As Arena International’s Outsourcing in Clinical Trials New England conference gets underway next week in Boston, MA, U.S., Clinical Trials Arena will be shining a spotlight on tech innovation. This is especially pertinent because OCT New England will feature a new ‘Clinical Trial Technology and Innovation’ track. Therefore, throughout the week, CTA will post articles uncovering the most pressing issues concerning the adoption of the latest tools.
Be sure to visit CTA tomorrow when Pnina Vortman of the Israel Innovation Institute draws attention to the rise of citizen science in the clinical trial space. On Wednesday, Sameer Tandon of Novartis examines protocol feasibility in the era of electronic medical records. On Thursday, Chris Adams, CEO of Andarix, explains how industry can leverage technology to make the drug development process more efficient. Lastly, on Friday, CTA explores the topic of clinical trial analytics.
In the meantime, catch up on some CTA’s most recent stories delving into the challenges of tech innovation… (click on the headline to finish reading).
Two Roads Diverge at the Pharma Crossroads: Part I
The pharmaceutical industry is moving in a direction where, in the not too distant future, a pause by the industry at the clinical trial crossroads will give rise to two roads diverging in a binary fashion. New innovations in terms of how clinical trials will be conducted, and with how new medicines will be approved by regulatory agencies. One road will lead the industry to innovations in the field of virtual clinical trials, where patients in a study will be monitored by their electronic mobile or wearable devices.
The other road will lead the industry to new developments in the field of personalized/precision medicine, where translational research and new genomic diagnostic tools will target specific patient profile features, and mitigate the risk of patient/screen failures in clinical trials. Technology will play a significant role in how innovation will drive these new processes, as technological developments in artificial intelligence, as well as in virtual and augmented reality platform tools, will play an integral part of a new paradigm shift in the industry.
ePRO and the eNaïve
Patient reported outcomes (PROs) are increasing in use for both supportive and primary endpoint assessment in clinical trials. One of the most common ways to collect PROs is the use of a diary as well as other self-administered questionnaires. Historically, paper-based systems have been used, but these are often criticized for the lack of control in data entry when the study subject is not being directly observed. Detractors have voiced concerns regarding the lack of a documented audit trail when it comes to data entry and integrity; some reviewers have even stated or implied a preference for electronic PRO (ePRO) data capture systems.
As clinical trial technology continues to rapidly develop, advancing into the patient-facing arena, we can incorporate electronic diaries and other smart devices that collect real-time study subject responses with reliable user access and time stamps. This can go some way to placating the concerns of detractors who lean toward paper-based alternatives as subject responses are accompanied with time-stamps and electronic audit trails. Nevertheless, as we embrace technology we run the risk of disenfranchising some segments of the population.
Examining the Impact of eTools in Clinical Trials
Although technology is advancing, clinical trials have changed little over the past 20 years. Using traditional methods to collect and track data, visibility into the information may take not only weeks but sometimes months, resulting in lack of insight into early data and reduced ability to decrease our risk. When we make decisions, we are basing them on data that is way too old. Business as usual is getting stale and not moving us forward. Hey guys, we are in the 21st century! We have a different way of thinking and doing business at Otsuka Pharmaceutical Development and Commercialization. Innovative tools and technologies are readily available for us to use in the clinical trials today. Let's review some of the new technologies and put them to use…