Research Governance Framework

The development of NICE in the UK is being watched keenly throughout the world to see if this organisation will have an indirect effect on reducing healthcare costs. There has been a perceived reduction in competitiveness in the UK pharmaceutical industry over the past few years, and to this end the ABPI and the Department of Health (DoH) established the Pharmaceutical Industry Competitiveness Task Force in April 2000. The first reports of the Task Force have established of the DoH Research Governance Framework, as well as further regulatory improvements complying with the EU GCP Directive. 

The next step is to identify the sponsor as defined in the Research Governance Framework (Department of Health, 2005) and SI 2004 1031. The identity of the sponsor is required for both the ethics application and EudraCT database. All drug trials should register with the EudraCT database. Where the trial has co-sponsors, these should be identified. The MHRA algorithm (MHRA, 2006) will enable researchers to decide whether the trial is under UK regulation. 

Department of Health (2005). Research Governance Framework for Health and Social Care. http //www.dh.gov.uk/assetRoot/04/12/24/27/04122427.pdf (accessed 13 August 2006). 

Mayor S. 2000. New governance framework for NHS research aims to stop fraud. BMJ 321 725. 

Traditional cost-effectiveness indices such as expected cost per expected number of lives saved provide useful insight, but as pointed out by many analysts and researchers, cost-effectiveness indices based on expected values are not sufficient for evaluating cost-effectiveness. Uncertainty must be considered beyond the cost-effectiveness indices. The main problem is that the expected values are conditional on specific background knowledge, and the expected values could produce poor predictions. Surprises may occur, and by just addressing expected values such surprises may be overlooked (Aven 2007, 2008). We also find similar ideas underpinning approaches such as the risk governance framework (Renn 2008) and the risk framework used by the UK Cabinet Office (Cabinet Office 2002). 

This research was carried out in the lAP-PAl framework funded by the Belgian government and the DWTC office. 

Figure 7.1 is adapted from the red book (actual title Risk Assessment in the Federal Government Managing the Process ). The committee offered this figure as a depiction of the broad framework under which the three major activities necessary to protect public health from the hazardous properties of environmental chemicals (very broadly defined) - research, risk assessment, and risk management -should be organized. The committee further emphasized that the three involve quite discrete sets of analytical undertakings, and serve different purposes, so that efforts should be made to reduce the chance of inappropriate influence of one upon another. Thus, for example, risk... 

Despite mission statements to the contrary, it often appears that the goal of the pharmaceutical industry is to protect its interests and exploit the incentives embedded in the framework that governs and supports it. It often develops in conjunction with other research establishments, manufactures, markets, and distributes drugs that may benefit most those suffering in the developed world - not necessarily those in developing countries. 

---