2Other unit staff Marion Campbell Craig Ramsay Adrian Grant And all of you!
3What is Practihc? Pragmatic Randomised Trials in Health Care Systems Funded by the European Commission's 5th Framework Programme for international collaboration with Developing CountriesAn international research and technology development (RTD) network to facilitate information for action on priority health problems
4What is the purpose of the project? (1) To improve partner countries health systems by increasing their capacity to evaluate health care delivery systems, specific health policy, public health and clinical choices and identify those options which are effective
5What is the purpose of the project? (2) To develop the global science of pragmatic RCTs and promote inclusion of their findings as an element in health care decision making
6What is the purpose of the project? (3) To promote RTD co-operation internationally by consolidating a network of established centres with expertise in RCTs, and to extend this network to support the achievement of scientific excellence and real world health system decision making relevance in neighbouring countries.
8Specific scientific and technological objectives (1) To locate or develop tools and resources to support development and use of pragmatic RCTsTo study up to 100 partner experiences in pragmatic RCTsTo systematically review the published literature on conduct of RCTs in developing countries
9Specific scientific and technological objectives (2) To develop and pilot a programme of workshops on the design and conduct of trialsTo promote the science of pragmatic randomised trialsTo reinforce scientific and technological co-operation between researchers in developing countries and in the European Community
10HSRUs contribution To locate or develop research tools and resources to aid the design of pragmatic trialse.g.Trial protocol templateGuidelinesChecklistsSoftwareInformation resourcesExamples
11Search strategy WWW search Ask known trialists and trial co-ordinators Practihc partnersNOTE: Not a comprehensive search
12Evaluation criteria Relevant to pragmatic trials Relevant to developing countriesGuidelines and checklists should be evidence based and not supercededSoftware should be free, user friendly, can be downloaded, can be packaged, and works.
13Trial protocol template A trial protocol template has been developedusing a variety of resources including:A web search for existing protocol templatesReview of existing trial protocolsConsultation with trial-co-ordinators
14Guidelines Declaration of Helsinki ICH GCP EU Data Protection Act Consort StatementGuidelines for clinical trials in South AfricaDeveloping Written Information for PatientsGood Practice Guidelines
15ChecklistsInitial search concludes that many checklists located are too specific and not relevantWill need to develop checklists for the purposes of practihcChecklists for each section of the protocol template have been developed within the context of ‘things to consider when writing a protocol’
16Software Software located: Randomisation programs Sample size calculator (HSRU)Data management and analysis tool (EpiInfo)Software to be commissioned:Budgeting toolProject management tools e.g. Gantt chart and monitoring tool
17Information resources Resource Centre for Randomised Trials (RCRT)TrialsCentralMRC Trials Managers’ NetworkThe Cochrane libraryDirectory of randomisation software and servicesUK Clearing House on Health Outcomes
18Examples Participants information leaflets Informed consent forms Recruitment strategiesParticipant retention strategiesDummy tablesSample size justificationsProgress and final reports
19PRACTiHC website www.practihc.org The collaboration will make all tools and resources accessible to people planning evaluations of health care interventions via the PRACTiHC website