How have clinical trials received a pandemic boost for product development?
The pandemic has given a strong tailwind to the clinical trials market, which is now valued at over US$67 billion, according to CB Insights. The game is to speed up product development using big data and artificial intelligence (AI), crunching time to market. Clinical trials involve a lengthy process of the regulatory approval process for drugs, devices, and digital therapies. However, the time and cost to complete them are prohibitive, and the likelihood of regulatory approval is low. This is where technology is coming into play to accelerate clinical trials and quicken drug development, besides enhancing the accuracy of the outcome of the trials.
Real-World-Data speeds up trials
The use of computers, mobile devices, and biosensors for healthcare purposes is rapidly accelerating the growth of health-related data. Real-world data (RWD) encompasses this data relating to the health status of patients as well as care delivery. RWD can come from various sources, such as Employee Health Records (EHRs), billing and claims, disease registries, patient-generated data (e.g., wearables), and data from mobile devices. It can enable better design and execution of clinical trials, as well as increase the odds of regulatory approval by supplementing clinical trial data.
Established tech giants like Google and Apple are also working to become significant players in clinical trials by leveraging their vast user networks, data sources, and AI expertise to build and launch products quickly. The pandemic has also forced pharma companies to minimize the number of in-person visits required for a clinical trial. Without a clear full-stack solution, pharmaceutical companies have their eyes set on emerging startups that can help them build more efficient and effective trials.
In December 2020, Google launched a new Android app called Google Health Studies, which streamlines study participation for consumers and provides transparency around how their data is being used for health research. Google also announced it would partner with Boston Children’s Hospital and Harvard Medical School to enroll Android users in a 100,000-person study of acute respiratory illnesses. The study utilizes survey responses and mobility data to analyze the transmission dynamics of pathogens such as Covid-19.
Startups are not the only companies working on RWD — big tech companies are leveraging their mobile devices to collect data and use it for clinical trials. Google is particularly active in the space through its subsidiary Verily Life Sciences. Verily launched Project Baseline in 2017 to fuel medical research by mapping human health through demographic, genetic, and behavioural data. By mid-2019, Novartis, Sanofi, Otsuka, and Pfizer had partnered with Verily on the project to use its tools for more efficient clinical trials. The initiative has also partnered with Stanford Medicine, the Duke University School of Medicine, and the American Heart Association.
Covid-19 spurs innovation
Clinical trials are a required path to getting transformative therapies and medical devices to market. However, getting from Phase 1 through approval can take up to a decade and can cost billions of dollars. Why now: The tailwinds of the Covid-19 pandemic are spurring innovation in the clinical trials space. Pharmaceutical companies are looking to complete clinical trials as quickly and efficiently as possible while abiding by safety protocols.
The pandemic has also forced pharma companies to minimize the number of in-person visits required for a clinical trial. Without a clear full-stack solution, pharmaceutical companies have their eyes set on emerging startups that can help them build more efficient and effective trials. The players looking for an edge: The future of clinical trials is largely being shaped by technology startups like Tempus, Medable, and Huma, which offer software platforms for trial planning and execution.
In 2020 and 2021, nearly 5,000 clinical trials were launched to test life-saving treatments and vaccines for the novel coronavirus. These Covid-19 clinical trials saw enrollment levels that were 80% higher than average. However, for many diseases, such as cancer, less than 10% of eligible patients enroll in a trial. Many patients only enroll in a drug trial when existing forms of treatments have already failed. Determining patient eligibility can be a massive challenge on its own. For those that are eligible, participation is often cost- and time-intensive. The process is inefficient for other stakeholders, too — timelines for drug trials average nearly a decade, typically costing over $1 billion.
IoT, Machine Learning solutions set new standards
To tackle these challenges, startups and big tech companies are actively developing tech solutions for clinical trials — from IoT-enabled devices for remote monitoring to machine learning for electronic health record (EHR) processing to AI-based cybersecurity for data protection. Decentralization is quickly becoming the new standard for clinical trials. Decentralized clinical trials (DCTs) are studies primarily completed through local healthcare providers or telemedicine.
Although most trials are not yet fully decentralized, solutions in this category enable clinical trials to be shifted closer to the patient. This approach results in simplified trial procedures that don’t require as many in-person visits, saving time and money for all stakeholders, including the patient. Features of DCT solutions often include electronic consent, remote patient monitoring, and electronic clinical outcome assessments (eCOAs). These allow trial sponsors to maintain links to trial participants without requiring in-person visits.
Riding the pandemic-driven transition to virtual care, a new generation of tech companies are hoping to decentralize clinical trials for vaccines, drugs, and other treatments. Moving away from medical centres in large metropolitan areas can improve access for individuals that live in more rural settings in the developed world as well as increase the diversity of the patient pool. The tailwinds of the Covid-19 pandemic are spurring innovation in the clinical trials space. Pharmaceutical companies are looking to complete clinical trials as quickly and efficiently as possible while abiding by safety protocols.
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(Abhijit Roy is a technology explainer and business journalist. He has worked with Strait Times of Singapore, Business Today, Economic Times and The Telegraph. Also worked with PwC, IBM, Wipro, Ericsson.)
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