The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.
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http://dx.doi.org/10.4103/0300-1652.132035 | DOI Listing |
Diabetes Obes Metab
January 2025
Research Center of Clinical Pharmacology, The First Affiliated Hospital of Yunnan University of Chinese Medicine, Kunming, China.
Objective: Previous experiments have demonstrated that BGM0504, a GLP-1R/GIPR dual agonist drug by molecular dynamics-guided optimization, had enhanced agonistic activity compared to tirzepatide. This study aims to investigate its safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in Chinese healthy volunteers.
Methods: A randomized, double-blind, placebo-controlled and dose-escalation Phase I study was conducted as follows: a single dose (2.
Mol Oncol
January 2025
Urologic Oncology Research Group, Cancer Research Program, Research Institute of the McGill University Health Center, Montreal, Canada.
Patient stratification remains a challenge for optimal treatment of prostate cancer (PCa). This clinical heterogeneity implies intra-tumoural heterogeneity, with different prostate epithelial cell subtypes not all targeted by current treatments. We reported that such cell subtypes are traceable in liquid biopsies through representative transcripts.
View Article and Find Full Text PDFAnn Surg
January 2025
Trauma and Transfusion Medicine Research Center, Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
Objective: To determine the feasibility, efficacy, and safety of cold stored compared to room temperature platelet transfusion in patients with traumatic brain injury.
Summary Background Data: Data demonstrating the safety and efficacy of cold stored platelet transfusion are lacking following traumatic brain injury.
Methods: A phase 2, randomized, open label, clinical trial was performed at a single U.
Recent Pat Biotechnol
January 2025
SRM Modinagar College of Pharmacy, SRM Institute of Science and Technology, Delhi NCR Campus, Modinagar, Ghaziabad, Uttar Pradesh, India.
Traditional drug discovery methods such as wet-lab testing, validations, and synthetic techniques are time-consuming and expensive. Artificial Intelligence (AI) approaches have progressed to the point where they can have a significant impact on the drug discovery process. Using massive volumes of open data, artificial intelligence methods are revolutionizing the pharmaceutical industry.
View Article and Find Full Text PDFCureus
December 2024
Department of Ophthalmology, Broward Health, Fort Lauderdale, USA.
This literature review explores the emerging role of digital twin (DT) technology in ophthalmology, emphasizing its potential to revolutionize personalized medicine. DTs integrate diverse data sources, including genetic, environmental, and real-time patient data, to create dynamic, predictive models that enhance risk assessment, surgical planning, and postoperative care. The review highlights vital case studies demonstrating the application of DTs in improving the early detection and management of diseases such as glaucoma and age-related macular degeneration.
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