Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development costs in general are rising …
The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new insights into the lives of …
Cardiovascular outcomes trials (CVOTs) are some of the largest interventional trials being conducted, enrolling several thousand subjects, sometimes with follow-up of several years to accrue …
Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM) approach. Effective RBM reduces costs, …
The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the new therapeutic. Astute use of …
To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence” of effectiveness from “adequate and …
The planning and execution of rare disease clinical trials involves unique considerations. Examples include the role of patient advocacy groups, the value of outcomes registries …
Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed in regional clinics and hospitals. …
The last few months have seen a battle build between the pharma industry and the EMA, following the issue of new guidance promoting greater transparency …
In November 2016, the ICH E6 (R2) Addendum to Good Clinical Practice was implemented, delivering a breath of fresh air for clinical trial sponsors and …
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