Therapeutic Areas

With sixty million Americans and Europeans diagnosed with one or more of 7,000 defined rare diseases, the availability of treatments has been less than expected.

A new group of collaborators has formed to determine the benefits and risk tradeoffs Parkinson’s disease patients are willing to make for a potential new therapy. Dr. Brett Hauber of RTI Health Solutions spoke to us about the collaborative.

Gene-editing technology has the ability to give oncology researchers an effective treatment option in the fight against cancer. CRISPR-Cas9 is such a technology that is currently being used to study genes in cancer cells.

Functional dyspepsia is noted globally as being a common condition that currently has no specific therapy despite years of research. This condition is in need of an operational definition so that drug development and treatment trials can move forward with a more definitive trial design.

Patients of gastroesophageal reflux disease (GERD) that have been frequently diagnosed, or misdiagnosed, have been dissatisfied with the available treatment. To resolve this issue, industry players must define meaningful endpoints for future trials, incorporate patient reported outcomes, and apply biomarkers.

Cancer therapy has seen progress - not groundbreaking, but improving thanks to the scientific and technological tools at our disposal. This fall offers industry events and trial evaluations that aim to continue this progressive trend toward a breakthrough.

Gastroparesis patients face a series of symptoms for which there is currently a significant void in treatment. With complications and questions aplenty, answers are in high demand as physicians search for suitable medicines to combat this disease.

Eosinophilic esophagitis (EoE) is a rare esophageal condition that currently has no FDA-approved medications resulting in major gaps in treatment. Therefore, the need for better options and opportunities for drug development is apparent.

Continuous Glucose Monitoring (CGM) devices have the ability to replace the traditional finger-prick to measure glucose levels in a patient’s blood. Quintiles’ device expert, Sam Osman, explains CGM and how the FDA decision could affect clinical trials.

Autism Spectrum Disorder (ASD) is a common neurodevelopmental disorder which does not have an approved medication to address its core symptoms. The Janssen Autism Knowledge Engine (JAKE) was designed to advance the clinical research process for autism by integrating emerging technologies into traditional clinical trial processes.

The Movement Disorders Society has recently published Clinical Diagnostic Criteria for Parkinson’s disease. These new guidelines allow for the diagnosis of clinically established and clinical probable Parkinson’s disease, which will help reduce errors in clinical trials.

With Britain’s potential succession from the EU looming, scientific leaders in Europe are voicing their concerns that losing the UK would be a blow to clinical research.

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.