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Adaptive Design Methods in Dialysis Clinical Trials: a Systematic Review Protocol

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Adaptive Design Methods in Dialysis Clinical Trials: a Systematic Review Protocol Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-036755 on 27 August 2020. Downloaded from Adaptive design methods in dialysis clinical trials: a systematic review protocol Conor Judge ,1,2,3,4 Robert P Murphy ,1 Sarah Cormican,3,4 Andrew Smyth,1,4 Martin O'Halloran,2 Martin O'Donnell1 To cite: Judge C, Murphy RP, ABSTRACT Strengths and limitations of this study Cormican S, et al. Adaptive Introduction Adaptive design methods are a potential design methods in dialysis solution to improve efficiency of clinical trials but their ► This study presents a comprehensive methodology clinical trials: a systematic uptake in dialysis is unknown. We aim to investigate review protocol. BMJ Open for a systematic review of the current state of adap- the use of adaptive design methods in dialysis clinical 2020;10:e036755. doi:10.1136/ tive designs (ADs) clinical trials in dialysis. trials and to cultivate further adoption of adaptive design bmjopen-2019-036755 ► Two researchers will independently perform the methods by the nephrology community. study selection, data extraction and risk of bias ► Prepublication history and Methods and analysis We will adhere to the Preferred assessment. additional material for this Reporting Items for Systematic Review and Meta- Analysis ► Detailed characteristics of trials will be collected and paper are available online. To Protocols guidelines and the Cochrane Collaboration view these files, please visit the analysed including nature of intervention, funding Handbook. We will perform a literature search through journal online (). source, dialysis modality and the nature of the AD. MEDLINE (PubMed), EMBASE and CENTRAL, a detailed ► Subgroup analysis will be performed to highlight data extraction of trial characteristics and a narrative Received 02 January 2020 differences in design characteristics between dial- synthesis of the data. There will be no language Revised 25 April 2020 ysis modality, temporal trends, types of intervention, Accepted 18 July 2020 restrictions. We will estimate the percentage of adaptive funding and geographical location. clinical trials per year in dialysis. Subgroup analysis will be performed by dialysis modality, funder and geographical location. Ethics and dissemination Ethical approval will not population but account for 7% of Medi- be required for this study as data will be obtained from care’s expenditures.9 Additionally, people publicly available clinical trials. We will disseminate our with ESRD experience higher mortality,10 http://bmjopen.bmj.com/ results in a peer- reviewed publication. morbidity and worse quality of life than the PROSPERO registration number general public.11 Adaptive clinical trials use the results INTRODUCTION from interim data analysis of ongoing trials Background to modify the study design in a predefined Randomised controlled trials (RCTs) are way.12 This is performed without under- the gold standard for confirming efficacy mining the integrity or validity of the trial © Author(s) (or their 1 on September 25, 2021 by guest. Protected copyright. employer(s)) 2020. Re- use or futility of new therapies. Nephrology as and thus preserving the type 1 error (false permitted under CC BY. a specialty, and especially patients with end- positive) rate. The most common type of Published by BMJ. stage renal disease (ESRD), has tradition- adaptive design (AD) is the Group Sequential 1HRB- Clinical Research Facility, ally had a low number of randomised trials Trial, where planned interim analysis enables National University of Ireland, compared with similar specialities.2 Many stopping of trials for efficacy or futility. Other Galway, Co. Galway, Ireland 2Translational Medical Device reasons have been cited for this including designs included sample size re-estimation, Lab, National University of recruitment difficulty, history of underpow- multiarm multistage (MAMS) trials, adap- 3 4 Ireland Galway, Galway, Co. ered trials and lack of funding. Nephrology tive randomisation, biomarker adaptive and Galway, Ireland studies are increasing in number but still lag seamless phase II/III trials.13 Adaptive clin- 3 Wellcome Trust – HRB, Irish behind other specialities.5 ical trials would appear particularly suitable Clinical Academic Training, There are an estimated 726 331 prevalent for evaluation of novel interventions in ESRD National University of Ireland 6 Galway, Galway, Ireland cases of ESRD in the USA and globally, in and according to the Food and Drug Admin- 4Deparrtment of Nephrology, 2010, an estimated 2.3–7.1 million people istration, ADs could reduce resource require- Galway University Hospital, with end- stage kidney disease (ESKD) died ments, decrease time to study completion Galway, Ireland without access to chronic dialysis.7 Projections and increase the likelihood of study success.14 Correspondence to estimate a 11%–18% increase in the crude A specific problem in previous ESRD trials 8 Dr Conor Judge; incidence rate from 2015 to 2030. People includes over reliance on observational data conor. judge@ nuigalway. ie with ESRD represent 1% of the Medicare in the design of clinical trials.15 Observational Judge C, et al. BMJ Open 2020;10:e036755. doi:10.1136/bmjopen-2019-036755 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-036755 on 27 August 2020. Downloaded from data are used to inform assumptions about the expected Type of intervention effect size and SD of effect size for power calculations. We will not place a restriction on the intervention type If these assumptions are incorrect, they can result in an and will include trials that study medications during dial- underpowered trial with an insufficient sample size to ysis, medical devices, dialysis parameters, and so on. answer the research question. Adaptive sample size re- es- timation has been used successfully in cardiology trials to Type of outcome help this problem.16 Planned blinded sample size re-es - We will include all outcomes including surrogate markers, timation can discover incorrect underlying assumptions patient- centred outcomes and hard clinical outcomes. and trigger increased recruitment targets mid trial to ensure adequate power to answer the research question. A Search method for the identification of trials second specific problem in previous ESRD trials is extrap- Electronic search olation of results from populations without Chronic We will perform electronic searches on MEDLINE Kidney Disease (CKD). An example of this was the 4D (PubMed), EMBASE and CENTRAL from database study,17 where 20 mg/day of atorvastatin in patients with inception until 1 January 2020. Zotero will be used as diabetes and ESRD did not reduce cardiovascular events, our reference manager and the Revtools package on R despite showing a 20%–30% reduction in populations will be used to eliminate duplicate records. The search without CKD.18 One concern was that a single level of will be conducted in English. The dialysis search terms statin or a single low- density lipoprotein cut- off would not were adapted fromBeaubien- Souligny et al21 and include convey the same benefit in a ESKD population compared dialysis(tiab) OR peritoneal dialysis(tiab) OR hemodialy- with a population without CKD.15 Adaptive MAMS trials sis(tiab) OR hemodiafiltration(tiab) OR haemodiafiltra- have been successfully used in HIV trials, Telmisartan and tion(tiab) OR hemofiltration(tiab) OR haemofiltration Insulin Resistance in HIV used a MAMS design with one OR extracorporeal blood cleansing(tiab) OR haemodial- interim analysis to access three telmisartan doses (20, 40 ysis(tiab) OR Renal Dialysis(mh) OR Renal replacement(- and 80 mg daily).19 MAMS designs are partially suited for tiab) OR end stage kidney(tiab) OR end stage renal(tiab) populations with ESRD where, compared with popula- OR stage five kidney(tiab) OR stage five renal(tiab). tions without CKD, pharmacokinetic differences can be The AD search terms were adapted from Bothwell large and alternative drug doses are often required.20 et al22 and include ‘phase ii/iii’(tiab) OR ‘treatment switching’(tiab) OR ‘biomarker adaptive’(tiab) OR Objectives ‘biomarker adaptive design’(tiab) OR ‘biomarker adjust- The systematic review will aim to: (1) summarise the use of ed’(tiab) OR ‘adaptive hypothesis’(tiab) OR ‘adaptive AD methods in dialysis clinical trials per year, (2) describe dose- finding’(tiab) OR ‘pick- thewinner’(tiab) OR ‘drop- the characteristics of the ADs including dialysis modality, the- loser’(tiab) OR ‘sample size re-estimation’(tiab) OR funding and geographical location, (3) describe the AD ‘re- estimations’(tiab) OR ‘adaptive randomization’(tiab) http://bmjopen.bmj.com/ characteristics of the trial, (4) estimate the percentage of OR ‘group sequential’(tiab) OR ‘adaptive seamless’(tiab) adaptive clinical trials in dialysis and (5) outline trends in OR ‘adaptive design’(tiab) OR ‘Interim monitoring’(tiab) all the above. OR ‘Bayesian adaptive’(tiab) OR ‘Flexible design’”(tiab) OR ‘Adaptive trial’(tiab) OR ‘play-the- winner’(tiab) OR ‘adaptive method’(tiab) OR (adaptive(All Fields) AND METHODS AND ANALYSIS dose(All Fields) AND adjusting(All Fields)) OR ‘response This systematic review has been registered with PROS- adaptive’(All Fields) OR ‘adaptive allocation’(All Fields) PERO (registration number: 163 946 (Temporary ID)). on September 25, 2021 by guest. Protected copyright. OR ‘adaptive signature design’(tiab) OR ‘treatment adap- We will conduct this systematic review according to the tive’(tiab) OR ‘covariate adaptive’(tiab)
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