All articles by jim findlay
jim findlay
NHS increases access to improved breast cancer test
A test able to predict the likely success of chemotherapy and the risk of recurrence will be widely available in England from April 2015. NHS hospital trusts will be able to sign up to an access scheme from April 2015 to offer a multi-gene Oncotype DX test designed to reduce over-treatment and unnecessary costs for the healthcare system.
Blood test doubles female heart attack diagnoses
A potentially groundbreaking heart attack test could save women’s lives, according to recent research. A study funded by the British Heart Foundation and published in the British Medical Journal found that a new blood test’s sensitivity to very small levels of the protein (troponin) released during heart attacks in females attacks enabled it to double the diagnoses achieved by conventional methods to a rate more in keeping with that found in males.
The sky’s the limit – cloud computing for clinical trials
Cloud computing may have become part of the zeitgeist, but what are the challenges of adapting it for clinical trial data, and do the benefits outweigh the risks compared with a single storage system? Dan Ringenbach, R&D IT director at Shire Pharmaceuticals, puts forward a compelling case for having your head in the cloud.
Final analysis – strategies for POC trials
Proof of concept (POC) trials play an important role in developing new treatments and determining whether existing drugs may be efficacious in broader populations of patients, but it can be a challenge to obtain sufficient information to make decisions in a cost-effective manner. Jennifer Gewandter, research assistant professor at the University of Rochester, details some promising strategies for using POC trials to reduce late-stage attrition rates in drug development.
Ahead of the game – risk management in clinical trial supply chains
Clinical trial supply chains are not always predictable or easy to control, so pharmaceutical companies need to take a proactive approach to risk management. Marc Sotty, head of R&D clinical supplies distribution at Sanofi, talks to Nic Paton about temperature monitoring methods that overcome these challenges.
Better together – rapid sourcing of quality drugs
The mechanisms for acquiring clinical trial comparator drugs can be unpredictable and inefficient, leading to study delays. As more sophisticated therapies enter the market, sourcing such supplies grows ever more challenging. Terry Walsh, head of the comparator network initiative for TransCelerate BioPharma and head of global comparator strategy at GSK, discusses the organisation’s project to overcome these hurdles and establish rapid sourcing of quality drug products. In the end, it all comes down to collaboration.
Risk and reward: tools and metrics for identifying and monitoring risk in clinical trials
As clinical trials grow in scale and complexity, it is important to identify sources of risk and determine ways of monitoring that risk while the trial is ongoing. Lori Convy, monitoring subject matter expert at Sanofi, explains how a risk-based approach can facilitate continuous improvements in trial conduct, and examines what sorts of tools and metrics are the best to help.
Safety conscious – the role of RMPs in pharmacovigilance
Risk management plans (RMPs) were introduced in 2005 and are routinely required by EMA as part of the medicine approval process. However, the rate at which drug safety uncertainties are resolved through this supposedly proactive move is unknown. Niels Vermeer, PhD candidate in regulatory science at Utrecht University and pharmacovigilance assessor at Medicines Evaluation Board, discusses his team’s study to determine knowledge gained since the method’s implementation.
Common cancers linked to higher BMI
Being overweight increases your risk of developing some of the most common cancers.
A study of more than five million UK adults carried out researchers at the London School of Hygiene and Tropical Medicine concluded that rising BMI was “clearly linked” with a higher risk of cancers of the uterus, gallbladder, kidney, cervix, thyroid and leukaemia.
WHO: untested Ebola drugs are OK in Africa
Untested drugs are an acceptable option for fighting Ebola in West Africa, says the World Health Organisation (WHO). The authority for health within the United Nations has declared that offering “unproven interventions with as-yet unknown efficacy and adverse effects, as potential treatment or prevention” is an ethical response to the ongoing outbreak in the region.