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Challenges in Conducting Clinical Trials in Nephrology www.kidney-international.org KDIGO executive conclusions Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) OPEN Controversies Conference Colin Baigent1,2,14, William G. Herrington2, Josef Coresh3, Martin J. Landray1,2, Adeera Levin4, Vlado Perkovic5, Marc A. Pfeffer6, Peter Rossing7,8, Michael Walsh9, Christoph Wanner10, David C. Wheeler11, Wolfgang C. Winkelmayer12 and John J.V. McMurray13,14; for the KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants15 1Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; 2Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, UK; 3Department of Epidemiology, John Hopkins University, Baltimore, Maryland, USA; 4University of British Columbia, Vancouver, British Columbia, Canada; 5The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia; 6Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA; 7Steno Diabetes Centre Copenhagen, Copenhagen, Denmark; 8University of Copenhagen, Copenhagen, Denmark; 9Population Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario, Canada; 10Würzburg University Clinic, Würzburg, Germany; 11Centre for Nephrology, University College London, London, UK; 12Selzman Institute for Kidney Health, Section of Nephrology, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA; and 13British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK Despite the high costs of treatment of people with kidney Kidney International (2017) 92, 297–305; http://dx.doi.org/10.1016/ disease and associated comorbid conditions, the amount of j.kint.2017.04.019 reliable information available to guide the care of such KEYWORDS: kidney disease; randomized clinical trials; trial conduct; trial patients is very limited. Some treatments have been design Copyright ª 2017, International Society of Nephrology. Published by assessed in randomized trials, but most such trials have Elsevier Inc. This is an open access article under the CC BY license (http:// been too small to detect treatment effects of a magnitude creativecommons.org/licenses/by/4.0/). that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled “Challenges in the Conduct of Clinical Trials in Nephrology” to identify the key barriers to conducting trials in patients hronic kidney disease (CKD) affects w10% of adults 1,2 with kidney disease. The conference began with plenary C in high-income countries, and its treatment is talks focusing on the key areas of discussion that included burdensome and costly, accounting for substantial 3,4 appropriate trial design (covering identification and proportions of health budgets. It is now recognized as evaluation of kidney and nonkidney disease outcomes) and an important cause of death, particularly in low- and sensible trial execution (with particular emphasis on middle-income countries where diabetes is becoming com- 5,6 streamlining both design and conduct). Break out group mon and resources for treatment are limited. Other con- 7,8 discussions followed in which the key areas of agreement ditions affecting the kidney, such as acute kidney injury 9 and remaining controversy were identified. Here we and kidney stone disease, also contribute a substantial summarize the main findings from the conference and set burden of morbidity and mortality. Despite the high indi- out a range of potential solutions. If followed, these vidual patient and societal burden of kidney diseases, solutions could ensure future trials among people with the amount of reliable information available to guide kidney 10 kidney disease are sufficiently robust to provide reliable patient care is very limited. Although some treatments answers and are not constrained by inappropriate have been assessed in randomized trials, most of these complexities in design or conduct. have been too small to detect treatment effects of a magni- tude that can realistically be achieved with a single interven- tion (e.g., reductions of 15%–20% in major outcomes such Correspondence: Colin Baigent, Richard Doll Building, Old Rd Campus, as death or disability). Experience to date indicates that con- Roosevelt Drive, Oxford OX37LF, UK. E-mail: [email protected] ducting trials in patients with kidney disease on the sort of 14 Conference co-chairs. scale that has led to major therapeutic advances in other 15See Appendix for other conference participants. specialties (e.g., oncology, diabetes, and cardiology11)is Received 17 March 2017; revised 12 April 2017; accepted 18 April 2017 challenging. Kidney International (2017) 92, 297–305 297 KDIGO executive conclusions C Baigent et al.: Clinical trials in nephrology: a KDIGO conference report Conference structure consider significant). Patients should be involved in discus- In order to discuss the most significant barriers to conducting sions when planning trials. trials in patients with kidney disease and to propose potential An important underlying principle in trials testing supe- solutions, KDIGO (Kidney Disease: Improving Global Out- riority of an intervention is that the aim should always be to comes) convened an international multidisciplinary Contro- compare treatment arms that differ substantially in their versies Conference in Paris, France, titled “Challenges in the expected effects on the primary outcome and to preserve this Conduct of Clinical Trials in Nephrology” in September 2016. separation for the duration of the trial. The likely magnitude The meeting began with plenary talks that aimed to identify of this difference can sometimes be usefully tracked through the key themes for discussion related to trial design (including assessing differences in a surrogate variable between the specific topics of how to measure kidney and nonkidney randomized treatment groups (e.g., plasma low-density outcomes) and trial execution before 4 breakout groups lipoprotein cholesterol in the SHARP trial14), provided that considered the key issues in detail. After each of the breakout blinding at an individual participant level is strictly enforced. sessions, ongoing deliberations were reported and discussed Failure to maintain adequate adherence to study treatment in plenary sessions. This paper synthesizes the main areas of leads to a loss of separation between groups and loss of sta- discussion, agreement, and remaining controversies addressed tistical power. This may be a particular problem in trials at the conference. The conference agenda and selected pre- among patients with CKD who are typically receiving mul- sentations from the meeting are available on the KDIGO tiple treatments, and are often required to attend clinics website (http://kdigo.org/conferences/clinical-trials/). frequently, and are particularly prone to drug toxicity and The discussion was based on the general principle that, in intercurrent illnesses that may require the trial treatment to order to conduct a successful randomized trial, there are 4 be modified (as observed in the EVOLVE trial in which study main requirements: randomization of a sufficient number of drug discontinuation was much higher than anticipated).15,16 patients (to ensure sufficient numbers of outcomes); assur- Selecting a suitable trial population. As a general principle, ance of adherence to the allocated treatment; reliable ascer- eligibility criteria should be practical and broad. This ensures tainment of relevant study outcomes; and appropriate a widely generalizable result and facilitates efficient recruit- statistical analysis.12 These requirements can be met through ment. Inclusion criteria should identify a suitable population a combination of sound trial design and efficient conduct. of patients who are likely to have the type of outcome that the Much of the discussion at the conference centered on the treatment is anticipated to prevent. Guideline committees concept of “streamlined” trial design, which focuses on the may help to maximize the size of eligible populations by main determinants of trial quality and avoids unnecessary highlighting areas of uncertainty, by avoiding making rec- elements of design or conduct that increase cost and ommendations where evidence is weak, and by stating where complexity.13 placebo-controlled trials are needed. Trial design (analogous to experimental design) and trial Exclusion criteria should be constructed that exclude conduct were considered separately. However, it should be patients who have a definite indication or contraindication for noted that many aspects of a trial’s design influence its at least 1 of the study treatments, who are likely to be non- conduct and can therefore be decisive in determining whether adherent to the trial protocol, or who are not expected to a trial is successful. Because of their large scope, discussions survive for the duration of the trial. Therefore, patients who about trial design were organized into 3 breakout groups that would have obvious safety issues (from relevant comorbidity) considered the design of trials in kidney disease, how to or who are at high risk of a potential pharmacologic inter- measure different
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