Imperial College London
Alternate

DrThiagarajahSasikaran

Faculty of Medicine, School of Public Health

Deputy Operations Manager
 
 
 
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Contact

 

t.sasikaran

 
 
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Location

 

Stadium House, 68 Wood LaneStadium HouseWhite City Campus

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Summary

 

Publications

Citation

BibTex format

@article{Bass:2021:10.1016/j.cct.2021.106485,
author = {Bass, EJ and Klimowska-Nassar, N and Sasikaran, T and Day, E and Fiorentino, F and Sydes, MR and Winkler, M and Arumainayagam, N and Khoubehi, B and Pope, A and Sokhi, H and Dudderidge, T and Ahmed, HU},
doi = {10.1016/j.cct.2021.106485},
journal = {Contemporary Clinical Trials},
title = {PROState pathway embedded comparative trial: the IP3-PROSPECT study},
url = {http://dx.doi.org/10.1016/j.cct.2021.106485},
volume = {107},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - IntroductionThe traditional double blind RCT is the ‘gold standard’ trial design. For a variety of reasons, these designs often fail to accrue enough participants to conclude. This is particularly challenging in localized prostate cancer. The cohort multiple randomised controlled trial (cmRCT) trial design may represent an alternative approach to delivering robust comparative data in prostate cancer.Patients and methodsIP3-PROSPECT is a cmRCT designed to test multiple prostate cancer interventions from eligible men in one cohort. Key to the design is two points of consent. First, at point of consent one, men referred for prostate cancer investigations are invited to join the cohort. They may then be randomly invited at a later date to consider an intervention at point of consent two. In the pilot phase we will test the acceptability and feasibility of developing the cohort.ResultsAcceptability and feasibility of the study will be measured by a combination of quantitative and qualitative methods. The primary outcome measure is the rate of consent to inclusion to the IP3-PROSPECT cohort. Secondary outcome measures include the completeness of data collection at sites and return rates of patient questionnaires. We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT.ConclusionThe IP3-PROSPECT study will evaluate the cmRCT design in prostate cancer. Initially we will pilot the design, assessing for acceptability and feasibility. The cmRCT is an innovative design that offers potential for building a modern comparative evidence base for prostate cancer.
AU  - Bass,EJ
AU  - Klimowska-Nassar,N
AU  - Sasikaran,T
AU  - Day,E
AU  - Fiorentino,F
AU  - Sydes,MR
AU  - Winkler,M
AU  - Arumainayagam,N
AU  - Khoubehi,B
AU  - Pope,A
AU  - Sokhi,H
AU  - Dudderidge,T
AU  - Ahmed,HU
DO  - 10.1016/j.cct.2021.106485
PY  - 2021///
SN  - 1551-7144
TI  - PROState pathway embedded comparative trial: the IP3-PROSPECT study
T2  - Contemporary Clinical Trials
UR  - http://dx.doi.org/10.1016/j.cct.2021.106485
UR  - https://www.sciencedirect.com/science/article/pii/S1551714421002214?via%3Dihub
UR  - http://hdl.handle.net/10044/1/89773
VL  - 107
ER  -
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