Advances in pharmaceutical technology are easing communication between researchers and participants to increase patient engagement.
Clinical trial technology is moving fast, with both pharma companies and patients having much to gain from streamlining the route from bench to bedside. From sophisticated data management tools to online patient registries, innovation is supporting the development of robust, meaningful research.
A new era of data mining
Clinical trial data analytics software heralds a new era for data mining, and was was one of the top trends seen at the last meeting of the Healthcare Information and Management Systems Society (HIMSS).
These packages offer bigger and better ways of collecting, querying, visualising and cleaning data in real time. They promise to streamline the delivery of clinical trials by pulling information from a multitude of sources, saving researchers hours of valuable time.
Launched in January this year, encapsia bills itself as the first in a new generation of Cloud-based clinical trial management systems. Louise Holliday, Director of Business Development, at Cmed said:
“It offers a single representation of the data which all of the modules access, thus removing the pain and delays of transporting of data from one system to another. A single configuration represents each trial, defining the data structures, visit schedule, forms, validation checks and workflow for all components.
“In addition, various monitoring strategies (e.g. Risk-based, remote source review, eSource) can be applied to the same trial while meeting regulatory requirements.”
The uptake of wearable technology
Wearable technology in clinical trials is about to move to the next level according to the experts, who believe the technology's ability to collect objective, real world data has huge clinical benefits.
Last month, PARAXEL Informatics announced the launch of its new patient sensor system, which uses wearables to capture, transmit, store, and visualise study subject data. Xavier Flinois, PAREXEL president said:
“Due to evolving regulatory and payer standards in today’s healthcare market, there is a growing need to leverage alternative data sources in clinical trials. Wearables and sensors have the potential to transform Phase I-IV trials as well as observational studies.
“PAREXEL’s offering could disrupt the industry standard of collecting data…allowing biopharmaceutical sponsors to more easily demonstrate safety and/or efficacy and differentiate treatments from competition using remote monitoring approaches.”
Clinical trial recruitment apps
One of the biggest problems facing researchers is a shortage of willing participants. Studies have blamed this on a lack of awareness and difficulty finding compatible studies. Enter a wave of trial finder apps and web-based platforms, designed to match subjects to researchers.
One such app, Wing, goes a few steps further. It helps people to not only search for trials but enrol and stay connected throughout. Using Wing, patients receive appointment reminders, an electronic diary and a messaging system for two-way conversation. All of which have been shown to keep study participants engaged and reduce drop-outs.
Mobile patient reported outcomes (PROs)
In a world of patient-centred care, PROs are becoming increasingly important, though their subjective nature means they can sometimes be difficult to capture and analyse in the clinic.
The immediacy of mobile technology can ease collection of these outcomes. Whether in the form of diaries, scales or questionnaires, mobile apps allow patients to make immediate note of any changes or side-effects that they experience.
Another advantage electronic PRO collection has over paper is that it allows for two-way communication. Relevant educational and/or motivational content can be shared throughout a trial, keeping participants engaged and reducing expensive, time consuming drop-out rates.
Online patient registries
The IBD Registry has become the vehicle of the biological audit and quality improvement programme for inflammatory bowel disease (IBD), with teams across the country using the system to collect real-time data during consultations. As the website states:
The Registry has the potential to become a unique resource for real-world clinical effectiveness and health economic studies in IBD care. While data can be collected on all IBD treatments, the focus for 2016/17 is on biologics.
Likewise, More than 15,000 people have signed up to the UK MS Register, agreeing to fill out a survey every three months and contribute to an ever growing bank of real-world data. The registry is also collaborating with the MS Society Tissue Bank, collecting samples from willing donors found via the site.
Online patient registries may not be the most thrilling of technological developments, but their power for recruitment cannot be underestimated.
Technological innovation breeds progress
In the fast-paced world of technological and digital development, innovation is future-proofing clinical trials.
It costs millions of pounds and many years to bring a new drug to market, with many failing to make it onto shelves. That’s why any technical innovations that can speed up the process are an invaluable asset to researchers, pharmaceutical companies and, ultimately, patients.