Therapeutic Areas

The European Reference Networks aims to join the efforts of the best specialists in Europe to tackle complex or rare medical conditions. The goal is to create networks covering a specific disease with an emphasis on procedures or techniques related to treatment.

With the initial promise of immunotherapy use in oncology, we need to continue supporting cross-industry collaborations among leaders from the biopharma community, academia, regulators, and private sector investors.

Results from an analysis of oncology trials suggest that many patients who are excluded from participation in clinical trials due to an elevated ECG machine-generated QTc measurement may actually have been eligible for study participation.

Aligning patient-centric approaches with personalized medicine and biomarker use is transforming the design of Alzheimer's trials.

An article recently appeared in Applied Clinical Trials, which indicated that oncology trials are taking longer to complete, and the article suggested that the duration of oncology clinical trials in certain phases increased by one year to one and a half years.1 Moreover, the article delineates that ameliorations in trial duration were most likely a result of increasing protocol complexi

Will emerging drug cost assessment initiatives provide useful, valid information on total drug value?

In the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.

While some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.

The need for robust and standardized psychiatric outcomes measures in oncology trials has grown immensely

Trulicity® (dulaglutide), approved by the EMA in November 2014 for the treatment of Type 2 diabetes in adults, is the first diabetes drug to have a Patient Reported Outcome.

This article will analyze factors that affect suicidal ideation from a clinical psychiatric pilot study.

This article will analyze the impact of Revlimid on a different outcome: multiple myeloma mortality rates in the US.

The prevalence of cardiovascular toxicity associated with oncology drugs has triggered a new clinical discipline that aims to promote safer drugs and better outcomes for cancer patients.

Improvements in data quality and data capture and reduced workload for sponsors and sites are evident.

Pharmaceutical companies need to integrate pediatric assessments into the standard drug development process and build up pediatric competence.

The data obtained by The Bellagio Child Survival Study Group has made the identification of priority research subjects more precise and relevant to developing countries.

The Pediatric Rule made everyone begin to assess, think, and plan for pediatric needs.

The process of conducting clinical trials with plasma-derived products is essentially similar to that for any pharmaceutical product. However, trials with these products do present some different challenges in terms of trial design, patient recruitment, and clinical trial supplies.

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