Clinical Trials Commons^™

Strengthening The Paediatric Clinical Trial Ecosystem To Better Inform Policy And Programmes, James A. Berkley, Judd L. Walson, Glenda Gray, Fiona Russell, Zulfiqar Ahmed Bhutta, Per Ashorn, Shane A. Norris, Ebunoluwa A. Adejuyigbe, Rebecca Grais, Bernhards Ogutu

Institute for Global Health and Development

The first WHO Global Clinical Trials Forum was convened in November, 2023 to develop a shared vision of an effective global clinical trial infrastructure. The Paediatric Clinical Trials Working Group was formed to provide perspectives, identify challenges, and propose solutions to strengthen the paediatric clinical trials ecosystem. Participants represented paediatric disciplines, including infectious diseases, nutrition, neonatology, pharmacology, oncology, neurodevelopment, public health, and policy. Childhood diseases have profound lifelong effects on health, livelihoods, and societies. Investment in early childhood results in highly cost-effective changes to lifelong health, productivity, and human capital returns. Yet, there remain substantial gaps in knowledge on the …

Lactoferrin And Lysozyme To Promote Nutritional, Clinical And Enteric Recovery: A Protocol For A Factorial, Blinded, Placebo-Controlled Randomised Trial Among Children With Diarrhoea And Malnutrition (The Boresha Afya Trial), Ruchi Tiwari, Kirkby Tickell, Emily Yoshioka, Joyce Otieno, Adeel Shah, Barbra Richardson, Lucia Keter, Maureen Okello, Churchil Nyabinda, Indi Trehan

Paediatrics and Child Health, East Africa

Introduction: Children with moderate or severe wasting are at particularly high risk of recurrent or persistent diarrhoea, nutritional deterioration and death following a diarrhoeal episode. Lactoferrin and lysozyme are nutritional supplements that may reduce the risk of recurrent diarrhoeal episodes and accelerate nutritional recovery by treating or preventing underlying enteric infections and/or improving enteric function.

Methods and analysis: In this factorial, blinded, placebo-controlled randomised trial, we aim to determine the efficacy of lactoferrin and lysozyme supplementation in decreasing diarrhoea incidence and improving nutritional recovery in Kenyan children convalescing from comorbid diarrhoea and wasting. Six hundred children aged 6–24 months with …

Ocular Gene Transfer In The Spotlight: Implications Of Newspaper Content For Clinical Communications, Shelly Benjaminy, Tania M. Bubela

Office of the Provost

Background: Ocular gene transfer clinical trials are raising hopes for blindness treatments and attracting media attention. News media provide an accessible health information source for patients and the public, but are often criticized for overemphasizing benefits and underplaying risks of novel biomedical interventions. Overly optimistic portrayals of unproven interventions may influence public and patient expectations; the latter may cause patients to downplay risks and over-emphasize benefits, with implications for informed consent for clinical trials. We analyze the news media communications landscape about ocular gene transfer and make recommendations for improving communications between clinicians and potential trial participants in light of …

Systematic Review Of Polyherbal Combinations Used In Metabolic Syndrome, Amber Hanif Palla, Faridah Amin, Bilqees Fatima, Arooj Shafiq, Najeeb Ur Rehman, Ikram Ul Haq, Anwar-Ul-Hassan Gilani

Department of Biological & Biomedical Sciences

Background: Metabolic syndrome (MetS) is a multifactorial disease, whose main stay of prevention and management is life-style modification which is difficult to attain. Combination of herbs have proven more efficacious in multi-targeted diseases, as compared to individual herbs owing to the "effect enhancing and side-effect neutralizing" properties of herbs, which forms the basis of polyherbal therapies This led us to review literature on the efficacy of herbal combinations in MetS.
Methods: Electronic search of literature was conducted by using Cinnahl, Pubmed central, Cochrane and Web of Science, whereas, Google scholar was used as secondary search tool. The key words used …

Tocilizumab And Covid-19: A Meta-Analysis Of 2120 Patients With Severe Disease And Implications For Clinical Trial Methodologies, Azza Sarfraz, Zouina Sarfraz, Muzna Sarfraz, Hinna Aftab, Zainab Pervaiz

Department of Paediatrics and Child Health

Background/aim: Since the outbreak of the COVID-19, numerous therapies to counteract this severe disease have emerged. The benefits of Tocilizumab for severely infected COVID-19 patients and the methodologies of ongoing clinical trials are explored.
Materials and methods: A systematic search adhering to PRISMA guidelines was conducted in PubMed, Cochrane Central, medRxiv, and bioRxiv using the following keywords: “Tocilizumab,” “Actemra,” “COVID-19.” An additional subsearch was conducted on Clinicaltrials.gov to locate ongoing tocilizumab trials.
Results: A total of 13 studies were included in the meta-analysis comprising 2120 patients. The treatment group had lower mortality compared to the control group (OR = 0.42, …

Randomised Trials At The Level Of The Individual, Jay J H. Park, Nathan Ford, Denis Xavier, Per Ashorn, Rebecca F. Grais, Zulfiqar Ahmed Bhutta, Herman Goossens, Kristian Thorlund, Maria Eugenia Socias, Edward J. Mills

Centre of Excellence in Women and Child Health

In global health research, short-term, small-scale clinical trials with fixed, two-arm trial designs that generally do not allow for major changes throughout the trial are the most common study design. Building on the introductory paper of this Series, this paper discusses data-driven approaches to clinical trial research across several adaptive trial designs, as well as the master protocol framework that can help to harmonise clinical trial research efforts in global health research. We provide a general framework for more efficient trial research, and we discuss the importance of considering different study designs in the planning stage with statistical simulations. We …

The Role And Challenges Of Cluster Randomised Trials For Global Health, Louis Dron, Monica Taljaard, Yin Bun Cheung, Rebecca Grais, Nathan Ford, Kristian Thorlund, Fyezah Jehan, Etheldreda Nakimuli-Mpungu, Denis Xavier, Zulfiqar Ahmed Bhutta, Jay J H. Park, Edward J. Mills

Department of Paediatrics and Child Health

Evaluating whether an intervention works when trialled in groups of individuals can pose complex challenges for clinical research. Cluster randomised controlled trials involve the random allocation of groups or clusters of individuals to receive an intervention, and they are commonly used in global health research. In this paper, we describe the potential reasons for the increasing popularity of cluster trials in low-income and middle-income countries. We also draw on key areas of global health research for an assessment of common trial planning practices, and we address their methodological shortcomings and pitfalls. Lastly, we discuss alternative approaches for population-level intervention trials …

Responsible Translation Of Stem Cell Research: An Assessment Of Clinical Trial Registration And Publications, Moses Fung, Yan Yuan, Harold Atkins, Qian Shi, Tania M. Bubela

Office of the Provost

We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most …

The Unseen And Untold Issues Of Clinical Trials And Research Ethics In Pakistan., Shahan Waheed, Emaduddin Siddiqui

Department of Emergency Medicine

No abstract provided.