In lieu of the recent draft guidance issued by FDA on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies document Using Structured Product Labeling” earlier this month, I thought of taking a trip down the memory lane to revisit how we got here on REMS.
The following diagram provides a snapshot of the timeline: REMS-Journey
For those keen to understand how REMS documents get converted to SPL elements, you can refer to this presentation on “REMS Standardization via Structured Product Labeling (SPL)” by Adam Kroetsch, Policy and Informatics Advisor, Office of Program and Strategic Analysis, Center for Drug Evaluation and Research from October 5, 2015.
I have talked about REMS in my past blog posts, specifically about “Implementing FDA REMS ETASU Requirements using a BPM Suite“. Feel free to check it out. I will have more to say on this topic in my future blog posts in relation to impact of the new guidance and how to prepare for it.
Oracle Argus Safety is a leading Safety & Pharmacovigilance platform in the market. Oracle has been able to successfully move many sponsors from diverse drug safety platforms it built (Oracle AERS) or acquired (PhaseForwards’ Clintrace and Relsys’ Argus) to Argus Safety, making it their strategic safety platform of the future.
Upgrade to latest version of the platform has always been a challenging task for many sponsors, given the complex nature of configurations, customizations and integration with various clinical, regulatory and safety applications in the R&D ecosystem. Typically it takes anywhere between 1 to 3 years for customers to get onto the new release after the version is available. Of course this time line will change with the amount of changes the new version brings to the table. The impact of change will also determine the duration of the upgrade project/program. This has been the root cause for many customers delaying the upgrades in the past. Not to mention the cost associated with these upgrades.
The latest release, Argus 8.1 addresses new regulatory compliance requirements, functional enhancements and biggest of them all technology platform currency. In my opinion,these three things are key drivers to upgrade to Argus 8.1.x .
Regulatory Compliance Requirements: The new E2B (R3) reporting guidance for transmission of Individual Case Safety Reports based on Health Level-7 (HL7) messaging protocol provides an advantage to capture more data with increased granularity and frequency. ICH E2B(R3) is a mandatory regulatory requirement that all safety organizations need to be compliant with, in future. Different Health Authorities have different milestones / timelines for compliance. At this time it appears that PMDA (Japan) deadline of April 1st 2019 as the most impending one. Also many sponsors have implemented interim solutions to process EMA’s Eudravigilance ICSRs that are available in E2B (R3) format. The interim solutions have to be done away with and what better than meeting this requirement through the core platform. Also, electronic Vaccine Adverse Event Reporting System (eVAERS) and electronic Medical Device Reporting (eMDR) requirements, connected with E2B (R3) and important initiatives for Vaccines and Med Device sponsors are key requirements to be complied with.
Bug Fixes and Functional Enhancements: As with any of the past releases, Oracle has also addressed a lot of requirements pouring in from sponsors to fix some of the existing issues and enhance the platform to meet some new requirements. In 8.x there are over 350 Issues fixed. New Expedited Report Updates adhering regulations are added. There are also various Case Management Updates. There are a bunch of changes specifically targeting Argus J (i.e. Japan). Japan Development Safety Update Report (JDSUR) is enhanced replacement for ‘Clinical Study Periodic Safety Report’ (CSPSR). Also, ability to convert existing CSPSR report to JDSUR on Copying the Existing Report has been added. There are updates to PSR, ReSD, Global Lock and local data locks and local case data locks specifically for Japan.
Technology Platform Currency: Many existing technology platforms that support Argus platform have become outdated in the last few years. This has led to Oracle adopting newer versions of Windows, Oracle Database, OBIEE, Axway Interchange, Oracle B2B (new) etc. Also, some of the legacy technology platforms like Windows 2008/R2 are going out of support, not to mention premium support for Argus 7.x as well. The Technology platform changes themselves should be a big reason for sponsors to consider upgrade to 8.1.x.
More specific details around the bugs/enhancements as well as specific software versions in the technology platform currency can be found in Oracle Argus Safety 8.1 Release Notes.
As always, your feedback and comments are welcome. I would be very interested to hear from consultants and technologists in the trenches, driving the upgrades. Also from sponsors who are considering upgrades in near future (or not) .
P.S: This is my first post after a very long hiatus. But I plan to share my thoughts and opinions more often going forward. Thanks for your support and feedback.
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.
Another “Eye Opener” of an infographic from Lily COI team. The data presented seems to indicate that 10% of the patients do not participate in the clinical trials. If only they saw the infographic published by this team in Decemeber that the patients on Placebo will also receieve the standard treatment, could they be swayed to join the trial? Interesting question, Isn’t it?
In December, we published our first infographic. Our goal was to start a discussion around the question: “How often do patients receive placebos in cancer clinical trials?” After digging into the data from cancer trials registered on ClinicalTrials.gov, we found less than a 1 percent chance of a patient receiving a placebo alone on a cancer study. The majority of placebo-based trials adminster the placebo along with standard of care treatments.
We received some great constructive feedback on the graphic from the patient advocacy and clinical research communities through our blog and Twitter. We appreciate those who asked clarifying questions and gave us suggestions for future infographics. Armed with their input, we went to work on our second infographic.
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