All articles by antonica jones
antonica jones
Up to the marker: clinical trial design
As pharma shifts from a one-size-fits-all approach to more personalised therapies, a number of challenges present themselves in the way clinical trials are conducted. Natalie Healey speaks to Pei He, a statistical scientist at Genentech, about the hurdles ahead and how professionals can choose the most appropriate study design for trials that apply biomarkers.
New recruits: Cancer Research UK
It can be challenging to recruit the required number of patients on to a clinical study and when it comes to oncology trials, persuading vulnerable patients to take part is no mean feat. Natalie Healey asks Kate Law from Cancer Research UK about the extent of the problem and what she’s learnt about overcoming the hurdles.
Central to success? Reliable data in trials
Since the 1990s, many sponsor companies have chosen to outsource their sample testing to central laboratories. Capable of handling logistics as well as data management, these labs often function as a one-stop shop for a wide range of essential requirements. But how does this framework compare with specialised local laboratories? Clinical Trials Insight explores the pros and cons of each with business management expert Robert Hoek, global outsourcing manager for Roche.
Check the forecast: supply challenges
As clinical trials go global, pharmaceutical companies face a range of supply challenges, from decreased availability of complex investigational products, to variable patient demands and the need for expensive comparators. In this new climate, planning ahead and correctly predicting demand is essential. Oliver Hotham speaks to David Gilliland, director of clinical supply operations at Daiichi Sankyo, about how the increasing size and scope of studies has impacted supply chains and the novel approaches used to manage them.
Same difference: biosimilars market growth
The biosimilars market is set for massive growth as the patents for a wide range of biologics expire in the near future. But what does this mean for the world of clinical trials? Clinical Trials Insight speaks to Richard Markus, vice-president of global development, head of research and development for biosimilars at Amgen, to hear about the challenges – and the opportunities – these products present.
Chain reaction: safety in logistics
With the increasing popularity of biologicals in clinical trials, difficulties are emerging when it comes to adhering to good distribution practice guidelines and multinational regulations. Clinical Trials Insight meets Rafik Bishara, chair of the Pharmaceutical Cold Chain Interest Group, to discuss strategies for the timely and safe delivery of biological products to trial sites.
A visible difference: clinical packaging
The current biosimilar labelling policy in the EU and the US includes no detail of the data used to demonstrate similarity to the reference product, potentially causing confusion for doctors and patients. The European Association for BioIndustries (EuropaBio), with colleagues from AbbVie, Amgen and Pfizer, explores the need for sufficiently detailed and transparent information on the packaging of these medicines.
Smart thinking: data management
Mobile technology has the potential to make clinical trial studies cheaper, easier and more accurate, but what sort of technology will be most beneficial for clinical trial leaders? Craig Lipset, head of clinical innovation within worldwide research and development at Pfizer, shares his views on the smart revolution with Nic Paton.
Adverse reactions: drug safety
Pharmacovigilance is an increasingly important tool to improve drug safety for patients and reduce risk within pharmaceutical medicine. Albert Wertheimer, professor of pharmacy at Temple University in the US, talks to Natalie Healey about how pharma’s shifting focus to more individual treatments will impact the future of the field.