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data monitoring committees. Third pillar in the methodical conduct of clinical trials

BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ 2008年第7期51卷 793-796页

作者： Fischer, T. Bundesinst Arzneimittel & Med Prod Sachgebietsleiter Klin Klin Pharmakol Fachgebiet Klin Prufung D-53175 Bonn Germany

data monitoring committees (DMC) are increasingly becoming integrated into the methodical procedure of clinical trials, in order to support sponsors in their central role. Whereas monitors and auditors, respectively, give quality assuring recommendations in compliance with GCP, an implemented DMC is able to give sponsors far-reaching recommendations owing to its access to unblinded data. Besides the main intention of enhancing safety during the conduction of clinical trials, the premature termination of clinical trials due to insufficient efficacy of the investigational medicinal product may be a result. Based on the European Guideline EMEA/CHMP/EWP/5872/03 Corr and based on published literature, criteria and crucial aspects for implementing this independent committee are being named If, in the course of a clinical trial, the implemented DMC notices an alteration in the risk-benefit assessment in the context of pharmacovigilance, immediate notification obligations of the Sponsor to the higher federal authorities and to the ethics committees arise.

关键词： data monitoring committee clinical trials pharmacovigilance

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A multi-centre randomised controlled study of pre-IVF outpatient hysteroscopy in women with recurrent IVF implantation failure: Trial of Outpatient Hysteroscopy - [TROPHY] in IVF

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Reproductive Health 2009年第1期6卷 1-7页

作者： El-Toukhy, Tarek Campo, Rudi Sunkara, Sesh Kamal Khalaf, Yacoub Coomarasamy, Arri Assisted Conception Unit Guy's and St Thomas' Foundation Trust London SE1 9RT United Kingdom Leuven Institute for Fertility and Embryology Leuven 168 3000 Tiensevest Belgium Academic Department Birmingham Women's Hospital Birmingham B15 2TG United Kingdom

Background. The success rate of IVF treatment is low. A recent systematic review and meta-analysis found that the outcome of IVF treatment could be improved in patients who have experienced recurrent implantation failure if an outpatient hysteroscopy (OH) is performed before starting the new treatment cycle. However, the trials were of variable quality, leading to a call for a large and high-quality randomised trial. This protocol describes a multi-centre randomised controlled trial to test the hypothesis that performing an OH prior to starting an IVF cycle improves the live birth rate of the subsequent IVF cycle in women who have experienced two to four failed IVF cycles. Methods and design. Eligible and consenting women will be randomised to either OH or no OH using an internet based trial management programme that ensures allocation concealment and employs minimisation for important stratification variables including age, body mass index, basal follicle stimulating hormone level and number of previous failed IVF cycles. The primary outcome is live birth rate per IVF cycle started. Other outcomes include implantation, clinical pregnancy and miscarriage rates. The sample size for this study has been estimated as 758 participants with 379 participants in each arm. Interim analysis will be conducted by an independent data monitoring committee (DMC), and final analysis will be by intention to treat. A favourable ethical opinion has been obtained (REC reference: 09/H0804/32). Trail Registration. The trial has been assigned the following ISRCTN number: ISRCTN35859078. © 2009 El-Toukhy et al;licensee BioMed Central Ltd.

关键词： Live Birth Rate Uterine Cavity Minimally Important Difference Clinical Pregnancy Rate data monitoring committee

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Active management of the third stage of labour without controlled cord traction: A randomized non-inferiority controlled trial

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Reproductive Health 2009年第1期6卷 1-10页

作者： Gülmezoglu, A Metin Widmer, Mariana Merialdi, Mario Qureshi, Zahida Piaggio, Gilda Elbourne, Diana Abdel-Aleem, Hany Carroli, Guillermo Hofmeyr, G Justus Lumbiganon, Pisake Derman, Richard Okong, Pius Goudar, Shivaprasad Festin, Mario Althabe, Fernando Armbruster, Deborah UNDP/UNFPA/WHO/World Bank Spec. Prog. of Res. Devmt. and Research Training in Human Reproduction Department of Reproductive Health and Research World Health Organization Geneva Switzerland Department of Obstetrics and Gynaecology Kenyatta National Hospital University of Nairobi Nairobi Kenya London School of Hygiene and Tropical Medicine London University London United Kingdom Department Obstetrics and Gynaecology Assiut University Hospital Assiut Egypt Centro Rosarino de Estudios Perinatales Rosario Argentina Effective Care Research Unit University of Witwatersrand University of Fort Hare East London South Africa Department of Obstetrics and Gynaecology Khon Kaen University Khon Kaen Thailand University of Missouri Kansas City United States Department Obstetrics and Gynaecology San Raphael of St. Francis Hospital Nsambya Kampala Uganda Department of Medical Education K L e Society's J N Medical College Belgaum India Philippine General Hospital Manila Philippines Department of Mother and Child's Health Research Buenos Aires Argentina Program for Appropriate Technology in Health (PATH) WA United States

Background: The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL) reduces the occurrence of severe postpartum haemorrhage by approximately 60-70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care. Objective: The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package. Methods: A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour. The simplified package will include uterotonic (oxytocin 10 IU IM) injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM), controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome measure is blood loss of 1000

关键词： Oxytocin Expectant Management data monitoring committee Skilled Birth Attendant Uterine Massage

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Prednisolone Trial: Study protocol for a randomised controlled trial of prednisolone for women with idiopathic recurrent miscarriage and raised levels of uterine natural killer (uNK) cells in the endometrium

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TRIALS 2009年第2009期10卷 102-102页

作者： Tang, Ai-Wei Alfirevic, Zarko Turner, Mark A. Drury, Jo Quenby, Siobhan Univ Liverpool Liverpool Womens Hosp Sch Reprod & Dev Med Liverpool L8 7SS Merseyside England

Background: Idiopathic recurrent miscarriage is defined as 3 consecutive pregnancy losses with no contributing features found on investigations. At present there are no treatments of proven efficacy for idiopathic recurrent miscarriage. Uterine natural killer (uNK) cells, the most predominant leucocyte in the endometrium are adjacent to foetal trophoblast cells and thought to be involved in implantation. The exact mechanisms of how uNK cells affect implantation are not clear but are probably through the regulation of angiogenesis. Multiple studies have shown an association between high density of uterine natural killer cells and recurrent miscarriage. We have shown that prednisolone reduces the number of uNK cells in the endometrium. The question remains as to whether reducing the number of uNK cells improves pregnancy outcome. Methods: We propose a randomised, double-blind, placebo controlled trial of prednisolone with a pilot phase to assess feasibility of recruitment, integrity of trial procedures, and to generate data to base future power calculations. The primary aim is to investigate whether prednisolone therapy during the first trimester of pregnancy is able to improve live birth rates in patients with idiopathic recurrent miscarriage and raised uNK cells in the endometrium. Secondary outcomes include conception rate, karyotype of miscarriage, miscarriages (first and second trimester), stillbirths, pregnancy complications, gestational age at delivery, congenital abnormality and side effects of steroids. The trial has 2 stages: i) screening of non-pregnant women and ii) randomisation of the pregnant cohort. All patients who fit the inclusion criteria (<40 years old, >= 3 consecutive miscarriages with no cause found and no contraindications to prednisolone therapy) will be asked to consent to an endometrial biopsy in the mid-luteal phase to assess their levels of uNK cells. Women with high levels of uNK cells(>= 5%), will be randomised to either prednisolone or

关键词： Live Birth Rate Recurrent Miscarriage Endometrial Biopsy data monitoring committee Trial Steering committee

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Maximising engagement, motivation and long term change in a Structured Intensive Education Programme in Diabetes for children, young people and their families: Child and Adolescent Structured Competencies Approach to Diabetes Education (CASCADE)

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BMC PEDIATRICS 2009年第1期9卷 57-57页

作者： Christie, Deborah Strange, Vicki Allen, Elizabeth Oliver, Sandy Wong, Ian Chi Kei Smith, Felicity Cairns, John Thompson, Rebecca Hindmarsh, Peter O'Neill, Simon Bull, Christina Viner, Russell Elbourne, Diana Univ Coll Hosp Child & Adolescent Psychol Serv London England Univ London Social Sci Res Unit Inst Educ London WC1E 7HU England Univ London Dept Practice & Policy Sch Pharm London WC1E 7HU England Univ London Sch Pharm Ctr Pharm Res London WC1E 7HU England London Sch Hyg & Trop Med Hlth Serv Res Unit London WC1 England Univ Coll Hosp Diabet Child & Adolescent Serv London England Univ Coll Hosp Dept Biochem Endocrinol & Metab London England Diabet UK London England UCL Inst Child Hlth London England London Sch Hyg & Trop Med Med Stat Unit London WC1 England

Background: This trial aims to evaluate effective delivery and cost effectiveness of an innovative structured psycho-educational programme (CASCADE) for young people and their families living with diabetes. The increase in numbers of people being diagnosed with diabetes is posing a challenge for both the UK and the rest of the world. The peak age for diagnosis is between 10 and 14 years of age. There is clear evidence that improved diabetes control from diagnosis in childhood can reduce the incidence and progression of long-term complications. However, despite the development of improved insulin regimens and delivery methods, the overall metabolic control in children and adolescents has improved little in the UK in the past decade. Therefore there is a need for novel interventions and health delivery mechanisms aimed at young people and their families to help improve control and reduce complications, illness burden and costs to the NHS. Methods/Design: The CASCADE trial is a multi-centre randomised control trial with 26 clinics randomised to control or intervention groups, with 572 children and young people involved in the study. The intervention will be delivered in 4 group sessions, over a 4 month period. A developmentally appropriate curriculum will be delivered to groups of 3-4 families, focusing on achievement of increasing competency in self-management of diabetes. The control group will receive standard care from their clinical team, usually consisting of regular 3-monthly clinic visits and telephone contact as required with the clinical nurse specialist and consultant. The primary outcomes of the trial will be change in HbA1c between baseline and 12 months and 24 months post recruitment. Secondary outcomes will include measures related to the economic evaluation, psychosocial outcomes, outcomes related to management of diabetes outcomes, and adherence to the intervention. Discussion: The trial will be run by independent research and service delivery teams an

关键词： Young People Clinic Staff data monitoring committee Trial Steering committee Clinical Nurse Specialist

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ADEPT - Abnormal Doppler Enteral Prescription Trial

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BMC PEDIATRICS 2009年第1期9卷 63-63页

作者： Leaf, Alison Dorling, Jon Kempley, Steve McCormick, Kenny Mannix, Paul Brocklehurst, Peter Southmead Hosp Neonatol Unit Bristol Avon England City Hosp Nottingham Neonatol Unit Nottingham England Royal London Hosp Neonatol Unit London E1 1BB England John Radcliffe Hosp Neonatol Unit Oxford OX3 9DU England Northwick Pk Hosp & Clin Res Ctr Neonatol Unit Harrow HA1 3UJ Middx England Univ Oxford Natl Perinatal Epidemiol Unit Oxford England

Background: Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation. Optimising neonatal feeding for this group of babies may have long-term health implications and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice. Methods and Design: Babies with gestational age below 35 weeks, and with birth weight below 10th centile for gestational age, will be randomly allocated to an "early" or "late" enteral feeding regimen, commencing milk feeds on day 2 and day 6 after birth, respectively. Feeds will be gradually increased over 9-13 days ( depending on gestational age) using a schedule derived from those used in hospitals in the Eastern and South Western Regions of England, based on surveys of feeding practice. Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis;secondary outcomes include sepsis and growth. The target sample size is 400 babies. This sample size is large enough to detect a clinically meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies, with 90% power and a 5% 2-sided significance level. Initial recruitment period was 24 months, subsequently extended to 38 months. Discussion: There is limited evidence from randomised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants. This multicentre trial will help to guide clinical practice and may also provide pointers for future r

关键词： Enteral Feeding Umbilical Artery data monitoring committee Trial Steering committee High Dependency Care

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Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

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TRIALS 2009年第1期10卷 49-49页

作者： Briel, Matthias Lane, Melanie Montori, Victor M. Bassler, Dirk Glasziou, Paul Malaga, German Akl, Elie A. Ferreira-Gonzalez, Ignacio Alonso-Coello, Pablo Urrutia, Gerard Kunz, Regina Culebro, Carolina Ruiz da Silva, Suzana Alves Flynn, David N. Elamin, Mohamed B. Strahm, Brigitte Murad, M. Hassan Djulbegovic, Benjamin Adhikari, Neill K. J. Mills, Edward J. Gwadry-Sridhar, Femida Kirpalani, Haresh Soares, Heloisa P. Abu Elnour, Nisrin O. You, John J. Karanicolas, Paul J. Bucher, Heiner C. Lampropulos, Julianna F. Nordmann, Alain J. Burns, Karen E. A. Mulla, Sohail M. Raatz, Heike Sood, Amit Kaur, Jagdeep Bankhead, Clare R. Mullan, Rebecca J. Nerenberg, Kara A. Vandvik, Per Olav Coto-Yglesias, Fernando Schuenemann, Holger Tuche, Fabio Chrispim, Pedro Paulo M. Cook, Deborah J. Lutz, Kristina Ribic, Christine M. Vale, Noah Erwin, Patricia J. Perera, Rafael Zhou, Qi Heels-Ansdell, Diane Ramsay, Tim Walter, Stephen D. Guyatt, Gordon H. Mayo Clin Knowledge & Encounter Res Unit Rochester MN 55905 USA McMaster Univ Dept Clin Epidemiol & Biostat Hamilton ON Canada Univ Basel Hosp Basel Inst Clin Epidemiol & Biostat CH-4031 Basel Switzerland Univ Childrens Hosp Tuebingen Dept Neonatol Tubingen Germany Univ Oxford Dept Primary Hlth Care Ctr Evidence Based Med Oxford England Univ Peruana Cayetano Heredia Lima Peru SUNY Buffalo Buffalo NY USA Hosp Santa Creu & Sant Pau Ctr Cochrane Iberoamer Barcelona Spain Teaching & Res Ctr Procardiaco Rio De Janeiro Brazil Univ Hosp Freiburg Pediat Hematol & Oncol Ctr Pediat & Adolescent Me Freiburg Germany USF Hlth Clin Res Ctr Evidence Based Med Tampa FL USA Sunnybrook Hlth Sci Ctr Toronto ON M4N 3M5 Canada Univ British Columbia British Columbia Ctr Excellence HIV AIDS Vancouver BC V5Z 1M9 Canada Univ Western Ontario London ON Canada Childrens Hosp Philadelphia Philadelphia PA 19104 USA Mt Sinai Med Ctr Miami Beach FL 33140 USA Univ Toronto St Michaels Hosp Keenan Res Ctr Toronto ON M5B 1W8 Canada Univ Toronto Li Ka Shing Knowledge Inst Toronto ON Canada Hosp Nacl Geriatria & Gerontol San Jose San Jose Costa Rica Natl Sch Publ Hlth ENSP Rio De Janeiro Brazil Univ Ottawa Ottawa Hosp Res Inst Ottawa ON Canada

Background: Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design: We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed bia

关键词： Systematic Review data monitoring committee Pool Relative Risk Portable Document Format Minimal Important Change

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IVF with preimplantation genetic screening, a promising new treatment with unexpectedly negative health outcomes: the Hippocratic role of data monitoring committees

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HUMAN REPRODUCTION 2008年第1期23卷 1-3页

作者： Ankum, Willem M. Reitsma, Johannes B. Offringa, Martin Univ Amsterdam Acad Med Ctr Dept Obstet & Gynaecol NL-1012 WX Amsterdam Netherlands Univ Amsterdam Acad Med Ctr Dept Clin Epidemiol & Biostat NL-1012 WX Amsterdam Netherlands Univ Amsterdam Acad Med Ctr Dept Paediat Clin Epidemiol NL-1012 WX Amsterdam Netherlands

A recently published randomized controlled trial showed preimplantation genetic screening (PGS) as part of an IVF programme to reduce ongoing pregnancy rates by 1/3 in comparison to the control group without PGS: rate ratio (RR) 0.69 (0.51-0.93), P = 0.01. A masked interim analysis already showed significant differences between treatment arms: RR 0.58 (0.35-0.94), P= 0.02. Despite this finding, the trial's data monitoring committee decided not to stop, but to continue the trial. This paper argues why this decision was sound, since it was based on (i) explicit statistical criteria and (ii) the trade-off between risks and benefits for current and future IVF patients. The trial's findings confront the medical community once again with the general problem of new technologies being implemented without randomized evidence of effectiveness.

关键词： IVF preimplantation genetic screening masked interim analysis data monitoring committee randomized controlled trial

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Response to: The BRAIN TRIAL: a randomized, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury Reply

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TRIALS 2009年第1期10卷 111-111页

作者： Roberts, Ian Shakur, Haleema Univ London London Sch Hyg & Trop Med Trials Coordinating Ctr London WC1E 7HT England

A response to the letter regarding The BRAIN TRIAL: a randomized, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury, by Mr Vincent Simmon President and... 详细信息

关键词： Traumatic Brain Injury Trial Protocol Ethical Obligation data monitoring committee Statistical Analysis Plan

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Coordinating data monitoring committees and adaptive clinical trial designs

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DRUG INFORMATION JOURNAL 2008年第4期42卷 297-301页

作者： Herson, Jay Johns Hopkins Univ Bloomberg Sch Publ Hlth Baltimore MD 21205 USA

There is a growing interest in employing adaptive clinical trial designs in drug development. Adaptation is usually based on accumulative efficacy data alone. This article examines issues that can arise when an independent data monitoring committee must interface their safety concerns when adaptive changes based on efficacy are taking place. Several types of adaptive changes are examined and the degree of complexity that safety concerns might introduce is discussed. Recommendations are made for sponsor-data monitoring committee communications when the latter has safety concerns that make a particular kind of adaptation inadvisable. Recommendations are made for making adaptive change decisions, minimizing bias, and training DMC and sponsor staff for participation in adaptive design trials.

关键词： data monitoring committee data analysis center internal safety review committee adaptive design

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