UBC Faculty Research and Publications

Canadian-led capacity-building in biostatistics and methodology in cardiovascular and diabetes trials:… Thabane, Lehana; Wells, George; Cook, Richard; Platt, Robert; Pogue, Janice; Pullenayegum, Eleanor; Matthews, David; McCready, Tara; Devereaux, Philip J; Cairns, John A; Yusuf, Salim Feb 18, 2011

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COMMENTARY Open AccessCanadian-led capacity-building in biostatisticsand methodology in cardiovascular and diabetestrials: the CANNeCTIN Biostatistics andMethodological Innovation Working GroupLehana Thabane1,2,3,4*, George Wells5, Richard Cook6, Robert Platt7, Janice Pogue4, Eleanor Pullenayegum1,2,3,David Matthews6, Tara McCready4, Philip J Devereaux1,4, John A Cairns8, Salim Yusuf1,4,9,the CANadian Network and Centre for Trials Internationally (CANNeCTIN) InvestigatorsAbstractThe Biostatistics and Methodological Innovation Working (BMIW) Group is one of several working groups withinthe CANadian Network and Centre for Trials INternationally (CANNeCTIN). This programme received funding fromthe Canadian Institutes of Health Research and the Canada Foundation for Innovation beginning in 2008, toenhance the infrastructure and build capacity for large Canadian-led clinical trials in cardiovascular diseases (CVD)and diabetes mellitus (DM). The overall aims of the BMIW Group’s programme within CANNeCTIN, are to advancebiostatistical and methodological research, and to build biostatistical capacity in CVD and DM. Our program ofresearch and training includes: monthly videoconferences on topical biostatistical and methodological issues inCVD/DM clinical studies; providing presentations on methods issues at the annual CANNeCTIN meetings;collaborating with clinician investigators on their studies; training young statisticians in biostatistics and methods inCVD/DM trials and organizing annual symposiums on topical methodological issues. We are focused on thedevelopment of new biostatistical methods and the recruitment and training of highly qualified personnel - whowill become leaders in the design and analysis of CVD/DM trials. The ultimate goal is to enhance global health bycontributing to efforts to reduce the burden of CVD and DM.BackgroundJointly funded beginning in 2008 by the Canadian Insti-tutes of Health Research (CIHR) and the Canada Foun-dation for Innovation (CFI), the CANadian Network andCentre for Trials INternationally (CANNeCTIN) wasamong five successful applications under the CIHR-CFIstrategic initiative to support clinical research programs,teams and network infra-structure that focused on high-impact, clinically relevant problems [1]. CIHR is theCanadian equivalent of the US National Institutes ofHealth. It was established by the Canadian federal gov-ernment in 2000, as the successor to the MedicalResearch Council and currently supports more than13,000 health researchers and trainees in universities,teaching hospitals and other health organizations andresearch centres across the country. CFI is an indepen-dent corporation created in 1997 by the Government ofCanada to fund research infrastructure. The CFI’s man-date is to strengthen the capacity of Canadian universi-ties, colleges, research hospitals, and non-profit researchinstitutions to carry out world-class research and tech-nology development that benefits Canadians.The focus for CANNeCTIN is to enhance the infrastruc-ture and to build capacity for clinical trials in cardiovascu-lar diseases (CVD) and diabetes mellitus (DM), especiallythose with a focus on neglected conditions, outcomes andinterventions. There is an explicit goal to build capacity bydeveloping young trialists who could emerge to be the lea-ders of large trials and expanding biostatistical expertise asit relates to clinical trials. Led by Salim Yusuf (Hamilton* Correspondence: thabanl@mcmaster.ca1Department of Clinical Epidemiology and Biostatistics, McMaster University,1200 Main Street West, Hamilton, Ontario, L8N 3Z5, CanadaFull list of author information is available at the end of the articleThabane et al. Trials 2011, 12:48http://www.trialsjournal.com/content/12/1/48 TRIALS© 2011 Thabane et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.Health Sciences and McMaster University) and JohnCairns (University of British Columbia), and coordinatedby the Population Health Research Institute (PHRI)(Hamilton, Ontario), CANNECTIN has engaged morethan 100 researchers from 19 universities including all ofCanada’s 17 medical schools. This network is linked to aninternational network of over 1500 affiliated hospitals andclinics from 80 countries [1] and is committed to develop-ing links with investigators in developing countries (e.g.South Africa, other African countries, South Americancountries and India). PHRI was launched as a joint Hamil-ton Health Sciences and McMaster University researchinstitute in 1999. It is located in the David Braley Cardiac,Vascular and Stroke Research Institute (DBCVSRI) atHamilton General Hospital. The PHRI provides an educa-tion, training, and mentorship environment for learnersworking on cutting-edge projects with world class scien-tists, with a vision of world class research for new discov-eries solving global health challenges. PHRI’s researchinterests span all frontiers of the globe and include abroad spectrum of health-related issues. Originally a cardi-ovascular disease research institute, PHRI’s programs haveexpanded to include a broad specrum of medical and soci-etal conditions in varied populations defined by ethnicityor geographic region.The organizational structure of CANNeCTIN includesWorking Groups which are disease/discipline-based (e.g.interventional cardiology, perioperative medicine, car-diac surgery) and technological/programmatic in type (e.g., biostatistics and methodological innovation, pharma-cogenomics, developing countries, education, knowledgetranslation (KT)) collaborative national and internationalnetworks and a coordination centre based within thePHRI [1]. A detailed description of the programme,organization, functions and goals is available at http://www.cannectin.ca.At the planning stage of the CANNeCTIN program, itwas recognized that biostatisticians play a critical role indesigning health studies (by helping to formulateresearch questions and to determine appropriateresearch designs, data collection procedures and analyticstrategies) and in conducting analyses of data from stu-dies to answer scientific questions. The universal short-age of biostatisticians has been documented in manycountries including the United States [2] and Australia[3]. In their “Strategy for patient-oriented research”released in February 2010, CIHR acknowledged that inCanada “...the clinical research workforce has not grownsince CIHR’s creation in 2000, with obvious shortages ofbiostatisticians, health economists, clinical epidemiolo-gists, social scientists, ...” and further noted that “...mostacademic health science centres conducting clinicalresearch report a critical shortage of biostatisticians andmethodologists“ (http://www.cihr-irsc.gc.ca) [emphasis isours]. Canada needs to train and support the careers ofbiostatisticians and research methodologists to enhanceits capacity to conduct patient-oriented research withthe potential to improve health and enhance the sustain-ability of the Canadian healthcare system. A fundamen-tal goal of CANNeCTIN is to improve this situation.The objectives of this paper are: 1) to describe the inno-vative research and training activities of the Biostatisticsand Methodological Innovation Working (BMIW) Groupin building capacity in biostatistics and clinical trial meth-ods; 2) to disseminate the activities of the BMIW Groupto other interested researchers; and 3) to encourage inter-ested biostatisticians and methodologically oriented clini-cal researchers to join the BMIW Group.The Biostatistics and Methodological InnovationWorking GroupAs one of the CANNeCTIN Working Groups, the BMIWGroup was created to bring clinical researchers and bios-tatisticians together from multiple universities acrossCanada to: a) identify and address complex biostatisticaland methodological problems relevant to clinical trialsand epidemiologic studies; b) advise clinical trialistsregarding these issues; and c) build capacity throughpractical and interactive training of future biostatisticiansand clinician-methodologists in CVD/DM trials.Innovations in biostatistical methods have alreadyplayed a major role in health research; however, clinicalresearchers face increasingly challenging problemsrequiring further innovation. Unresolved biostatisticalchallenges include: a) optimal ways to analyze pharmaco-genomic data; b) developing new statistical methods inthe design and analysis of CVD/DM trials; c) addressingcomplexities in non-inferiority and adaptive trial designs.Using simulations and existing datasets from large com-pleted studies (see PHRI website for a complete listing ofcompleted and on-going multi-centre studies: http://www.phri.ca/body.cfm?id=22), the BMIW Group is ableto empirically test their hypotheses on many of the abovebiostatistical and methodological issues.The original core centres in the Group were the Univer-sity of Waterloo, University of Ottawa, McGill Universityand McMaster University with PHRI as the coordinatingcentre. Other centres that have joined the Group includethe University of Toronto and University of WesternOntario. Figure 1 shows the key members from eachcentre.Innovations in Biostatistical Research andTrainingOur innovative program of research and training activ-ities includes: monthly videoconferences on topical bios-tatistical and methodological issues in CVD/MD clinicalstudies; providing presentations on methodologicalThabane et al. Trials 2011, 12:48http://www.trialsjournal.com/content/12/1/48Page 2 of 7issues at the annual CANNeCTIN meetings; recruitingand training young statisticians in biostatistics andmethods in CVD/DM trials and organizing annual sym-posiums on topical methodological issues. These activ-ities were deliberately chosen to share knowledge,provoke interactive discussion, stimulate research ideas,encourage research collaboration and cultivate academiccross-fertilization among biostatisticians, clinicians andtrainees.Monthly video-conferencesThe BMIW Group holds regular videoconference/webcastseminars on advanced issues in clinical trials methodology.The seminars take place every second Friday of the monthbetween September to June. Participants can join the livevideoconference sites at the Hamilton General Hospital,McMaster University, University of Waterloo, McGillUniversity, and the University of Ottawa Heart Institute orview a live webcast of the presentation through theOntario Telemedicine Network (OTN) website (http://webcast.otn.ca). The webcasts are archived on the OTNwebsite for two years and then moved to the CANNeC-TIN website. Individuals interested in taking part in thevideoconferences can email cannectin@phri.ca for infor-mation about adding their centres to the live videoconfer-ence, join the videoconference in person at http://www.cannectin.ca/default.cfm?id=66 or watch a live webcast onthe OTN website. The seminars have been running forthree years and have covered a wide spectrum of issues inclinical studies (see Table 1). The pdf versions and someof the video webcasts of presentations are available onlineat http://www.cannectin.ca/default.cfm?id=25 and canform a useful learning resource for individuals both withint and outside of the network.Figure 1 Key Members of the CANNeCTIN Biostatistics and Methodological Innovation Group by Centre.Thabane et al. Trials 2011, 12:48http://www.trialsjournal.com/content/12/1/48Page 3 of 7Presentations at CANNeCTIN annual meetingsTo facilitate cross-fertilization between statisticians andclinicians, the BIMW Group regularly engages in inter-active discussions with clinicians on methodologicalissues that arise in CANNeCTIN studies. Clinical inves-tigators are invited to present to their studies to thegroup at our monthly biostatistics videoconferences andreceive input from the group. The group members alsogive presentations at the annual CANNeCTIN meeting.At the CANNeCTIN Junior investigator meeting held inWinter 2010, the members of the group delivered thefollowing presentations:• How CANNeCTIN investigators can collaboratewith statisticians at PHRI;• What you need to know about pilot studies: thewhat, how and why [4];• Some issues in the design and analysis of RCTs -covering issues in cluster randomization trials andtime-to-event outcomes; and• Common errors in CIHR RCT grants.These presentations are available at http://www.can-nectin.ca/default.cfm?id=116. We plan to continue to fos-ter these interactions in future meetings and to expandthe coverage to include more topics. The BMIW Groupalso participated in the Cutting Edge Symposiums onPharmacogenomics that took place in May 2009 andPerioperative Medicine held in April 2010, in Hamilton(Ontario, Canada) (http://www.cannectin.ca/body.cfm?id=68). In these symposiums, we collaborate closely withour clinician investigators to discuss the biostatistical andmethodological issues arising from different studies. Forexample, one of the trials - PADIT (Prevention ofArrhythmia Device Trial) [ClinicalTrials.gov identifier #:NCT01002911] involved both the use of both a cross-over design and cluster-randomization. The trial uses“site” as a unit of randomization. The primary objectiveis to compare conventional pre-operative antibiotics ver-sus conventional intra-operative plus post-operative anti-biotics in preventing hospitalization attributed to deviceinfection in patients undergoing cardiac surgery. Thisraised interesting discussions among biostatisticians andclinicians about the design and analysis of the trial.The group also takes part in the annual Trout-CAN-NeCTIN workshop - an intensive, interactive trainingprogram led by Dr David Sackett, which guides youngresearchers in the design, implementation, and analysisof high-quality clinical studies, as well as in effectivegrant writing and academic career development. Ourrole includes providing biostatistical feedback and sup-port to the trainees.Capacity-building through training andmentorship of young biostatisticiansOne of our goals is to build capacity in biostatistics withinCanada through advanced and practical training of graduateand postgraduate students. This occurs in an interdisciplin-ary environment, with clinicians and biostatisticians work-ing together on applied problems. As noted earlier, theworldwide need for experienced biostatisticians in manycountries is high in all areas of health research [2,3] andCanada is no exception. Our program is to recruit and trainbiostatisticians within Canada with the necessary practicalexperience and skills to work with clinical investigators.The specific objectives of this training and mentorshipTable 1 Coverage of topics and issues at monthly videoconferences for 2008-2010Topic Issues covered*Issues in RCTs • Biases resulting from patient withdrawal in RCTs and how to address them;• Design and analysis issues in knowledge translation trials in primary care;• Testing for blinding at the end of an RCT [5];• Prognostic imbalance in RCTs;• Dynamic allocation methods: why the controversy?• Statistical issues in the use of composite outcomes clinical trials.Issues in cluster RCTs • Clustered measurement in cluster randomized trials;• Imputation strategies for missing binary outcomes in cluster randomized trials.Non-inferiority designs • What’s wrong with non-inferiority designs?Pragmatic Trials • A pragmatic-explanatory continuum summary (PRECIS) [6];Meta-analysis issues • Empirical priors for between-study heterogeneity in meta-analysis;• Precision in meta-analysis;• Indirect comparisons for evaluating healthcare interventions [7].Other issues • Bias in logistic regression due to omitted covariates;• Statistical genetics and coronary artery disease;• Longitudinal modeling when the response and time-dependent covariates are measured at distinct time-points.*Pdf Slides and audio versions of the presentations are available at http://www.cannectin.ca/default.cfm?id=25.Thabane et al. Trials 2011, 12:48http://www.trialsjournal.com/content/12/1/48Page 4 of 7programme are to promote enthusiasm and commitmentto excellence in statistical collaboration in CVD and DMclinical research; to enhance communication of statisticalissues to clinician collaborators; to train young statisticiansto acquire biostatistical self-sufficiency and develop skills inapplied statistics in CVD and DM trials; and to enhance aculture of collaboration among statisticians and clinicianresearchers. We introduce our trainees to the rewards andchallenges of health care research, through practical train-ing obtained by working on real problems that are encoun-tered in ongoing trials. We provide partial funding for allCANNeCTIN biostatistics trainees, who have a primarysupervisor at their “home” institution. All supervisors haveto be active members of the BMIW Group. The studentsubmits a proposal and receives input from all the membersof the group (collective mentoring). By providing hands-onexperience in large clinical studies, our training approachcomplements training programs already existing in manyuniversities and builds biostatistical capacity specific toCVD and DM trials in Canada.Table 2 provides a summary of our trainees to date(11 trainees), their “home” institution, project title andprimary supervisor(s).Other Activities: Special Invited Sessions atScientific Meetings and the Annual Biostatisticsand Methods SymposiumThe BMIW Group has organized some special sessionssponsored by CANNeCTIN at various biostatistical meet-ings including the Canadian Society for Epidemiology andBiostatistics annual meeting held in Ottawa (Ontario,Canada) in, 2009; and the Statistical Society of Canadaannual meeting held in Vancouver (British Columbia,Canada) in 2009. We are currently organizing anotherinvited sessions at the annual meetings of the StatisticalSociety of Canada (SSC) in Wolfville (Nova Scotia,Canada) in June 2011 and International Society for Clini-cal Biostatistics (ISCB) in Ottawa (Ontario, Canada) inAugust 2011. These activities have provided good forumsfor the group to share their research with national andinternational statistical communitiesThe BMIW group plans to organize annual sympo-siums on challenging and relevant topics in biostatisticsin RCTs or observational studies that will involve otherexperts from Canada and abroad, and be suitable forpublication in peer-reviewed journals. Each symposiumwill focus on answering four key questions: 1) what isthe state-of-the-art? ii) what are the outstanding or con-troversial issues that remain unresolved or need to beaddressed? iii) what guidance can we provide toresearchers on these issues based on the current knowl-edge?; and iv) what research needs to be done to fullyaddress the issues?Topical biostatistical and methodological issues thathave been identified so far include composite outcomes,stopping rules, surrogate outcomes, non-inferioritydesigns, non-compliance, adjustment for baseline imbal-ance in RCTs, adaptive designs, and large vs. small trials.The first CANNeCTIN Cutting Edge Symposium onAdvanced Biostatistics and Methodological Issues inTable 2 Current List of CANNeCTIN Biostatistics TraineesInstitution Trainee Project SupervisorMcMasterUniversityKristianThorlundMethodological improvements in meta-analysis Drs. Lehana Thabaneand PJ DevereauxJinhui Ma Issues in the Statistical Analysis and Imputation Strategies for Binary outcomefrom Cluster Randomized Trials in Management of Cardiovascular Risk FactorsDr. Lehana ThabaneRachel Chu Intraclass correlation in multicentre RCTs and prognostic heterogeneity/imbalance Dr. Lehana ThabaneHoi Suen Generalised Additive Models for the analysis of health utility data Dr EleanorPullenayegumUniversity ofWaterlooHaocheng Li Design of Clinical Trial and Statistical Analysis with Missing Data Dr. Grace YiLongyang Wu Design of Clinical Trials with Recurrent Events and Competing Risks Dr. Richard CookAudreyBoruvkaEvent history analysis with incomplete data Dr. Richard CookMin Chen Empirical Likelihood Methods for Pretest-Posttest Studies Drs Mary Thompson andChangbao WuUniversity ofOttawaRobert WilliamDaviesStatistical Issues Which Pertain to the use of GWAS for the Identification, Characterizationand Quantification of Genetic Effects in Cardiovascular DiseaseDr. George WellsMcGillUniversityMaria EstherPerez TrejoThe problem of extra variation induced by double clustering Dr. Robert PlattMichael Regier Develop causal methods appropriate for repeatedly measured data Dr. Robert PlattMenglan Pan Marginal Structural Models, Odds Ratios, and Collapsibility Drs. Robert Platt and JayKaufmanThabane et al. Trials 2011, 12:48http://www.trialsjournal.com/content/12/1/48Page 5 of 7Clinical Trials is planned for Hamilton, Canada for April28-29, 2011, will focus on outcomes in CVD trials - cov-ering both composite and surrogate outcomes, andadaptive designs. More details on the symposium can befound at http://www.cannectin.ca/default.cfm?id=128.Lessons LearnedEffective use of information technology (IT) to link dif-ferent centres through videoconferences has been key tothe success of our monthly seminars. Occasionally, weencounter some technical problems in connecting sites,but these problems are always resolved without muchdifficulty and with some patience. To date, no seminarshave been cancelled because of IT challenges.Mentoring the next generation of biostatisticians incardiovascular trials has been a worthwhile journey sofar. Collectively, we have 11 trainees from four Canadianuniversities, supervised or mentored by seven BMIWGroup biostatisticians. We hope that this effort will con-tinue to expand the training opportunities to morenational and international centres.Interacting and collaborating with clinicians in addres-sing CVD/DM problems has been a rewarding experi-ence for many of us. The CANNeCTIN programmeprovides an excellent opportunity to promote academicdialogue among biostatisticians and clinicians (includingour trainees). By sharing knowledge, provoking interac-tive discussion, stimulating research ideas, encouragingcollaboration and fostering academic cross-fertilization,we can make our biostatistical research more relevantand applicable to important problems in CVD and DMresearch.Some Concluding RemarksThere is a severe shortage of biostatistical expertise inCVD/DM research. Our efforts to reduce the global bur-den of these diseases depend on the conduct of largewell-designed trials to advance our understanding of thekey predictors of the disease and the best strategies forprevention, treatment and management. The BMIWGroup is making substantial contributions towards therealization of CANNeCTIN’s vision to advance globalhealth through building the capacity of the Canadianresearch community to lead major CVD and DM clinicaltrials. The long-term contributions of the BMIW Groupwill include the development of new biostatistical meth-ods and recruitment and training of highly qualified per-sonnel. These personnel will become leaders incollaborative health research through contributions tothe design and analysis of CVD/DM trials, and also serveas committee members and reviewers for granting agen-cies such as CIHR that support clinical research inCanada. We believe that with suitable investments, this isa model that can be useful for building human capacityin other areas of clinical research experiencing similarshortage of biostatistical expertise.AcknowledgementsDr Thabane is a clinical trials mentor the Canadian Institutes of HealthResearch. Dr. Cook is Canada Research Chair in Statistical Methods for HealthResearch and is supported by CIHR and NSERC (Natural Sciences andEngineering Research Council). Dr. Platt is a Senior Chercheur-boursier of theFonds de la Recherche en Santé du Québec.CANNeCTIN Lead Investigators: Salim Yusuf (McMaster University,Hamilton, Ontario), John Cairns (University of British Columbia, Vancouver,British Columbia), Sonia Anand (McMaster University), Todd Anderson(University of Calgary, Calgary, Alberta), Malcolm Arnold (University ofWestern Ontario, London Ontario), Stuart Connolly (McMaster University),Jafna Cox (Dalhousie University, Halifax, Nova Scotia), Gilles Dagenais (LavalUniversity, Quebec City, Quebec), PJ Devereaux (McMaster University), PaulDorian (University of Toronto, Toronto, Ontario), Vlad Dzavik (University ofToronto), Stephen Fremes (University of Toronto), Hertzel Gerstein (McMasterUniversity), Scott Lear (Simon Fraser University, Vancouver, British Columbia),Finlay McAlister (University of Alberta, Edmonton, Alberta), Michel Nguyen(Universite de Sherbrooke, Sherbrooke, Quebec), Richard Novick (Universityof Western Ontario, London, Ontario), Robert Roberts (University of Ottawa,Ottawa, Ontario), Thomas Schricker (McGill University, Montreal, Quebec),Ashfaq Shuaib (University of Alberta), Chris Simpson (Queen’s University,Kingston, Ontario), Samuel Siu (University of Western Ontario), Bruce Sussex(Memorial University of Newfoundland, St John’s, Newfoundland andLabrador), James Tam (University of Manitoba, Winnipeg, Manitoba), KoonTeo (McMaster University), Lehana Thabane (McMaster University), PierreTheroux (Universite de Montreal, Montreal, Quebec), Jack Tu (University ofToronto), Richard Cook (University of Waterloo, Waterloo, Ontario), GeorgeWells (University of Ottawa), Bernie Zinman (University of Toronto), KellyCoverett (University of Sasketchewan, Saskatoon, Sasketchewan)Sources of Funding: CIHR and CFIAuthor details1Department of Clinical Epidemiology and Biostatistics, McMaster University,1200 Main Street West, Hamilton, Ontario, L8N 3Z5, Canada. 2BiostatisticsUnit, St Joseph’s Healthcare Hamilton, 50 Charlton Avenue East, Hamilton,Ontario, L8N 4A6, Canada. 3The Centre for Evaluation of Medicines, StJoseph’s Healthcare Hamilton, 105 Main St. East, Level P1, Hamilton, Ontario,L8N 1G6, Canada. 4Population Health Research Institute, Hamilton HealthSciences, 237 Barton Street East, Hamilton, Ontario, L8L 2X2, Canada.5University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, Ontario, K1Y4W7, Canada. 6Department of Statistics and Actuarial Science, University ofWaterloo, 200 University Avenue West, Waterloo, Ontario, N2L 3G1, Canada.7Department of Epidemiology and Biostatistics, McGill University, 1020 PineAvenue West, Montreal, Quebec, H3A 1A2, Canada. 8Department ofMedicine, University of British Columbia, 2329 West Mall, Vancouver, BritishColumbia, V6T 1Z4, Canada. 9Department of Medicine, McMaster University,1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada.Authors’ contributionsLT drafted the manuscript. All authors reviewed and edited draft versions ofthe manuscript and approved the final version.Competing interestsThe authors declare that they have no competing interests.Received: 14 November 2010 Accepted: 18 February 2011Published: 18 February 2011References1. Cairns JA, Yusuf S, Cook RJ, for CANNeCTIN, et al: Canadian Network andCentre for Trials Internationally (CANNeCTIN): a national network forCanadian-led trials in cardiovascular diseases and diabetes mellitus.Canadian Journal of Cardiology 2010, 26(7):353-8.2. DeMets DL, Stormo G, Boehnke M, et al: Training of the next generationof biostatisticians: a call to action in the U.S. Statistics in Medicine 2006,25:3415-3429.Thabane et al. Trials 2011, 12:48http://www.trialsjournal.com/content/12/1/48Page 6 of 73. Simpson JM, Ryan P, Carlin JB, et al: Training a new generation ofbiostatisticians: A successful consortium model. Journal of StatisticsEducation 2009, 17(2)[http://www.amstat.org/publications/jse/v17n2/simpson.html], Last date of access: 2010-11-12.4. Thabane L, Ma J, Chu R, Cheng J, et al: A Tutorial on Pilot Studies: TheWhat, Why and How. BMC Medical Research Methodology 2010, 10:1.5. Sackett DL: Commentary: Measuring the success of blinding in RCTs:don’t, must, can’t or needn’t? International Journal of Epidemiology 2007,36(3):664-5.6. Thorpe KE, Zwarenstein M, Oxman AD, et al: A pragmatic-explanatorycontinuum indicator summary (PRECIS): a tool to help trial designers.Canadian Medical Association Journal 2009, 180(10):E47-57.7. Wells GA, Sultan SA, Chen L, et al: Indirect Evidence: Indirect TreatmentComparisons in Meta-Analysis. Ottawa: Canadian Agency for Drugs andTechnologies in Health; 2009 [http://www.cadth.ca/media/pdf/H0462_itc_tr_e.pdf], Last date of access: 2010-11-04.doi:10.1186/1745-6215-12-48Cite this article as: Thabane et al.: Canadian-led capacity-building inbiostatistics and methodology in cardiovascular and diabetes trials: theCANNeCTIN Biostatistics and Methodological Innovation WorkingGroup. Trials 2011 12:48.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitThabane et al. Trials 2011, 12:48http://www.trialsjournal.com/content/12/1/48Page 7 of 7


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