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Looking back at an unprecedented year

Never before have clinical trials been so heavily popularised and never before have people been so educated on clinical research – this has been reflected in recruitment timelines and this creates a model for how patient recruitment should move forward, to include a larger, longer conversation with patients.

The COVID-19 pandemic has given rise to a set of new challenges for the recruitment of patients for clinical trials, but has also been a welcome catalyst for change. Through the international response and collaboration to try and slow the pandemic, this novel virus has led to greater global awareness of the role of clinical trials in research and healthcare.

The rise of telemedicine

For clinical trial managers, several adaptations and novel solutions have been implemented in order to resume currently paused trials and begin new trials. Solutions include respective governments responses in fast-tracking of clinical trials related to the Covid-19 virus itself, due to its urgency as a public health issue; with approximately 35% of studies approved between February and September 2020 being an urgent COVID-19 study (1).

Despite the initial drop in recruitment due to restrictions and worldwide fear, the world has quickly adapted and technology has been used as tool to decentralise parts of the clinical trial recruitment process, such as to undertake the consent process remotely (1) . While giving consent digitally is still an uncommon practice due to requirements for informed consent on paper, these electronic methods have been used as an alternative or in addition to paper forms in some studies, in the wake of face-to-face restrictions. In implementing such a strategy, these same studies have found an increase in patient recruitment, in part due to the sped-up consent process and prioritising of which visits are required in person.

“Doctors and research nurses are spending way too long recruiting patients to research studies… patients are not getting the experience they deserve, and these effects snowball into delays in scientific advancements… and into people getting lifesaving treatments.” – Livia Ng, CEO Neucruit

Patient centricity and AI to gauge patient attitudes

Trends in patient centricity have been a recent hot topic. Through the design of more patient-centric trials, conversations with patients now have a much larger part to play in clinical trials than before, and these more detailed conversations with patients will likely contribute to lower attrition rates (2).

Techniques seen over the course of the pandemic to improve these patient-researcher conversations have involved consulting patient advocacy groups when designing trials, individualising questions to patients during pre-screening, to gain trust, and finally, acknowledging changing trends in patient’s views of clinical trials, and adjusting language to address concerns accordingly (3).

Through this exploration of patient views towards clinical trials, Neucruit in particular is aiming to improve the recruitment process. So far, Neucruit has had success with optimising pre-screening for three academic studies in 2020:

  • Neucruit has digitally pre-screened 101 participants for the Kings College London ‘Repeated Assessment of Mental health in Pandemics’ (RAMP) study, seeking to evaluate the impact of the pandemic on mental health.

  • The University of Liverpool ‘Impact of Covid-19 on Mood and Alcohol’ study, where Neucruit has pre-screened a total of 96 participants to check the impact of COVID-19 on their alcohol consumption levels

  • The Long Tail Study where Neucruit has pre-screened 65 participants, with the aim of identifying those to take further for screening, to evaluate the long-term effects of COVID-19.

Following this, Neucruit has received the Innovate UK Grant, with an aim to optimise patient recruitment for three more Covid-19 trials, as part of the UKRI Innovate UK COVID-19 government grant. With this funding, Neucruit also aims to better target patients using natural language processing (NLP) and artificial intelligence (AI) to modify outreach messages, for faster recruitment, and from more diverse patient samples at a much lower cost than traditional recruitment methods.

In utilising technology such as Neucruit to change the way recruitment is approached, particularly in the wake of a pandemic, the recruitment of patients for clinical trials can only be improved.

References:

  1. Mitchell EJ, Ahmed K, Breeman S, Cotton S, Constable L, Ferry G, et al. It is unprecedented: trial management during the COVID-19 pandemic and beyond. Trials. 2020;21(1):784.

  2. Baker W. CLINICAL TRIAL OPTIMIZATION. Applied Clinical Trials. 2020;29(3):9.

  3. Kantor E. Antidote [Internet]2021. Available from: https://www.antidote.me/blog/what-does-patient-centricity-in-research-look-like-today.

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