Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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Appendix J: Discussion Paper: Novel Ways to Get Good Trial Data: The UK Experience
Appendix J: Discussion Paper: Novel Ways to Get Good Trial Data: The UK Experience
Pages 211-224
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From page 211... ...
2 Participants in the activities of the IOM Forum on Drug Discovery, Development, and Translation. This discussion paper is based on a submission to the Forum's November 2011 workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States: Estab lishing an Agenda for 2020, to inform the workshop discussions surrounding international case studies in the area of clinical research transformation.
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and to develop clinical disease registers and managed clinical networks (Morris et al., 1997) , but more recently record-linkage has been seen as an accurate way to track the outcomes of subjects randomised in clinical trials (Ford et al., 2007; West of Scotland Coronary Prevention Study Group, 1995)
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The benefit of using such a system is that large populations of patients who meet the inclusion and exclusion criteria for a study can be screened efficiently and invited to participate. Thus, in the SCOT study, for exam ple, more than 630 family practices, representing a total population in excess of 4 million patients, have signed research contracts and had their records electronically searched to identify suitable study subjects.
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Engaging Patients in Research A major hurdle facing streamlined studies (as well as other clinical studies) is how to engage patients in the health research agenda.
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Because of this, streamlined studies have to limit recruitment to older subjects preferably with additional risk factors in order to limit the size and duration of the trial to reasonable parameters. As with all studies that restrict inclusion of subjects, the generalisability, or external validity, of such studies is reduced by such restrictions.
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Randomising Family Practice Prescribing or Cluster Randomisation In the United Kingdom, family practices invariably adopt a limited list or practice formulary of medications to which their practice computer systems default when they prescribe. These formularies are often derived from regional formularies which in turn are derived from the recommendations of bodies such as the Scottish Medicines Consortium (SMC)
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This is a British Hypertension Society Research Network study titled A Randomised Policy Trial to Evaluate the Optimal Policy Diuretic for the Treatment of Hypertension. This trial seeks to formally evaluate the new proposals from NICE to change diuretic therapy for hypertension in the United Kingdom from bendroflumethiazide to chlortalidone or indapamide,7 guidance which has been criticised for having a poor evidence base (Brown et al., 2012)
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This means that the trial sponsor has no way of determining which patients experience serious adverse events. However, family doctors can still report such events directly to the regulatory authorities in an anonymous fashion.
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This system worked well and has stimulated other study designs that could be adapted. An example is the British Hypertension Society Research Network Treatment In the Morning versus Evening (TIME)
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Table 1 summarizes the pros and cons of each of the trial designs discussed above. CONCLUSION Most of the design concepts presented here have been implemented by us at least into the pilot phase.
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vaccination: A safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes. British Journal of Clinical Pharmacology (Nov 15)
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222 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE BOX 1 Patient Recruitment/Public Engagement Initiatives That Have Not Worked in Our Experience • Television campaigns aimed at engaging patients (Mackenzie et al., 2010) -- Very costly, raised awareness but did not change recruitment • Advertisements in local and national newspapers and local radio -- Costly, ineffective, and attracted small numbers of mostly unsuitable subjects • Publicity for clinical trials in local newspaper articles -- Attracted mostly unsuitable subjects • Study-specific websites (i.e., http://www.scottrial.co.uk/)
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D • ot suitable for all health outcome N need a clinical trials studies authorisation Prospective • onsented subjects C • educed data privacy issues R observational • atient-reported P • utcomes need to be validated (via O follow-up outcomes family doctor) and coded studies • ble to contact A • ase of capture of further data E patients • T and clinical support resource I • arge cohorts & L issues frequent e-mail • ay not be representative of the M contact population • atients self-selected P • ot randomised N & more likely to take part in other research • bserves normal care O Internet-only • heoretically feasible T • ust comply with clinical trials M randomised • nexpensive I legislation trials of drug • atient-driven P • ata-quality assurance required D therapy recruitment • equire family doctor assent R • ecruited by targeted R • eed to engage public in research N advertising (i.e.
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