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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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.
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.