Introduction to Randomised Withdrawal

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10.1136/annrheumdis-2020-219717

Methods COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP).

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10.1136/thoraxjnl-2021-217694

To overcome the dilemma between ethically problematic trials and lack of evidence, the full repertoire of clinical trial designs (eg, observational, randomisedregistry trials as well as randomised withdrawal and randomised clinical trials) is needed to adequately address the different patient groups and different research questions (quality of life vs longterm cardiovascular outcomes).

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10.1136/bmjopen-2020-045493

Methods and analysis The PATCH trial is a double-blind, enriched enrolment with randomised withdrawal, vehicle-controlled trial, aiming to explore the effects and safety of LMP in patients with TN.

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10.3390/medicina56010006

We suggest that an enriched enrolment with randomised withdrawal design may overcome some of these methodological shortcomings.

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10.1136/annrheumdis-2019-eular.1176

At Wk41, the number of patients on CAN was limited (crFMF n=9, HIDS/MKD n=6 and TRAPS n=4) due to the design of the trial (randomised withdrawal part).

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10.1136/BMJRESP-2019-BSSCONF.5

A 2-week, placebo-controlled, randomised withdrawal (RW) phase was conducted after 6 months.

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Randomised Withdrawal

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Mar 25, 2023

What is/are Randomised Withdrawal?

Randomised Withdrawal - Methods COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). ^[1] To overcome the dilemma between ethically problematic trials and lack of evidence, the full repertoire of clinical trial designs (eg, observational, randomisedregistry trials as well as randomised withdrawal and randomised clinical trials) is needed to adequately address the different patient groups and different research questions (quality of life vs longterm cardiovascular outcomes). ^[2] Methods and analysis The PATCH trial is a double-blind, enriched enrolment with randomised withdrawal, vehicle-controlled trial, aiming to explore the effects and safety of LMP in patients with TN. ^[3] We suggest that an enriched enrolment with randomised withdrawal design may overcome some of these methodological shortcomings. ^[4] At Wk41, the number of patients on CAN was limited (crFMF n=9, HIDS/MKD n=6 and TRAPS n=4) due to the design of the trial (randomised withdrawal part). ^[5] A 2-week, placebo-controlled, randomised withdrawal (RW) phase was conducted after 6 months. ^[6]