Getting involved in clinical trials research in the UK: how can Clinical Research Networks help?
Ontology highlight
ABSTRACT:
SUBMITTER: Hull MA
PROVIDER: S-EPMC5517261 | biostudies-other | 2012 Apr
REPOSITORIES: biostudies-other
Similar Datasets
Project description:OBJECTIVE:To determine levels of public registration for a cohort of clinical trials reviewed and given a favourable opinion by research ethics committees in the United Kingdom. STUDY DESIGN:Audit of records. SETTING:Clinical trials receiving a favourable ethics opinion between 1 January 2016 and 30 June 2016. MAIN OUTCOME MEASURES:Correlation between trials on the UK research ethics committee database and any primary registry entry on the WHO International Clinical Trials Registry Platform or clinicaltrials.gov as of 29 August 2017 (14 to 20 months after the favourable ethics committee opinion). RESULTS:Over the study period 1014 trials received a favourable ethics opinion, with 397 (39%) registered on the European Union Drug Regulating Authorities Clinical Trials database, and 18 with an agreed clinical trial registration deferral. Excluding these trials, the total number subsequently requiring registration was 599, and of these 405 (40% of total) were found to be registered. Follow-up with the 194 investigators or sponsors of trials not found to be registered produced 121 responses with a further 10 (1%) trials having already registered, 55 commitments to register and a variety of other responses. The overall registration rate was therefore 80%. CONCLUSIONS:Despite researchers and sponsors being reminded that registration of clinical trials is a condition of the research ethics committee (REC) favourable opinion, one-fifth of clinical trials either had not been registered, or their registration could not easily be found, 14 to 20 months after receiving the favourable opinion letter. The methodology trialled here proved effective, and although there are positive indications of a culture change towards greater registration, our results show that more still needs to be done to increase trial registration.
| S-EPMC6398673 | biostudies-other
Project description:ObjectivesTo assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees.DesignReview of original research protocols.Study selectionUnpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicinal products submitted to research ethics committees in the United Kingdom during 1 January to 31 December 2009.Main outcome measuresCompleteness of reporting of the sample size determination, including the justification of design assumptions, and disagreement between reported and recalculated sample size.Results446 study protocols were reviewed. Of these, 190 (43%) justified the treatment effect and 213 (48%) justified the population variability or survival experience. Only 55 (12%) discussed the clinical importance of the treatment effect sought. Few protocols provided a reasoned explanation as to why the design assumptions were plausible for the planned study. Sensitivity analyses investigating how the sample size changed under different design assumptions were lacking; six (1%) protocols included a re-estimation of the sample size in the study design. Overall, 188 (42%) protocols reported all of the information to accurately recalculate the sample size; the assumed withdrawal or dropout rate was not given in 177 (40%) studies. Only 134 of the 446 (30%) sample size calculations could be accurately reproduced. Study size tended to be over-estimated rather than under-estimated. Studies with non-commercial sponsors justified the design assumptions used in the calculation more often than studies with commercial sponsors but less often reported all the components needed to reproduce the sample size calculation. Sample sizes for studies with non-commercial sponsors were less often reproduced.ConclusionsMost research protocols did not contain sufficient information to allow the sample size to be reproduced or the plausibility of the design assumptions to be assessed. Greater transparency in the reporting of the determination of the sample size and more focus on study design during the ethical review process would allow deficiencies to be resolved early, before the trial begins. Guidance for research ethics committees and statisticians advising these committees is needed.
| S-EPMC3604970 | biostudies-literature
Project description:ObjectiveTo evaluate a training intervention aimed at improving healthcare professionals' communication with cancer patients about randomised clinical trials.DesignBefore and after evaluation of training programme.SettingMembers of the National Cancer Research Network, Scottish Trials Network, and the Welsh Cancer Trials Network.Participants101 healthcare professionals (33 clinicians and 68 research nurses).InterventionFour modules delivered by a trained facilitator using videotapes and interactive exercises to cover general issues about discussing randomised clinical trials with patients, problems specific to adjuvant trials, trials with palliation as the goal, and trials where patients had a strong preference for one treatment arm.Main outcome measuresBefore and after the intervention, participants were videotaped discussing a trial with an actor portraying a patient. These consultations were assessed for presence of information required by good clinical practice guidelines. The actor patients gave an assessment after each interview. Participants reported their self confidence about key aspects of trial discussion.ResultsAnalysis of the videotaped consultations showed that, after intervention, significantly more participants displayed key communication behaviours such as explaining randomisation (69 v 81, odds ratio 2.33, P = 0.033), checking patients' understanding (11 v 31, odds ratio 3.22, P = 0.002), and discussing standard treatment (73 v 88, odds ratio 4.75, P = 0.005) and side effects (69 v 85, odds ratio 3.29, P = 0.006). Participants' self confidence increased significantly (P < 0.001) across all areas. Actor patients' ratings of participants' communication showed significant improvements for 12/15 key items.ConclusionThis intensive 8 hour intervention significantly improved participants' confidence and competence when communicating about randomised clinical trials.
| S-EPMC549112 | biostudies-literature
Project description:ObjectiveTo investigate the length of time taken to open UK research sites in multicentre clinical trials and to identify reasons for any delays.DesignA case study, recording key milestone dates from the time a site receives ethical approval through to opening to recruitment. Delay reasons were prospectively logged by trial staff at a minimum of fortnightly periods using a coding system.SettingSANADII, a phase IV pragmatic trial, managed by the Clinical Trials Research Centre, Liverpool. The trial seeks to work with over 100 National Health Service (NHS) sites to meet its recruitment target of 1510 patients.Outcomes and analysisThe primary outcome was time from Multicentre Regional Ethics Committee (MREC) approval to site opening using survival analysis. Where sites took over a specified time to reach milestones (>3 months from MREC to Site Specific Information (SSI) submission, >30 days from SSI validation to local R&D approval, or >30 days from local Research and Development (R&D) approval to opening to recruitment), the longest continuous delay during that milestone was identified.ResultsThe median opening time for participating sites was 9.7 months (IQR 6.2 to Not Reached). SSI submission took 7 months (IQR 4.1-12.3) from ethics approval, R&D approval took 16 days (IQR 5.0-32.0) from SSI validation and site opening took 15 days (IQR 8.5-40.0) following R&D approval. The longest delays before SSI submission resulted from negotiating excess treatment costs, finalising logistics, collecting CVs and ongoing participation discussions.ConclusionsWhile recently imposed targets are reducing the time taken for R&D departments to approve valid applications, the time taken to open UK research sites remains excessive and must be reduced. At present significant public funds are being used inefficiently in order to navigate NHS systems, challenging the resolve of trial teams and the competitiveness of the UK.
| S-EPMC4166133 | biostudies-literature
Project description:BackgroundFat deposits enable a female mammal to bear the energy costs of offspring production and thus greatly influence her reproductive success. However, increasing locomotor costs and reduced agility counterbalance the fitness benefits of storing body fat. In species where costs of reproduction are distributed over other individuals such as fathers or non-breeding group members, reproductive females might therefore benefit from storing less energy in the form of body fat.ResultsUsing a phylogenetic comparative approach on a sample of 87 mammalian species, and controlling for possible confounding variables, we found that reproductive females of species with allomaternal care exhibit reduced annual variation in body mass (estimated as CV body mass), which is a good proxy for the tendency to store body fat. Differential analyses of care behaviours such as allonursing or provisioning corroborated an energetic interpretation of this finding. The presumably most energy-intensive form of allomaternal care, provisioning of the young, had the strongest effect on CV body mass. In contrast, allonursing, which involves no additional influx of energy but distributes maternal help across different mothers, was not correlated with CV body mass.ConclusionsOur results suggest that reproducing females in species with allomaternal care can afford to reduce reliance on fat reserves because of the helpers' energetic contribution towards offspring rearing.
| S-EPMC5468974 | biostudies-literature
Project description:A randomized clinical trial is widely regarded as the most rigorous study design to determine the efficacy of intervention because spurious causality and bias associated with other experimental designs can be avoided. The purpose of this article is to provide clinicians and clinical researchers the types of randomized clinical trials used in stroke studies and to discuss the advantages and the limitations for each type of randomized stroke clinical trials.
| S-EPMC2837939 | biostudies-other
Project description: Not available
| S-EPMC4103932 | biostudies-literature
Project description:To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published.2 major research institutions supported by the National Institute of Health Research (NIHR).The proportion of trials reporting results within 12 months, 24 months and 'ever'. Factors associated with non-publication were analysed using logistic regression.Phases 2-4 clinical trials identified from internal documents and publication lists.In total, 286 trials were identified. We could not find registration for 4 (1.4%) of these, all of which were completed and published. Of the trials with a registered completion date pre-January 2015, just over half (56%) were published, and half of these were published within 12 months (36/147, 25%). For some trials, information on the public registers was found to be out-of-date and/or inaccurate. No clinical trial characteristics were found to be significantly associated with non-publication. We have produced resources to facilitate similar audits elsewhere.It was feasible to conduct an internal audit of registration and publication in 2 major research institutions. Performance was similar to, or better than, comparable cohorts of trials sampled from registries. The major resource input required was manually seeking information: if all registry entries were maintained, then almost the entire process of audit could be automated--and routinely updated--for all research centres and funders.
| S-EPMC4785314 | biostudies-other
Project description:BackgroundBlinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statisticians. Guidelines recommend that statisticians remain blinded to allocation prior to the final analysis. As these guidelines are not based on empirical evidence, this study undertook a qualitative investigation relating to when and how statisticians should be blinded in clinical trials.MethodsData were collected through online focus groups with various stakeholders who work in the delivery and oversight of clinical trials. Recordings of the focus groups were transcribed verbatim and thematic analysis was used to analyse the transcripts.ResultsThirty-seven participants from 19 CTUs participated in one of six focus groups. Four main themes were identified, namely statistical models of work, factors affecting the decision to blind statisticians, benefits of blinding/not blinding statisticians and practicalities. Factors influencing the decision to blind the statistician included available resources, study design and types of intervention and outcomes and analysis. Although blinding of the statistician is perceived as a desirable mitigation against bias, there was uncertainty about the extent to which an unblinded statistician might impart bias. Instead, in most cases, the insight that the statistician offers was deemed more important to delivery of a trial than the risk of bias they may introduce if unblinded. Blinding of statisticians was only considered achievable with the appropriate resource and staffing, which were not always available. In many cases, a standard approach to blinding was therefore considered unrealistic and impractical; hence the need for a proportionate risk assessment approach identifying possible mitigations.ConclusionsThere was wide variation in practice between UK CTUs regarding the blinding of trial statisticians. A risk assessment approach would enable CTUs to identify risks associated with unblinded statisticians conducting the final analysis and alternative mitigation strategies. The findings of this study will be used to design guidance and a tool to support this risk assessment process.
| S-EPMC9235168 | biostudies-literature
Project description:Promoting research to improve stroke prevention, acute care, and recovery is a key mission of the European Stroke Organisation (ESO). Stroke research networks may increase efficiencies and reduce waste in randomised clinical trials of stroke treatments. Several European countries have established national or regional stroke research networks, or have informal groups or stroke registers which may serve as a foundation for establishing a research network. To increase international collaboration on randomised trials for stroke in Europe, the ESO Trials Network Committee is leading the development of an alliance of national networks, the ESO Trials Alliance (ESOTA). Following initial consultation work in 2017, this paper describes an overview of progress to date in the first year of ESOTA activity. Beginning with five founding networks in England, Ireland, Netherlands, Spain, and Switzerland, ESOTA aims to gradually grow, ultimately including several hundred stroke centres and affiliated investigators working collectively on randomised trials of new stroke treatments.
| S-EPMC6960687 | biostudies-literature