These include lengthening the patent time for new drugs, examining alternative methods of investigating application to novel indications, removing the requirement for a 6-month, placebo-controlled trial before licence approval (moving Europe into line with the US), and revising the regulatory route by examining alternative methods of investigating application to novel indications leading to provisional approval. Smaller RCTs, cohort and case-control studies could also play a role in contributing to the information that underpins Inhibitors,research,lifescience,medical the licensing evidence base [Harbour and Miller,

2001]. Others have suggested that new drug development should in part be driven along the lines of strategic long-term health needs. Recommendations might include allotting public funding for drug PF-562271 in vitro trials Inhibitors,research,lifescience,medical based on the clinical need to establish evidence based data [Segman and Weizman, 2008], or awarding provisional approval

that could be withdrawn if satisfactory clinical data did not later validate clinical benefits or long-term safety [Wood, 2006]. Inhibitors,research,lifescience,medical While the motives for the growing practice of ‘repurposing’ are often strategic and financial [Oprea and Mestres, 2012], considering complementary trials for potential secondary indications and excluded groups, earlier on in the medicines licensing process should also become more common place Inhibitors,research,lifescience,medical [Stafford, 2008]. There is a need for strong

drug regulation. The MHRA and other regulatory authorities have their origins in the medicines disasters of the early 1960s and the establishment of the Committee on Safety of Drugs (CSD) in 1964. These systems are essential to protect Inhibitors,research,lifescience,medical patients, but it can be argued that in an effort to do so they have become overly restrictive and the licensing system is now inhibiting positive clinical developments. At present clinical trials are commonly designed to show the short-term efficacy and safety of a novel drug under optimal clinical situations aminophylline in contrast with no treatment (placebo), to fulfil regulatory standards for drug authorization and marketing [Segman and Weizman, 2008]. Participants are usually recruited using highly restrictive criteria including only a single diagnosis, no comorbidity or substance misuse, and being able to reliably attend long-term follow up. Such features are not generalizable to routine clinical practice. Medicine licensing needs to relate better to real-world patients and clinical use [Chen et al. 2009]. A more pragmatic approach could be to include patients with multiple diagnoses and other heterogeneity. Establishing an accessible evidence base that associates a drug with a specific but off-label indication has already been recommended for children [Tishler and Reiss, 2011].