The National Institute for Health and Care Excellence (NICE) serves as the U.K.’s primary auditor for drug products, ultimately deciding whether or not the value and efficacy of each drug is worth the cost. With this information, it is evident why pharma companies have historically expended a significant amount of resources toward staying within NICE’s good graces; however, the Institute has recently released a statement and corresponding guidance requesting more transparency.
NICE has established a requirement for new drug submissions to include a signed document “declaring that all clinical trial data have been identified.” If the data provided by the submitter is deemed insufficient for the drug appraisal process, the agency will contact the European regulatory authorities directly to obtain the information, as NICE’s statement suggests.
Although these new requirements will likely add to the existing tension between the agency and major pharma companies, NICE hopes to see an upward trend in transparency as part of the AllTrials campaign effort to register and report the results of all past and present clinical trials.
Click here to read NICE’s statement. For more information, read Arlene Weintraub’s article on fiercepharma.com.