As we enter 2022, the third year of the Covid-19 pandemic, the clinical research landscape is undergoing a transformation – and the future of clinical trials is being forged.
The accelerated adoption of agile, or hybrid, clinical trials is one of the most important trends currently shaping clinical research. Agile trials combine elements of traditional site-based clinical trials with the capabilities of technologically enabled decentralised clinical trials (DCTs) to enable the most effective, patient-centric design.
“In this third year of the pandemic, I expect to see the concept of decentralisation becoming more mature among contract research organisations (CROs).” says Angela Wang, China commercial director for leading Asia Pacific CRO, Novotech. “More and more trials will be decentralised across the US, Europe and Australia. Countries like China may take more time to adopt decentralisation.
“Moving forward, I expect to see DCT technologies becoming more mature, including monitoring devices and wearables, and we will see lots more hybrid trials.”
The shift to agile
Traditional site-based clinical trials are typically slow and costly. Requiring patients to attend testing sites can present huge logistical challenges, making trials inaccessible to as much as 90% of the population.
DCTs, conducted remotely, enable patients to participate from their homes. More convenient for patients, they have been shown to produce faster enrolment, higher retention rates and improved patient experience.
“Different trials have different characteristics; some can use decentralised solutions, and some cannot,” says Wang. Hybrid trials enable operators to combine elements of in-person and remote methods to suit their needs and make their operation as streamlined and patient-focused as possible.
In recent years, there has been a significant trend among biopharmaceutical organisations towards adopting decentralised trial elements, including eConsent, remote patient monitoring, telemedicine, mobile nurses, and remote sites.
A new challenge
Alongside the benefits, introducing innovative new tools and methodology into a clinical trial can also bring extra complexity and unique challenges.
“The first challenge is adoption,” says Wang. “There’s always an adoption curve with new technology, and pharmaceuticals is a very conservative industry. It is important to educate the customer.”
With adoption comes the need for integration. The pandemic presented a huge challenge, forcing clinical trial operators to adapt to new methodologies very quickly and during a time of great uncertainty. Moving forward, the outlook is more positive: as organisations adapt, they will be able to implement more thorough integration strategies.
“It is also important that regulatory agencies collaborate,” adds Wang. “Every new technology needs a collaborative effort between the regulatory agency, technology developers, sponsors and CROs.”
Strategies for an agile future
The shift to agile clinical trials is already underway, and this trend is unlikely to reverse. Organisations that are prepared to embrace decentralisation will reap its rewards.
The technology, including hardware and software, is fundamental, Wang explains: “The reliability of monitoring systems or devices is very important.
“Quality is the most important thing. When adopting this new technology, is important to make sure you don’t compromise on quality.”
To ease integration, it is essential to bring sites along for the journey. “There is always an adoption curve when it comes to new technologies,” says Wang. “It is very important to educate the customer and to shorten the adoption curve. Solution providers should do a very thorough Voice of Customer study to understand those needs.”
As we progress into 2022 and beyond, clinical trial operators and sponsors should be prepared to embrace progress.
“It will take some time for this to become more mature,” says Wang, “And for it to be adopted around the world. But I see technology being developed at an accelerated pace, as well as an increase in agile trials.”
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