NICE demands more transparency from pharma
- There has been an ongoing demand in the UK for more clinical trial transparency, including the creation of the AllTrials register, which calls for registration of all past and present clinical trials.
- NICE is currently updating guidance on how much data will be needed so that it can properly conduct a full-scale appraisal of a drug’s value and cost-effectiveness.
- Now, when a pharma company submits a medication or therapy for review, the company’s medical director must sign a declaration stating that they have identified and included all available clinical trial data.
The demand for greater clinical trial transparency is growing to a crescendo as the AllTrials petition gains more and more signatories. So far, approximately 80,000 people and 500 organizations -- including NICE -- have signed on to the petition. The sole pharma company signatory is GlaxoSmithKline.
One flashpoint in this continuing controversy was Roche’s refusal to release all of its Tamiflu data to the Cochrane Collaboration. This fueled the widely held contention that Tamiflu is not cost-effective. Increasing pressure on the sector and the clarion call for clinical trial data transparency will likely shift industry behavior over time.
- pharmafile.com NICE seeks more trial data from pharma