Applied Clinical Trials
With the expectation of a new ‘pharmaceutical strategy for Europe’ in the fall, the management and design of clinical trials feature prominently among the issues the strategy is expected to cover.
The European Union is planning to deliver a new ‘pharmaceutical strategy for Europe’ in the autumn-and the management and design of clinical trials feature prominently among the issues the strategy is expected to cover.
Some clues emerged on June 16 of what EU officials’ thinking is on the subject, when a consultation document appeared seeking public views on a wide range of pharmaceutical-related issues that-it says-“cover the whole life-cycle of pharmaceutical products from scientific discovery to authorization and patient access.”
On clinical trials, the document-a survey designed to elicit views from a wide audience-explains carefully what is involved before going on to pose specific questions.
“Clinical trials are investigations in humans to discover if a new medicine is safe and effective”, and “can also be used to test if a new treatment is more effective and/or safer than the standard treatment”, it says. It adds that “‘pragmatic clinical trials’ can be conducted to compare the safety and effectiveness of different standard treatments in a real-world setting.”
“How could clinical trials in the EU be driven more by patients’ needs while keeping them robust, relevant and safe for participants?” asks the survey, offering a range of choices. These include providing more national support for the conduct of pragmatic trials, “with the aim to optimize treatment to patients”, and “better coordination for larger trials comparing different treatment strategies (covering medicines and other treatments such as surgery, radiotherapy, physiotherapy)”.
There is an emphasis on the personal as well as the scientific aspect. Should, the survey asks, involve “patients’ experiences in early phases of medicine design (e.g. factor-in how the disease affects their lives and develop medicines to target symptoms that are particularly important to patients)”? Should more trials be designed to “collect information on medicine tolerability or the impact of a treatment on the quality of life”? Or should consideration be given during the design of a trial to “the burden of trial participation on patients’ life”?
It also suggests providing support for non-commercial organizations to conduct clinical trials in fields where financial interest is weaker.
The survey also canvasses views on support for innovative research and development, asking for a ranking of options that include research and development incentives via intellectual property or market exclusivity rights for pharmaceutical companies. Other options offered are a more adaptive legislative framework for new technologies and advances in science, simplified requirements for clinical trials, more public funding for research, and support for wider research collaboration, private-public partnerships or medical research start-ups. And on promoting R&D for unmet need-notably in rare diseases or pediatric care-the options listed are market protection from competition, intellectual property protection, clinical data protection, economic support to companies, funding of more targeted research, or agreeing on a common understanding of unmet need.
The online consultation is open for three months.