Artificial intelligence and machine learning in clinical trial design and application

In 2020, COVID-19 changed how health care was approached both in the United States and globally. In the early phases, the vast majority of energy and attention was devoted to containing the pandemic and treating the infected. Toward the end of 2020, that attention expanded to vaccinating people across the globe. What was not being considered at the time were challenges to future health and clinical trials that power new treatments for COVID-19 and non-COVID-19 treatments. © 2023 Elsevier Inc. All rights reserved.

Factors impacting participation in research during the COVID-19 pandemic: results from a survey of patients in the ophthalmology outpatient department.

BACKGROUND: Understanding public and patient attitudes to clinical research is paramount to successful recruitment. The COVID-19 pandemic has led to additional hurdles in achieving this. Our aim is to understand the current factors and attitudes towards clinical trial participation in order to assist in recruitment to clinical trials. METHODS: We conducted face-to-face interviews with patients in the outpatient department at a tertiary eye hospital facilitated by a 32-item questionnaire developed by the research team. Patient characteristics were correlated with their responses, in addition to qualitative thematic text analysis. RESULTS: A total of 53 patients were interviewed. Forty per cent indicated that they would be willing to participate in clinical research in the current climate. General motivating factors for involvement in research included personal gain, altruism and contribution to innovation. Factors limiting participation included concerns regarding own safety, inconvenience, accessibility and lack of benefit. 22.6% of participants felt that the COVID-19 pandemic has changed their outlook on research. These were categorised into positive (increased awareness of the importance and need for research, altruism) and negative (increased anxiety, need to minimise exposure to the hospital environment) influences. CONCLUSIONS: Factors influencing patients' decisions to participate in trials are similar to those observed prior to COVID-19 but with an increased focus on the environment the research is conducted in. The COVID-19 pandemic has had positive and negative impacts on patient attitudes towards research. Trial design, with a particular focus on setting and safety measures, in reassuring patients is increasingly important.

The RIC COVID-19 Recruitment & Retention Toolkit: A community-informed resource of recruitment tools and strategies for clinical trial investigators.

The Recruitment Innovation Center (RIC) has created a toolkit of novel strategies to engage potential participants in response to recruitment and retention challenges associated with COVID-19 studies. The toolkit contains pragmatic, generalizable resources to help research teams increase awareness of clinical trials and opportunities to participate; produce culturally sensitive and engaging recruitment materials; improve consent and return of results processes; and enhance recruitment of individuals from populations disproportionately impacted by COVID-19. This resource, the "RIC COVID-19 Recruitment and Retention Toolkit," is available free online. We describe the toolkit and the community feedback used to author and curate this resource.

A national open-access research registry to improve recruitment to clinical studies.

INTRODUCTION: Barriers to recruitment for dementia studies are well documented. As part of the UK government's Dementia 2020 strategy, a nationally consistent system to increase public engagement and participation in research was launched in February 2015. METHODS: We describe the development of the "Join Dementia Research" registry, including evolution of policy, involvement of people with dementia in co-production, data requirements, governance, technology, and the impact on study recruitment and what factors may have contributed to the services success. RESULTS: The UK-wide online, telephone, and postal service has registered 47,071 volunteers, with 33,139 people (67.9% of all volunteers) taking part in 378 studies, with 49,954 total study enrolments. This has taken place across 295 research sites, involved 1522 researchers, and resulted in 134 peer-reviewed publications. DISCUSSION: Public registries of individuals interested in research, with user-provided data enabling basic phenotyping, are effective at increasing public engagement with research and removing barriers to study recruitment. Deeper pheno/genotyping could be undertaken to improve matching, but how and when that information is collected will be a key factor.

Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies.

Covid-19 raised many novel ethical issues including regarding the allocation of opportunities to participate in clinical trials during a public health emergency. In this article, we explore how hospitals that have a scarcity of trial opportunities, either overall or in a specific trial, can equitably allocate those opportunities in the context of an urgent medical need with limited therapeutic interventions. We assess the three main approaches to allocating trial opportunities discussed in the literature: patient choice, physician referral, and randomization/lottery. As, we argue, none of the three typical approaches are ethically ideal for allocating trial opportunities in the pandemic context, many hospitals have instead implemented hybrid solutions. We offer practical guidance to support those continuing to face these challenges, and we analyze options for the future.

Misalignment between COVID-19 hotspots and clinical trial sites.

Hundreds of interventional clinical trials have been launched in the United States to identify effective treatment strategies for combating the coronavirus disease 2019 (COVID-19) pandemic. However, to date, only a small fraction of these trials have completed enrollment, delaying the scientific investigation of COVID-19 and its treatment options. This study presents novel metrics to examine the geographic alignment between COVID-19 hotspots and interventional clinical trial sites and evaluate trial access over time during the evolving pandemic. Using temporal COVID-19 case data from USAFacts.org and trial data from ClinicalTrials.gov, U.S. counties were categorized based on their numbers of cases and trials. Our analysis suggests that alignment and access have worsened as the pandemic shifted over time. We recommend strategies and metrics to evaluate the alignment between cases and trials. Future studies are warranted to investigate the impact of the misalignment of cases and clinical trial sites on clinical trial recruitment.