How much is the lack of retention evidence costing trial teams in Ireland and the UK?


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
12 May 2022
Historique:
received: 23 11 2021
accepted: 26 03 2022
entrez: 13 5 2022
pubmed: 14 5 2022
medline: 18 5 2022
Statut: epublish

Résumé

Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK. We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel. Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention strategies can be extremely expensive; some of the costliest strategies included "data collection scheduled with routine care" (€900-€32,503.25), "a timeline of participant visits for sites"-with integrated participant reminder (€304.74-€14,803.70), and "routine site visits by CTU staff" and "investigator meetings face to face", both costing (€777.67-€14,753.48). Others such as "telephone reminders for questionnaire response" (€34.58-€568.62), "a timeline of participant visits for sites"-site reminder alone (€79.18-€112.23), and "targeted recruitment of sites/GPs" (€30-€1620) were less costly compared to the other strategies. The resources invested in the use of some retention strategies may outweigh known or imagined benefits on retention. Where benefits are currently unknown, evaluation should be a priority. More evaluation of the effectiveness and cost of trial retention strategies is needed to avoid widespread use of strategies that are both expensive and ineffective.

Sections du résumé

BACKGROUND BACKGROUND
Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK.
METHODS METHODS
We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel.
RESULTS RESULTS
Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention strategies can be extremely expensive; some of the costliest strategies included "data collection scheduled with routine care" (€900-€32,503.25), "a timeline of participant visits for sites"-with integrated participant reminder (€304.74-€14,803.70), and "routine site visits by CTU staff" and "investigator meetings face to face", both costing (€777.67-€14,753.48). Others such as "telephone reminders for questionnaire response" (€34.58-€568.62), "a timeline of participant visits for sites"-site reminder alone (€79.18-€112.23), and "targeted recruitment of sites/GPs" (€30-€1620) were less costly compared to the other strategies.
DISCUSSION CONCLUSIONS
The resources invested in the use of some retention strategies may outweigh known or imagined benefits on retention. Where benefits are currently unknown, evaluation should be a priority.
CONCLUSION CONCLUSIONS
More evaluation of the effectiveness and cost of trial retention strategies is needed to avoid widespread use of strategies that are both expensive and ineffective.

Identifiants

pubmed: 35550607
doi: 10.1186/s13063-022-06223-x
pii: 10.1186/s13063-022-06223-x
pmc: PMC9097420
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

396

Subventions

Organisme : Chief Scientist Office
ID : HSRU1
Pays : United Kingdom
Organisme : Health Research Board
ID : HRB TMRN 2017-1.
Pays : Ireland

Informations de copyright

© 2022. The Author(s).

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Auteurs

Ellen Murphy (E)

Trials Research and Methodologies Unit (TRAMS), Health Research Board Clinical Research Facility at University College Cork, Cork, Ireland. ellen.murphy@ucc.ie.

Frances Shiely (F)

Trials Research and Methodologies Unit (TRAMS), Health Research Board Clinical Research Facility at University College Cork, Cork, Ireland.
School of Public Health, University College Cork, Cork, Ireland.

Shaun Treweek (S)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

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