Learn More
BACKGROUND Hypersensitivity reaction to abacavir is strongly associated with the presence of the HLA-B*5701 allele. This study was designed to establish the effectiveness of prospective HLA-B*5701 screening to prevent the hypersensitivity reaction to abacavir. METHODS This double-blind, prospective, randomized study involved 1956 patients from 19(More)
BACKGROUND Recently, the Data collection of Adverse events of Anti-HIV Drugs Group (D:A:D) described results from their international observational cohort of 33,347 HIV-1-infected individuals, suggesting unexpected increased risk of myocardial infarction (MI) associated with abacavir (ABC) therapy [relative rate 1.9, 95% confidence interval (CI): 1.47 to(More)
Pharmacogenetics (PGx) - the study of DNA variation in the human genome and the way this impacts the efficacy and safety of medicines - is becoming an increasingly important research tool as physicians, patients, regulatory authorities and payers look for innovative ways to improve the risk:benefit ratio of medicines. While scientific knowledge about PGx is(More)
In May 2013, GlaxoSmithKline (980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) established a new online system to enable scientific researchers to request access to anonymised patient level clinical trial data. Providing access to individual patient data collected in clinical trials enables conduct of further research that may help advance medical(More)
The European Agency for the Evaluation of Medicinal Products has recently completed the consultation of a draft guidance on how to implement conditional approval. This route of application is available for orphan drugs, emergency situations and serious debilitating or life-threatening diseases. Although there has been limited experience in implementing(More)
Considerable statistical research has been performed in recent years to develop sophisticated statistical methods for handling missing data and dropouts in the analysis of clinical trial data. However, if statisticians and other study team members proactively set out at the trial initiation stage to assess the impact of missing data and investigate ways to(More)
In an environment where (i) potential risks to subjects participating in clinical studies need to be managed carefully, (ii) trial costs are increasing, and (iii) there are limited research resources available, it is necessary to prioritize research projects and sometimes re-prioritize if early indications suggest that a trial has low probability of(More)