A Hybrid Clinical Trial Model Has The Potential To Save Time, Money & Lives

Additionally, this hybrid design preserves the benefit of randomization, collecting high quality clinical and real-world data building stronger evidence packages, while potentially accelerating product development and lowering the cost of data collection and participant follow-up.

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Reportedly, the recommendation to stop the development program for fezagepras was not based on safety concerns. (File)

By Akshay Daftary

Drug trials are expensive and cumbersome in normal times. On average, pharmaceutical companies spend $2.6 billion to develop a new drug and get it to the market. While results vary by discipline, only a fraction of the candidate drugs that enter clinical trials make it to the market. The Covid-19 pandemic added to the problems of clinical trials in the healthcare sector, due to the social distancing protocols which hampered physical visits to hospitals.

In order to alleviate this challenge, there was a need to conduct trials in a manner without involving physical visits. This brought in methodologies of handling clinical trials with the help of innovative technologies which are termed Decentralised or Hybrid clinical trial models.

Traditional clinical trial execution involves physical visits of participants to the clinical site where in efficacy and safety assessments are performed by trained staff. In these trials, participants who stay in far off locations may sometimes be unable to visit clinical sites on specified time schedules leading to protocol deviations and errors in data analysis. Also data collection and analysis work involves a lot of manual intervention starting from hospital records maintenance, transcribing to electronic data tools and repeated crosschecks to reduce errors which overall increases time and cost of the study budgets.

The rising costs and the pressure of time to bring new drugs to market boosted the demand for decentralised and hybrid trials and it has now steadily gained momentum. These alternative trial models can range in shape and form to include digital health technologies, in-home clinical visits and remote monitoring.

Decentralised and hybrid clinical trials are a pragmatic approach concept which will simply make use of available digital technologies to enable more efficient and effective clinical processes. By combining participant-centric design with innovative technologies, the need for physical in-person interaction between the participants and researchers is reduced or even removed.

Hybrid clinical trials are now increasingly adopting technologies to allow trial activities to a place in or nearer to participants’ homes. These trials where some or all elements of the trial are selected to reduce the need for a physical visit, decrease the burden of trial participation, boost trial accessibility and recruitment, and improve the demography of the trial generated evidence and also lower the overall costs of clinical research and medicines and medical device development.

After Pfizer launched a virtual trial in 2011, now many pharmaceutical organizations have adopted decentralised and hybrid clinical trials as a strategic priority to conduct trials remotely or through local healthcare providers to improve participant experience and increase pace of trial result turnaround.

Evolution of new technologies is fuelled by record level venture capital investments in digital health such as wearable digital healthcare devices like smart watches, fitness trackers and sensors, telemedicine and digital pharmacies. Tools and approaches involving evolved technology, have not only dramatically changed the focus of the pharmaceutical perspective and enabled hybrid clinical trials via digital platforms, but also enhanced the participant expectations of their clinical trial experience.

Additionally, this hybrid design preserves the benefit of randomization, collecting high quality clinical and real-world data building stronger evidence packages, while potentially accelerating product development and lowering the cost of data collection and participant follow-up. The value created for participants is also better reflected.

Though the advantages are many, the challenges of hybrid clinical trials cannot be ignored. Availability and validation of necessary technologies, familiarisation of medical fraternity in using such technologies, developing competent tools to gather and protect the data with appropriate securities in place, training of research staff in utilising the new tools are some of the noteworthy challenges to be met. Moreover, not all diseases have digital assessment methods to allow decentralized clinical trials.

With any new foray into technology, there are always challenges to be faced in the long and short run. These technologies need continuous iteration and though the regulatory agencies have not come up with any strict definitions, it needs to be ensured that the methodologies are kept secure and meet the regulations mandated by government agencies and regulatory bodies in healthcare. Despite these challenges, shifting drug trials from physical site-centric approach to a hybrid model has potential long term benefits in saving lives, time and money. Hybrid clinical trials will continue to transform the future of healthcare, resulting in a greater overall value for all stakeholders.

(The author is Director, SIRO Clinpharm . Views expressed are personal and do not reflect the official position or policy of FinancialExpress.com.)

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