The doctrine of marginal gains in prostate cancer; testing improvement philosophy with multiple randomised interventions.
File(s)
Author(s)
Bass, Edward
Type
Thesis
Abstract
The level one evidence for surgical advancements in prostate cancer is thin and has been for
some years. This is not for lack of trying on the part of researchers. In the last 10-15 years
several traditional randomised controlled trials intending to evaluate novel localised
prostate cancer interventions, failed. This was due to inadequate participant recruitment for
a wide variety of reasons. Multiple national and supranational bodies have recognised the
knowledge gap, calling for novel methodologies to be trialled. One such design is the cohort
multiple randomised control trial (cmRCT).
Imperial Prostate 3 – PROState Pathway Embedded Comparative Trial (IP3-PROSPECT)
(NCT04400656) is a cmRCT to test multiple prostate cancer interventions on eligible men in
one cohort. It differs to a traditional RCT by way of its consent process. Men referred for
prostate cancer investigations consent to join the cohort, then they may be randomly
invited to consider an intervention. In this pilot phase, the acceptability and feasibility of
developing the cohort is tested using a combination of quantitative and qualitative
methods. Additionally, hypothesis generation for each step in the prostate cancer pathway
was conducted.
This research concludes that the cmRCT design offers is a feasible and acceptable research
platform by which to build a level one evidence base. It is recognised that the design comes
with challenges, some unique and some shared with traditional designs. What interventions
may be best tested within the cmRCT platform will depend on local / national pathways and
practices. Further work is proposed to demonstrate feasibility of a wide variety of
interventions.
some years. This is not for lack of trying on the part of researchers. In the last 10-15 years
several traditional randomised controlled trials intending to evaluate novel localised
prostate cancer interventions, failed. This was due to inadequate participant recruitment for
a wide variety of reasons. Multiple national and supranational bodies have recognised the
knowledge gap, calling for novel methodologies to be trialled. One such design is the cohort
multiple randomised control trial (cmRCT).
Imperial Prostate 3 – PROState Pathway Embedded Comparative Trial (IP3-PROSPECT)
(NCT04400656) is a cmRCT to test multiple prostate cancer interventions on eligible men in
one cohort. It differs to a traditional RCT by way of its consent process. Men referred for
prostate cancer investigations consent to join the cohort, then they may be randomly
invited to consider an intervention. In this pilot phase, the acceptability and feasibility of
developing the cohort is tested using a combination of quantitative and qualitative
methods. Additionally, hypothesis generation for each step in the prostate cancer pathway
was conducted.
This research concludes that the cmRCT design offers is a feasible and acceptable research
platform by which to build a level one evidence base. It is recognised that the design comes
with challenges, some unique and some shared with traditional designs. What interventions
may be best tested within the cmRCT platform will depend on local / national pathways and
practices. Further work is proposed to demonstrate feasibility of a wide variety of
interventions.
Version
Open Access
Date Issued
2023-08-24
Date Awarded
01/01/2024
License URL
Advisor
Ahmed, Hashim
Winkler, Mathias
Sponsor
Wellcome Trust (London, England)
Grant Number
204998/Z/16/Z
Publisher Department
Department of Surgery & Cancer
Publisher Institution
Imperial College London
Qualification Level
Doctoral
Qualification Name
Doctor of Philosophy (PhD)