Medicinal drugs act as the central line of the healthcare system to treat diseases and allow patients to live a quality life. With the rising number of diseases and rare medical conditions, the pharmaceutical sector is eagerly working on bringing advanced technology to meet the requirements of drugs into the healthcare sector. Drug designing is a lengthy and complex process that involves identification, screening, optimization, testing, and efficacy tests during clinical trials. The process of drug designing involves a lot of patient information and animal models to study the effect of designed medicine during clinical trials.
The traditional process of drug discovery is time-consuming, costly, and prone to errors. Driven by all these factors, many pharmaceutical companies have shifted to virtual clinical trials that allow researchers to do trials virtually with the help of biosensor-based devices. Technologies such as digital twin, artificial intelligence, and wearable devices help to collect data in real-time, which shortens the drug optimization and screening process, thereby allowing companies to develop drugs faster than ever before. Virtual clinical trials bring a new revolution in the drug development process, resulting in the growth of the market.
What is the Significance of Clinical Trial Data?
Clinical trials refer to the set of experiments designed meticulously for the evaluation of the efficacy of drugs, interventions, and therapies. It may involve physical volunteers to understand the effect of medicines at the clinical trial stages. The information collected from these trials provides valuable insight to develop drugs precisely. Each pharmaceutical company has to follow the protocol of clinical trials that explains the purpose of the drug, the procedure of drug development, its effectiveness, and how the drug works to treat a patient and determine the side effects such as toxicity, and immune response. The research committees have approved the protocol for safety, regulatory ethics, and patient protection.
Challenges Associated With Clinical Trial Data Analysis and Tracking
The data evaluation process in clinical trials is challenging but crucial to provide positive outcomes of drugs to treat diseases. While the significance of clinical trials is immense, the traditional data analysis and tracking process comes with challenges.
▪ Managing Records Manually is Difficult.
The clinical trial experiments generate an enormous amount of data, including laboratory results, patient records, as well as positive and negative results. It requires a lot of paperwork, and the calculation of data becomes daunting.
▪ Errors and Inconsistent Data Quality
Data accuracy and credibility are of utmost importance in clinical research. Traditional data compilation leads to errors, which may affect the conclusion of drug development.
▪ Security of Data
The information of the clinical trials, especially those associated with patients, should be secure and non-negotiable. Paper records can be stolen, lost, and prone to damage if not handled carefully. Data security should be a top priority during clinical trials.
▪ Data Integration is Complex
Clinical trial processes may involve multiple stakeholders who contribute their data associated with research on drug development. Compilation and integration of disparate data is time-consuming and may lead to errors when done manually.
Virtual Clinical Trials: A Revolutionary Approach to Address Challenges
A virtual clinical trial is a transformative approach that involves tech-driven devices and machine learning to collect data, streamline the process, screen record, and provide results in real-time. During COVID-19, healthcare experts require vaccines and drugs to combat the virus infection. Drug development with a traditional approach may take ages and chances of failure. The paradigm shift to digital technologies and tools helps researchers fill the gap between research, production, and commercialization of drugs.
A virtual clinical trial involves technology volunteers such as digital twins instead of physical ones, facilitate trials easily, and allow instant data tracking and analysis. In contrast, the virtual clinical trial involves remote patient monitoring using digital devices that bridge the gap between the physical evaluation of data and the optimization of drug manufacturing processes.
▪ Virtual clinical trials help reduce the cost of the experiments. The technological models provide data with the highest accuracy level within real-time, reducing the chances of failure at the final stage and saving a lot of costs invested at the initial stage of the trial.
▪ Virtual clinical trials involve cloud computing, which allows secured data compilation and saving for later use. Furthermore, data from the cloud is easy to access and gives a real-time picture of the progress of drug design.
▪ The adaptation of the virtual clinical trial model reduces labor work and allows safe monitoring of data.
▪ Virtual clinical trials reduces requirement of human volunteers and multiple clinical visit as it allow real time data analysis━ reduces time and cost researchers do on human volunteers.
The Technology behind Virtual Clinical Trial Success
Medical researchers and pharmaceutical players have started leveraging technology to set the stage for virtual clinical trials. The widespread adoption of digital technologies in research and drug development helps to enhance the virtual clinical trial market. It is expected to increase at a steady speed in the future. The technology that has been integrated into the virtual clinical trial system includes:
▪ Artificial Intelligence: The use of AI-driven technology helps in the efficient processing of data evaluation, predicting results, and tailoring drug development strategy faster to meet demand. The systems where artificial intelligence has been adopted in pharmaceutical sectors involve patient screening, clinical trials, processing, and manufacturing. For example, Pfizer, the leading drug developer, is using artificial intelligence and has adopted digitized tools in their drug development process for predictive analysis of data.
▪ Digital Twin Technology: The digital twin is a virtual model of the human body and their parts for drug testing. It helps to record data such as the effectiveness of the drug and examine hypothetical drugs within real-time, saving time for testing and optimization of drugs. For example, GlaxoSmithKline, the leading pharmaceutical company is leveraging digital twin technology in R & D departments to enhance their production capabilities
▪ ePro (Electronic patient-reported Outcomes): ePRO tools enable researchers to capture data about drug trials on patients and record health status after drug administration. The model has been used in virtual clinical trials as it offers accurate data collection and real-time analysis, saving a lot of time during clinical trials.
▪ Blockchain Technology: The implementation of blockchain technology in clinical trials provides security of data. Blockchain technology also allows secured data sharing, which further helps to build trust between stakeholders—the real-time example of a Blockchain-based system in MediLedger®(Source).
▪ Biosensors and Wearable Devices: Virtual clinical trial becomes possible with the integration of biosensors and wearable devices. These sensor-based devices help to continuous monitoring of health parameters such as sleep patterns and heart rate in real time, allowing researchers to gain better insight into patients during clinical trials.
What is the Future of Virtual Clinical Trials?
The horizon of virtual clinical trials is expanding, as it has great potential to reduce the time of drug development with clear data insight in real time. Advances in technology allow virtual clinical trial companies to provide more innovative solutions to facilitate the research sector. With the facts above and the benefits of involving VCTs in drug development, it is evident that the global virtual clinical trial market will grow at a CAGR of 13% in the upcoming years, according to Roots Analysis
Moreover, in May 2023, the USFDA also published a detailed draft guidance on decentralized clinical trials that covers information on the use of digital health technologies for VCTs. In the meantime, several trends that have to be implemented by virtual clinical trial companies include.
▪ Digital health technology solutions, such as wearable devices, will be incorporated into virtual clinical trials to collect patient-generated data.
▪ Machine learning and artificial intelligence will play a significant role in research and drug discovery.
▪ Electronic health record devices will be added to virtual clinical trials for real-time data analysis.
Virtual Clinical Trial- The Future of Clinical Trial
Virtual clinical trials are just the beginning of an era of incorporating technology into drug development. The continuous advancement and innovative solutions accelerate the research and development of drugs more precisely and potentially help in designing therapies. In addition, the FDA also stated digital technologies bring new opportunities to centralize the clinical trial.
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