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Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations

THERAPEUTIC INNOVATION & REGULATORY SCIENCE 2016年第1期50卷 15-21页

作者： Knepper, David Fenske, Christian Nadolny, Patrick Bedding, Alun Gribkova, Elena Polzer, John Neumann, Jennifer Wilson, Brett Benedict, Joanne Lawton, Andy Allergan Business Operat Jersey City NJ USA Eli Lilly & Co Clin Risk Management Indianapolis IN 46285 USA Allergan Clin Programming & Performance Management Bioinformat Operat & Syst Irvine CA USA Roche Prod Ltd Biostat Welwyn Garden City AL7 3AY Herts England Pfizer Clin Trial Support & Compliance Moscow Moscow Russia Eli Lilly & Co Global Stat Sci Indianapolis IN 46285 USA Genentech Inc Clin Data Management Roche Grp San Francisco CA 94080 USA Bristol Myers Squibb Co Global Dev Operat Res & Dev Princeton NJ USA Genentech Inc Global Prod Dev Roche San Francisco CA 94080 USA Boehringer Ingelheim KG Biometr & Data Management Bracknell RG40 4XF Berks England

Background: Data quality issues in clinical trials can be caused by a variety of behaviors including fraud, misconduct, intentional or unintentional noncompliance, and significant carelessness. Regardless of how these behaviors are defined, they may compromise the validity of the study results. Reliable study results and quality data are needed to evaluate products for marketing approval and for decisions that are made on the use of medicine. This article focuses on detecting data quality issues, irrespective of origin or motive. Early detection of data quality issues are important so that corrective actions taken can be implemented during the conduct of the trial, recurrence can be prevented, and data quality can be preserved. Methods: A survey was distributed to TransCelerate member companies to assess current strategies for detecting and mitigating risks involving fraud and misconduct in clinical trials. A review of literature across many industries from 1985 to 2014 was conducted using multiple platforms. Results: Eighteen TransCelerate member companies anonymously responded to the survey. All of the respondents had one or more existing strategies for fraud and misconduct detection. The literature search identified current practices and methodologies across many industries. Conclusions: TransCelerate recommends the creation of an integrated, multifaceted approach to proactively detect data quality issues. Detection methods should include a strategy tailored to the characteristics of the study. Some sponsors are taking advantage of more advanced methods and integrated processes and systems to proactively detect and address issues, relying on advances in technology to more efficiently review data in real time. Further research is underway to assess statistical data quality detection methodology in clinical trials.

关键词： good clinical practice risk-based monitoring centralized monitoring statistical monitoring risk indicators clinical trial fraud clinical trial misconduct

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Prevalence of maternal colonisation with group B streptococcus: a systematic review and meta-analysis

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LANCET INFECTIOUS DISEASES 2016年第9期16卷 1076-1084页

作者： Kwatra, Gaurav Cunnington, Marianne C. Merrall, Elizabeth Adrian, Peter V. Ip, Margaret Klugman, Keith P. Tam, Wing Hung Madhi, Shabir A. Univ Witwatersrand Fac Hlth Sci Sch Pathol Med Res CouncilResp & Meningeal Pathogen Res Uni Johannesburg South Africa Univ Witwatersrand Fac Hlth Sci Sch Pathol Natl Res FdnVaccine Preventable Dis Johannesburg South Africa GlaxoSmithKline Real World Evidence London England GlaxoSmithKline Biostat & Stat Programming Amsterdam Netherlands Chinese Univ Hong Kong Dept Microbiol Hong Kong Hong Kong Peoples R China Chinese Univ Hong Kong Dept Obstet & Gynaecol Hong Kong Hong Kong Peoples R China Emory Univ Dept Global Hlth Atlanta GA 30322 USA Bill & Melinda Gates Fdn Pneumonia Program Washington DC USA Natl Inst Communicable Dis Natl Hlth Lab Serv ZA-2131 Johannesburg Gauteng South Africa

Background The most important risk factor for early-onset (babies younger than 7 days) invasive group B streptococcal disease is rectovaginal colonisation of the mother at delivery. We aimed to assess whether differences in colonisation drive regional differences in the incidence of early-onset invasive disease. Methods We did a systematic review of maternal group B streptococcus colonisation studies by searching MEDLINE, Embase, Pascal Biomed, WHOLIS, and African Index Medicus databases for studies published between January, 1997, and March 31,2015, that reported the prevalence of group B streptococcus colonisation in pregnant women. We also reviewed reference lists of selected studies and contacted experts to identify additional studies. Prospective studies in which swabs were collected from pregnant women according to US Centers for Disease Control and Prevention guidelines that used selective culture methods were included in the analyses. We calculated mean prevalence estimates (with 95% CIs) of maternal colonisation across studies, by WHO region. We assessed heterogeneity using the I-2 statistic and the Cochran Q test. Findings 221 full-text articles were assessed, of which 78 studies that included 73 791 pregnant women across 37 countries met prespecified inclusion criteria. The estimated mean prevalence of rectovaginal group B streptococcus colonisation was 17.9% (95% CI 16.2-19.7) overall and was highest in Africa (22.4, 18.1-26.7) followed by the Americas (19.7, 16.7-22.7) and Europe (19.0,16.1-22.0). Studies from southeast Asia had the lowest estimated mean prevalence (11.1%, 95% CI 6.8-15.3). Significant heterogeneity was noted across and within regions (all p <= 0.005). Differences in the timing of specimen collection in pregnancy, selective culture methods, and study sample size did not explain the heterogeneity. Interpretation The country and regional heterogeneity in maternal group B streptococcus colonisation is unlikely to completely explain geograp

关键词： DISEASE prevalence COLONIZATION STREPTOCOCCUS META-analysis MEDLINE DISEASE incidence

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A CASE STUDY OF MODELING AND EXPOSURE-RESPONSE PREDICTION FOR COUNT DATA

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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2014年第5期24卷 1073-1090页

作者： Quan, Hui Mao, Xuezhou Wei, Lynn Wang, Lin Sanofi Biostat & Programming Bridgewater NJ 08807 USA

Even with two doses of an experimental drug in Phase III studies, with the commonly used approach for assessing treatment effects of individual doses, it may still be difficult to determine the final commercial dose. In such a scenario, with plasma concentration data collected in the studies, a modeling approach can be applied to predict treatment effects at different plasma concentration levels. Through an established relationship between plasma concentration and dose, the treatment effects of doses not studied in the Phase III studies can then be predicted. The results can further be applied to justify the final dose confirmation or selection. In this article, a Phase III program example with count data as the primary endpoint in the multiple sclerosis area is used to illustrate the application of such a technique for dose confirmation. Several models, such as the overdispersion Poisson model, negative binomial model, and recurrent event models, are considered. The negative binomial model is preferable due to better data fitting and the capability of within-treatment assessment and between-treatment comparison.

关键词： Annualized relapse rate Negative binomial Plasma concentration Recurrent event Risk ratio Trial simulation

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Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk

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CARDIOVASCULAR DIABETOLOGY 2017年第1期16卷 70-70页

作者： Mueller-Wieland, Dirk Leiter, Lawrence A. Cariou, Bertrand Letierce, Alexia Colhoun, Helen M. Del Prato, Stefano Henry, Robert R. Tinahones, Francisco J. Aurand, Lisa Maroni, Jaman Ray, Kausik K. Bujas-Bobanovic, Maja Univ Hosp Aachen Dept Internal Med 1 Pauwelsstr 30 D-52074 Aachen Germany Univ Toronto St Michaels Hosp Li Ka Shing Knowledge Inst Toronto ON Canada Univ Toronto St Michaels Hosp Keenan Res Ctr Biomed Sci Toronto ON Canada CHU Nantes Inst Thorax Nantes France Sanofi Biostat & Programming Dept Chilly Mazarin France Univ Edinburgh Edinburgh Midlothian Scotland Univ Pisa Dept Clin & Expt Med Pisa Italy Univ Calif San Diego Sch Med Ctr Metab Res Vet AffairsSan Diego Healthcare Syst San Diego CA 92103 USA Malaga Univ Hosp Virgen de la Victoria CIBERobn Malaga Spain Sanofi Bridgewater MA USA Regeneron Pharmaceut Inc 777 Old Saw Mill River Rd Tarrytown NY 10591 USA Imperial Coll Dept Primary Care & Publ Hlth Imperial Ctr Cardiovasc Dis Prevent London England Sanofi Paris France

Background: Type 2 diabetes mellitus (T2DM) is often associated with mixed dyslipidaemia, where non-high-density lipoprotein cholesterol (non-HDL-C) levels may more closely align with cardiovascular risk than low-density lipoprotein cholesterol (LDL-C). We describe the design and rationale of the ODYSSEY DM-DYSLIPIDEMIA study that assesses the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk with non-HDL-C inadequately controlled despite maximally tolerated statin therapy. For the first time, atherogenic cholesterol-lowering with a PCSK9 inhibitor will be assessed with non-HDL-C as the primary endpoint with usual care as the comparator. Methods: DM-DYSLIPIDEMIA is a Phase 3b/4, randomised, open-label, parallel group, multinational study that planned to enrol 420 individuals. Main inclusion criteria were T2DM and mixed dyslipidaemia (non-HDL-C >= 100 mg/dl [>= 2.59 mmol/l], and triglycerides >= 150 and < 500 mg/dl [>= 1.70 and < 5.65 mmol/l]) with documented atherosclerotic cardiovascular disease or >= 1 additional cardiovascular risk factor. Participants were randomised (2: 1) to alirocumab 75 mg every 2 weeks (Q2W) or lipid-lowering usual care on top of maximally tolerated statin (or no statin if intolerant). If randomised to usual care, investigators were able to add their pre-specified choice of one of the following to the patient's current statin regimen: ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid, in accordance with local standard-of-care. Alirocumab-treated individuals with non-HDL-C >= 100 mg/dl at week 8 will undergo a blinded dose increase to 150 mg Q2W at week 12. The primary efficacy endpoint is non-HDL-C change from baseline to week 24 with alirocumab versus usual care;other lipid levels (including LDL-C), glycaemia-related measures, safety and tolerability will also be asses

关键词： Alirocumab PCSK9 Diabetes Mixed dyslipidaemia Non-HDL-C ODYSSEY

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ROBUST SMALL SAMPLE INFERENCE FOR GENERALISED ESTIMATING EQUATIONS: AN APPLICATION OF THE ANOVA-TYPE TEST

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AUSTRALIAN & NEW ZEALAND JOURNAL OF STATISTICS 2014年第3期56卷 237-255页

作者： Fan, Chunpeng Zhang, Donghui Sanofi US Inc Dept Biostat & Programming Bridgewater NJ 08807 USA

Asymptotically, the Wald-type test for generalised estimating equations (GEE) models can control the type I error rate at the nominal level. However in small sample studies, it may lead to inflated type I error rates. Even with currently available small sample corrections for the GEE Wald-type test, the type I error rate inflation is still serious when the tested contrast is multidimensional. This paper extends the ANOVA-type test for heteroscedastic factorial designs to GEE and shows that the proposed ANOVA-type test can also control the type I error rate at the nominal level in small sample studies while still maintaining robustness with respect to mis-specification of the working correlation matrix. Differences of inference between the Wald-type test and the proposed test are observed in a two-way repeated measures ANOVA model for a diet-induced obesity study and a two-way repeated measures logistic regression for a collagen-induced arthritis study. Simulation studies confirm that the proposed test has better control of the type I error rate than the Wald-type test in small sample repeated measures models. Additional simulation studies further show that the proposed test can even achieve larger power than the Wald-type test in some cases of the large sample repeated measures ANOVA models that were investigated.

关键词： GEE ANOVA-type statistic Wald-type statistic quadratic form

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Estimating the Interaction Index in Drug Combination Experiments

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STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2014年第2期6卷 144-153页

作者： Fan, Chunpeng Zhang, Donghui Sanofi US Inc Dept Biostat & Programming Bridgewater NJ 08807 USA

Studies of interactions among biologically active agents have become increasingly important in many branches of biomedical research. Based on the Loewe additivity model, which is one of the best models to define drug interactions, synergy occurs when the interaction index is less than one, and antagonism occurs when it is greater than one. When a ray design experiment is conducted to assess drug synergy, two common issues may arise: the calculation of the interaction indexes together with their confidence intervals and how to design the experiment to achieve more accurate estimations of the interaction index. This article addresses these two issues. In terms of the calculation, we compare the joint fitting mechanism which combines all rays into one estimating equation and the separate fitting which fits each ray separately and conducts further calculations to get the inference, and weights are considered in the comparison. We derive that both fitting mechanisms give identical point estimates of the interaction indexes and simulation studies show that the weighted joint fitting and the separate fitting work similarly well in terms of the model convergence and the coverage proportion of the confidence intervals. Simulation studies also suggest that to reduce the bias in the estimation of the interaction indexes, one should increase sample sizes in all rays by adding more doses or more replicates in each dose, and increasing only the sample size in the rays of pure drugs may even enlarge the bias. A two-drug, seven-ray design is used to illustrate the application of the methods.

关键词： Confidence interval Drug interaction Ray design Synergy

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Safety and immunogenicity of MAGE-A3 cancer immunotherapeutic with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma: an open phase I/II study with a first assessment of a predictive gene signature

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ESMO OPEN 2017年第5期2卷 e000203-e000203页

作者： Grob, Jean-Jacques Mortier, Laurent D'Hondt, Lionel Grange, Florent Baurain, Jean Francois Dreno, Brigitte Lebbe, Celeste Robert, Caroline Dompmartin, Anne Neyns, Bart Gillet, Marc Louahed, Jamila Jarnjak, Silvija Lehmann, Frederic F. Aix Marseille Univ La Timone APHM Hosp Dept Dermatol & Skin Canc Marseille France Univ Lille INSERM U1189 Dept Dermatol Lille France Ctr Hosp Univ UCL Namur Site Godinne Dept Med Oncol Louvain Belgium Univ Reims Hop Robert Debre Dept Dermatol Reims France Catholic Univ Louvain Clin Univ St Luc Ctr Canc Dept Med Oncol Brussels Belgium Hop Hotel Dieu Clin Dermatol Nantes France St Louis Hosp APHP Univ Dept Dermatol Paris France Fac Med Serv Dermatol Dept Med Oncol Paris France Univ Paris Sud Paris France Univ Caen Basse Normandie CHU Caen Dept Dermatol Caen France Univ Ziekenhuis Brussel Dept Med Oncol Brussels Belgium GSK Biostat & Stat Programming Dept Rixensart Belgium GSK R&D Dept Rixensart Belgium GSK Rixensart Belgium Celyad Oncol Franchise Mont St Guibert Belgium

Background We assessed safety, immunogenicity and clinical activity of recombinant MAGE-A3 antigen combined with AS15 immunostimulant (MAGE-A3 immunotherapeutic) in association with dacarbazine in patients with metastatic melanoma. Methods In this open-label, phase I/II, uncontrolled multicentre trial conducted in Belgium and France, patients with MAGE-A3-positive melanoma received up to 24 doses of MAGE-A3 immunotherapeutic (four cycles) coadministered with eight doses of dacarbazine. Adverse events (AE) were recorded until 31 days postvaccination, and serious AEs (SAE), until 30 days following the last dose. MAGE-A3-specific antibodies were measured by ELISA. Clinical activity of MAGE-A3 immunotherapeutic was assessed in patients positive/negative for previously identified gene signature (GS) associated with clinical outcome. Results Forty-eight patients were enrolled and treated (32 GS+, 15 GS-, 1 unknown GS status);two patients completed the study. All patients reported AEs, the most common were 'general disorders and administration site conditions' (94%). Treatment-related AEs were reported by 85% of patients;the most common was pain at injection site (38%). Sixteen SAEs were reported by 21% of patients;two were considered as treatment related (neutropenia and thrombocytopenia;grade 4). Postdose 4, all patients were seropositive for MAGE-A3-specific antibodies, with a geometric mean titre of 2778.7 ELISA units (EU)/mL (95% CI 1638.3 to 4712.8). One complete and three partial responses were reported (only in GS+ patients). Median overall survival was 11.4 months for GS+ and 5.3 months for GS- patients. Conclusion Although this trial shows poor results compared with the new results with checkpoint inhibitors, it gives an interesting insight in rapidly developing fields like combinations of immunotherapy and chemotherapy, new generation vaccines and the use of gene profile as a predictive marker.

关键词： immunotherapy melanoma

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Role of CD20 expression and other pre-treatment risk factors in the development of infusion-related reactions in patients with CLL treated with obinutuzumab

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LEUKEMIA 2016年第8期30卷 1763-1766页

作者： Freeman, C. L. Dixon, M. Houghton, R. Kreuzer, K-A Fingerle-Rowson, G. Herling, M. Humphrey, K. Boettcher, S. de Costa, C. S. Iglesias, V. Stilgenbauer, S. Gribben, J. Hallek, M. Goede, V. Queen Mary Univ London John Vane Canc Ctr Barts Canc Inst Dept Haematooncol Charterhouse Sq London England Roche Prod Ltd Dept Biostat Welwyn Garden City Herts England Roche Prod Ltd Dept Stat Programming & Anal Welwyn Garden City Herts England German CLL Study Grp Ctr Integrated Oncol Cologne Bonn Germany Univ Hosp Cologne Dept Internal Med Cologne Germany F Hoffmann Roche Ltd Pharma Dev Oncol Basel Switzerland Roche Prod Ltd Pharma Dev Clin Sci Welwyn Garden City Herts England Univ Hosp Schleswig Holstein Campus Kiel Kiel Germany Roche Innovat Ctr Basel PS Roche Pharmaceut Res & Early Dev pRED Basel Switzerland Univ Ulm Dept Internal Med 3 Ulm Germany Ctr Integrated Oncol Koln Dept Internal Med 1 Bonn Germany Univ Cologne Cluster Excellence Cellular Stress Responses Agin Cologne Germany

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Long-term velaglucerase alfa treatment in children with Gaucher disease type 1 naive to enzyme replacement therapy or previously treated with imiglucerase

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MOLECULAR GENETICS AND METABOLISM 2016年第2期117卷 164-171页

作者： Smith, Laurie Rhead, William Charrow, Joel Shankar, Suma P. Bavdekar, Ashish Longo, Nicola Mardach, Rebecca Harmatz, Paul Hangartner, Thomas Lee, Hak-Myung Crombez, Eric Pastores, Gregory M. Childrens Mercy Kansas City Ctr Pediat Genom Med 2401 Gillham Rd Kansas City MO 64108 USA Childrens Hosp Wisconsin Milwaukee WI 53201 USA Ann & Robert H Lurie Childrens Hosp Chicago Dept Pediat Chicago IL 60611 USA Emory Univ Sch Med Dept Human Genet Div Med Genet Atlanta GA USA Emory Univ Sch Med Dept Ophthalmol Atlanta GA 30322 USA King Edward Mem Hosp Res Ctr Dept Pediat Gastroenterol Pune Maharashtra India Univ Utah Dept Pediat Salt Lake City UT USA Kaiser Permanente Los Angeles CA USA UCSF Benioff Childrens Hosp Oakland Dept Gastroenterol Hepatol & Nutr Oakland CA USA Wright State Univ Dept Biomed Ind & Human Factors Engn Dayton OH 45435 USA Shire Biostat & Stat Programming Dept Lexington MA USA Shire Rare Dis Unit Lexington MA USA Mater Misericordiae Univ Hosp Dept Med Natl Ctr Inherited Metab Disorders Dublin Ireland

Background: Gaucher Disease type 1 (GD1) often manifests in childhood. Early treatment with enzyme replacement therapy (ERT) may prevent disease complications. We report the assessment of velaglucerase alfa ERT in pediatric GD1 patients who participated in a long-term extension study (HGT-GCB-044, *** Identifier NCT00635427). Methods: Safety and efficacy were evaluated in pediatric patients receiving velaglucerase alfa 30-60 U/kg by intravenous infusion every other week. In addition to key hematological and visceral efficacy assessments, exploratory assessments conducted specifically in pediatric patients included evaluation of height, bone age, bone marrow burden, and Tanner stage of puberty. Results: The study included 24 pediatric patients. Fifteen patients were naive to ERT on entry into the preceding trials TKT032 (12-month trial) or HGT-GCB-039 (9-month trial): in the preceding trials, ten of these 15 patients received velaglucerase alfa and five patients received imiglucerase ERT. Nine patients in the study were previously treated with imiglucerase for >30 months and were switched to velaglucerase alfa in the preceding trial TKT034 (12-month trial). Cumulative ERT exposure in the clinical studies ranged from 2.0 to 5.8 years. Three serious adverse events, including a fatal convulsion, were reported;none were deemed related to velaglucerase alfa. One patient tested positive for anti-velaglucerase alfa antibodies. An efficacy assessment at 24 months showed that velaglucerase alfa had positive effects on primary hematological and visceral parameters in treatment-naive patients, which were maintained with longer-term treatment. Disease parameters were stable in patients switched from long-term imiglucerase ERT. Exploratory results may suggest benefits of early treatment to enable normal growth in pediatric patients. Conclusion: The safety profile and clinical response seen in pediatric patients are consistent with results reported in adults. (C) 20

关键词： Gaucher disease Velaglucerase alfa Enzyme replacement therapy Pediatric patients Children and adolescents

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Dose-finding studies, MCP-Mod, model selection, and model averaging: Two applications in the real world

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CLINICAL TRIALS 2014年第4期11卷 476-484页

作者： Verrier, Dominique Sivapregassam, Sindou Solente, Anne-Catherine Sanofi R&D Biostat & Programming Dept F-34184 Montpellier France Inserm DGOS CIE 802 Ctr Invest Clin Epidemiol Clin Antilles Guyane Guyane France Sanofi R&D Dept Biostat & Programming Paris France

Background Phase II clinical trials are important milestones to determine whether a dose-effect exists and to decide on future doses to use in confirmatory studies. To take into account the overall shape of the dose response curve, modeling the relationship by linear or non-linear models is preferable to the classical pair-wise comparisons of the effect of each dose versus the placebo or the comparator. The multiple comparisons and modeling approach has been developed within the last 10 years to address this important question in the clinical development of drugs. Despite some recent publications referring to this methodology, few detailed applications have been shown so far and several practical questions remain to be addressed. Methods Starting from a set of candidate models, model selection using classical methods criteria is possible. However, it suffers some limitations, not taking into account the uncertainty of the selection process itself. An attractive solution is to use model averaging, which applies appropriate weights to the parameters (e.g., the minimum effective dose) obtained from each model. Results A discussion of the selection criteria is first presented. Through two real examples, how to proceed with model selection and model averaging is presented and discussed. Limitations The first multiple comparisons and modeling approach papers addressed normal responses. More recently, an extension of this methodology has been proposed to deal with other types of responses, in particular binary, time-to-event and longitudinal data. Questions that remain are concerned with the choice of the candidate models and of their parameters' guesstimates. Conclusions The analysis of clinical dose-finding studies using a modeling of the entire curve offers a promising alternative as compared with the classical multiple comparisons methods, while not compromising the necessary rigor of the analysis.

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