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Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016.

ABSTRACT: The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact and benefits of the programme are listed, divided into a) the effects of the introduction of the standards, b) the effects of the certification programme in general, and c) the effects of the certification programme on individual units. The discussion emphasises the generally positive impact of the programme so far but stresses the need to better clarify the perspective and role of the programme.

SUBMITTER: Ohmann C

PROVIDER: S-EPMC5936703 | biostudies-other | 2017 Mar

REPOSITORIES: biostudies-other

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Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016.

Ohmann C C Canham S S Demotes J J Chêne G G Lauritsen J J Martins H H Mendes R V RV Nicolis E B EB Svobodnik A A Torres F F

Contemporary clinical trials communications 20170214

The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact an ...[more]

PMID: 29740631

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Project description:BackgroundMeasuring research impact is of critical interest to philanthropic and government funding agencies interested in ensuring that the research they fund is both scientifically excellent and has meaningful impact into health and other outcomes. The Beat Cancer Project (BCP) is a AUD $34 m cancer research funding scheme that commenced in 2011. It was initiated by an Australian charity (Cancer Council SA), and supported by the South Australian Government and the state's major universities.MethodsThis study applied Buxton and Hanney's Payback Framework to assess research impact generated from the BCP after 3 years of funding. Data sources were an audit of peer-reviewed publications from January 2011 to September 2014 from Web of Knowledge and a self-report survey of investigators awarded BCP research funding during its first 3 years of implementation (2011-2013). Of the 104 surveys, 92 (88%) were completed.ResultsThe BCP performed well across all five categories of the Payback Framework. In terms of knowledge production, 1257 peer-reviewed publications were generated and the mean impact factor of publishing journals increased annually. There were many benefits to future research with 21 respondents (23%) reporting career advancement, and 110 higher degrees obtained or expected (including 84 PhDs). Overall, 52% of funded projects generated tools for future research. The funded research attracted substantial further income yielding a very high rate of leverage. For every AUD $1 that the cancer charity invested, the BCP gained an additional AUD $6.06. Five projects (5%) had informed policy and 5 (5%) informed product development, with an additional 31 (34%) and 35 (38%) projects, respectively, anticipating doing so. In terms of health and sector and broader economic benefits, 8 (9%) projects had influenced practice or behaviour of health staff and 32 (34%) would reportedly to do so in the future.ConclusionsResearch impact was a priority of charity and government funders and led to a deliberate funding strategy. Emphasising research impact while maintaining rigorous, competitive processes can achieve the joint objectives of excellence in research, yielding good research impact and a high rate of leverage for philanthropic and public investment, as indicated by these early results.

Project description:To investigate the impact of a multifactorial treatment programme in a real-life setting on clinical outcomes and estimated cardiovascular disease (CVD) risk.A retrospective observational cohort study, using data from the electronic medical records and national registers.Tertiary diabetes centre in Denmark.Patients with type 2 diabetes (n=4299) referred to a programme with focus on treatment of hyperglycaemia, hypertension and dyslipidaemia between 1 January 2001 and 1 April 2016.Primary outcomes were changes in haemoglobin A1c (HbA1c), blood pressure (BP) and low-density lipoprotein (LDL) cholesterol as well as proportion reaching treatment targets. Our secondary outcome was to investigate changes in antidiabetic, antihypertensive and lipid-lowering treatment, together with the impact on estimated CVD risk. Linear mixed model for repeated measurements were used for continuous variables and logistic regression for dichotomous variables.The patients achieved a mean±SD?decrease in HbA1c, systolic and diastolic BP and LDL cholesterol of 1.0%±0.04% (10.6±0.4?mmol/mol), 6.3±0.4?mm Hg, 2.7±0.2?mm Hg and 0.32±0.02?mmol/L, respectively (p<0.0001). The proportion of patients who met the treatment goal for HbA1c (<7% (<53?mmol/mol)) increased from 31% to 58% (p<0.0001); for BP (<130/80?mm Hg) from 24% to 34% (p<0.0001), and for LDL cholesterol (<2.5?mmol/L (patients without previous CVD) or <1.8?mmol/L (patients with previous CVD)) from 52% to 65%. Those reaching all three guideline treatment targets increased from 4% to 15% (p<0.0001), and when relaxing the BP target to <140/85 from 8% to 24%. The estimated CVD risk was relatively reduced by 15.2% using the Swedish National Diabetes Register risk engine and 30.9% using the UK Prospective Diabetes Study risk engine.Our data support that short-term multifactorial treatment of patients with glycaemic dysregulation in a specialist outpatient setting is both achievable and effective, and associated with a clinically meaningful improvement in CVD risk.

Dataset Information

Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016.

Publications

Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016.

Similar Datasets

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