Weighing up the risks and benefits of bringing new drugs to market
University of Hertfordshire publishes universal framework for regulatory authorities to use when commissioning new medicines
Professor Sam Salek at the University of Hertfordshire has published a universal framework for global regulatory agencies and the pharmaceutical industry to use when weighing up the benefits and risks of bringing new medicines to market.
In the book Benefit-Risk Assessment of Medicines, a collaboration with Professor Stuart Walker, Centre for Innovation in Regulatory Science, London and Dr James Leong, Centre of Regulatory Excellence, Singapore, Professor Salek calls for the framework to be taken up worldwide to speed up the currently disjointed decision-making process around the commissioning of new drugs.
It is hoped that the framework will streamline practices globally and give all patients worldwide equal access to new, potentially life-saving treatments. ‘This new universal framework could have a huge global impact on policy,' said Prof Salek. 'The issue of benefit-risk assessment when deciding whether to bring new medicines to market is a hot topic and, for years, regulatory bodies have been struggling to find the best model to use, meaning that a huge gap exists between countries when it comes to patients accessing new medicines.
‘We have developed a comprehensive system that can be adopted universally, so that the currently non-structured non-transparent decision-making process on new medicines can be streamlined and speeded up. We hope that this will result in significant and potentially life-saving drugs reaching patients more quickly and ultimately all regions of the world being on a level playing field,’ he added.
During the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a universally recognised, structured, standardised approach, although until now this has not existed.
The universal framework examines a number of factors, to decide whether or not the benefits of a medicine outweigh the risks, including efficacy, clinical relevance, safety and responsiveness of patients to treatment. The book also reviews the strategies of major regulatory authorities (US FDA, EMA, Australia and Health Canada) for communicating benefit-risk decisions to stakeholders and how they can be improved using the newly developed template.