Verteporfin photodynamic therapy for neovascular age-related ...

DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6191Appendix 3Key observations and recommendationsarising from an interim project review of thestudy (1 July 2005)It is worth noting that it was not possible to undertake a truly comprehensive review. In thewriting up of this report, a number of other issues have come to light and been discussed butthese have not been included. If the NCCHTA wish to further explore some of these issues then itwould be possible to seek additional feedback from the individuals most closely involved both inthe implementation of the Cohort Study and the service within the NHS.Key observations1. This is an example of how a number of influential people and organisations anticipatedthat there could be major problems with the introduction of a new treatment and aimedto deal with the issues proactively. Despite this foresight and attempts to avoid problemsarising, introducing both the treatment and the cohort study has been one of the mostdifficult exercises.2. The model developed in the cohort study can be used to meet many of the needs of theNHS in the introduction of an expensive therapy by providing postmarketing surveillance, amanaged introduction to standard treatment protocols, evidence of effectiveness in routineclinical practice and data for optimisation of treatment protocols.3. Two important communications problems arose which complicated implementation:a. The NICE guidance did not explicitly refer to the cohort study.b. The Department of Health did not explicitly support the cohort study nor did it issueclear directions in relation to it. In particular, this left those tasked with setting up thecohort study without any mandate to implement it in the NHS.It is not clear why NICE and the DOH did not feel able to provide this explicit support.4. It is not clear:a. Why NICE did not recommend a RCT and why the National Coordinating Centre forHealth Technology Assessment was willing to support a cohort study instead of a RCT.b. Why the cohort study was seen as the best option.5. There was initial hostility to the cohort study from many of the clinicians, in part because oftheir general reluctance to gather clinical data and in part because they perceived the cohortstudy to be a threat to their clinical freedom. Many, but not all, have since changed that view.6. During the implementation of the cohort study, significant weaknesses in the capabilitiesof clinicians, clinical teams and trusts in understanding the principles and practicality ofgathering systematic information were identified.7. Commissioners were initially unsupportive of the cohort study. This probably stemmed froma lack of understanding of what it was trying to achieve. Some have remained indifferent toit. The lack of clarity about the aims and objectives of the cohort study meant that interests ofcommissioners were never made explicit.8. Both patient groups and the manufacturer (Novartis) were also initially hostile to the cohortstudy, although patient groups were not initially averse to the idea of a RCT. From the© Queen’s Printer and Controller of HMSO 2012. This work was produced by Reeves et al. under the terms of a commissioning contract issued by theSecretary of State for Health.