By Edwin Ng
COVID-19 highlighted the vital importance of clinical trials for drug and vaccine development, but it has also spurred India’s pharmaceutical and healthcare companies to reevaluate how these trials are run.
When lockdowns and restricted movements made it more challenging for many participants to get to physical sites, the clinical trial industry accelerated the pace of moving some of its services from clinics to the cloud or even the patient’s couch so that important research could continue remotely.
The move toward decentralized clinical trials has many benefits including patient-centricity, which ensures greater engagement, access, and the possibility of shortening timelines for important drug and vaccine development. However, the issues of interoperability and continued patient engagement will need to be urgently addressed for it to achieve its full potential in India.
India has a thriving clinical trials industry – it accounted for an 8.3% share of the global clinical trials activity in 2020, an increase when compared with the last ten-year average of a 6.2% share. For a fast-growing sector, moving clinical trials into a home setting is the next frontier, following on from the shift of other healthcare services out of hospital and clinical settings since the start of the pandemic.
From online consultations with doctors to remote monitoring of patients’ vital signs, COVID-19 has accelerated the growth of telehealth in India. Telemedicine has also been used for the management of chronic health issues including bronchial asthma, hypertension, and diabetes mellitus, where timely intervention is critical. Before the pandemic, telehealth accounted for only 5% of India’s overall IT market. This number has since risen to 47% according to Neeraj Lal, Chief Operating Officer of Apollo Hospitals in Ahmedabad. The pandemic also saw the change of telemedicine guidelines in India in 2020, paving the way for doctors and hospitals to adopt technologies that support telehealth. An analysis performed by Fortune Business Insights projected that the telemedicine industry in India will reach USD 396.76 billion in 2027, a growth from USD 79.79 billion in 2020.
For clinical trials, the opportunity centers around using apps, sensors and wearable technologies outside traditional clinical trial locations to track important health indicators – respiratory rate, sleeping patterns, blood pressure and heart rate, for example – that were previously measured at specific points in time during onsite visits and check-ins.
Moving away from traditional patient monitoring methods that were dependent on in-person appointments for data collection, it is now possible to continuously collect data and monitor patients through passive devices working in the background 24/7.
The development of eConsent systems and patient portals – whereby patients can access all information relating to the trial in one place and consent via an eSignature – also makes the enrollment process much easier, without patients having to leave the comfort of their sofas. eConsent also creates a unified experience for sites, CROs and sponsors to understand the consenting process and gain insights on patient enrollment.
A major paradigm shift
For an industry that has relied on patients being monitored at fixed sites for decades, moving clinical trials into a home setting is a major breakthrough with huge potential benefits. Commuting to trial sites can be a burden on patients, including lost days from work, travel costs and time, so removing the barriers to taking part is a major boon for an industry that regularly cites patient recruitment and retention as its biggest obstacle.
Collecting and analyzing patient data in real-time also allows for early detection of both trends and issues, so that important adjustments can be made while trials are ongoing.
The decentralization of clinical trials also promises to free staff from cumbersome administrative tasks so they can focus more attention on value-add roles, and continuous monitoring will provide a much richer data set. With the help of technology, staff can now rely on mobile applications and devices to receive valuable data and patient records crucial for clinical trials. According to a study conducted by Deloitte, India is expected to have about 1 billion smartphone users by 2026. India’s inauguration of its first 5G testbed in 2022 has been identified as a contributing factor for an increase in smartphone adoption. Ongoing digital healthcare initiatives that have been rolled out by the government under the Digital India flagship initiative including telehealth make India an ideal hub for innovations in the digital health sphere.
However, some issues to a wider adoption of remote clinical trials remain.
Putting the patient first
Patient willingness to take part in trials from home will be the main deciding factor in how quickly and successfully this new model can be adopted in India.
Allowing patients to use their own smartphones and devices, rather than having to incorporate separate, provisioned devices into their daily routine, is one way to get patients on board. By using their own devices, patients are able to stay in the loop with the clinical trial process and the personal touch keeps them connected. However, the challenge is to ensure patients are able to stay engaged throughout the trial when they are not able to visit a brick-and-mortar site due to various limitations9. This can be addressed by continuing to tailor the experience for each patient to best meet their individual needs.
In traditional clinical trials, face to face communication is a key aspect in keeping patients engaged throughout the process. Decentralized clinical trials need to find the right balance between remaining convenient for the patient while ensuring that the patient is involved in a personalised experience from start to end. The convenience of using a unified platform and employing the use of personal devices will keep patients motivated and increase patient retention rates for trials.
Interoperability is the other major challenge. For remote clinical trials to be effective, all of the different devices and systems in the patients’ homes and the lab need to connect seamlessly. This includes the patients’ own smartphones and devices.
COVID-19 pushed the industry to rethink its approach to clinical trials. Enhanced patient centricity, engagement, and access, along with a shorter lab-to-patient timeline are significant advances that should be built upon. Ten years from now, clinical trials might not measuring potential biomarkers continuously rather than at discrete points in time, whenever they can. India, which already has one of the fastest-growing clinical trial sectors in the world, has the potential to lead in this field, provided government and industry work together to put patients first.
(The author is a Senior Vice President, Asia Pacific, for Medidata, a Dassault Systèmes company. Views expressed are personal and do not reflect the official position or policy of the FinancialExpress.com.)