Article
Medicine, General & Internal
Akash Goyal, Tony Schibler, Brooke Alhanti, Karen L. Hannan, Christopher B. Granger, Michael A. Blazing, Renato D. Lopes, John H. Alexander, Eric D. Peterson, Sunil Rao, Jennifer B. Green, Matthew T. Roe, Tyrus Rorick, Lisa G. Berdan, Craig Reist, Kenneth W. Mahaffey, Robert A. Harrington, Robert M. Califf, Manesh R. Patel, Adrian F. Hernandez, W. Schuyler Jones
Summary: This study evaluated the start-up time of cardiovascular RCTs in North America and found a median start-up time of about 9 months overall, but less than 4 months for top-performing sites. The findings suggest that using central IRBs may improve RCT efficiency.
Article
Medicine, General & Internal
Caroline Marra, William J. Gordon, Ariel Dora Stern
Summary: The use of connected digital products (CDPs) in clinical trials increased slightly after the onset of the COVID-19 pandemic, mainly in observational studies and non-industry funded trials where virtual protocols were likely medically necessary due to the participants' COVID-19 diagnosis.
Article
Oncology
Leslie Andriani, Jinhee Oh, Erin Mcminn, Emily Gleason, Nathanael C. Koelper, Jesse Chittams, Fiona Simpkins, Emily M. Ko
Summary: Telehealth and remote clinical trial operations were found to be safe and feasible during the COVID-19 pandemic in gynecologic oncology clinical trials. These adaptations did not compromise the clinical trial protocols. Larger-scale evaluations are needed to determine their continued utility after the pandemic.
GYNECOLOGIC ONCOLOGY
(2023)
Editorial Material
Biochemistry & Molecular Biology
Ameeta Retzer, Olalekan Lee Aiyegbusi, Anna Rowe, Philip N. Newsome, Jessica Douglas-Pugh, Sheeba Khan, Saloni Mittal, Roger Wilson, Daniel O'Connor, Lisa Campbell, Sandra A. Mitchell, Melanie Calvert
Summary: Patient-reported outcomes can offer preliminary evidence of efficacy and tolerability from the patient's perspective, and they can also support regulatory review.
Article
Public, Environmental & Occupational Health
Anna Heath, M. G. Myriam Hunink, Eline Krijkamp, Petros Pechlivanoglou
Summary: Traditional error-driven approach in clinical trial design may be inefficient, waste research resources, and lead to studies with limited impact on daily practice as it has limited relevance to policymakers. On the other hand, the novel value-driven approach focuses on designing trials that directly inform policy and treatment decisions, ensuring the efficient use of research resources and accelerating the implementation of beneficial healthcare interventions.
EUROPEAN JOURNAL OF EPIDEMIOLOGY
(2021)
Article
Clinical Neurology
Bruce C. Campbell, Maarten G. Lansberg, Joseph P. Broderick, Colin P. Derdeyn, Pooja Khatri, Amrou Sarraj, Jeffrey L. Saver, Achala Vagal, Gregory W. Albers
Summary: By hosting a webinar and discussion session, experts discussed prioritizing stroke imaging and reached consensus recommendations on optimal imaging strategies for primary stroke centers. Positive acute stroke clinical trials have extended the treatment window for reperfusion therapies through imaging selection, emphasizing the importance of rapid and high-quality stroke imaging for both primary and comprehensive stroke centers.
Review
Pharmacology & Pharmacy
Alex Aliper, Roman Kudrin, Daniil Polykovskiy, Petrina Kamya, Elena Tutubalina, Shan Chen, Feng Ren, Alex Zhavoronkov
Summary: Drug discovery and development is a risky process with high failure rates at every stage. Accurate prediction of clinical trial outcomes can improve efficiency and benefit patients. inClinico is an AI software platform that uses multimodal data to predict the outcome of phase II clinical trials. It has been validated internally and externally, achieving high accuracy and demonstrating investment potential.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Medicine, General & Internal
Takahiro Sato, Shota Mizumoto, Midori Ota, Mayumi Shikano
Summary: This study comprehensively elucidated the current landscape of decentralised clinical trials (DCTs) in the USA and Japan, identifying widely implemented DCT components and the therapeutic areas in which they are implemented. International consensus guidelines for DCTs are necessary to promote multiregional clinical trials with DCT components.
Review
Oncology
Wanda Cui, Rodney P. Rocconi, Ramya Thota, Richard A. Anderson, Suanna S. Bruinooge, Ioanna A. Comstock, Neelima Denduluri, Audrey Gassman, Julie Gralow, Karla J. Hutt, Laleh Amiri-Kordestani, Matteo Lambertini, John Leighton, Karen H. Lu, Sogol Mostoufi-Moab, Teri Pollastro, Shan Pradhan, Haleh Saber, Caroline Schenkel, Daniel Spratt, Suparna Wedam, Kelly-Anne Phillips
Summary: Anticancer agents can cause ovarian dysfunction, but there is currently inadequate assessment in clinical trials. ASCO recommends measuring and evaluating ovarian toxicity and function in relevant trials to better guide treatment choices for patients.
Review
Cardiac & Cardiovascular Systems
Muhammad Shahzeb Khan, George L. Bakris, Milton Packer, Izza Shahid, Stefan D. Anker, Gregg C. Fonarow, Christoph Wanner, Matthew R. Weir, Faiez Zannad, Javed Butler
Summary: Heterogeneity in the reporting of kidney function and kidney outcomes in clinical trials poses challenges in comparing results and evaluating the benefits of interventions. Future stakeholders need to develop a consensus solution to improve the consistency of reporting in this area.
EUROPEAN HEART JOURNAL
(2022)
Review
Pharmacology & Pharmacy
Xue Wang, Courtney Bishop, James O'Callaghan, Ali Gayhoor, Justin Albani, Wendy Theriault, Michael Chappell, Xavier Golay, Danny Wang, Lino Becerra
Summary: Neurodegenerative mechanisms affect the brain through changes in structure and physiology. Cerebral blood flow (CBF) is a challenging biomarker to harmonize for clinical trials. Arterial spin labeling (ASL) perfusion MRI is a promising method for quantifying CBF without contrast agents and has been increasingly applied in clinical trials. This review presents ASL MRI techniques, implementation strategies, confidence levels in assessing disease progression and treatment effects, and image analysis details.
DRUG DISCOVERY TODAY
(2023)
Article
Oncology
Jason J. Z. Liao, Feng Zhou, Heng Zhou, Lilli Petruzzelli, Kevin Hou, Ekaterine Asatiani
Summary: This article introduces a novel hybrid design method for determining the maximum tolerated dose (MTD) and recommended Phase II dose in cancer treatment. By incorporating the advantages of existing methods, the design demonstrates robust performance in both real trials and simulations, providing more accurate recommendations.
INTERNATIONAL JOURNAL OF CANCER
(2022)
Article
Cardiac & Cardiovascular Systems
Ravi B. Patel, Jozine M. Ter Maaten, Joao Pedro Ferreira, Finnian R. McCausland, Sanjiv J. Shah, Patrick Rossignol, Scott D. Solomon, Muthiah Vaduganathan, Milton Packer, Aliza Thompson, Norman Stockbridge, Faiez Zannad
Summary: Patients with chronic cardiovascular or metabolic diseases often have comorbid kidney disease, leading to worse long-term outcomes. Certain novel treatments have shown beneficial effects on both cardiac and kidney outcomes, sparking interest in formally acknowledging and defining composite cardio-kidney outcomes in future cardiovascular trials.
Article
Critical Care Medicine
Simon Finfer, Deborah Cook, Flavia R. Machado, Anders Perner
Summary: Extra digital content is available in the text.
CRITICAL CARE MEDICINE
(2021)
Review
Agriculture, Multidisciplinary
Pauline Duffuler, Khushwant S. Bhullar, Stepheny C. de Campos Zani, Jianping Wu
Summary: Food-derived bioactive peptides and protein hydrolysates have gained attention as diet-based strategies for preventing and mitigating chronic diseases, but their clinical translation is limited by a lack of understanding of their mechanisms of action and pharmacokinetics. Commercialization is also hindered by limited information on efficacy, safety, bitter taste, and cost-effective production methods.
JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
(2022)