Digital technology, mobile solutions, novel data collection modalities and integrated systems are becoming game-changing features of modern clinical trials. However, the adoption of latest technology solutions to improve overall outcomes and garner operational efficiencies, has been slower than expected. In this blog Nikhil Gopinath mentions his key takeaways from the SCOPE Summit 2017, For Clinical Ops Executives, organized by the Cambridge Healthtech Institute.
Last week I had the opportunity to be a part of the 8th annual SCOPE (Summit for Clinical Operations Executives) in Miami, Florida. SCOPE is one of the most comprehensive events in the pre-commercial space with dedicated tracks focused on key areas like on issues related to each aspect of clinical trial planning and management: Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Real World Evidence and Precision Medicine, amongst others. In all, SCOPE brings together all members of the clinical development and operations industry under one roof to discuss problems, innovations, and challenges in regards to the numerous categorical areas of clinical trials.
Being one of the Premier Sponsors of the event, Team Saama had the opportunity to learn from some excellent presenters/presentations as well as share Saama’s approach and technologies at the vendor presentation space.
I personally found three presentations that were truly disrupting and interesting to learn from.
- Roche’s Christian Gossens presented mobile application to track patient measurements at all times (for Multiple Sclerosis and Parkinson’s Disease)
- Hassan Kadhim’s thesis on moving beyond the concept of remote trials
- AstraZeneca’s Amir Handzel presented a lucid approach to innovative trial designs for precision medicine
Roche’s Mobile Application tracking patient measurements:
Christian Gossens from Roche discussed how his team build a mobile application to track measurements of patients at all times (for Multiple Sclerosis and Parkinson’s Disease) via inbuilt sensors on an Android phone. Using balance, gait, and interaction with touch screen based assessments, Dr. Gossen’s team was able to demonstrate striking differences between severely ill patients and healthy patients. The publication on these findings is soon to be released this summer, and is guaranteed to be an exciting read. Looking forward to it.
Thesis on moving beyond the concept of remote trials:
Hassan Kadhim from Boehringer Ingelheim discussed his recent thesis work on moving beyond the concept of remote trials. He addressed the complications of conducting remote trials, technology considerations, and the paradigm shift an implementation represents to the clinical research community. Ultimately, this talk presented a very executive-friendly way to approach a truly innovative idea through a proof-of-concept, pilot, followed by the implementation.
A lucid approach to innovative trial designs for precision medicine:
Amir Handzel from AstraZeneca presented a truly concise and easy to understand view of innovative trial designs for precision medicine. Amir is the Global Statistical Science Head of the company, and he imparted knowledge on progressing towards drug registration. He mentioned that it could be done by identifying patients those respond the best to an investigational drug. He simplified the problem statement further by determining number of patients required for an effective trial and explained that biomarkers help us understand which patients will exhibit the highest levels of efficacy.
With this knowledge, we need not recruit many patients thereby ‘using less to prove more’. Of course there are many challenges and practical considerations while doing this, but there is a pilot study in which a ‘basket trial’ is employed. This means that many drugs are evaluated against one indication in context of many relevant biomarkers to direct the treatment of patients who have failed on prior therapy.
I also had the opportunity to represent Saama by speaking on centralizing Clinical Data. I presented a point of view that in order to bring pertinent information to specific clinical operations stakeholders quickly, data must be centralized and contextualized with modern technologies. I also covered the importance of creating intuitive interfaces that allow these stakeholders to understand trends and recommendations without the need of technological skills. Finally, we showcased the company’s real capabilities in Pharma space by demonstrating the applications; Clinical Development Analytics and Clinical Development feasibility.
Overall, SCOPE was quite an experience! We learned that innovations are truly vast and complex in various areas of the industry. Whether it’s the use of wearable devices to track neurological disorders, to the progress towards patient centricity with remote trials, or the fundamental shift in trial design with biomarkers; there are many opportunities for technology and science to team up.