Study identification

PURI

https://redirect.ema.europa.eu/resource/35414

EU PAS number

EUPAS35413

Study ID

35414

Official title and acronym

Development of a Multivariable Model to Predict the Risk of Dose Delays following Chemotherapy

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Cancer chemotherapy is administered to patients at fixed time points to incorporate a rest period to recover from adverse effects (AEs) and delays to recovery will result in delays to scheduled treatments. These treatment delays occur in over 10% of chemotherapy patients and cause both patient and service inconvenience. The aim of this research is to develop a prediction model to understand those patients most susceptible to dose delays, enabling clinicians to action any mitigation strategies. This study is a retrospective cohort study using chemotherapy prescribing data from 4 UK hospitals to develop and internally validate a risk prediction model. Predictor variables have been identified from the literature. These will be initially analysed by univariable analysis to understand their associations with outcome, dose delays. These variables will enable the development of a multivariable logistic regression model. The model will be tested for performance and internally validated.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Chambers Pinkie

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

National Institute of Health Research
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable