Virtual clinical trials (VCTs), also known as decentralized clinical trials or remote clinical trials, are conducted remotely by taking advantage of technologies and tools such as telemedicine, electronic consent forms, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM), apps, wearables, digital biomarker collection, and online engagement platforms.
Clinical development in drug development is a complex and lengthy process. It costs about USD 2.5 Billion to develop a drug from R&D to market approval. Most treatments fail in the early stage of development and over two-thirds in the clinical phase.
The common issues seen by the researchers in conventional trial methods are low patient recruitment, patient retention, and high costs.
Virtual trials help reduce patient burdens, increase patient comfort, and improve patient recruitment and retention rates. Virtual trials are innovative solutions for traditional methodologies by enhancing the patient experience through digital technologies.
The virtual trials theme was underutilized for many years in the clinical trial industry, but after the impact of COVID-19, things have changed remarkably. There was a significant disruption in the ongoing trials during COVID-19. It was primarily due to lockdowns and social distancing measures during the pandemic.
Some of these disruptions in ongoing trials include
- Delays in trial initiation,
- Suspension of enrollment,
- Termination of ongoing trials.
This immense impact has led to the acceleration of digital innovation and the move toward virtual trials. Many CROs are now providing full-range virtual trial services. Older reports show that 80% of clinical trials face patient recruitment issues, and 20% face dropouts. But now, these numbers are changing with modern trial methods utilizing data collection, tracking devices, use of patient recruitment & management platforms, and involvement of patients in protocol development.
Top advantages of virtual clinical trials over conventional trials
- Virtual clinical trials widen the pool of participants, improve patient retention, and offer a patient-centric experience.
- It improves patient education activity, safety monitoring, and data verifications.
- Cost efficiency is remarkable with virtual trials. The overall clinical trial cost reduces due to low site setup and patient reimbursement costs.
- It improves overall early market access, reduces clinical trial lifecycle by faster trial initiations, faster recruitments, lower patient dropouts, and improves data quality for regulatory acceptance.
Patient recruitment in virtual clinical trials
The critical task in clinical trials is patient recruitment. The requirement to travel to trial sites, time, and financial burden on research participants are some challenges that affect patient recruitment. Narrow patient eligibility criteria also impact patient recruitment for sponsors.
Virtual Clinical Trials overcome patient recruitment challenges from conventional clinical trials. In conventional clinical trials, sites recruit patients through hospital visits, newspaper/radio/television, etc. However, here the reach is limited and not so cost-effective. VCTs use traditional recruitment methods along with digital platforms. These digital platforms have more reach than traditional methods and are cost-effective. It also helps to recruit a diverse group of study participants.
Remote patient monitoring in clinical trials
Patient monitoring is the most crucial factor in clinical trials. The success of a clinical trial and data quality depends on patient monitoring. Conventional patient monitoring utilizes on-site and face-to-face tracking of patients. But virtual clinical trials use tracking devices that track patient health and send data to the centralized monitoring center, virtual interaction modules to connect with patients, treatments results, and take feedback from patients.
- Using this technology reduces the frequency of patient visits to clinical sites and improves patient retention rates.
- It provides a platform where patients can directly register their responses. This prompt response from patients reduces data loss.
- The level and quality of data increase drastically from prompt reporting.
- Tracking devices provide minute-to-minute health data that adds great value to data quality. All the data is stored in cloud-based secured platforms.
Rare disease, Oncology and virtual trials
One of the biggest challenges in rare disease and oncology trials is patient recruitment and retention. As the disease is rare, there are very few patients scattered geographically. Factors like traveling long distances would be uncomfortable for patients. Even it puts an extra financial burden on the sponsors in providing allowances and reimbursements. Patient recruitment in rare diseases takes a few months to years. This pullback the researchers and also causes financial burdens for sponsors.
There is a need for a new approach that reduces patient recruitment timelines and dropouts. Virtual trials are one such approach and use various digital platforms for recruitment. Digital platforms and social platforms increase the exposure to a pool of patients.
Education through digital platforms and communication through apps would help retain patients. These platforms also help patients provide a response and feedback and take advice from site personnel from a patient perspective. It improves communication and helps to retain patients.
Patient site visits are very few in virtual trials and benefit both the sponsor and the participants. It removes geographical barriers and allows patients to participate irrespective of their location.
Regulators like FDA and EMA always welcome innovation in conducting clinical trials. The overall result of any clinical trial is to answer the research question in the best possible way. Here virtual clinical trials present the best and most cost-effective approach to clinical trials. During the COVID pandemic, US-FDA released guidance on virtual sites visit to support the clinical trial industry and manage clinical trials during COVID.
Real-world data from virtual trials
The data from tracking devices in virtual trials provide real-world data. This real-world data helps to accelerate the development process, enhance trial designs, improve patient eligibility criteria, and present deeper patient insights.
Future of clinical trials
Virtual trials were in the early phase of development a few years back before the COVID pandemic. Very few CROs adopted virtual clinical trials. But now, most drug developers prefer virtual clinical trials after the lesson from the COVID pandemic, where patients were unable to visit sites due to lockdown and social distancing. Here, virtual trials came into the picture, and it became necessary for many clinical trials which had already begun.
The actual benefit of virtual trials occurs in later phases of clinical trials like Phase II, Phase III, and Phase IV. It eliminates errors during manual entry, speeds up the clinical trial phase, and makes data analysis for submission easy.
The future of virtual trials is a little more different by utilizing artificial intelligence technology, machine learning, and virtual patient interactions.
What are the resources you need to implement a virtual trial?
- patient recruitment,
- in-home health visits,
- eCOA collection,
- remote monitoring
- device integration,
- data collection and
- DTP drug supply, & many more.https://credevo.com/articles/2021/12/05/electronic-informed-consent-eicf-in-your-clinical-trial/
VCTs are showing promising results which are not only feasible but are also successful. VCTs are showing higher recruitments than convection trials improving cost-efficiency.
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