Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. In order to gain marketing approval from regulatory authorities for a novel therapeutic intervention, highly accurate and elaborate clinical trial data is required to validate the drug’s safety and effectiveness towards a specific target indication. Clinical research can be classified into two types: observational studies and clinical trials.
Observational Studies: Observational studies track people in daily circumstances. Researchers collect data from people and compare changes throughout time.
Clinical Trials: Clinical trials are research investigations in which people are subjected to a medicinal, surgical, or behavioral intervention. These trials are the primary means by which researchers evaluate whether a new type of therapy or prevention, such as a new medicine, diet, or medical gadget, will be effective.
There are several challenges associated with this traditional way of clinical research, including high capital investment, low patient recruitment rates and lack of robust data, faced by various pharmaceutical companies involved in the development of various therapeutic interventions. This leads to inefficiency in generating sufficient clinical evidence, resulting in massive capital losses for drug developers, as well as patients to access these life-saving therapies. In the past, clinical trial sponsors have shown reluctance to integrate technological solutions into clinical research, primarily, because several investigator sites still use old software and conventional techniques of data collection and reporting. However, in the past few years, the potential advantages associated with the use of electronic data capture handling systems have become highly evident. This entails giving rise to the adoption of big data, cloud computing and mobile health technologies by various firms across the globe. In fact, as per a recent survey by Oracle and Informa Pharma Intelligence, 76% clinical researchers had incorporated digital technologies for clinical trial during the COVID 19 pandemic. In addition, the emergence of virtual clinical trial models offered by various virtual clinical trial companies has provided pharmaceutical companies with an option to successfully conduct clinical research remotely.
Existing Constraints in Clinical research
The clinical trial studies are currently dealing with several research related challenges, such as high capital investment, growing complexities in the trial conduct, complex regulatory requirements, patient recruitment and retention-related concerns and inefficient data processing. The following figure represents the major constraints related to conduct of clinical trials in contemporary settings.
Increasing Trial Costs and Complexity: As per a research article published in Cancer Research UK (a registered charity in England and Wales), the entire process of developing a single prescription drug, from lead discovery to it receiving market approval, takes 15 or more years. The average cost for the approval of a new drug for clinical use costs more than USD 1 – 2 billion.
Decentralized clinical trials can reduce the reliance on physical sites and minimize the travel expenses as well, leading to substantial financial benefits. Therefore, companies engaged in clinical research often prefer these trials due to their cost-effectiveness compared to traditional methods.
Evolving Regulatory Standards: Over the last decade, the regulatory and ethical standards in the pharma industry have evolved significantly, to accommodate various novel therapeutic interventions that are being evaluated across different stages of development.
Further, during the COVID 19, many trials were postponed and interrupted due to lockdown, restrictions, prioritization of resources towards COVID 19 studies. This had led industry to adopt decentralized clinical trials, wherein patients could participate from home, reducing the need for on-site visits.
Patient Recruitment / Retention-related Challenges: Recruiting and retaining patients in a clinical trial is an important aspect of the drug development process. As per report by Biopharma Dive, 85% of all clinical studies fail to enroll a sufficient number of patients, and 80% are delayed due to recruiting issues.
Decentralized clinical trials offer flexibility to the patient by reducing the burdens related to travelling. This has helped in expanding the geographical reach, leading to greater diversity in the clinical data.
Inefficient Data Handling: Although several industries have incorporated advanced data management technologies in their service portfolio and reaped the benefits of increased efficiency, lower operational costs and enhanced consumer experience. However, the clinical trials domain still falls behind when it comes to embracing new data capture and management technologies, due to their inherent unpredictable complications. As per a research article published by Oracle Health Sciences Around 80% of the failed clinical trials have been recorded due to inconsistent data or missing patient data.
What are Virtual Clinical Trials?
Virtual clinical trials, also known as decentralized clinical trials or remote clinical trials, leverage digital technologies to collect real time medical data from the patients, with few visits to the investigational sites. Patients utilize software applications, monitoring devices and online social media engagement platforms to conduct the complete clinical trial process, including recruitment, patient engagement, counseling, informed consent, electronic data capture, measuring clinical endpoints and adverse reactions, as per the patients’ comfort.
Key Attributes by Virtual Clinical Trials
The following figure presents the key attributes offered by various virtual clinical trials companies.
Mobile Technologies: Mobile technologies and wearable gadgets allow trial investigators to capture patient reported outcomes with remote patient monitoring. This further offers a holistic view of patient experience, drug efficacy and safety to trial sponsors. As such technologies help reduce the need for on-site patient visits, there is a significant decrease in the overall cost associated with the conduct of trials, as well as the patient burden.
Artificial Intelligence and Predictive Analytics: Over the years, artificial intelligence has witnessed increased adoption in pharmaceutical companies, particularly within clinical research. This has optimized the traditional ways of evaluating the safety and efficacy of therapeutic interventions. Incorporating AI in decentralized clinical trials offers various advantages, including identification and validation of clinical hypotheses, minimum risk of improper study protocol design, and prompt identification and recruitment of eligible trial participants. It is important to note that the advantages are beyond this.
Real World Data Sources: Real world data (RWD) provides service providers with access to organized and structured data, which can be used to identify eligible patient populations with remote patient monitoring
. In addition, RWD can help sponsors to optimize protocol design and avoid trial delays by expediting the selection of trial investigators. In addition, virtual clinical trial companies often use novel analytical tools to extract and analyze insightful data from abundant sources; this is one of the prerequisites to perform clinical studies virtually.
Drug Logistics: Currently, a range of technologies and processes are available wherein patients can receive the required medication at their home. Several virtual clinical trial companies are offering data-driven supply chain management solutions. These virtual clinical trial companies connect investigator sites and clinical vendors with real time patient data, which enables effortless management of drug re-supply and patient inventory.
The Future of Virtual Clinical Trials
Several researchers and market analysts believe that decentralized clinical research is the future of clinical drug evaluation. Owing to which, various traditional clinical trial service providers are likely to expand their portfolio to offer decentralized clinical trial services. In fact, more than 70% of service providers are headquartered in North America offering services related to decentralized clinical trials. The utilization of cutting-edge technologies such as artificial intelligence and machine learning is on the rise. Digital patient engagement tools, such as telemedicine, remote patient monitoring, wearable devices and sensors are being incorporated with decentralized clinical trials to smoothen the clinical studies virtually. In fact, as per a survey, conducted by American Cancer Society Cancer Action Network, over 1,100 patients stated they would be more likely to participate in a study if the time and travel difficulties associated with participation were decreased.