January 10, 2018

For many doctors, researchers, and clinicians, 2017’s AWS re:Invent conference in Las Vegas was an eye opener. The global pharmaceutical giant Eli Lilly’s technology architect spoke at length about their interactions with patients and caregivers across the country. Through these interviews, the company realized the need to go beyond their reductive mandate of simply developing and trialing new drugs. For Eli Lilly, this meant refocusing on engaging patients meaningfully during the course of clinical trials while alleviating the burden of participating in them.

High Cost of Non-Compliance

As of this moment, there are approximately 93,208 ongoing clinical trials in the United States alone, including observational and interventional studies. The average cost of operating such studies – from protocol approval to final clinical trial report – is approximately USD 3.4 million for phase I trials, USD 8.6 million for phase II trials, and USD 21.4 million for phase III trials. Phase II onwards, patient non-compliance has a direct influence on the duration and cost of a trial.

Not only does it compromise the statistical validity of a study’s outcome but also results in USD 600,000 per day in lost revenue opportunity for niche products and up to USD 8 million per day for blockbuster medical products. If reports are to be believed, 40% of the patients fail to adhere to study protocols after 150 days into the trial – suffering from temporary bouts of toxicity and introducing irregularities into the data being captured by clinicians.

Connected Clinical Study Network

Although technology has been largely viewed as a cost driver by the pharmaceutical industry, IoT is being widely implemented to turn this scenario around. Particularly, digital solutions, as well as increasing access to smartphones and social media can play a vital role in pairing patients with the right study at the right time. Potential candidates can be seamlessly enrolled into studies, gaining complete visibility into the schedule, procedures, and clinic appointments, made available as an electronic consent form on the patients’ smartphone.

In order to further create a connected community of patients and caregivers, IoT-enabled smart pills and blisters along with mobile applications can provide not just dosing and assessment reminders but also access to ‘how-to’ videos, integrated diaries, and survey modules. In time, this will enhance communication amongst stakeholders, simplify the enrolment process further, and improve adherence to study procedures with patient-specific, easily readable electronic drug label supporting multiple languages, and similar patient centric solutions.

This will also help eliminate manual tasks associated with drug accountability and patient adherence tracking—helping site staff improve quality of a clinical trial. Digital solutions empowered with IoT promise to provide solutions to many of the clinical trial challenges, eliminating manual processes, improving data quality, thereby reducing rework and cost overheads and speeding up trial completion.

The Data Security Dilemma

The pharmaceutical industry however has exhibited some degree of reluctance towards adopting emerging technologies with the introduction of General Data Protection Regulation (GDPR) and similar governance policies around the world. These policies have already begun to influence the drug development landscape—promising to change the way such trials are conducted. As healthcare IoT matures further, it will help clinicians securely exchange patient data in near real-time while being supported by strong security frameworks and privacy policies.

With IoT coming to the forefront of medical research, do you think this is the right time to start rethinking how sensitive clinical data can be protected without restricting access to the wider medical community? Please let us know in the comments section below.

Dr. Niraj Vyas is the Assistant General Manager, Life Sciences at TCS. He has 16 years of experience in the biopharmaceutical industry, managing cardiac safety and centralized clinical monitoring operations. He has graduated in medicine from Seth GS Medical College and KEM Hospital in Mumbai. He also has a PG diploma in clinical research from Bombay College of Pharmacy and a Masters in Business Administration from Indira Gandhi National University.