Clinical trials and tribulations the mascot study

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Abstract Read article for free, via Unpaywall a legal, open copy of the full text. Warren Lenney Search articles by 'Warren Lenney'. Lenney W ,. Sophie Perry Search articles by 'Sophie Perry'. Perry S ,. Price D. A comment on this article appears in " Lessons to be learnt from unsuccessful clinical trials. Share this article Share with email Share with twitter Share with linkedin Share with facebook. Abstract No abstract provided.

Smart citations by scite. The number of the statements may be higher than the number of citations provided by EuropePMC if one paper cites another multiple times or lower if scite has not yet processed some of the citing articles. Explore citation contexts and check if this article has been supported or disputed. Challenges in the design, planning and implementation of trials evaluating group interventions.

Comparative costs and activity from a sample of UK clinical trials units. New medications were promised by October but they did not arrive until early By then the GSK inhalers were close to expiry so new batches were needed. All medications were promised by January , so we decided to begin recruiting patients.

When the medicines did not arrive, the six patients recruited had to be withdrawn, leading to disappointment and disillusionment within the MASCOT team. Children in secondary care were mainly too young for the study preschool age or were already receiving add-on therapy. Contact with primary care was complex, with few practices confident about recruiting or undertaking studies in children. Approximately 30 children per average-sized general practitioner GP practice were identified as potentially suitable for study inclusion.

Letters were posted but only one or two of the 30 families replied and most did not meet the inclusion criteria. The study researchers, who were not part of the primary care team, were not allowed to approach parents directly. Children suitable for inclusion from research-aware practices were often receiving add-on therapy.

This made it very difficult to identify eligible patients. Families agreed to participate and then frequently failed to attend study appointments. The complexity and variability of communications between the newly developed medicines for children, primary care and comprehensive research networks proved very trying.

We met the study nurses in June to develop new recruitment strategies. WL and SP contacted other potential UK centres where staff understood childhood asthma and had good communication among their research networks. Nineteen centres were deemed suitable, but more funding was needed. A meeting was requested with the HTA in November ; we submitted a detailed business case to include the new sites, without which the study would fail. Further protocol revisions included new innovative recruitment strategies in both primary and secondary care.

No money was available for new centre inclusion. Huge efforts were devoted by MASCOT teams; immense numbers of letters, files and other documentation were generated to meet governance requirements. Many new recruitment strategies were developed and initiated.

By May , children had entered the run-in expected with 65 children randomised into the double-blind arm required. A total of study invitation letters had been posted to families; responses were received; follow-up letters were sent; 83 responses were returned. One hundred and fifty-five phone calls to families were made in five general practices—no child was recruited as a result. One patient was recruited using this method. The number recruited into the run-in more than doubled, but randomisation into the double-blind phase increased little as patients were often asymptomatic at the end of the run-in.

There was no clear explanation for this as inclusion parameters were unchanged. The HTA closed the study in June The new recruitment strategies were not really given sufficient time to demonstrate their effectiveness. Asthma prevalence in the UK is equivalent to or higher than in the USA, yet our study was dogged by bureaucratic, communication, governance and recruitment issues.

In the USA specialist doctors follow their own patients through the primary and secondary care setting, which may enhance recruitment and reduce bureaucracy. Questions which could be important for future UK study development and success are highlighted below. Sixteen years have elapsed since the publication of LABA benefits in adults. Prescribing practice in UK children has changed despite no good evidence-based studies.

Recent articles have even suggested an overuse of combination treatment. Research is not an accepted part of clinical practice in the eyes of many busy clinicians.

Parental priorities revolve around work, school, after-school activities, etc. Recruitment of children into clinical studies poses specific problems different from those of adults.

This is particularly true in common conditions where few studies are taking place at present. Provenance and peer review Not commissioned; internally peer reviewed. You will be able to get a quick price and instant permission to reuse the content in many different ways.

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