Further into the future, clinical trials to test the efficacy of new drugs would not require the test subject physically traveling to a clinical research facility or hospital.
Mobile devices – smart phones, watches or glasses with inbuilt wearable sensors – would be enough to connect one to the clinical research study and report general information and adverse events.
These sensors would record data such as body temperature and blood glucose levels, which would be sent to the Electronic Data Capture (EDC) record.
The clinician would then visit the subject at home for drug administration and follow-up.
One could even postpone or pre-pone the visit using automated reminders in their devices but within a time frame permitted by the study protocol.
The future of pharmaceutical clinical trials looks more comfortable, efficient and promising.
This relatively new method of collecting safety and efficacy data from clinical trial subjects is called a virtual clinical trial.
Benefits of Virtual Trials
1. Traditional patient recruitment and enrollment are often the longest stages of a clinical trial with almost 80% of trials failing to meet initial targets.
Unlike site-based clinical trials, virtual trials are based from the patient’s home so those with mobility issues – elderly patients or patients who live in rural areas – are also able to participate in the trial.
Virtual trials will maximize patient availability and enrollment in the study.
2. Patient willingness to enroll increases due to the ease and comfort provided by virtual trials.
3. While virtual trials still require support staff and investments in data collection and analysis platforms, they can be significantly more cost effective as they eliminate multiple study sites.
4. Virtual trials can keep subjects engaged with the study and aware of the proceedings as they can keep track of data continuously.
5. In traditional trials, as per case studies, nearly 40% of Phase III trial subjects become disinterested and drop out of the study, mostly out of fear or uncertainty of the procedure and, at other times, due to inconvenience of travel and waiting.
Virtual clinical trials would automate data collection from the comfort of the subject’s home.
6. Virtual trials help reduce the risk in the drug discovery & development process by making the data from remote monitoring devices accessible to trial investigators in real time. Investigators could then clean up the data and suggest corrections to the process.
Virtual clinical trials make it possible for course corrections during the process, without harming any of the subjects or the process itself.
7. The virtual trial design may allow all stakeholders, including patients, investors, physicians, government agencies, and patient advocacy groups, to play an active role in the study; potentially leading to better data quality and shorter timelines.
Conclusion
These trials harness the power of apps, monitoring devices and other technologies, such as online social engagement platforms, to conduct each stage of the clinical trial– including recruitment, informed consent, patient counseling, through to measuring clinical endpoints and adverse reactions – from the comfort of the patients’ homes.
Virtual clinical trials show potential in offering a more patient-centered approach.
