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?
Originally posted on Lilly Clinical Open Innovation:
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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While Placebos have been in use in Clinical Trials for a long time, I always wondered about the fate of patients who would receive a Placebo rather than the actual drug. This Inforgraphic by Lilly COI team provided an insight into Cancer Clinical Research and the use of Placebos. Thought I’d share it. Personally, I feel we ought to leverage newer technology like Human Genomes and perform more targeted research to not only reduce the cost of clinical research but more importantly reduce the impact of a critically ill patient receiving a Placebo instead of teh actual treatment.
Originally posted on Lilly Clinical Open Innovation:
Back in September, we spent some time looking into the overall use of infographics in the clinical research space for a blog post titled, “Using Infographics to Increase Understanding of Clinical Trials.” What we learned is that there is a real opportunity to create more infographics that present information about clinical trials in a way that’s clear, concise and visually-appealing, and that helps answer some of patients’ most frequently asked questions.
So, we decided to take a stab at putting together an infographic of our own. The question we set out to answer: “How often do patients receive placebos in cancer clinical trials?”
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The WordPress.com stats helper monkeys prepared a 2013 annual report for this blog.
Here’s an excerpt:
A New York City subway train holds 1,200 people. This blog was viewed about 4,300 times in 2013. If it were a NYC subway train, it would take about 4 trips to carry that many people.
In my previous post titled “Transition to Oracle Argus Safety – Key Considerations – Part 1” I summarized the key considerations for Transition to Oracle Argus Safety. The Infographic included in the previous post, summarizes the considerations across the Business Process, Business Support and Application Support areas.
In this post, I will outline the considerations in Single Case Handling. This is one of the most resource intensive and critical functions of a safety organization. This is one function that cannot be interrupted, despite transition to a new tool/system, as it his many implications on the sponsor organization as well as on the patients.
- Business Process Services:
- Process Optimization: This is one of the aspects of the safety organization that will be impacted immediately. The business teams processing the cases would have reached their peak performance within the current environment. Introducing Argus will impact the team as they have to learn new tool and also readjust to a process that most likely was reengineered
- Case Receipt Automation: Many organizations would have automated the Case Intake process. The process of automation and any tools associated with it would have to be reengineered to leverage Argus’ Intake capabilities instead
- QA, Metrics & Best Practices: The quality assurance of the single case processing, the performance metrics associated with it and the best practices established over the course of time will all be impacted and probably take a dip with the introduction of Argus. This has to do more with the change in itself rather than the functions/features/capabilities of Argus tool
- Business Support:
- Access Management: The users need to be configured in the new system. Also, if any new users are being on boarded as part of consolidation then this will have to be accounted part as part of access management
- Partner Support: The Safety organization will have established relationships with CRO partners. These partners need to be supported during the transition. This might also mean reengineering some of the Intake processes, tools and systems. If Argus Affiliate module is being leveraged for capturing AEs from the affiliates, this could add additional entity to the support organization from a configuration as well as help desk support perspective.
- Report Distribution: The established channels of distribution of expedited reports to regulators will be impacted with the introduction of Argus. This might mean retesting any electronic E2B report submission channels. The review, approval and submission of reports may need to be configured using Argus and Argus Interchange modules.
- Application Support:
- Workflow Configuration: The Case Processing workflow need to be reconfigured. For large organizations this is usually a complex task as the automated routing of cases to the right groups/personnel is key to efficient processing. If a global consolidation is undertaken as part of the transition, this task would become even more complex.
- E2B and Reconciliation: The established process and tools for collection and/or distribution of safety data/reports to/from partners should be reengineered with the inroduction of Argus. Also, the safety case reconsiliation that happens between the clinical and safety systems will be impacted and should be reengineered and automated to account for changes due to Argus
- Distribution: As mentioned in the Business Support, the reporting process will be reconfigured, which will necessitate a reengineering of distribution process.
In the next part, we will look at additional considerations from an Aggregate Reporting perspective.