Making Virtual Clinical Trials a Reality

A recent study by revealed that the global market size for virtual clinical trials is expected to reach US$10 billion by 2026, with a compounded annual growth rate (CAGR) of 6.5 percent forecast for 2020-2026. While virtual clinical trials have yet to be adapted by pharmaceutical companies to realise their full global potential, Medidata, a Dassault Systèmes company, has forayed into this space with much aplomb.

Medidata’s offering, myMedidata, recently received the prestigious International Innovation Award (IIA) 2020 for “myMedidata – the Industry’s First Patient Portal Platform”. Medidata aims to be the facilitator for fully virtual clinical trials worldwide. Their investments and efforts are likely to pay off as the global healthcare IT market has been forecast by Meticulous Research to grow at 13.8 percent from 2019 to reach US$511.06 billion by 2027.

BizQ speaks to Mr Edwin Ng, Senior Vice President, General Manager Sales for APeJ at Medidata on how the healthcare market is progressing toward digitalisation.

Edwin Ng, Senior Vice President, General Manager Sales for APeJ, Medidata

How has digitalisation transformed the healthcare sector, specifically for the clinical trial process?

Unlike traditional clinical trials, which used to be conducted face-to-face, digitalisation has now made it virtually possible to conduct such trials. For example, a doctor can now diagnose and track a patient’s conditions without an actual face-to-face consultation. Data is digitally recorded through devices such as an iPads, wearable sensors, and other gadgets, and this approach has led to faster treatments and reduced costs. It has transformed the patient’s entire experience by limiting travel to hospitals, lowering their burden, and enabling doctors to be more scalable.

Digitalisation also helps make patients feel like an integral part of the clinical trial process. A patient has to enroll for the trial to gain a much better understanding of the process before undergoing it. This process can now be easily explained graphically on simple handheld devices, and patients can access this information at the convenience of their own homes. This promotes an interactive process which brings about more timely and faster treatments.

How will this benefit the community, from healthcare facilities and workers to patients and the wider public?

The health and safety of patients is of utmost importance to conduct an effective trial. Every patient could be different and the type of trial that they undergo would be based on precise information. For example, cancer patients, to the general population, will be grouped under oncology trials. However, we need to be mindful that the treatment for cancer patients differs based on the type of cancer. Hence, digitalising the process of data collection and the effective use of that data enable us to adapt to trials faster, safer, and more accurately. There is also better engagement with patients through this process, which encourages them to enroll and participate in the virtual trials.

Even before the onset of the COVID-19 pandemic, Medidata has started selective virtual trials. We facilitated the biggest virtual cardiovascular trial in the US from July 2016 to June 2019, known as the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) Aspirin study through our RAVE virtual trial tools. Approximately 15,000 patients enrolled for the trial, and these patients provided input at each stage of the trial through digital devices – from the consent and day to day activities to completion of the study. The entire process was efficient, interactive, and helped to improve compliance. The single source of data is also more reliable.

Given that certain vaccines for COVID-19 have been authorised for use in some countries, including Singapore, how will such end-to-end solutions play a critical role?

The COVID-19 pandemic caused disruptions in clinical trial processes, with many trials terminated or interrupted due to restrictions on site visits and face to face meetings as countries lockdown. A virtual trial, however, is much safer for both the staff conducting the trial and the participants.

With a massive population required for the COVID-19 vaccine study and the logistics required, it would not be possible to have all the patients at one location. The challenge is how to collect accurate data and ensure that the whole process is not disrupted by any lockdown.

Virtual clinical trials have accelerated the formulation of COVID-19 vaccines. Traditional vaccine studies used to take as long as a decade, but now the efficacy can be realised in a relatively short time. The unprecedented pandemic has reinforced the fact that a virtual trial may be necessary during any uncertain times.

Could you share more about the reach of myMedidata?

myMedidata is an extension of our existing RAVE solution. We have the industry’s largest structured, standardised clinical data repository of more than 6.4 million patients. We also have over 22,000 clinical trials, including 6,000 current active trials, on the Medidata platform.

myMedidata is the industry’s first patient portal providing a holistic solution, from patient recruitment to virtual participation with remote patient data capture and live video visits, along with the return of patient data to the participant. We have always pushed the boundaries of technology and myMedidata is a new technological breakthrough for us.

What are the immediate plans for Medidata?

We are planning to extend the reach of our platform beyond clinical trials to research and development, commercialization, and manufacturing. We look forward to having a wider patient population from more countries in virtual trials as the real-world data collected in the process will become valuable in the supporting the quality and success rates of future trials.