ContextSelective eligibility criteria of randomized controlled trials (RCTs) are vital to trial
feasibility and internal validity. However, the exclusion of certain patient populations may …

Risk is an inescapable aspect of clinical research and is increasingly pertinent to the gene
therapy field as the imperative for clinical trial activity grows. In recent years, the widely …

Background: This paper presents the results of an exploratory qualitative study that
assesses Canadian pediatric researchers' perceptions of a pre-selected group of ethical …

It has historically been very difficult to conduct early phase drug studies in children for a
number of reasons related to ethics, acceptability, rarity, standardization, end points, safety …

Unlicensed drugs are those that do not have marketing authorization. Off-label use is
prescribing outside the terms of the product licence, for example in a different indication, age …

Randomized controlled clinical trials are felt by the medical community to provide the best
evidence. Participation in trials involves the possibility of obtaining benefits but also of …

Children were often referred to as “therapeutic orphans” in the past due to different reasons
such as ethical, regulatory, economic, scientific, etc., ones. They were exposed to avoidable …

Background: As standards of care in pediatrics improve, pharmacists are providing services
to a growing pediatric population taking complex drug therapies. Challenges unique to this …

Does the inclusion of children in pharmacogenomic research raise new ethical issues?
Through an exploration of the relevant laws, policies, guidelines and literature, we have …

• Intravenous route of administraton–requires appropriate equipment and monitoring for
administration, either in a health care facility or at a freestanding infusion clinic•• if at a …