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LATEST NEWS
HHS awards $17 million for patient-centred outcomes research
03 September 2010
The US Department of Health and Human Services (HHS) will award three grants and cooperative agreements totalling nearly $17 million, for patient-centred outcomes research (PCOR), or research that compares treatments and strategies to improve health outcomes for patients. The three-year funds, made ...
NIH expands US research network...
Collaboration formed to better match trial patients through ...
European Commission urged to expand clinical trials initiative focusing on Africa
24 August 2010
The European Commission is being urged to expand the scope of an EU research and development programme that was set up to accelerate the development of new drugs against HIV/AIDS, malaria and tuberculosis and that focuses on conducting clinical trials in Sub-Saharan Africa. The European and ...
Trials held back by regulations says Canadian research director
19 August 2010
Overwhelming regulations surrounding the safety of patients in clinical trials is discouraging new studies and could hold back the development of new drugs, according to an article in this July's Canadian Medical Association Journal (CMAJ). The editorial was written by CMAJ's editor-in-chief, Paul ...
Japan's clinical data managers benefit from GCDMP translation
18 August 2010
The not-for-profit Society for Clinical Data Management (SCDM) has published a Japanese translation of its award-winning Good Clinical Data Management Practices (GCDMP) resource, giving clinical data managers in the country their first up-to-date collection of best practices in their local language ...
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FEATURES
Strategies for successful FDA-approved labelling with patient reported outcomes
13 August 2010
Any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else, is a patient-reported outcome (PRO). A PRO instrument is a measuring scale or questionnaire that serves as a means to ...
Reflection and recommendation; foreign trial data under scrutiny
08 July 2010
The integrity of clinical trial data is never far from the spotlight these days, with companies and regulators coming under increasing pressure to be more transparent in how they report and publish trial results. Now attention is increasingly turning to the global stage. As the number of clinical ...
The Chinese climate for clinical trials
21 June 2010
China is the world’s second-largest economy and has a pharmaceutical industry that has grown by approximately 22% annually over the past five years. Industry analysts predict that in 2010, the total value of the global pharmaceutical market will grow by 4-6%, to more than $825 billion. China, at ...
Optimising country selection: the strategic importance of a feasibility database
26 May 2010
One of the chief challenges for clinical trials is the development of an optimal country distribution plan, Kendle ’s Chantal Demblon and Louise Bissett-Bryson explore the best strategies. To assess the appropriate countries for a specific protocol or study design on a daily basis is easy to do ...
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PEOPLE
Advanced Clinical names new VP
CRO Advanced Clinical , has named Julie Heneghan as vice-president. Heneghan has been in the outsourcing and staffing solutions industry for more than 20 years. As vice-president, she will be responsible for overseeing the strategic planning and direction of the US Midwest and Eastern division and ...
Outcomes Health strengthens IT team
Outcomes Health Information Solutions , a data abstraction and analytics company working with CROs and pharmaceceutical companies, has named David Jeans as the new vice-president of data management and chief enterprise architect. Jeans is responsible for leading the execution and enhancement of ...
Prism appoints Nigel Brooksby as non-exec chairman
Drug development consultancy Prism Ideas , has appointed Nigel Brooksby , as non-executive chairman. Brooksby has more than 35 years experience in the life sciences industry, culminating in his position as chairman and managing director for Sanofi-Aventis UK and leading the UK's Association of the ...
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COMMENTARY
MHRA Guidance; impacts for the central lab
Our quality assurance officer in Europe, Elizabeth Atkin , and I attended the MHRA conference – GCP for Clinical Laboratories – Clinical Pursuits in York, England, at the beginning of the year. The various sessions throughout the day provided comprehensive overviews of how the clinical trials ...
As Scott Reuben faces jail, just how common is fraud in clinical trials?
Last month, the prominent and pioneering anaesthesiologist Scott Reuben , chief of acute pain at Baystate Medical Centre , was sentenced to six months in prison for falsifying the data in, or entirely inventing, dozens of clinical trials. In the end, what caught Reuben was an audit of two papers ...
As wages increase, is China still a good location for clinical trials?
The recent condemnation by Charles River Laboratories ' largest shareholder of that company's proposed acquisition of the leading Chinese CRO, WuXi PharmaTech , raised questions about whether companies are being too optimistic about the potential of China as a location for clinical research and the ...
Publication bias on the agenda again
IQWiG , the German health technology assessment institute, has renewed its call for legislation to make the prospective registration of clinical trials mandatory and to compel trial sponsors to publish the full results of all trials in a results database. The demand comes in a new study, published ...
Decision time: how to take the EDCTP forward
A proverb attributed to the Chinese philosopher Lao Tsu says: give a man a fish and you feed him for a day; teach a man to fish and you feed him for a lifetime. That sentiment could well be applied today to the provision of medicines for diseases that predominantly affect resource-poor countries, ...
Challenges and breakthroughs in IBD
Inflammatory bowel disease is a term used to cover two specific conditions that are both chronic diseases that affect the gastrointestinal tract – Crohn's disease and ulcerative colitis. The main difference between them is the area of the gut that they affect. In Crohn's disease, the inflammation ...
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EVENTS
Clinical trial supply Asia 2010
14 September 2010
Singapore
Children's Medicines Working Party
28 September 2010
London, UK
Drafting and negotiating clinical trials agreements
09 November 2010
London, UK
