All industries, including health care and drug development, are being disrupted by new technologies. Technological innovations can improve efficiency and productivity by utilizing novel outcomes, increasing patient engagement, reducing patient burden, and improving trial management. Indeed, technology can help the field fulfill its ethical obligation to conduct efficient next-generation clinical trials.
Technology evolves in an increasingly complex landscape that begins with study approval and planning and extends to long-term sample storage, from e-health records (EHR) to direct data capture. Understanding best practices for technology integration can help clinical trial partners such as sponsors and suppliers create reliable, patient-centric, and compliant trials that bring necessary treatments to markets faster.
The drug development process is being transformed by digital technology. With the rise of wearable and mobile technologies, cloud technology, AI, and related platforms, it is now possible to collect frequent, specific, and multidimensional data throughout trials. These technologies have the potential to enable novel trial designs, improve patient experience, act as recruitment and retention tools, and establish previously unknown endpoints in clinical studies. As a result, large amounts of data are collected using these technologies. In the digital era, key issues to address include evaluating fit-for-purpose, standardization, ethical concerns, and regulatory approaches.
As the shift to home working proliferated during the pandemic, work became decentralized, and many businesses were able to function with a workforce at home. Teams and Zoom became the backbones of communication, and businesses embraced new ways of working. To improve diversity, reduce bias, and reinforce inclusion, the same principles are increasingly being applied to clinical trials. Virtual and decentralized clinical trials, in which tests are performed outside of traditional study sites, have the potential to reach more participants in rural communities or those who are unable or unwilling to visit a traditional study site, such as a general hospital, on a regular basis. While virtual trials have their access barriers, the theoretical benefits are clear.
Because of the various organizational and clinical trial implications, technology adoption in the R&D market is growing at around 22 to 23 percent. In addition, technology adoption has proven to be time- and cost-efficient for sponsors. North America currently accounts for approximately 40% of the R&D technology market. However, it is expected to grow significantly over the next five years. Europe is the next most significant contributor, accounting for approximately 25% of technology adoption, owing to solid infrastructure and widespread use of mobile devices and EHRs. Finally, although APAC’s contribution is currently low, it is expected to rise over time due to an increase in clinical trials in that region, particularly in China, India, Japan, and the Philippines.
Over the last decade, in and outpatient hospital data collection has been nearly wholly transformed from paper-based medical records to EHRs, which are real-time digital records containing patient diagnoses, treatments, laboratory tests, administered drugs, and clinical encounters. EHR-based clinical data can facilitate significant components of trials such as trial planning and design, site start-up, study execution, data collection, trial representativeness determination, and clinical event follow-up. EHRs have the potential to revolutionize many aspects of trial operations. Still, to realize their full potential, multi-stakeholder collaborations must work to overcome significant barriers, such as sub-optimal accuracy and completeness of EHR data, privacy concerns, and platform interoperability issues.
Participants’ health markers, such as physical activity, sleep, heart rate, medication adherence, and respiration patterns/rate, can already be measured in a user-friendly manner using digital health technologies. However, these technologies were not created for research purposes but are part of the burgeoning health and wellness industry. As a result, many will require additional testing and validation before they are ready for use in clinical research. For example, while some may lack the precision of standard medical devices, the longitudinal data may yield valuable information compared to validated measures.
When asked about adoption challenges, 9% of those polled in a recent survey mentioned a lack of regulatory clarity. There is a need for more specific and granular guidance on specific technology adoption and use, particularly in support of patient data privacy and safety. Collaboration with regulators and other peer organizations, as well as sharing concerns and roadblocks, can help to accelerate the adoption of digital tools.
Digital health technologies have hampered improving privacy, safety, ethics, and regulatory norms. As a result of digital technology and remote monitoring, security methods to defend against data breaches during data collection, transfer, and storage are becoming more critical. While identifiable patient data must be safeguarded, some methods, such as GPS/location data, may expose trial participants to legal action and financial harm due to stigma. Therefore, the FDA has made cybersecurity mandatory for medical device approval to achieve this goal.
Cloud-enabled technology will continue to play an essential role in ensuring solid data management and compliance while increasing efficiency and lowering costs in the future. Cloud-enabled technology will benefit hybrid virtual trials in particular, allowing patients to participate in tests at home or in a traditional medical setting, just as cloud infrastructure supports hybrid working in general business.
In addition, Blockchain technology employs a peer-to-peer, decentralized computer network to store encrypted timestamped records and documents in databases. This technology is still being researched in the health sciences to address the issue of common threats to the security and integrity of clinical trials and patient data. This technology can also aid in the prevention of data manipulation.
The unprecedented global scenario brought about by COVID-19 has quickly heightened the importance of decentralized clinical trials (DCTs) in medical research. Surprisingly, public health concerns and travel restrictions aided contract research organizations (CROs) in developing novel and transformative clinical study designs. As a result, CROs are constantly looking for ways to reduce study time and accelerate data-driven insights through secure means.