Digital disruption in clinical trials
Human Genetics Scientist, Joyce El Hokayem examines where the digital era is taking today’s clinical trials.
Nowadays, many would struggle to function without enjoying the integration of digital technologies into their daily lives. This era of digitalizing information has not left the fields of healthcare and pharmaceutical development
In fact, the future of medicine and clinical research is greatly dependent on new tendencies and tools. Pharmaceutical manufactueres and research companies need to advance R&D efforts to keep pace with industry shifts. Especially when looking to de-risk the large failure rates that stand in drug
Clinical trials are growing in complexity and in the volumes of data collected. Many firms are approaching clinical trials in new ways, but as ever with R&D, it's going to be a slow
Lately, pharmaceutical companies have tried to supplement the different steps in clinical trials with digital approaches. Some have succeeded, Pfizer for example has launched a web-based clinical trial resource PfizerLink – an online community for Pfizer clinical trial
In 2011, Pfizer launched one of the first clinical trials to involve remote participation, the drugs were delivered by mail to patients. By digitalizing the data, patients can easily access results and their own clinical data. Patient can use the findings to manage their own health and discuss it with their
Digital technologies changing clinical
Kevin Julian, managing director of Accenture has identified three main technology categories that might change the clinical trials: cloud, analytics and
Patient instrumentation allows sponsors to obtain a very objective set of patient data that is closer to the real world experience. For example, when a patient is taking a treatment which makes them less tired, a smart watch can let the pharma company track their mobility. The amount of steps the patient took a day before the study, during and as well tracking their sleeping patterns.
Some new wearables don’t require in-clinic monitoring and less visits as participants are able to transmit the data remotely.
In addition to helping collect data for clinical trials, wearables help cut costs since participants have less visits and less overnight stays.
The technology behind the wearables also helps with calculations which previously would have been done manually by the researchers with room for error and higher costs.
Experts believe that over the next five years this field is going to expand rapidly with more people moving to partake. Wearables present a huge opportunity to collect data more efficiently to establish safety and efficacy.
However, wearables are just the tip of the iceberg. Digital technologies are changing almost every part of the clinical trial process, from patient recruitment passing by electronic health records through to cloud and collaboration consortiums such as TransCelerate.
Remote clinical trials
Recently, eClinicalHealth company has implemented a new technology model in the VERKKO remote online phase IV clinical study for diabetes. VERKKO has been developed with Sanofi, Langland and Mendor. The aim is to study the use of an online clinical study platform integrated with Mendor’s 3G-enabled wireless blood glucose meter in a completely remote setting.
Patients were recruited via Facebook and then registered interest on eClinicalHealth’s cloud based trial system Clinpal. Once selected, the patients signed an electronic consent form. Afterwards, they received the study material and the smart, wireless glucose meter was connected to their personal Clinpal account.
Innovation for pharma
Thanks to the advances in software technologies that allow specialists to create new clinical trials designs, researchers are making gains in time and cost efficiencies.
Social networks and smartphones use are rising so that technology can as well be used to improve patient recruitment process in collaboration with other key study centers. Digital tools such as instant messaging, live video chat or voice activation can be fused with big data analytics to support the patient from home with real time contact between the local study site and the national sponsor representatives. With the help of wearables, patients can track the updates of their treatments.
As technology continues to develop, I am sure many innumerable opportunities will innovate to improve all features of the clinical study process, most importantly focus should remain fixed on the wellbeing of the patient and how technology can facilitate the patient’s life and locate the best treatment.