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Does clinical equipoise apply to cluster randomized trials in health research?

TRIALS 2011年第2011期12卷 118-118页

作者： Binik, Ariella Weijer, Charles McRae, Andrew D. Grimshaw, Jeremy M. Boruch, Robert Brehaut, Jamie C. Donner, Allan Eccles, Martin P. Saginur, Raphael Taljaard, Monica Zwarenstein, Merrick Univ Western Ontario Dept Philosophy Rotman Inst Philosophy London ON N6A 5B8 Canada Univ Western Ontario Dept Med London ON N6A 5A5 Canada Univ Western Ontario Dept Epidemiol & Biostat London ON N6A 5C1 Canada Univ Calgary Div Emergency Med Foothills Med Ctr Calgary AB T2N 2T9 Canada Ottawa Hosp Clin Epidemiol Program Res Inst Ottawa ON K1Y 4E9 Canada Univ Ottawa Dept Med Fac Med Ottawa ON K1H 8L6 Canada Univ Penn Wharton Sch Grad Sch Educ Philadelphia PA 19104 USA Univ Penn Wharton Sch Dept Stat Philadelphia PA 19104 USA Univ Ottawa Dept Epidemiol & Community Med Ottawa ON K1H 8M5 Canada Robarts Res Inst London ON N6A 5K8 Canada Newcastle Univ Inst Hlth & Soc Newcastle Upon Tyne NE2 4AA Tyne & Wear England Univ Ottawa Dept Med Ottawa ON K1Y 4E9 Canada Ottawa Hosp Res Inst Ottawa ON K1Y 4E9 Canada Sunnybrook Hlth Sci Ctr Ctr Hlth Serv Sci Toronto ON M4N 3M5 Canada

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally

关键词： Experimental Intervention Ethical Concern Ethical Problem Trust Relationship data monitoring committee

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Ethical issues posed by cluster randomized trials in health research

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TRIALS 2011年第2011期12卷 100-100页

作者： Weijer, Charles Grimshaw, Jeremy M. Taljaard, Monica Binik, Ariella Boruch, Robert Brehaut, Jamie C. Donner, Allan Eccles, Martin P. Gallo, Antonio McRae, Andrew D. Saginur, Raphael Zwarenstein, Merrick Univ Western Ontario Dept Philosophy Rotman Inst Philosophy London ON N6A 5B8 Canada Univ Western Ontario Dept Med London ON N6A 5A5 Canada Univ Western Ontario Dept Epidemiol & Biostat London ON N6A 5C1 Canada Ottawa Hosp Res Inst Clin Epidemiol Program Ottawa ON K1Y 4E9 Canada Univ Ottawa Fac Med Dept Med Ottawa ON K1H 8L6 Canada Univ Ottawa Dept Epidemiol & Community Med Ottawa ON K1H 8M5 Canada Univ Penn Grad Sch Educ Philadelphia PA 19104 USA Univ Penn Dept Stat Wharton Sch Philadelphia PA 19104 USA John P Robarts Res Inst London ON N6A 5K8 Canada Newcastle Univ Inst Hlth & Soc Newcastle Upon Tyne NE2 4AX Tyne & Wear England Univ Western Ontario Schulich Sch Med & Dent London ON N6A 5C1 Canada Univ Calgary Foothills Med Ctr Div Emergency Med Calgary AB T2N 2T9 Canada Univ Ottawa Dept Med Ottawa ON K1Y 4E9 Canada Sunnybrook Hlth Sci Ctr Ctr Hlth Serv Sci Toronto ON M4N 3M5 Canada

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

关键词： Knowledge Translation Human Subject Research data monitoring committee Clinical Equipoise Surrogate Decision Maker

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A Benefit-risk Model to Facilitate DMC-sponsor Communication and Decision Making

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DRUG INFORMATION JOURNAL 2011年第6期45卷 749-757页

作者： Sashegyi, Andreas Eli Lilly & Co Lilly Corp Ctr Indianapolis IN 46285 USA

In drug development, independent data monitoring committees (DMCs) are routinely engaged by clinical trial sponsors to monitor patient safety. Transferring the obligation of interim data monitoring to an independent party helps ensure trial integrity by allowing the sponsor to remain blinded to emerging treatment results. But it also poses a dilemma: after each interim analysis, the DMC makes a recommendation to the sponsor regarding the continuation or modification of the ongoing trial, on the basis of which the sponsor must make a decision. Yet the unblinded results, which alone are the ideal basis for decision making, are only seen by the DMC and by design are withheld from the sponsor. We propose application of a multiattribute benefit-risk model to enable more informed decision making. The model provides an assessment of the emerging benefits and risks of active therapy versus control, based on an evaluation of attributes prespecified by the sponsor. While revealing no specific study outcomes, it allows an appreciation of the direction and magnitude of differentiation between treatment groups in terms of benefit and risk, enabling conversations around scenarios that would lead to this kind of assessment. The model also reflects uncertainty in the evaluation of benefits and risks, an essential feature in the analysis of interim data. This type of assessment may be leveraged to provide meaningful context accompanying the textual recommendation of a DMC to enable more informed decision making, while upholding the sponsor's commitment to remain blinded to particular study results.

关键词： data monitoring committee Multiattribute model Benefit-risk Blinding

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Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) Protocol

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TRIALS 2011年第2011期12卷 124-124页

作者： Mendelow, A. David Gregson, Barbara A. Mitchell, Patrick M. Murray, Gordon D. Rowan, Elise N. Gholkar, Anil R. Newcastle Univ STICH Off Neurosurg Trials Unit Newcastle Upon Tyne NE2 4AE Tyne & Wear England Univ Edinburgh Sch Med Ctr Populat Hlth Sci Edinburgh EH8 9AG Midlothian Scotland Royal Victoria Infirm Reg Neurosci Ctr Newcastle Tyne Hosp NHS Fdn Trust Newcastle Upon Tyne NE1 4LP Tyne & Wear England

Background: Within the spectrum of spontaneous intracerebral haemorrhage there are some patients with large or space occupying haemorrhage who require surgery for neurological deterioration and others with small haematomas who should be managed conservatively. There is equipoise about the management of patients between these two extremes. In particular there is some evidence that patients with lobar haematomas and no intraventricular haemorrhage might benefit from haematoma evacuation. The STICH II study will establish whether a policy of earlier surgical evacuation of the haematoma in selected patients will improve outcome compared to a policy of initial conservative treatment. Methods/Design: an international multicentre randomised parallel group trial. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible. All patients must have a CT scan confirming spontaneous lobar intracerebral haemorrhage (<= 1 cm from the cortex surface of the brain and 10-100 ml in volume). Any clotting or coagulation problems must be corrected and randomisation must take place within 48 hours of ictus. With 600 patients, the study will be able to demonstrate a 12% benefit from surgery (2p < 0.05) with 80% power. Stratified randomisation is undertaken using a central 24 hour randomisation service accessed by telephone or web. Patients randomised to early surgery should have the operation within 12 hours. Information about the status (Glasgow Coma Score and focal signs) of all patients through the first five days of their trial progress is also collected in addition to another CT scan at about five days (+/- 2 days). Outcome is measured at six months via a postal questionnaire to the patient. Primary outcome is death or severe disability defined using a prognosis based 8 point Glasgow Outcome Scale. Secondary outcomes include: Mortality, Rankin, Barthel, EuroQol, and Survival.

关键词： Glasgow Coma Scale Intracerebral Haemorrhage Glasgow Outcome Scale Glasgow Coma Score data monitoring committee

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Some Controversial Issues in Clinical Trials

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DRUG INFORMATION JOURNAL 2011年第2期45卷 163-174页

作者： Chow, Shein-Chung Yang, Lan-Yan Lu, Ying Natl Cheng Kung Univ Dept Stat Tainan 70101 Taiwan Duke Univ Sch Med Dept Biostat & Bioinformat Durham NC USA Beijing Univ Technol Dept Probabil & Stat Beijing Peoples R China

In clinical development of a test treatment, clinical trials are usually conducted to collect data for evaluation of safety and efficacy of the test treatment under investigation. To provide accurate and reliable assessment, well-controlled clinical trials under valid study designs are necessarily conducted. The clinical trial process is lengthy and costly, consisting of protocol development, trial conduct, data collection, statistical analysis and interpretation, and reporting. In practice, some controversial issues are commonly encountered regardless of compliance with good clinical practice. These issues include, but are not limited to, statistical hypotheses for clinical evaluation, instability of classical sample size calculation, integrity of blinding, clinical strategy for endpoint selection, impact of protocol amendments, flexibility and feasibility of adaptive design methods, multiplicity in clinical trials, and independence of data monitoring committees. In this article, these issues are briefly outlined. The impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation is assessed and discussed with examples whenever applicable. Recommendations regarding possible resolutions of these issues are also provided whenever possible.

关键词： Composite hypotheses Instability of sample size Integrity of blinding Clinical strategy for endpoint selection Protocol amendments data monitoring committee Multiplicity

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Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study);a multicenter randomized placebo controlled trial

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BMC PEDIATRICS 2011年第1期11卷 102-102页

作者： Onland, Wes Offringa, Martin Cools, Filip De Jaegere, Anne P. Rademaker, Karin Blom, Henry Cavatorta, Eric Debeer, Anne Dijk, Peter H. van Heijst, Arno F. Kramer, Boris W. Kroon, Andre A. Mohns, Thilo van Straaten, Henrica L. te Pas, Arjan B. Theyskens, Claire van Weissenbruch, Mirjam M. van Kaam, Anton H. Univ Amsterdam Acad Med Ctr Dept Neonatol Emma Childrens Hosp NL-1105 AZ Amsterdam Netherlands Univ Amsterdam Acad Med Ctr Dept Paediat Clin Epidemiol Emma Childrens Hosp NL-1105 AZ Amsterdam Netherlands Univ Ziekenhuis Brussel Dept Neonatol Brussels Belgium Univ Med Ctr Utrecht Dept Neonatol Wilhelmina Childrens Hosp Utrecht Netherlands Univ Ziekenhuis Antwerpen Dept Neonatol Antwerp Belgium Ctr Hosp Univ Charleroi Dept Neonatol Charleroi Belgium Univ Ziekenhuis Leuven Dept Neonatol Louvain Belgium Univ Groningen Univ Med Ctr Groningen Dept Neonatol NL-9713 AV Groningen Netherlands Radboud Univ Nijmegen Dept Neonatol Med Ctr NL-6525 ED Nijmegen Netherlands Maastricht Univ Dept Neonatol Med Ctr Maastricht Netherlands ErasmusMC Dept Neonatol Rotterdam Netherlands Isala Clin Dept Neonatol Zwolle Netherlands Leiden Univ Dept Neonatol Med Ctr Leiden Netherlands Ziekenhuis Oost Limburg Dept Neonatol Genk Belgium Vrije Univ Amsterdam Dept Neonatol Med Ctr Amsterdam Netherlands

Background: Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD). However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants. Methods/Design: The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age < 30 weeks and/or birth weight < 1250 grams), who are ventilator dependent at a postnatal age of 7 - 14 days. Hydrocortisone (cumulative dose 72.5 mg/kg) or placebo is administered during a 22 day tapering schedule. Primary outcome measure is the combined outcome mortality or BPD at 36 weeks postmenstrual age. Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age. Analysis will be on an intention to treat basis. Discussion: This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants.

关键词： Hydrocortisone Preterm Infant Congenital Diaphragmatic Hernia Bronchopulmonary Dysplasia data monitoring committee

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Self management, joint protection and exercises in hand osteoarthritis: a randomised controlled trial with cost effectiveness analyses

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BMC MUSCULOSKELETAL DISORDERS 2011年第1期12卷 156-156页

作者： Dziedzic, Krysia S. Hill, Susan Nicholls, Elaine Hammond, Alison Myers, Helen Whitehurst, Tracy Bailey, Jo Clements, Charlotte Whitehurst, David G. T. Jowett, Sue Handy, June Hughes, Rhian W. Thomas, Elaine Hay, Elaine M. Keele Univ Arthritis Res UK Primary Care Ctr Keele ST5 5BG Staffs England Univ Salford Ctr Hlth Sport & Rehabil Res Salford M6 6PU Greater Manches England Univ British Columbia Sch Populat & Publ Hlth Vancouver BC V5Z 1M9 Canada Univ Birmingham Sch Hlth & Populat Sci Birmingham B15 2TT W Midlands England

Background: There is limited evidence for the clinical and cost effectiveness of occupational therapy (OT) approaches in the management of hand osteoarthritis (OA). Joint protection and hand exercises have been proposed by European guidelines, however the clinical and cost effectiveness of each intervention is unknown. This multicentre two-by-two factorial randomised controlled trial aims to address the following questions: Is joint protection delivered by an OT more effective in reducing hand pain and disability than no joint protection in people with hand OA in primary care? Are hand exercises delivered by an OT more effective in reducing hand pain and disability than no hand exercises in people with hand OA in primary care? Which of the four management approaches explored within the study (leaflet and advice, joint protection, hand exercise, or joint protection and hand exercise combined) provides the most cost-effective use of health care resources Methods/Design: Participants aged 50 years and over registered at three general practices in North Staffordshire and Cheshire will be mailed a health survey questionnaire (estimated mailing sample n = 9,500). Those fulfilling the eligibility criteria on the health survey questionnaire will be invited to attend a clinical assessment to assess for the presence of hand or thumb base OA using the ACR criteria. Eligible participants will be randomised to one of four groups: leaflet and advice;joint protection (looking after your joints);hand exercises;or joint protection and hand exercises combined (estimated n = 252). The primary outcome measure will be the OARSI/OMERACT responder criteria combining hand pain and disability (measured using the AUSCAN) and global improvement, 6 months post-randomisation. Secondary outcomes will also be collected for example pain, functional limitation and quality of life. Outcomes will be collected at baseline and 3, 6 and 12 months post-randomisation. The main analysis will be on an inten

关键词： National Health Service Occupational Therapist data monitoring committee Trial Steering committee General Practitioner Practice

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Prehospital randomised assessment of a mechanical compression device in cardiac arrest (PaRAMeDIC) trial protocol

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SCANDINAVIAN JOURNAL OF TRAUMA RESUSCITATION & EMERGENCY MEDICINE 2010年第1期18卷 1-8页

作者： Perkins, Gavin D. Woollard, Malcolm Cooke, Matthew W. Deakin, Charles Horton, Jessica Lall, Ranjit Lamb, Sarah E. McCabe, Chris Quinn, Tom Slowther, Anne Gates, Simon Univ Warwick Warwick Med Sch Warwick Clin Trials Unit Coventry CV4 7AL W Midlands England Coventry Univ Prehosp Emergency & Cardiovasc Care Appl Res Grp Coventry CV1 5FB W Midlands England Southampton Gen Hosp Dept Anaesthet Southampton SO16 6YD Hants England Univ Leeds Leeds Inst Hlth Sci Acad Unit Hlth Econ Leeds LS2 9LJ W Yorkshire England Univ Surrey Fac Hlth & Med Sci Div Hlth & Social Care Guildford GU2 7XH Surrey England

Background: Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC) trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest. Methods/design: The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness. Methods: Ambulance service vehicles will be randomised to either manual compression (control) or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics committees. Consent will be sought from survivors for participation in the followup phase. Conclusion: The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942).

关键词： Cardiac Arrest Chest Compression Ambulance Service data monitoring committee International Standard Randomise Control Trial

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Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated)

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CRITICAL CARE 2010年第6期14卷 R229-R229页

作者： Shorr, Andrew F. Janes, Jonathan M. Artigas, Antonio Tenhunen, Jyrki Wyncoll, Duncan L. A. Mercier, Emmanuelle Francois, Bruno Vincent, Jean-Louis Vangerow, Burkhard Heiselman, Darell Leishman, Amy G. Zhu, Yajun E. Reinhart, Konrad Washington Hosp Ctr Washington DC 20010 USA Eli Lilly & Co Lilly Corp Ctr Lilly Res Labs Indianapolis IN 46285 USA Autonomous Univ Barcelona CIBER Enfermedades Resp Sabadell Hosp Crit Care Ctr Sabadell 08208 Spain Tampere Univ Hosp Dept Intens Care Med Crit Care Med Res Grp Tampere 33521 Finland Guys & St Thomas NHS Fdn Trust Adult Intens Care Unit London SE1 7EH England CHRU Hop Bretonneau CRICS Grp Serv Reanimat Polyvalente F-37044 Tours France CHRU Dupuytren CRICS Grp INSERM Serv Reanimat PolyvalenteCIC P 0801 F-87042 Limoges France Univ Libre Bruxelles Erasme Univ Hosp Dept Intens Care B-1070 Brussels Belgium Univ Jena Dept Anesthesiol & Intens Care D-07743 Jena Germany

Introduction: Serial alterations in protein C levels appear to correlate with disease severity in patients with severe sepsis, and it may be possible to tailor severe sepsis therapy with the use of this biomarker. The purpose of this study was to evaluate the dose and duration of drotrecogin alfa (activated) treatment using serial measurements of protein C compared to standard therapy in patients with severe sepsis. Methods: This was a phase 2 multicenter, randomized, double-blind, controlled study. Adult patients with two or more sepsis-induced organ dysfunctions were enrolled. Protein C deficient patients were randomized to standard therapy (24 mu g/kg/hr infusion for 96 hours) or alternative therapy (higher dose and/or variable duration;24/30/36 mu g/kg/hr for 48 to 168 hours). The primary outcome was a change in protein C level in the alternative therapy group, between study Day 1 and Day 7, compared to standard therapy. Results: Of 557 patients enrolled, 433 patients received randomized therapy;206 alternative, and 227 standard. Baseline characteristics of the groups were largely similar. The difference in absolute change in protein C from Day 1 to Day 7 between the two therapy groups was 7% (P = 0.011). Higher doses and longer infusions were associated with a more pronounced increase in protein C level, with no serious bleeding events. The same doses and longer infusions were associated with a larger increase in protein C level;higher rates of serious bleeding when groups received the same treatment;but no clear increased risk of bleeding during the longer infusion. This group also experienced a higher mortality rate;however, there was no clear link to infusion duration. Conclusions: The study met its primary objective of increased protein C levels in patients receiving alternative therapy demonstrating that variable doses and/or duration of drotrecogin alfa (activated) can improve protein C levels, and also provides valuable information for incorporation into

关键词： Severe Sepsis Alternative Therapy Drotrecogin Alfa data monitoring committee Interactive Voice Response System

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Viewpoints on the FDA Draft Adaptive Designs Guidance from the PhRMA Working Group

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JOURNAL OF BIOPHARMACEUTICAL STATISTICS 2010年第6期20卷 1115-1124页

作者： Gallo, Paul Anderson, Keaven Chuang-Stein, Christy Dragalin, Vladimir Gaydos, Brenda Krams, Michael Pinheiro, Jose Novartis E Hanover NJ 07936 USA Merck N Wales PA USA Pfizer Kalamazoo MI USA Quintiles Morrisville NC USA Eli Lilly & Co Indianapolis IN 46285 USA Johnson & Johnson Consumer Prod Inc Titusville NJ USA Johnson & Johnson Consumer Prod Inc Raritan NJ USA

The US Food and Drug Administration has recently released a draft guidance document on adaptive clinical trials. We comment on the document from the particular perspective of the authors as members of a PhRMA working group on this topic, which has interacted with FDA personnel on adaptive trial issue during recent years. We describe the activities and prior work of our working group, and use this as a basis to discuss the content of the guidance document as it relates to several issues of current relevance, such as data monitoring processes, adaptive dose finding, so-called seamless trial designs, and sample size reestimation.

关键词： Adaptive dose finding Confirmatory trial data monitoring committee Exploratory trial Sample size reestimation

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