Tag Archive | adverse events

Oracle Argus Safety and Adverse Event Reconciliation

Adverse Events / Adverse Drug Reactions are imperative to all interventional therapies, be it drugs, devices, vaccines or biologics. The frequency, seriousness, breadth etc. may vary from drug to drug, person to person. We have made a lot of progress in ensuring that all the adverse events are identified, processed and reported to regulators. However there are still a lot of challenges in ensuring consistency, of how this is done across organizations, in terms of people, process and technology.

Oracle’s Argus Safety Suite is a leading drug safety system in the market. It is a very good application with rich features. However, there are still certain functions, the industry needs, that needs to mature and some others that are still evolving. I would like to write about one such features i.e. Adverse Event Reconciliation. The module in Argus Suite that provides this functionality is “Argus Reconciliation”. The datasheet lists the benefits of reconciliation and the ability of this module to make it easy, to reconcile the AE data between Argus and other Clinical Data Management systems.

What is reconciliation?

Reconciliation is typically the process of identifying any discrepancies in the data captured for the Adverse Events in Clinical Data Management system and Safety System.

Why do they have similar data in two systems?

Adverse event data is captured in CDM systems as part of the clinical trial data collection process. This data is also entered in Safety Systems in order to capture, process and report it to regulators. Sponsors should ensure that the data that is submitted to regulators during the course of the trial and the data that is submitted as part of the overall submission are consistent. Hence, reconciliation of data is essential. Ideally this situation should not arise if the data is collected electronically and the systems are integrated so the information flows bi-directionally. However, that is not the case in real world.

For customers that have Argus Safety there are essentially three options for reconciliation:

  1. Manual
  2. Automated  (COTS) and
  3. Automated (Custom)

Manual: This method, to a large extent is self-explanatory. One has to extract the AE records from the Safety and CDM systems and compare the data elements line item-by-line item. Any discrepancies identified may lead to a) change to the data in CDM system or b) change to the data in Safety system

Automated (COTS): This method can be used in case a commercially available integration exists between the CDM system and Argus. If we look at some of the popular CDM systems in the market, InForm (Oracle), Oracle Clinical and Rave (Medidata) two are from Oracle. The following information outlines the integration in case of each CDM system:

1)      In case of Oracle Clinical, the reconciliation is available through the Argus Reconciliation module. Customers have to buy licenses to this module as part of the Safety Suite in order to leverage this functionality.

2)      For Inform to Argus integration, Oracle has released a Process Integration Pack (PIP) that is part of their Application Integration Architecture (AIA), which in turn is part of their Fusion Middleware strategy. This essentially requires customers to install an AIA foundation pack and then purchase the PIP (Oracle® Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety) and install/configure it.

3)      Medidata Rave’s Safety Gateway product can be leveraged for integration between Rave and Argus Safety. This is basically an E2B based integration.

Automated (Custom): In cases where the volume of cases is very high, which eliminates the manual option, and a COTS integration does not exist, customers may have to rely on a custom integration. This can be accomplished in multiple ways. However, an E2B based integration is recommended.

Hope this post helps you get basic knowledge about AE reconciliation and options available for reconciliation between Argus Safety and three popular Clinical Data Management systems. As always, your feedback will be very valuable and welcome.

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Safety Signal Management process automation using Microsoft SharePoint

In recent years the Life Sciences industry has seen many product recalls and withdrawals from market due to safety concerns from patients and the resultant actions by regulators. Pharmacovigilance has become a more proactive process as opposed to a more reactionary process in the past.

Electronic data collection and submission of Adverse Events (AEs) in recent years has enabled organizations to collect huge data sets of safety information. Some pharmaceutical organizations have invested heavily on building or procuring IT systems that can analyze these datasets and produce safety observations that have the potential to become signals. This method of applying mathematical / scientific statistical algorithms to identify potential signals is termed as ‘Quantitative Signal Detection’. Another way of identifying safety observations is the manual process of reviewing all cases being reported, by a medical professional, to identify potential signals. This process is termed as ‘Qualitative Signal Detection’. Many small to medium organizations employ this method of detecting potential signals. More than the size, it is the volume of cases that need to be analyzed that would be a key criterion for organizations leaning one way or the other. Some organizations may also employ a hybrid model i.e. quantitative analysis followed by qualitative analysis.

Microsoft SharePoint is a very popular collaboration and content management platform adopted by many organizations across the globe. Life Sciences organizations are no exception to this trend. In recent years SharePoint has seen rapid growth in even areas that require more cautious adoption of new technology due to the impending regulatory requirements (e.g. 21 CFR Part 11 compliance). However, due to the efforts from Microsoft as well as other IT and Life Sciences organizations SharePoint is being adopted in areas where it requires validation.

Signal Management, the process that ensues once the Signals are detected using one of the two methods i.e. Qualitative or Quantitative Signal Detection, is the process where the information related to a safety observation and the corresponding cases that lead to the observation are reviewed by professionals and scientists and decision is made on whether the signal is refuted or verified (other states are also possible).  The information is usually captured in forms and passes on from one state to another following a specific workflow with associated service levels for each step in the process. This yields itself as a potential candidate for automation. SharePoint natively supports configuration of forms, management of documents as well as simple workflows. As mentioned above, many organizations have already made investments in SharePoint and hence will be able to save costs by leveraging this tool for Signal Management automation.

Update on 02/15/2012: Please refer to an article by me, on this topic, published by “Drug Safety Directions”  here: Signal Management using SharePoint

Cheers,

Venu.

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…)

Social Media and Drug Safety, arranged marriage?

Social media is all about freedom of expression. safety and Pharmacovigilance is about patient safety and utmost confidentiality of patient information and not to mention the huge financial implications of misinformation. Having said that, life sciences organizations have recognized the need for proactively managing risk and having access to information related to patient safety, good or bad, before anybody else. In the light of this realization, there is tremendous pressure on heads of safety to formulate a social media strategy. While there is anxiety on their part as to the implications of such a strategy in terms of cost, productivity and compliance they are also grappling with not having the right guidance from the regulatory authorities.

Despite the challenges, there are some organizations that are making best use of social media while there are a few that got burned in the process. My interest in this subject is more from a technology perspective. What does this mean from an automation, integration and analysis stand point? As such organizations have recognized the need for safety data integration and analysis and started moving towards setting up safety data warehouses. The chatter on social media about adverse events from drug, device or vaccine use becomes another source to be scanned, filtered, reviewed and stored. Each of these activities pose a great challenge for technology implementation as well as effort required to setup the process and maintain it efficiently.

The key to successfully handling these challenges lies in finding answers to questions like:
1. Is our social media strategy in line with our organizational and regulatory policies?
2. What are the technology implications?
3. Is our IT team ready for this challenge?
4. Is the market mature enough to provide solutions and services to assist out IT and Business teams?
5. If not, which of the partners in our Ecosystem can help us develop the right solutions and provide services?

While these are some random thoughts and questions, it has to be seen how the market matures and rises to this challenge. The key is for the industry, as a whole, to figure out the use of social media in safety and Pharmacovigilance context and subsequently identify the right solutions that will provide the necessary support to make this a reality. As long as this doesn’t happen, the early movers will always be at a disadvantage and end up spending lot of effort and money while struggling to justify the return on this investment.

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