The digital age is upon us, yet many clinical trials are still rooted in cumbersome paper-based procedures. An integrated data management platform can reduce trial costs and times, as Margaretta Nyilas, senior vice-president, clinical and business operations, at Otsuka Pharmaceutical Development & Commercialization, tells Ross Davies.
Collecting clinical trial data can be complex and laborious. The more difficult it is to amass such data, the longer the delay in getting around to the important stage of analysing the information at hand. Despite this, many clinical trials in this otherwise almost wholly digital age still rely on paper-based processes.
Using paper-based data often entails long hours handling copious forms, becoming even more convoluted when formatting is not standardised across trial sites that may cover the entire globe.
In order to be turned into electronic datasets, administrative staff must often transcribe report forms manually, increasing the potential for mistakes.
Paper-based patient consent forms, too, still prove to be problematic, and can lead to regulatory proceedings in the case of errors being spotted. All of the above make the case even stronger for incorporating technology into trial design, says Margaretta Nyilas, senior vice-president of clinical and business operations at Otsuka Pharmaceutical Development & Commercialization.
An integrated data platform, she believes, has the potential to increase the quality, efficiency and precision of data collection. It also allows study teams the opportunity to gather information from multiple sites in multiple countries for real-time analysis.
Just in time
“In contrast to the previous model, which was subject to long transfer wait times, an integrated data platform can offer real-time, or near real-time, remote-based monitoring of clinical data, enabling opportunity for real-time action,” explains Nyilas.
“Data trends and inconsistencies can be quickly identified, while duplicate entries and data anomalies can be addressed instantaneously. Decision-making is much faster, and current and future errors are minimised.”
As real-time data analytics allows the close performance monitoring of sites across international locations, site visits can also be more productive, with more of a strategic focus on needs and risks – all while complying to good clinical practice.
“Enhanced data quality helps address issues around screen failure rates, and decreases enrolment and randomisation of poor-quality subjects, reducing demand on sites and patients, while elevating compliance on all levels,” says Nyilas.
As previously mentioned, the length of a clinical trial can have a significant impact on how data is collected. If it is too long, in particular, companies run the real risk of squandering time and money – only for functionless data and no end treatment.
These are not minor problems. Recent research conducted by auditing firm KPMG revealed that the average return on R&D expenditure in the pharma space was just 3.7% in 2016. Just five years earlier, it stood at 10.0% – itself by no means an impressive figure.
What that means we are left with is a tiny percentage of drugs making it through trials and on to the market. In 2016, pharmaceutical companies spent $169.3 billion on research and development, accounting for around 85% of the total R&D outlay across the global life sciences industry.
The cost to develop new drugs is now more than $2.5 billion, with an estimated lead time of ten years. However, the number of drugs that gain approved medicine status is less than 12%. It’s safe to say that the odds are not in pharma’s favour.
Shorter, faster, cheaper
As a means of shortening trials and driving down costs, Otsuka uses digital trial technology that lets data flow in near-real time, enabling Nyilas and her colleagues to conduct remote, risk-based monitoring of studies.
“Data is collected from hundreds of sites in multiple countries on a single digital platform, which the team can immediately access to analyse the study performance,” she tells says. “Visualisation of data is available in real time, or near-real time, to all study partners to ensure high quality and safety surveillance.”
Through this improvement in how data is collected, managed and analysed, activities that once took six to 12 weeks have been reduced to “just a few days”, adds Nyilas.
“Otsuka is also improving how it processes the insights trials are delivering and hopes to reduce response times to 72 hours from what currently takes eight to 15 business days,” she says.
“This can translate into significant cost savings, while shortened timelines mean we can obtain regulatory approvals and provide new drugs to patients much sooner.”
While the biopharmaceutical industry is currently looking at new ways to harness the potential of a growing digital landscape in which people, devices and data are connected, progress in this area has been sluggish compared with other consumer-based sectors. This is primarily due to the complex nature of healthcare data.
That’s not so say that no promising new technology is entering the fray. A recent study sponsored by the US Government backed the wider use of electronic data capture – through smartphones and wearables – to improve the outcomes of clinical trials.
EDC systems, claimed the paper, have improved clinical trial management by improving recruitment; statistical analysis; site monitoring timelines and costs; site management; data collection; security; accessibility; and error rates.
Increased efficiency has contributed to a 17.6% decrease in trial timelines, as well as a 9.8% decrease in trial costs. EDC also includes new innovations, such as patient engagement apps.
“For study participants, these apps provide a way enhancing engagement through targeted and interactive patient-facing content to ensure the patient understands the demands of the trial,” says Nyilas.
“The consent process is becoming much more simplified for the patient, while the ongoing development of wearable tracking devices is leveraging technology to help personalise the patient’s healthcare experience. Digital sensors, along with electronic diaries, reduce the burden on study volunteers by allowing them to provide real-time data electronically.”
Mobile devices also have the potential to revolutionise the way in which clinical trials are conducted. They offer the chance for patients to be monitored from the comfort of their own homes, while measurements can be taken at any time during the day – as opposed to being restricted to office visits. More crucially, real-time data can improve patient safety by enabling data to be reviewed more precisely, and ensuring the correct study compound is being administered to the right patient.
Data security is another nonnegotiable area. Organisations working in the biopharma space are obliged to follow guidance on ePlatforms, as issued by the US FDA.
Despite this, horror stories over digital healthcare and personal data breaches persist.
Last year, it emerged that Indianapolis-based health insurer Anthem had suffered a leak of more than 80 million records. Underground markets dealing in patient data are said to be growing.
“Otsuka’s digital trial technology is comprised of several components including sourcing, consent, scanning and surveillance; every component of the platform has been fully tested and validated, is HIPAA [Health Insurance Portability and Accountability Act of 1996] compliant and follows FDA guidelines,” says Nyilas, referring to US legislation. “Security and compliance should always be a top priority for organisations as they navigate the new digital technology landscape and evolve their business models.”
Make it personal
In terms of the evolution of data reconciliation in clinical trials, Nyilas anticipates a more personalised experience for patients. “With improving processing power and device miniaturisation, healthcare is becoming increasingly more personalised,” she says. “This is truly empowering for patients, and helps caregivers closely monitor patients and tailor therapies.”
With opportunities for connectivity, and patient monitoring set to increase, more data will be available for analysis, which Nyilas believes will “enhance the quality of data and timeliness of clinical study decision-making”.
There are caveats, however. Advances will require support from FDA, which has received criticism in the past for hindering technological progress in clinical trials.
However, things may be moving on this front. In June this year, FDA revised its guidance to incorporate recommendations to include electronic systems and electronic records in clinical trials.
In order to achieve all of this, technology will also need to keep pace with increasing amounts of data. Moreover, it will require thorough understanding of how to analyse such information.
To ensure that this happens, says Nyilas, clinical operations experts, tech innovators and healthcare IT professionals will all need to work closely together.
“There is an exciting future for the biopharmaceutical industry as technology and data management capabilities advance,” she says. “This will undoubtedly lead to faster, safer, cheaper, and more efficient therapies for patients in need.”