Newcastle Clinical Trials Unit exploiting the benefits of MACRO

The Newcastle Clinical Trials Unit (NCTU) selected MACRO in the spring of 2013 as its new online clinical data management system and today we can report on a series of trials that are fully exploiting MACRO's study design potential.

 

The Newcastle Clinical Trials Unit (NCTU) selected MACRO in the spring of 2013 as its new online clinical data management system and today we can report on a series of trials that are fully exploiting MACRO’s study design potential.

One of these trials is TOPPITS, a Trial of Proton Pump Inhibitors in Throat Symptoms. This is a randomised double-blind, placebo controlled trial that aims to compare the symptomatic response in patients with persistent throat symptoms at the end of 4 months (16 weeks) therapy of treatment with lansoprazole versus placebo. Further details of the study are available on the NCTU website if you click here.

The InferMed team worked closely with the trial team at NCTU to exploit MACRO's underlying study design capabilities and to manage the TOPPITS design in a way that enhances the experience of the clinical study team with user-friendly data entry and real-time data quality checks.

Ruth Wood, Database Manager at the NCTU commented, “It has been a very useful learning experience for us to work with experienced MACRO developers. Our database manager team have successfully developed and are currently managing several live trials including the FiCTION trial - Filling Children’s Teeth: Indicated or Not?; SORTED - Study of Optimal Replacement of Thyroxine in the Elderly; EXTRAS - A trial to evaluate an extended rehabilitation service for stroke patients."

Professor Janet Wilson, Chief Investigator of the TOPPITS trial added on behalf of the TOPPITS trial team, “I found MACRO very easy to use, it has a quick and easy system to access the data you require at that time."

The design consultancy offered by InferMed is one of many support services available to MACRO users. Further details of what else is available are on the MACRO Solutions page.

Other study designs in development in MACRO at the NCTU are a randomised controlled trial of biomarker-based exclusion of VAP to improve antibiotic stewardship and a trial of effectiveness of glycopyrronium vs. hyoscine for treatment of drooling in children with neurodisability.

Duane Lawrence, CEO of InferMed, commented, “It has been a pleasure for InferMed to have worked with the NCTU team over the past year and to be working in conjunction with them on the development of some of these important study designs. We look forward seeing these studies going live in MACRO.”

Click here to read news of MACRO’s arrival on the NCTU website.

Newcastle Clinical Trials Unit (NCTU)

In conjunction with the Newcastle Biomedicine Clinical Research Platforms, the NIHR Research Design Service North East, and Institute of Health & Society colleagues, the Newcastle Clinical Trials Unit (NCTU) provides a ‘one stop shop’ for investigators planning, designing, conducting and analysing trials and other high quality clinical research studies.

The unit supports trials of a wide range of health technologies, including pharmaceuticals, medical devices, surgery and complex interventions aimed at health professional, patient or public behaviour change.

NCTU’s main market is university- and NHS-based investigators conducting non-commercial trials, funded by research councils, the National Institute of Health Research and charities, as well as investigator-initiated industry-supported studies.

Its services in respect of preparation of applications for ethical, regulatory and R&D approvals and site monitoring are also available to commercial companies.