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A large part of development is delayed because of inefficient participant recruitment.

Direct to patient clinical trials are a decentralised clinical trial model where aspects of the trial occur outside the main trial site.

In traditional clinical trials, patients travel to the investigator site and commit to this for the entirety of the study, which can present a significant burden for patients depending on their disease profiles or even location. As approximately 70% of US potential participants live more than two hours away from a study centre, there is clearly a wide range of people that may be reluctant to contribute to clinical trials (1).

In decentralised clinical trial models, the phases of traditional trials are monitored with the same blinded protocols but often are conducted at the patient’s home, workplace or pharmacy instead of a study centre, so the patient becomes the study site, in essence.

In direct to patient monitoring, there is increasing integration with digital technology such as wearable sensors and telemedicine to allow for remote monitoring. With fewer in person visits to study centres, there may be improved patient experiences. The benefit of easier patient participation in direct to patient clinical trials presents an increased likelihood of participation, due to increased flexibility in patient schedules; even more so when considering that approximately 70% of US potential patients live far from a study centre.

Moreover, a recent study comparing clinical trial designs found that the decentralised arm with virtual telemedicine visits had an 89% patient completion rate, compared to 60% completion rate in the conventional on-site study arm, with much faster recruitment seen in the decentralised arm. This decreased attrition rate clearly shows the increasing trend and preference for patients to participate in trials that adapt to their lifestyles and schedules (2). Through further adoption of direct to patient trials, there would not only be increased retention rates but also reduced patient recruitment timelines, which would benefit both the clinical trial
administrators and pharmaceutical companies, financially.

Considering this patient recruitment timeline is often the longest part of clinical studies, and the most expensive, adopting a hybrid approach to designing trials around patient day-to day life may be the single easiest change to adopt in the clinical trials industry.

“Demand for DTP has dramatically increased since 2014. In fact, it more than doubled between 2015 and 2016 alone.” – Michael Sweeney of World Courier Group

Similarly, in the wake of the coronavirus pandemic, there has been a shift to an increasing use of technology to conduct healthcare visits via telemedicine and the clinical trials industry has seen similar trends. Digital consent forms and remote monitoring have been used in some trials to continue trials in a COVID-safe manner. In conducting remote or direct to patient studies, patients feel more secure in participating, further contributing to higher retention rates and patient satisfaction.

Another advantage of these direct to patient setting is that when combined with digital monitoring and sensors, constant and real time and continuous data can be gathered, to better support data collection and analysis, further improving treatments.

Besides better patient recruitment and retention seen in decentralised trials, direct to patient trials much better match natural patient environments and provide more natural insights and patient-centred endpoints for trials to work towards, to gauge “realer” responses, without the hostility of some clinical settings. This almost “collaborative” nature of direct to patient trials provides valuable patient feedback that can shape treatment or product experiences (1).

Taking advantage of this changing trend in decentralised clinical trials, Neucruit have been involved in this direct to patient model where patients became the ‘site’ in an academic study conducted by King’s College London Worry Reduction Training. In October and November 2020, patients were trained online and assessed to see if two virtual sessions within 48 hours could help them to worry less, all from the comfort of their home.

Further to this, Neucruit aims to improve the patient recruitment process using thorough pre-screening and in future, using NLP to make patients aware of the conditions of studies (such as direct to patient). Neucruit’s API identifies all channels related to the inclusion criteria of the trials, where patients behind each conversation are identified, and launches targeted campaigns for specific patients.

Through Neucruit’s targeting, the patients have greater power in choosing which trials they would like to participate in, with greater participation flexibility and overall better clinical outcomes.

Resources

  1. Anderson DF, Jonathan, Elsner N. Digital R&D: Transforming the future of clinical development. Deloitte; 2018.

  2. Sommer C, Zuccolin D, Arnera V, Schmitz N, Adolfsson P, Colombo N, et al. Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain. Contemporary Clinical Trials Communications. 2018;11:120-6.

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