The Importance of Decentralized Clinical Trials.

Human clinical trials are conducted on volunteers to gauge a medical, surgical, or behavioural reaction to a new treatment. These trials are crucial to ensure researchers understand the efficacy of a new drug, diet or medical device and ensure it is safe and effective for human use.

In traditional trials, testing and monitoring has exclusively occurred in person at a designated physical location, known as a research site. This process involves investigators and research staff conducting questionnaires and recording physical notes, which are later transcribed and analysed. This process therefore requires participants to travel to the site to take part, which involves making an appointment, travel arrangements, and taking time off work.

Decentralized Trials

Due to the COVID-19 pandemic, most sponsors saw a significant shift to a ‘decentralized clinical trials’ (DCTs) format. This is a more patient-centric approach, where technology and digitised processes are utilised to gather data, meaning participants are not required to be physically present on-site for the entirety of the trial. By adopting this method, factors such as travel and time off are no longer an issue. Eliminating or reducing these barriers to participation, will hopefully lead to more equal representation within trials. 

At the beginning of 2021 my colleague Elisabeth discussed this topic in an article. After speaking with industry experts helping lead the rollout of decentralised trials, she noted the opportunity for increased representation of minority communities in the test groups as a result of a decentralised approach. Studies have shown that participation in clinical trials for new drugs is noticeably skewed towards a Caucasian majority, in some cases up to 90% white. By removing the geographical barriers and time constraints required for traditional clinical trials, a wider audience can be reached for trial recruitment. The result? A noticeable increase in enrolment for lesser represented minorities. 

Who’s doing it?

Thanks to COVID (never thought we’d be saying that), there has been an industry-defining move to this remote method of research and analytics. The shift to the decentralized approach was originally a necessity in order to maintain the safety and availability of crucial medical functions, now all major CROs have begun adapting the method in some way, in some cases discovering brand new innovation and learnings as a result. 

Leo Pharma wants to reduce clinical trial costs and time by 25%. The medical dermatology company announced a partnership with Veeva Systems at the end of 2021, to aid their shift to digital trials. The company plans to improve patient experience, increase diversity within the trial group and increase accuracy of clinical data, through a decentralised clinical trials system. 

IQVIA announced that its “DCTs are here to stay”. Highlighting how its decentralized trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Through a mix of hybrid and fully virtual solutions, the company has had success with more than 90 DCTs across more than 40 countries and 30 indications. Results have shown a more adaptable, approachable experience which are less burdensome for patients with diverse socio-economic backgrounds, racial and cultural identities, and specific healthcare needs. 

Worldwide Clinical Trials (WCT) are another influential CRO recognising decentralized trials as a more impactful way for patients to take part in drug research. Its recent partnership with trial tech firm Science 37 will see WCT use their clinical trial Operating System to accelerate recruitment, boost retention rates and enhance participant diversity. 

The deal sees WCT join a network of CROs to provide “training, and commercial support to successfully deliver decentralized clinical studies at scale”, highlighting the influence of these partnerships on the wider market. 

The company’s Senior Vice President, Jeff Zucker, comments on the importance of the partnership as part of a wider effort to focus on the needs of research participants. 

When speaking with InformaConnect in a recent interview, he said:

In addition to site-based studies, Worldwide Clinical Trials has integrated several components of DCTs in recent years as we’ve explored ways to make it easier for patients to participate in clinical trials. For example, we offer via partners home nursing, remote monitoring, direct-to-patient drug shipment, electronic clinical outcomes assessment, and electronic patient-reported outcomes.”

What does this mean for the market?

A recent report based on responses from 125 professionals from around the world stated that 58% of participants saw decentralized trials as faster, with studies being completed on average three months earlier. 71% highlighting how effective decentralized trials are for patient recruitment, and 74% for retention. 

After seeing the success of the bigger market players, with key learnings including the vast increase in diversity, accessibility, and efficiency, I’m intrigued by the trickle-down effect on the future market. Are newer companies entering and establishing themselves in the market taking a fully decentralized approach? Will traditional trials ever return as they once were? 

Clinmark, for example, cooperates with start-ups inventing devices for telemedicine by supporting them in clinical development and CE mark certification to help them launch to market. They comment that:

Telemedicine in general has still not been recognized as a sufficient and universal solution to patients’ treatment. It is difficult to expect the establishment of telemedicine as an efficient and widely accepted sole method in the near future.”

However, the company recognises the need for implementation of methods which improve subject wellbeing. For them, gathering reliable, real-world data for studies is crucial, therefore the ability to conduct studies on remote data collection and verification is a vital factor for the future success of Clinmark. Despite the successes of DCT, however, the company recognises that this method cannot be considered fully sufficient.

What’s next?

Decentralized trials are more beneficial in terms of recruitment, inclusivity, and efficiency, but they can also be costly to implement with investment in highly digitised systems. Concerning smaller CROs, who may have invested in traditional trial systems, a hybrid trial system may be considered the most logical step. 

According to Science 37, the continued growth in the decentralized clinical trial landscape could outpace traditional site-based studies in the coming year. With 77% of 127 senior clinical research executives saying they plan to run a hybrid trial in the next 12 months compared to 59% for the previous year, I look forward to seeing the effect this has on the growth of the market. 

Despite initial upheaval, it remains clear that a decentralized or hybrid approach is the realistic future to ensure truly diverse clinical trials. I look forward to seeing how newer companies joining the market plan to utilise the capabilities of this digital first approach, as well as how current company leaders continue to adapt their approach to remain relevant and innovative. 

Are you interested in discussing the future of clinical trials with me in some more detail? I’d love to hear from you. Drop me a message at elissa.buxton@lifesci-cm.com.

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