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Urgently seeking efficiency and sustainability of clinical trials in global health.

ABSTRACT: This paper shows the scale of global health research and the context in which we frame the subsequent papers in the Series. In this Series paper, we provide a historical perspective on clinical trial research by revisiting the 1948 streptomycin trial for pulmonary tuberculosis, which was the first documented randomised clinical trial in the English language, and we discuss its close connection with global health. We describe the current state of clinical trial research globally by providing an overview of clinical trials that have been registered in the WHO International Clinical Trial Registry since 2010. We discuss challenges with current trial planning and designs that are often used in clinical trial research undertaken in low-income and middle-income countries, as an overview of the global health trials landscape. Finally, we discuss the importance of collaborative work in global health research towards generating sustainable and culturally appropriate research environments.

SUBMITTER: Park JJH

PROVIDER: S-EPMC8424133 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Urgently seeking efficiency and sustainability of clinical trials in global health.

Park Jay J H JJH Grais Rebecca F RF Taljaard Monica M Nakimuli-Mpungu Etheldreda E Jehan Fyezah F Nachega Jean B JB Ford Nathan N Xavier Denis D Kengne Andre P AP Ashorn Per P Socias Maria Eugenia ME Bhutta Zulfiqar A ZA Mills Edward J EJ

The Lancet. Global health 20210501 5

This paper shows the scale of global health research and the context in which we frame the subsequent papers in the Series. In this Series paper, we provide a historical perspective on clinical trial research by revisiting the 1948 streptomycin trial for pulmonary tuberculosis, which was the first documented randomised clinical trial in the English language, and we discuss its close connection with global health. We describe the current state of clinical trial research globally by providing an o ...[more]

PMID: 33865473

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Project description:BackgroundDigital health technologies (DHTs) can facilitate the execution of de-centralized trials that can offer opportunities to reduce the burden on participants, collect outcome data in a real-world setting, and potentially make trial populations more diverse and inclusive. However, DHTs can also be a significant source of electronic waste (e-waste). In recognition of the potential health and environmental impact from DHT use in trials, private and public institutions have recently launched initiatives to help measure and manage this e-waste. But in order to develop sound e-waste management policies, it will be necessary to first estimate the current volume of e-waste that results from the use of DHTs in trials.Materials and methodsA Web Ontology Language (OWL)-compliant ontology of DHTs was created using a list of 500 DHT device names derived from a mixture of public and private sources. The U.S. clinical trials registry, ClinicalTrials.gov, was then queried to identify and classify trials using any of the devices in the ontology. The ClinicalTrials.gov records from this search were then analyzed to characterize the volume and properties of trials using DHTs, as well as estimating the total volume of individual DHT units that have been provisioned (or are planned to be provisioned) for clinical research.ResultsOur ontology-driven search identified 2326 unique clinical trials with a reported "actual" enrollment of 200,947 participants and a "planned" enrollment of an additional 4,094,748 participants. The most-used class of DHTs in our ontology was "wearables," (1852 trials), largely driven by the use of smart watches and other wrist-worn sensors (estimated to involve 149,391 provisioned devices). The most-used subtype of DHTs in trials was "subcutaneous" devices (367 trials), driven by the prevalent use and testing of glucose monitors (estimated to involve 17,666 provisioned devices).ConclusionThousands of trials, involving hundreds of thousands of devices, have already been completed, and many more trials (potentially involving millions more devices) are planned. Despite the great opportunities that are afforded by DHTs to the clinical trial enterprise, if the industry lacks the ability to track DHT use with sufficient resolution, the result is likely to be a great deal of e-waste. A new ontology of DHTs, combined with rigorous data science methods like those described in this paper, can be used to provide better information across the industry, and in turn, help create a more sustainable and equitable clinical trials enterprise.

Project description:BackgroundTrial informativeness describes the likelihood of a clinical trial to have a meaningful impact on clinical practice, research, or policy decisions. A dedicated scientific review process for protocols at the post-funding stage is not common, yet is an opportunity to enhance trial informativeness. The Bill and Melinda Gates Foundation (BMGF), one of the largest funders of clinical trials, created a group called Design, Analyze, Communicate (DAC). DAC's first completion of an expert scientific review of a grantee's trial protocol was in 2020. We categorized and quantified areas of scientific review feedback provided for 52 clinical trial protocols submitted to DAC over a 3-year period. Most trials planned to study treatment interventions and included at least one trial site in a low- and middle-income country. Feedback themes offer insight into areas of trial design weakness.MethodsWe conducted a retrospective analysis of protocol review feedback provided by DAC to grantees. Reviews were completed by BMGF between 2020 and 2022. A qualitative content analysis was conducted by developing a codebook of clinical trial methodology topics and subtopics and systematically coding free-text review feedback. Manual text classification of individual feedback statements enabled quantification and frequency analysis of review feedback.ResultsA total of 1537 individual recommendations were made across all 52 protocols. The median number of recommendations per protocol was 28 (range: 13 to 52), covering a wide range of issues related to clinical trial design, implementation, analysis, and impact. Nearly half of all recommendations (47%) were characterized by the review team as high priority. The areas with the highest frequency of recommendations were statistics and data analysis, trial procedures, and intervention/dose.ConclusionsThis study provides a taxonomy of scientific review feedback topic areas that can be used to categorize clinical trial design topics. The high number of recommendations per protocol review across several distinct topic areas highlights the need for a scientific review to enhance trial informativeness. This review must take place prior to trial initiation and review teams should include statistical and trial design expertise with additional expertise tailored to the trial/intervention type and phase.

Project description:A personal health record is an eHealth technology in which users can observe their progress over time for a given condition. A research gap was identified in the literature concerning the study of the amount of energy that these systems need for their operation, and the energy efficiency that may be attained depending on their design. After the selection of five representative personal health records, a total of 20 tasks commonly done, and based on previous work, were performed with regard to two proposed scenarios, namely patient use and health personnel usage. The power consumption of the main components of a host machine was measured during the performance of the proposed duties. To that end, a hardware tool called the Energy Efficiency Tester was employed. The data collected were analyzed statistically, and significant differences were found in the respective consumption of the display (χ2 (4) = 23.782, p = 0.000), the processor (χ2 (4) = 29.018, p = 0.000) and the whole PC (χ2 (4) = 28.582, p = 0.000). For all of these components, NoMoreClipBoard was the personal health record that required the least energy (57.699 W for the display, 3.162 W for the processor and 181.113 W for the whole PC). A total of two strong correlations were found in the energy consumption between the hard disk and the graphics card (r = 0.791, p < 0.001), and the processor and the PC (r = 0.950, p < 0.001). Some features generated special amounts of power consumption, such as the news wall found on PatientsLikeMe, or the use of load icons that had an impact on most PC components. In addition, an in-depth analysis of the user interfaces was performed. A discussion was carried out on the design of the user interfaces, also taking into account recommendations drawn from the literature, checking for their implementation in the personal health records selected. With the aim of promoting sustainability among software developers, a best practice guideline on sustainable software design was proposed. Basic sustainability recommendations were collected for professionals to consider when developing a software system in general, and a personal health record in particular.

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Urgently seeking efficiency and sustainability of clinical trials in global health.

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Urgently seeking efficiency and sustainability of clinical trials in global health.

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