Telemedicine: A New Norm in Clinical Trials

Every human health crisis brings along opportunities that enhance the functioning of traditional healthcare models and systems. As the COVID-19 pandemic disrupted the life sciences and healthcare ecosystem, the usage of telemedicine surged multifold all over the world with physicians limiting physical access to patients, and hospitals canceling or doing away with elective procedures. Though telemedicine is hardly a new tool or concept, the pandemic situation resulted in its accelerated adoption. Trends suggest its continued use even in the future with accrued benefits including reduction in travel time and costs involved thereof.

Outside of healthcare providers, health systems, and patients, the adoption of telemedicine has benefited the pharmaceutical industry too that is involved in clinical trials. Regulations mandate pharmaceutical companies to report the real-world effects of medications with clinical trials before marketing them on a larger scale. According to a research report, the drug R&D spend in the USA in 2019 had seen a tenfold increase from the 1980s. This is a huge expenditure outlay considering most drugs take years for regulatory approval. During COVID-19, with lockdown restrictions and social distancing norms being strictly enforced, there was a drastic reduction in the number of clinical trials that could be conducted, impacting the execution of ongoing trials or the initiation of new ones, and ultimately resulting in delays for the rollout of critical drugs and medicines.

The rapid adoption of telemedicine

As the industry stared at this state of flux in the clinical trials space, digital transformation helped to quickly embrace telemedicine enabling a streamlined trial process and the recruitment of diverse population for studies within the safe confines of trial participants’ homes by bringing in modalities such as remote patient recruiting, remote consenting, video conference assessments, and at-home phlebotomy.

The benefits of telemedicine are numerous in that the participants’ concern for safety and convenience is automatically taken care of. Also, diversity in the recruitment of trial participants and engagement in clinical trials has vastly improved, leading to a more accurate observation and reporting of real-world effects of drugs and various therapies. In the traditional clinical trial setting, the subject or a researcher is required to commute to the site and report to the investigator resulting in the wastage of an entire day. Due to telemedicine, travel time is entirely nullified thus reducing the time and cost, and the zero-touch approach minimizes the risk of contracting any infection with the entire process being executed from the comfort of one’s home.

Sustenance of telemedicine in a post-pandemic world

While the adoption of telemedicine has been a gamechanger for clinical trial sponsors and all the stakeholders involved, its sustenance should be given high importance in the post-COVID-19 world, which is slowly falling back to its new ‘normal’ way of functioning. The most important factor for any modern technology to sustain is to make it simple, unified, patient-centric, and with an agile regulatory framework design incorporating critical elements such as privacy and cybersecurity into consideration.

Trial participants must be made comfortable with the technology irrespective of their educational or social backgrounds. The aspects of enhanced patient safety and data quality due to adoption of new modalities like electronic and multimedia consenting as well as the enablement of real-time alerts to patients and physicians should be reinforced. Various telemedicine tools that help in reporting and managing adverse events during the trial phase must be streamlined and efficiently configured for both the subjects and site investigators. Maturing these technologies in a post-COVID-19 world is of utmost importance.

Before the pandemic struck, one of the most reported causes for patients not wholeheartedly embracing telemedicine was issues around privacy and security. The need for processes to be made regulatory compliant cannot be overstressed. Industry compliance assures the user of safety and integrity of the telemedicine process. Personally identifiable and sensitive data related to phone and video visits must be kept safe and secure by following the required protocols and compliances. remote patient monitoring (RPM), patient-reported outcomes (PRO) and telehealth approaches must be added to the routine methodologies of clinical trials. Patient portals must be made unified, simple, and easy to understand by making technology an enabler rather than a complex and mystic tool. This will help create health equity among all users irrespective of their educational, social, or economic backgrounds.

The way forward

Though the scope of making these pathbreaking and disruptive changes sustainable to the healthcare system in terms of telemedicine is still at an early research stage, factors such as ease-of-use, affordability of the technology, flexibility of the regulatory guidelines, and robust technology framework have the potential to pave the way for an agile and lean model of virtual clinical trials in the future.