Steve Healy and Karen Adams, from SCA Cool Logistics, discuss how supply chain partners provide specialised insights into the safe and effective transport of clinical trial materials around the globe, and are continuing to expand into the Middle East, the region which acts as a gateway from West to East, and which is also becoming more of a potential subject base.
Currently, the majority of clinical trial sites in the United States use paper cheques as their primary method of payment. Samuel Whitaker, Co-Founder & Chief Executive Officer at Greenphire, overviews the conventional subject payment process, identifies its shortcomings, and discusses how new electronic payment solutions are set to revolutionise subject payment in clinical trials.
Large molecule drugs are complex, biologically synthesised pharmaceutical compounds. Owing to their complexity, large molecule drugs, such as proteins and antibodies, can be efficiently analysed using indirect immunochemical/ligand binding techniques. However, these techniques are time-consuming, creating an additional burden for bioanalytical applications. Chris Beaver, Director of Immunochemistry Services at PharmaNet, summarises the challenges of managing commercially available research grade kits during clinical trials and outsourcing to contract research organisations.
With many thousands of experienced investigators globally, and innumerable completed studies, why do we need to be particularly concerned with assessing the feasibility of a clinical trial? Dr Guy Patrick MD PhD, Chief Executive Officer and Chief Medical Officer of Centrical Global Clinical Trials, explores significant pressures that have been building within the clinical trials industry to drive greater cost efficiencies and to ensure delivery of complete and quality data on time and on budget.
Twenty years ago, research sites alone would provide their total enrolment quota simply by reaching into their own database of patients. But in the last two decades, the clinical trial landscape has changed and the ripple effect has meant that sites need to go outside their practice for patients. Scott Connor, Vice President of Marketing, and Joe O’Rourke, Manager of Customer Solutions, at Acurian, consider the reasons why additive patient recruitment is no longer a nice-to-have or a rescue solution.
The essential background of technology is being masterminded by specialists in the exacting science of cryogenics. Patrick Jackson, a qualified engineer at Vindon Scientific, explores how technology is often reliant on the expertise of one or more partners joining forces to improve overall resources.
Maria Toloudi, Marina Chatziioannou and Loannis Papasotiriou, of Research Genetic Cancer Centre Ltd, investigate the efficacy of Anvirzel™, an extract of Nerium oleander, in more than 35 different human cancer cell lines, including all types of tumours, and how the drug has a wider field of action in other cancer cell lines.
Dr James Sawyer, CEO of Prism Ideas, explores the effect of the completion of the human genome project in 2003, and how the field of personalised medicine has been advancing at a fast pace, with scientists and clinicians gaining critical insight into the biology of numerous medical conditions. This knowledge, combined with the long-known fact that risk of disease and response to treatment varies from person to person, has enabled the development of personalised medicine, with oncology being one of the fields reaping the greatest benefits.
Bacterial resistance to traditional antibiotics over the last twenty years has reached unprecedented heights. For the first time since the discovery of penicillin, some bacterial infections such as MRSA can be considered untreatable. Other major pathogen species are displaying similar increases, which is causing considerable concern. Such a worrying scenario has fuelled the search for alternative antimicrobials. One such option is the development of cationic antimicrobial peptides (CAPs). John T George, D Rowley and R Zheng of University of East London (UEL) review the challenges that this class of antimicrobials face in order to become viable alternatives to the traditional antibiotics.
For many years, submissions have been prepared in accordance with the specific national requirements of the countries where the medicinal products are to be marketed. Increasing co-operation among the regulatory authorities, spurred on by initiatives such as ICH, have looked at ways of reducing time-consuming reworking of data for each region and focused on producing a harmonised set of requirements. Tim Felgate, Regulatory Intelligence Consultant at Applied Regulatory Consulting Ltd portrays the sometimes painful transition from paper to electronic submission dossiers, and the potential future trends.