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The world of clinical research is currently witnessing a revolutionary transformation. Amid the third year of the COVID-19 pandemic, the industry is increasingly veering towards the adoption of agile clinical trials. This blog will delve into the concept of agile clinical trials, the technology behind it, the challenges involved, and the strategies required for future implementation.
Agile clinical trials, also known as hybrid trials, merge the aspects of traditional site-based clinical trials with the features facilitated by technologically advanced decentralized clinical trials (DCTs). The main aim is to devise a patient-centric design that boosts efficiency.
Note: The term 'agile' signifies adaptability and swift response to changes, which is exactly what these clinical trials offer.
Traditional site-based clinical trials have often been criticized for being slow and expensive. They require patients to visit specific testing sites, which can pose massive logistical issues, thereby excluding a large part of the population from participating.
On the contrary, DCTs allow patients to partake from the comfort of their homes. This convenience has led to quicker enrolment, enhanced retention rates, and a better patient experience. Agile clinical trials take the best of both worlds, combining in-person and remote methods to tailor an operation that's both streamlined and patient-focused.
Biopharmaceutical organizations are increasingly adopting elements of decentralized trials, such as eConsent, remote patient monitoring, telemedicine, mobile nurses, and remote sites. This trend is only expected to grow as more trials get decentralized across various regions, including the US, Europe, and Australia.
While the advantages of agile clinical trials are evident, introducing innovative tools and methodologies also comes with its share of complexities and unique challenges.
The initial challenge lies in the adoption of the new technology. The pharmaceutical industry tends to be conservative, and therefore, customer education becomes a crucial part of the process.
With adoption comes the need for integration. The pandemic put forth a significant challenge, compelling clinical trial operators to adjust to new methodologies amidst a time of immense uncertainty. However, as organizations adapt, they'll be able to implement more thorough integration strategies.
For the successful implementation of new technology, a collaborative effort is required between the regulatory agency, technology developers, sponsors, and Contract Research Organizations (CROs).
The movement towards agile clinical trials is in full swing and shows no signs of reversing. Organizations that are open to embracing decentralization are set to reap its benefits.
The technology involved, including hardware and software, is the backbone of agile clinical trials. The reliability of monitoring systems or devices is of utmost importance.
When introducing new technology, it's essential to maintain quality. Compromising on the quality could jeopardize the entire operation.
To smoothen integration, it's crucial to involve sites in the process. Simultaneously, educating the customer and shortening the adoption curve becomes vital.
As we progress into 2022 and beyond, clinical trial operators and sponsors must be prepared to embrace progress. Technology development is happening at an accelerated pace and an increase in agile trials is expected.
