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Creating My Own "Brand" Through Clinical Research

24 Apr 2021

I am sure most of you would agree with me that in today's competitive world, it is not easy to make an informed choice on what would be an exciting career path ahead. I wanted to create my own "brand" in life and work toward a long-term legacy but did not want to walk on the oft-traveled paths charted by other dreamers (fellow Pisceans) like me.

The choices in life are never easy and one cannot simply go with the flow. I was deeply interested in medicine during my formative years, which is why I chose clinical research as my primary area of focus. Clearing the CSIR UGC NET examination during my MSc days helped fuel my aspirations for a doctoral degree, which I followed up with another one in management so that I may adapt to overcoming adversities through prudence and resilience.

Working with big pharma on both sides of the value chain and understanding the intricacies of clinical development by taking up diverse roles and responsibilities through my career sojourn, I took up this role at Indegene with a growth trajectory in mind where unleashing the power of digital transformation can be put effectively into practice by creating a roadmap for digital clinical research organizations.

Unique opportunities like this come knocking once in a while where technology enablers disrupt the status quo on the traditional way global clinical trials have been managed over the years, leveraging clinical, patient, and site-centric approaches. Indegene is a high-impact player, deploying AI-enabled solutions to reduce product life cycle time, enhance quality, and deliver high-value solutions for pharma and biotech clients.

COVID-19 changed the clinical trial landscape overnight and enabled clinical trials to be upscaled to greater efficiency levels, and local regional trials were either being converted to decentralized/virtual trials overnight or modifying trial protocols to allow technologies to facilitate the enrollment and patient care workflow.

Most trials faced challenges in not getting the "right" patients; there were high dropout rates because of withdrawal of consent, patients who were lost to follow-up, or patients who lost motivation to continue to support the rigor of documentation. When the hospital sites were not covering costs of transportation, social reasons prohibited patient compliance in meeting protocol-defined checkpoints with the PI or possibly absence of adequate support systems at home to take care of elderly and vulnerable family members.

For companies early adopter of decentralized trials, there is a high focus on patient centricity where technology is harnessed to enhance patient experience by using telehealth to communicate with patients during study visits and directly capture patient observations. Telehealth is the use of an electronic data capture system to store data in real time along with facilities of e‑consenting, having sample collections done at the patient's home and minimizing exposure of the patient to secondary hospital infections or becoming an asymptomatic carrier of COVID-19, thereby improving overall outcomes for the clinical trial enterprise.

In 2009, the first fitbit was launched, which was supposed to capture personal health data and be a tech-enabler. But somehow over the years it has not been a widely accepted go-to product by pharma and biotech for collecting clinical trial data on patients.

E-consent solutions have helped patients provide their consent and undergo screening without having to travel to hospital sites. Virtual trial recruitment has a significant advantage over traditional recruitment when trials require difficult-to-approach patient groups such as the elderly who can now be effectively screened and evaluated for trial eligibility without having to travel to the designated hospital sites.

The hospital sites have generator backup for air conditioners and controlled drug storage facilities, which may not be available at patient's homes. Can you imagine the loss of clinical trial data if a wearable device has a technical malfunction? The device cannot be replaced immediately and, depending on how far the hospital site is from the patient's home and the time at which the patient and the site team detect the malfunction, it could take at least a day or more to get it replaced.

Dependence on technology could have serious challenges, especially for elderly populations who are least likely to be tech savvy. Training them remotely on new wearables/devices can be a time-consuming and labor-intensive process.

The clinical trials industry has migrated from a traditional clinical trial model to decentralized/virtual clinical trials in an accelerated manner, keeping in mind the guidance set by drug regulators and maintaining compliance with renewed focus. There have been several technology enablers with plug-and-play solution offerings for pharma/biotech clients to transition to a remote or virtual clinical trial management setting through meticulous planning, team restructuring, test runs, and, eventually, execution, leading to considerable savings in time and money.

Let me share some figures with you. The cost of developing a new drug is approximately USD 2 billion, where around two-thirds of the overall cost is incurred during the clinical phase! Patient recruitment contributed predominantly to delaying clinical trials, which could cost pharmaceutical organizations a loss of around USD 4 million per day in revenue.

Additionally, most clinical trials fail to keep patient engagement levels high throughout the study, and dropout rates could be between 30% and 40%. To overcome these challenges, and in the wake of COVID-19, pharmaceutical organizations have embraced the decentralized/virtual clinical trials approach, which unlocks value using technology via monitoring devices, live patient tracking apps and e-platforms for informed consent, randomization, measurement of trial endpoints, capturing adverse events, and bringing the trials to a patient's home.

Decentralized/virtual trials offer the highest success due to optimized recruitment rates, higher patient compliance with protocol, and low dropout rates. They are conducted in the shortest timelines vis-a-vis traditional clinical trials. The relative ease of evaluating a patient's condition and mapping the patient's longitudinal journey in real time virtually enables prompt and accurate diagnosis based on patient symptomatology, thereby accelerating the clinical R&D pathway by ensuring superior patient experience.

I firmly believe that this is what #FutureReadyHealthcare looks like in the clinical trials space.


Sudip Sinha
Sudip Sinha