Increasing the rate of clinical productivity and bringing the products to market faster remain key focal points for pharma in these times of pricing pressures, hyper-competition from generics and outcomes-based reimbursement contracts from payers.
With the signing of 21st Century Cures Act in late 2016, USFDA has led initiatives to accelerate medical product development to bring newer innovations and advances in drug development to patients who need them faster and in a more efficient way.
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 post consumption of the experimental drug entity via smart devices (PRO), thereby becoming important determinants for the success of these entities.
“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.”
This is a significant departure from the traditional visit based clinical trial data collection methods to more contemporary e-visit enabled clinical trials. The operational activities such as recruiting patients, improving medication adherence, providing day-to-day safety monitoring of trial subjects are being done online, thereby minimizing the occurrences of adverse events.
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”.
‘Internet of Things’ enabled trials is the future of clinical development
Streamlining clean data collection process and making the entire clinical development workflow ‘smart and intuitive’ by engaging patients in managing their own care - presents the biggest opportunity for pharma sponsors and study sites alike.
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, prescriptive protocol amendments, etc.
Online data collection and analysis offer the below benefits:
- Patient Empowerment and Engagement
- Flexible Trial Design
- Faster patient enrollment and lesser dropouts
- Higher data quality and integrity
- Reduced operations expenses
- Remote patient monitoring
However, given the profound benefits, are pharma and biotech industries ready to onboard internet of things within 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 top priority for digital transformation projects currently in flight.
Increasingly, pharma and biotech industries are keen to conduct pilot studies with sensor enabled patient held devices and managed clinical network to run their patient engagement and chronic disease management programs leveraging IoT platforms. This helps improve patient medication adherence and thereby avoid potential adverse events as well as saving time, effort, and capital for pharmaceutical companies.
However, these are still early days and we’re yet to witness successful large-scale enterprise-wide IoT project implementation impacting clinical development pipeline.
Hopefully, with CIO’s mandated to budget technology spends for digital and IoT, we’ll get clusters of companies making a beeline for implementation of these initiatives across their global enterprises.
Ariful Deepu is Vice President & Global Head, Healthcare & Pharmaceuticals, IoTWoRKS at HCL Technologies
Disclaimer: This article is published as part of the IDG Contributor Network. The views expressed in this article are solely those of the contributing authors and not of IDG Media and its editor(s).