Four digital trends in global clinical trials
Digital health encompasses a few technologies: mobile health (mHealth), health information technology (HIT), wearable devices, telehealth, telemedicine and personalised medicine, for example. But only recently have we seen healthcare providers move from experimenting with these solutions to fully deploying them. This is paving the way for early adoption across developed and developing nations, ensuring that a patient’s data and services are kept consistent.
While the paperless trial era is not yet in full swing, it won’t be long before paper processes for data capture, labelling, global clinical trial recruiting, regulatory compliance, translation and internal centralisation are phased out. In the meantime, what tools can the industry expect to take advantage of?
1) Social media
Clinical trials are by no means excluded from social media, a modern staple for daily life. In fact, social media is used by trial sponsors and CROs across a variety of applications, from setting up recruitment websites to educating trial participants.
The importance of social media as a platform for educational content, especially to the millennial generation, can’t be overlooked. According to PwC, 40 percent of consumers say social media content affects the way they manage their health, and 90 percent of 18 to 24-year-olds would trust medical information shared by their peers.
Most popular for gaming, mobile apps are in fact becoming integral to the clinical trial process. As compatible mobile devices (including tablets and smartphones) face wider adoption worldwide, so do health information apps. Technology companies have even begun to develop apps for electronic labelling of investigational medicines, using QR codes that can be scanned to convey instructions for use.
Widespread adoption of mobile devices is also helping to collect patient-reported outcomes (PROs), an increasingly important endpoint in clinical trial design, and opening new channels of communication between doctors and patients. Instead of making an appointment to see their GP, patients in remote locations can use their smartphones to initiate e-consultations — a service which the NHS recently launched in the UK. Pharma and biotech companies, too, can use specialised apps to administer patient questionnaires and remind patients about scheduled trial site visits.
3) Wearable devices
Worldwide adoption of wearable devices is expected to jump from 325 million in 2016 to about 830 million in 2020 thanks to an increasingly ‘always-on’ environment. The popularity of Fitbits and other wearables has exploded, helping patients monitor their blood pressure, glucose levels and other risk factors whilst also facilitating medical access to information about symptoms, disease patterns and adverse events.
Wearables not only benefit the user but may have enormous cost-saving potential. If they motivate users to take control of their health, they can help curb unhealthy lifestyles that lead to chronic conditions. An even more exciting development is wearable tech’s ability to detect serious medical conditions.
4) Companion diagnostic devices
Much like the paperless era, the personalised medicine revolution has yet to fully take hold. However, the pharmaceutical industry and research committees are clearly moving in that direction — and advanced analytics may play a key role.
Technology companies are developing in-vitro companion diagnostic devices that pharma companies can use to target specific diseases based on patients’ personalised genomic profiles. Diagnostic tests can help healthcare providers weigh a product’s benefits and risks, and may also be helpful for data-gathering purposes. As a result they may encourage drug companies and regulatory bodies to share data.
The Compliance Factor
We can’t know for sure which new technologies will be accepted as the norm for global clinical trial recruiting and management, especially those in early development or yet to be invented. But these advances are expected to make clinical trials more efficient and possibly shorten drug development timelines, reducing the wait time for lifesaving drugs to reach the hands of those in most need.
Of course, the collection, use and exchange of personal data raise significant concerns about data storage, security and privacy. If they have not already done so, life sciences companies handling sensitive personal information will need to safeguard patient data and ensure global clinical trial compliance with privacy laws of relevant markets.
The debate, now and in the near future, is how compliance will affect the adoption of new technologies — and whether pharma companies are prepared to overcome regulatory pitfalls quickly to adopt innovations before their competitors do.
Peter Quigley is director of global regulatory solutions, life sciences, at Lionbridge.