Recent scientific advances and the introduction of sophisticated clinical research platforms have enabled medical researchers and healthcare practitioners to cater to the evolving challenges within the pharmaceutical industry and deliver improved quality of care to patients.
Healthcare systems are now recognising the need to fully understand exogenous factors (such as genomics, behaviour, and social and environmental factors) affecting disease progression, as well as response to the treatment. Further, the industry is witnessing a drastic change in its functioning, post the advent of big data, the introduction of wearable devices, and increased use of telemedicine and eHealth solutions.
As per the estimates, the number of connected wearable devices is expected to exceed a billion by 2022, with the world’s data volume doubling in less than three years. This surge in data availability is known to potentially revolutionise clinical research across various application areas.
Clinical trials are crucial for assessing the efficacy of novel therapeutic products. However, these studies are prone to significant delays due to various constraints, such as insufficient patient recruitment, inefficient study protocols and low patient retention.
Even though clinical research is a highly expensive process, such delays increase the expenditure of drug developers to meet the primary and secondary endpoints. It has been observed that researchers are proactive in implementing advanced technological solutions to generate valuable insights from the enormous amount of unstructured clinical data.
Additionally, trial sponsors are incorporating operational data, financial data and real-world evidence to benefit the most from their R&D investments. Virtual clinical trials, also known as decentralised clinical trials, are believed to significantly reduce the time and capital invested in clinical research by using certain advanced technologies, such as remote monitoring devices and sophisticated custom-made applications.
Virtual clinical trials in healthcare
Virtual clinical trials present a novel approach to collecting safety and efficacy data from clinical trial participants, starting from study start-up through execution to follow-up. In such designs, the participants need not travel to a clinical research site, facility, or a doctor’s clinic. Such trials make use of software applications, monitoring devices and online social engagement platforms to conduct the complete clinical trial process, including recruitment, patient counselling, informed consent, measuring clinical endpoints and adverse reactions, as per the patients’ comfort. Although virtual trials still require the study site to accommodate support staff and invest resources in data gathering and analysis, these are significantly more cost-effective as they do not require traditional brick-and-mortar set-up of multiple investigation sites.
In addition, these trials enable elderly individuals or patients living in far-off areas to actively participate, thus enabling the involvement of a highly diverse population. Such an arrangement offers opportunities for a more patient-centric approach, as patients can participate in the trial at their convenience and without worrying about the need to travel to study sites. Virtual trials also enable researchers to capture and access data through remote monitoring devices in real time, thereby, improving the trial designs based on accumulated data.
In 2011, Pfizer pioneered the first-ever virtual research on electronic monitoring of overactive bladder treatment experience (REMOTE) trial. It was the first randomised clinical trial that used web-based patient recruitment and collection of study data without requiring patients to visit the actual study site.
Virtual clinical trials have experienced rapid investment growth in the past years, with investments of over US$1 billion in 2019 for applying modern technological solutions to clinical research. Further, the existing constraints in clinical drug development have prompted trial sponsors to incorporate various innovative technological solutions to improve the ongoing processes.
Opportunities associated with virtual clinical trials management
- Virtual models for trial conduct are known to offer numerous advantages over traditional models; some of these have been highlighted below:
- Innovative technological solutions enable trial sponsors to achieve maximum patient enrolment and minimise patient attrition rates.
- Virtual studies provide sponsors with access to a larger and more diverse patient pool, which minimises trial delays and prevents innovator companies from incurring significant losses.
- Such studies leverage advanced monitoring and data collection solutions that allow remote participation of patients in clinical studies, further enhancing patient engagement.
- Virtual clinical studies require significantly lower capital investments, by eliminating the need for multiple study sites.
- These trials hold the potential to minimise the risk of drug failure by allowing investigators to study the data generated from monitoring devices on a real-time basis.
- This approach has the potential to reduce enrollment challenges associated with studies related to rare diseases.
By eliminating challenges such as distance and discomfort, and thereby, assisting patients from rural areas and those from an unfavourable socio-economic background, there is a direct positive impact on patient comfort and understanding, which is likely to drive retention and compliance.
Future perspectives
Clinical drug development is associated with several challenges, such as inadequate patient recruitment, poor patient engagement and monitoring, and improper study design and site selection, which leads to significant delays and capital loss. Clinical trial software solutions offer a novel approach to address these inherent challenges. Since virtual/decentralised clinical trials are more patient-centric, this approach not only reduces the clinical drug development timelines but also addresses the challenge of high capital investments required in the development of pharmaceutical products.
Science 37, one of the clinical research service providers, claims to have achieved 97 per cent patient retention in their virtual trials and expedited the process. Virtual clinical studies augment traditional study practices and workflows by leveraging remote monitoring workflows and sophisticated data analysis software. Decentralisation of trials is also effective in improving patient enrolment, retention and satisfaction while preserving the data quality.
The outbreak of COVID-19 further led to increased adoption of virtual clinical trial platforms, thereby, prompting stakeholders to develop novel clinical trial methods that can easily engage patients, sites and sponsors. Moreover, regulatory authorities have issued several guidelines for conducting studies virtually amidst the ongoing pandemic. Driven by the increasing preference for virtual clinical trials and ongoing technical advancement in this field, the clinical trial software market is anticipated to grow at a commendable pace in the foreseen future.
Sanyukta Katkar is the SEO Specialist at Roots Analysis, a global leader in pharma and biotech market research.
This article appears in Omnia Health magazine. Read the full issue online today.
