Sciences industry. While these are macro challenges, teams responsible for clinical, regulatory and safety for clinical trials, regulatory submissions and patient safety respectively have a totally different set of challenges that they deal on a regular basis.

Information Silos:

Data and documents generated during the course of the trials are managed by IT systems that have been either built in house or procured off the shelf. A major challenge that is faced by IT teams in large enterprises is to provide information and intelligence to their business teams that would cross (by integrating information) these siloes and help them make sound business decisions.

SOA based Information Integration:

Imagine a situation where all these systems in the clinical enterprise are integrated and connect seamlessly.  The glue that binds all these systems can be a fully Service Oriented Enterprise Service Bus (ESB). Not just that, it should also be standards based. This will reduce the dependency on interfaces between systems in use and future proof the enterprise from replacement, retirement and enhancements to the individual systems. In order to bring visibility to data and documents across the systems there is a need to aggregate data and documents into Clinical Data Repository (CDR) and an Enterprise Electronic Document Management System (EEDMS).

Clinical Information Enterprise Service Bus

Clinical Information Super Highway

The diagram above depicts a few information systems within the Clinical, Regulatory and Safety areas of Life Sciences R&D. This integration has to be:

  • Loosely Coupled (SOA)
  • Standards Based (CDISC / HL7)
  • Open Architecture (XML, SOAP) and
  • Survive system upgrades, replacements and retirements

Advantages:

Some of the advantages with the above mentioned integration would be:

  • Integrated Clinical Enterprise Information Systems
  • Easier and simpler integrations with partners and third parties
  • Adoption of standards
  • Integrated data and documents to enable faster decision making
  • Faster Time to Market
  • Lower Total Cost of Ownership and
  • Better ROI
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