Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
In our December/January issue, View from Brussels columnist Peter O’Donnell writes about discussions in November that surrounded antibiotics and anti-microbial issues. The article briefly touched on the lack of engagement from sponsor companies because of the lack of incentives. While public-private partnerships such as the European Innovative Medicines Initiative (IMI) are considered a plus, examination of other approaches, such as the use of transferable patent vouchers, or even paying more for antibiotics, should be explored.
The disengagement of major drug firms is described as “a type of market failure” in a briefing paper published last month by the UK think-tank Chatham House. “A new sustainable business model would be key to fueling antibiotic development,” says its author, Gemma L. Buckland Merrett. In her view, prerequisites are clear market signals to stimulate R&D, and delinking the cost of R&D from sales revenues. “In order to correct current misaligned incentives, the right institutions, incentives, cost- and risk-sharing, and funding mechanisms are needed.” John H. Rex of AstraZeneca, speaking on the economics of antibiotics at the EMA meeting, put it like this: “We can’t make companies do this work... we have to make them want to do this work.”
A challenge unmet
It is now nearly two years since the European Union launched an initiative boldly titled “The Microbial Challenge—An Emerging Threat to Human Health,” with ambitious goals for collaboration among policy-makers, healthcare agencies, the research community and the drug industry. But despite its long list of recommendations for working together to boost research, more than 25,000 people are still dying each year in the EU from resistant infections. And the problem continues to grow, in terms of human suffering and social costs. Some progress has been registered in reducing the indiscriminate use of antimicrobials that contributes to resistance. But, as the Council recognized, that is only part of the challenge. The development of resistance and the emergence of new infections are unavoidable facts of life. The reality is that so far, little has been done to respond to these inevitabilities.