Increasing the rate of clinical productivity and bringing the products to market faster remain the key focal points for the Pharma industry. This is especially true in these times of pricing pressures, hyper-competition from generics, and outcomes-based reimbursement contracts from payers. With the enactment of the 21st Century Cures Act in late 2016, the USFDA has led initiatives to accelerate medical product development to bring newer innovations and advances in drug development.
The Cures Act enhances FDA’s ability to help Pharma modernize Clinical Trial Designs and Clinical Outcome Assessments. Patients are being encouraged and empowered to report all therapeutic experiences on consumption of the experimental drug entity via smart devices (PRO). Thus, they become important determinants for the success of these entities. This is a significant departure from the traditional visit-based clinical trial data collection methods toward a more contemporary e-visit-centric clinical trials. It leverages the internet to perform operational activities, such as recruiting patients, improving medication adherence, providing day-to-day safety monitoring of trial subjects that minimizes the occurrences of adverse events (AEs). Such inclusionary ecosystem has been made possible through “the Internet” and which is a connected infrastructure of medical devices (BYOD), software applications and health systems and services “the things”.
IoT-enabled smart clinical trials are the future of clinical development.
Streamlining the clean data collection process and making the entire clinical development workflow smart and intuitive by engaging patients in managing their own care is the biggest opportunity for pharma sponsors and study sites alike. Clinical solutions can be channeled into traditional study bottlenecks like expediting trial enrollments, ensuring medication adherence, remote profiling, and safety monitoring of patients as well as study sites for their KPIs, and prescriptive protocol amendments. An illustration of the benefits will highlight the need for downstream internet-enabled data collection and analysis.
Internet of Things (IoT) and connected smart devices have the potential to improve clinical trials through higher patient retention and reduced trial spans. However, in order to gain these benefits, life sciences companies must be able to collect, process, and submit IoT data to the health authorities in a compliant manner.
However, given the profound benefits, are the pharma and biotech industries ready to onboard IoT on their ecosystem?
Statistics prove the industry is experimenting with IoT enablement within their business functions. An IDC Health study in 2018 pointed IoT as the No. 1 priority for digital transformation projects currently in flight. Increasingly, the pharma and biotech industries are keen on conducting pilot studies with sensor-enabled, patient-held devices, and managed clinical network. The idea behind this to run their patient engagement and chronic disease management programs by leveraging IoT platforms. This helps improve patient medication adherence and avoid potential adverse events as well as saves time, effort, and capital for pharmaceutical companies.
However, these are the early days and we are yet to witness the successful enterprise-wide implementation of IoT in clinical trial projects, impacting the clinical development pipeline. With the CIO defining the budget for technology spends for digital and IoT, we are expecting a cluster of companies to implement these initiatives.
Can HCL enable enterprises to be IoT empowered?
HCL has been an early proponent in leveraging technologies in the pharma R&D ecosystem with a view of expediting clinical trial outcomes. Keeping in mind the rapid infestation of automation with the pharma ecosystem, HCL has invested in developing multiple global ‘IoT Innovation Labs’ to identify and build IoT-led clinical solutions and downstream life sciences use cases. The result? Companies get to view IoT-enabled clinical studies and the resulting transformation benefits with tangible dollar savings. The idea here is to help companies touch and feel automation with smart clinical solutions and evaluate its plausible uses in their operating environments.
About IoT WoRKSTM
IoT WoRKSTM is a dedicated Internet of Things (IoT) business unit of HCL Technologies. Our award-winning, best-in-class, customer- and industry-specific, deployment-ready solutions co-created with customers, enable them to maximize effectiveness and returns on their asset investments. Rated as a global leader in IoT consulting and services by top analysts, our solutions, which are co-created with customers, enable IoT-led business transformation through the creation of more efficient business processes, new revenue streams, and models that deliver measurable business outcomes. The transformative impact of IoT is realized by IoTizing the ‘things,’ connect the assets to a data platform, and then use the data to derive business insights and make business decisions, which ultimately lead to change in enterprise’s processes and people practices.