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Patients, families, healthcare providers and funders face multiple comparable treatment options without knowing which provides the best quality of care. As a step towards improving this, the REthinking Clinical Trials (REaCT) pragmatic trials program started in 2014 to break down many of the traditional barriers to performing clinical trials. However, until other innovative methodologies become widely used, the impact of this program will remain limited. These innovations include the incorporation of near equivalence analyses and the incorporation of artificial intelligence (AI) into clinical trial design. Near equivalence analyses allow for the comparison of different treatments (drug and non-drug) using quality of life, toxicity, cost-effectiveness, and pharmacokinetic/pharmacodynamic data. AI offers unique opportunities to maximize the information gleaned from clinical trials, reduces sample size estimates, and can potentially "rescue" poorly accruing trials. On 2 May 2023, the first REaCT international symposium took place to connect clinicians and scientists, set goals and identify future avenues for investigator-led clinical trials. Here, we summarize the topics presented at this meeting to promote sharing and support other similarly motivated groups to learn and share their experiences.
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http://dx.doi.org/10.3390/curroncol31030104 | DOI Listing |
JCI Insight
September 2025
Division of Nephrology, Boston University Chobanian & Avedisian School of Medicine, Boston, United States of America.
Background: Active vitamin D metabolites, including 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D (1,25D), have potent immunomodulatory effects that attenuate acute kidney injury (AKI) in animal models.
Methods: We conducted a phase 2, randomized, double-blind, multiple-dose, 3-arm clinical trial comparing oral calcifediol (25D), calcitriol (1,25D), and placebo among 150 critically ill adult patients at high-risk of moderate-to-severe AKI. The primary endpoint was a hierarchical composite of death, kidney replacement therapy (KRT), and kidney injury (baseline-adjusted mean change in serum creatinine), each assessed within 7 days following enrollment using a rank-based procedure.
J Med Internet Res
September 2025
Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Leipzig, Germany.
Background: The loss of a loved one is a common yet stressful event in later life. Internet- and mobile-based interventions have been proposed as an effective treatment approach for individuals with prolonged grief.
Objective: The AgE-health study aimed to investigate the efficacy of an eHealth intervention, trauer@ktiv, in reducing prolonged grief symptoms in a sample of older adults.
JAMA Netw Open
September 2025
Department of Psychiatry, Psychosomatics, and Psychotherapy, University of Lübeck, Lübeck, Germany.
Importance: Patients with inflammatory rheumatic diseases (IRDs) frequently experience psychological distress; however, access to psychological support remains limited.
Objective: To investigate the effectiveness of a digital psychological intervention for individuals with IRDs.
Design, Setting, And Participants: Participants aged 18 years or older were recruited across Germany between February 22 and June 4, 2024, if they had been diagnosed with rheumatoid arthritis, psoriatic arthritis, or systemic lupus erythematosus and reported psychological distress and reduced quality of life.
Qual Life Res
September 2025
The Kids Research Institute Australia, The University of Western Australia, P.O. Box 855, West Perth, WA, 6872, Australia.
Purpose: CDKL5 deficiency disorder (CDD) is a rare developmental and epileptic encephalopathy. Greater understanding of the smallest meaningful improvements for individuals with CDD in clinical trials and practice is needed for a person-centred approach to treatment efficacy. This study explored how parent/caregivers of people with CDD understood meaningful improvements and described change for priority functional domains including communication, gross motor, fine motor, feeding.
View Article and Find Full Text PDFMed Oncol
September 2025
Department of Pharmacognosy, Faculty of Pharmacy, Mansoura University, Mansoura, 35516, Egypt.
Gynecological cancer, encompassing cancers such as endometrial and cervical cancer, is a growing concern worldwide, with a rising incidence and significant impact on women's health. Pterostilbene (PT), a natural compound, has shown promising therapeutic potential in gynecological cancer treatment. This review aims to summarize the current state of knowledge on PT's effects in gynecological cancer, focusing on its molecular mechanisms, preclinical studies, and clinical trials.
View Article and Find Full Text PDF