To broaden patient participation in cancer clinical trials, the US Food and Drug Administration (FDA) in March released four draft guidance documents on cancer clinical …

Study failure is every sponsor’s biggest nightmare, and there are multiple reasons why it could happen. These may include a failure to properly recruit the …

In post-industrial countries, the average person spends five hours a day on their smartphone – and cancer patients are no exception. As such, it is …

Why a new clinical trial landscape demands greater collaboration and flexibility Travis Caudill of Worldwide writes that clinical research professionals have witnessed a shift in …

Much progress has been made in paediatric medication development since the implementation of paediatric legislation in the US and EU. Marketing authorisation for new medicines, …

As demonstrated by numerous initiatives globally, cooperation and convergence activities among national regulatory authorities (NRAs) accelerate the drug development process, improve access to medicines and …

Christene Leiper of Onorach examines clinical trials in Latvia and Lithuania, which have been conducted since the early 1990s. The number of studies has increased …

The use of health technology assessments (HTAs) to determine whether a healthcare technology should be paid for and at what price is well established in …

Sridhar S et al. of JSS College of Pharmacy consider the haemovigilance system, which must include all appropriate stakeholders and coordinate between blood transfusion service, …

With an ever-increasing amount of clinical trials reporting significant benefits in long-term overall survival of patients with specific cancers following mono-immunotherapy, the goal has shifted …