The medication development process is being transformed by digital technology. Wearable and mobile technologies, as well as cloud technology, Artificial Intelligence, and related platforms, have made it possible to collect frequent, particular, and multidimensional data over the course of trials.
These technologies have the potential to enable novel trial designs, improve patient experience, serve as recruitment and retention aids, and establish new end goals in clinical investigations.
Clinical trials are essential for the causal assessment of novel medical treatments, medicines, and devices' efficacy and safety. Traditional clinical trials, on the other hand, present difficulties that can stymie the efficient conduct of research in order to establish a knowledge foundation that supports goods for patient groups.
Current operational inefficiencies in the identification, recruitment, data acquisition, and follow-up of participants drive up costs, increase participant burden, and lengthen already lengthy clinical trial timelines, all of which contribute to low clinical trial participation: only about 8% of cancer patients, for example, enroll in cancer trials.
Participating in research can be costly or even difficult for persons who do not reside near a study site or who have mobility or scheduling constraints, raising gaps in access to research and reducing the diversity of trial participants.
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What defines a "Digital" clinical trial?
A digital trial is one in which technology is used to increase recruiting, retention, data collecting, and analytics.
The National Institutes of Health (NIH) and the National Science Foundation in the United States (US) are both interested in using digital technology to reduce clinical trial expenses and efforts while moving closer to a patient-centered trial experience (NSF).
In April 2019, the National Institutes of Health and the National Science Foundation held a workshop in Bethesda, Maryland, bringing together US experts in clinical trials, digital technology, and digital analytics to discuss strategies for implementing digital technologies while taking into account the challenges.
Furthermore, the National Institutes of Health has prioritized pragmatic studies, which include the use of digital technology. Leaders at the National Institutes of Health (NIH) are urging trialists to appropriately integrate digital technology and other pragmatic features that disrupt and create efficiency while preserving the strength of our randomized clinical trials system. The importance of digital technologies has also been acknowledged by Congress, which has established two laws requiring several federal activities.
There is a significant possibility now to use digital technology to speed up the rate at which clinical trials create evidence. By strengthening and complementing the role of investigators and study teams, digital technology can improve trial efficiency.
Many studies can be completed without the need for in-person visits, and participants may never meet their study teams. Trials involving major illnesses, extensive procedures such as advanced imaging and biopsies, and therapies involving high risk, on the other hand, will necessitate close monitoring and oversight by experienced doctors and investigators.
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Data compilation on digital health
Data must be collected as part of the clinical study process after participants have been recruited. Clinical and demographic data sensed physiological and activity data, patient-reported outcomes and images collected via a smartphone or tablet, electronic medical record data from a vendor API, and biological samples drawn at home or in a local lab are all examples of digital data in clinical trials.
Biomarkers and digital monitoring
Digital biomarkers are objective measures of physiologic, pathologic, anatomic, behavioral, social, or activity characteristics, as well as patient self-report, that can be obtained using digital technology and "evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to therapeutic interventions."
While many digital biomarkers are still being verified, they may eventually give detailed information about physiological processes that can be used to inform diagnostics, dose adjustment, and clinical trial outcomes.
Wearable sweat sensing for glucose, lactate, and electrolytes, cardiogenic chest wall vibrations to check the clinical status of patients with heart failure, and structural health markers for knee joint injury collected via a brace are just a few examples.
Digital technology can also be used to capture data that would otherwise be impossible to obtain. The FDA recently approved digital techniques to detect rhythm problems, such as atrial fibrillation, using sensors in the Apple Watch, such as electrodes for electrocardiography and optical sensors for photoplethysmography.
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Digital clinical trial safety monitoring
Researchers are increasingly coupling novel technologies with established biomarker assessments to confirm their safety and usefulness as digital technology becomes more integrated into standard clinical trial operations.
Using digital technologies to capture data in real-time that can be sent immediately to researchers could help researchers detect infrequent events or ones that are situation-specific and unlikely to happen during a study visit.
The speed with which adverse and safety events are recognized and reported could have a substantial impact on the timeliness with which clinical studies are completed and reported.
Nonetheless, significant concerns will continue to influence the deployment of digital tools, such as their evaluation to ensure that they fulfill requirements for dependability and validity, which can be difficult to create for detecting transitory, instantaneous, or unique phenomena.
The expectations placed on research participants, investigators, and trial sponsors must also be clarified. Attempts are being made in this direction.
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Security of data (privacy and security)
The efforts to improve norms for privacy, safety, ethics, and regulation have clearly been hampered by digital health technologies. Security methods to defend against data breaches during data collection, transfer, and/or storage are becoming more important as a result of digital technology and remote monitoring.
While identifiable patient data must be protected, some methods, such as GPS/location data, may expose trial participants to legal action and financial damage as a result of stigma. To that aim, the FDA has made cybersecurity a requirement for medical device approval.
Even as we work to improve patient access, all stakeholders must be informed about the risks and advantages of sharing individual and/or pooled patient data. Breach of confidential databases continues to be a concern, while the usage of distributed ledgers, such as blockchain, or decentralized databases, may help to lessen the danger.
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In order to establish a digital clinical trial economy in the United States, empirical study into the risks and benefits of digital trials will be required. This includes studies on privacy and security issues, as well as training practices and the potential negative consequences of employing technology.
Efforts should also be directed toward the creation of an evidence base of effective intervention components that can be used to guide the development of future interventions. Because digital technologies in the biomedical arena have a steep learning curve, implementation will necessitate more risky research than previous clinical trials.
The majority of individuals now developing these technologies are not collaborating with clinical researchers, and clinical researchers lack the expertise required to conduct digital clinical trials. To acquire the knowledge needed to fuel a viable digital clinical trial organization, leadership will need to make a significant commitment, which will be required for growth.