What is Digital Clinical?
I noticed this term used quite often in my conversations with customers, colleagues and industry analysts in the last couple of years. As is the case with many things in the past, the building blocks of “Digital Clinical” have been in the works for a long time now. At its core, in my opinion, it is all about various technology advances coming together to progress and enhance the clinical research. To name a few, the core technologies/developments include Mobility, Analytics, Social, Cloud Computing, Big Data, Semantic technologies. As mentioned while this is not a comprehensive list, it is a good start to understand how these are being leveraged to improve clinical research and the impact they are having on Heathcare & Life Sciences Industry, Patients and society at-large.
Areas of Focus:
The following are some of the focus areas across the R&D Value Chain being considered as Digital Clinical initiatives by various life sciences companies in the market space:
- Mobile Data Collection in clinical trials, patient reported outcomes and general quality of life data
- Data aggregation from Payer, Provider, Rx, Clinical and other Health Economic & Outcomes Research Data
- Ontology based repositories, Master data management, meta data repositories and text analytics
- Bio-Sensor and other wearable data capture, aggregation & analysis by leveraging cloud computing
- Mining of data from EHR/EMR, Social Media and other data sources
- Leverage OMOP, Sentinel and other such industry initiative outcomes to kick-start Real World Evidence/Real Life Evidence strategies
Business Use Cases being considered:
Some of the use cases being considered are:
- Site selection and Patient Recruitment
- Use wearable Bio-sensors in Clinical Trials
- Adverse Events in Social Media & Safety Surveillance
- Protocol Validation : Inclusion/Exclusion criteria assessment
I hope this gives a high level overview of what Digital Clinical means, some of the technologies influencing and enabling it and practical use cases being considered by the industry to leverage these technologies and provide better quality of life to patients.
It is amazing to see how fast things change, when right technology comes along, picks up the willfully reluctant “legacy” way of doing things and takes them on a ride of their life time. Not too long ago paper based clinical trials was the norm, and still is in some countries. Then came the electronic data capture systems and technology. While that is, people used eCRFs same way as they did paper CRFs. Slowly that started to change with data validation, edit checks etc.
With the cloud revolution came the thought of having clinical data capture/management systems on the cloud and be managed by a third party while pharma companies controlled the protocol and trial design as well as data transformation, analysis and submission management. Off late we are seeing companies being more open to store and share clinical trial data on the cloud. I think the days of ‘Clinical Platforms on The Cloud’ as the norm will soon be a reality. These platforms will not be limited to Clinical Trial Data but will host systems that provide end-to-end clinical research process support capabilities. Not only that, they will also stretch the boundaries further, by accommodating social media, mobile, big data & analytics capabilities.
Future of technology companies that are pioneers in enabling this transformation is going to be interesting and bright with ample opportunities to take the lead and leap to the next orbit.
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:
- Automated (COTS) and
- 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.