Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
Clinical Trials in Vulnerable Populations / / edited by Milica Prostran
| Clinical Trials in Vulnerable Populations / / edited by Milica Prostran |
| Pubbl/distr/stampa | Croatia : , : IntechOpen, , 2018 |
| Descrizione fisica | 1 online resource (224 pages) : illustrations |
| Disciplina | 610.724 |
| Soggetto topico | Clinical trials |
| ISBN |
1-83881-259-8
1-78923-201-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910317821103321 |
| Croatia : , : IntechOpen, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / / Margaret B. Liu and Kate Davis
| A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / / Margaret B. Liu and Kate Davis |
| Autore | Liu Margaret B. |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Chichester, [England] : , : Wiley-Blackwell, , 2010 |
| Descrizione fisica | 1 online resource (432 p.) |
| Disciplina | 615.5072/4 |
| Soggetto topico |
Clinical trials
Drugs - Testing |
| ISBN |
1-282-46164-8
9786612461644 1-4443-1522-6 1-4443-1521-8 1-4443-5788-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Lessons from a horse named Jim and other events in history affecting the regulation of clinical research -- The process : developing new drugs, biologics, and devices -- Good clinical practice and the regulations -- Informed consent and the regulations -- Institutional review boards -- Adverse events and unanticipated problems involving risks to subjects and others -- Monitoring, audits, and inspections -- The principal investigator, the clinical research coordinator, and the study site -- The protocol -- Study feasibility : reviewing a specific protocol -- Study activities -- Study documents/essential documents -- Management of study drugs, biologics, and devices -- Managing clinical trial data -- Global health and international trials. |
| Record Nr. | UNINA-9910265229803321 |
Liu Margaret B.
|
||
| Chichester, [England] : , : Wiley-Blackwell, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical trials week
| Clinical trials week |
| Pubbl/distr/stampa | Atlanta, Ga., : NewsRx |
| Disciplina | 616 |
| Soggetto topico |
Clinical trials
Medicine |
| Soggetto genere / forma |
Periodical
Periodicals. |
| ISSN | 1543-6764 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996336465003316 |
| Atlanta, Ga., : NewsRx | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
Clinical trials with missing data : a guide for practitioners / / Michael O'Kelly, Bohdana Ratitch
| Clinical trials with missing data : a guide for practitioners / / Michael O'Kelly, Bohdana Ratitch |
| Autore | O'Kelly Michael |
| Pubbl/distr/stampa | Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 |
| Descrizione fisica | 1 online resource (473 p.) |
| Disciplina | 610.72/4 |
| Altri autori (Persone) | RatitchBohdana |
| Collana | Statistics in practice |
| Soggetto topico |
Clinical trials
Clinical trials - Statistical methods |
| ISBN |
1-118-76253-3
1-118-76251-7 1-118-76250-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Clinical Trials with Missing Data; Contents; Preface; References; Acknowledgments; Notation; Table of SAS code fragments; Contributors; 1 Whats the problem with missing data?; 1.1 What do we mean by missing data?; 1.1.1 Monotone and non-monotone missing data; 1.1.2 Modeling missingness, modeling the missing value and ignorability; 1.1.3 Types of missingness (MCAR, MAR and MNAR); 1.1.4 Missing data and study objectives; 1.2 An illustration; 1.3 Why cant I use only the available primary endpoint data?; 1.4 Whats the problem with using last observation carried forward?
1.5 Can we just assume that data are missing at random?1.6 What can be done if data may be missing not at random?; 1.7 Stress-testing study results for robustness to missing data; 1.8 How the pattern of dropouts can bias the outcome; 1.9 How do we formulate a strategy for missing data?; 1.10 Description of example datasets; 1.10.1 Example dataset in Parkinsons disease treatment; 1.10.2 Example dataset in insomnia treatment; 1.10.3 Example dataset in mania treatment; Appendix 1.A: Formal definitions of MCAR, MAR and MNAR; References; 2 The prevention of missing data; 2.1 Introduction 2.2 The impact of "too much" missing data 2.2.1 Example from human immunodeficiency virus; 2.2.2 Example from acute coronary syndrome; 2.2.3 Example from studies in pain; 2.3 The role of the statistician in the prevention of missing data; 2.3.1 Illustrative example from HIV; 2.4 Methods for increasing subject retention; 2.5 Improving understanding of reasons for subject withdrawal; Acknowledgments; Appendix 2.A: Example protocol text for missing data prevention; Section X Subject retention; References; 3 Regulatory guidance - a quicktour 3.1 International conference on harmonization guideline: Statistical principles for clinical trials: E93.2 The US and EU regulatory documents; 3.3 Key points in the regulatory documents on missing data; 3.4 Regulatory guidance on particular statistical approaches; 3.4.1 Available cases; 3.4.2 Single imputation methods; 3.4.3 Methods that generally assume MAR; 3.4.4 Methods that are used assuming MNAR; 3.5 Guidance about how to plan for missing data in a study; 3.6 Differences in emphasis between the NRC report and EU guidance documents; 3.6.1 The term "conservative" 3.6.2 Last observation carried forward 3.6.3 Post hoc analyses; 3.6.4 Non-monotone or intermittently missing data; 3.6.5 Assumptions should be readily interpretable; 3.6.6 Study report; 3.6.7 Training; 3.7 Other technical points from the NRC report; 3.7.1 Time-to-event analyses; 3.7.2 Tipping point sensitivity analyses; 3.8 Other US/EU/international guidance documents that refer to missing data; 3.8.1 Committee for medicinal products for human use guideline on anti-cancer products, recommendations on survival analysis 3.8.2 US guidance on considerations when research supported by office of human research protections is discontinued |
| Record Nr. | UNINA-9910132240603321 |
|
O'Kelly Michael
|
||
| Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical trials with missing data : a guide for practitioners / / Michael O'Kelly, Bohdana Ratitch
| Clinical trials with missing data : a guide for practitioners / / Michael O'Kelly, Bohdana Ratitch |
| Autore | O'Kelly Michael |
| Pubbl/distr/stampa | Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 |
| Descrizione fisica | 1 online resource (473 p.) |
| Disciplina | 610.72/4 |
| Altri autori (Persone) | RatitchBohdana |
| Collana | Statistics in practice |
| Soggetto topico |
Clinical trials
Clinical trials - Statistical methods |
| ISBN |
1-118-76253-3
1-118-76251-7 1-118-76250-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Clinical Trials with Missing Data; Contents; Preface; References; Acknowledgments; Notation; Table of SAS code fragments; Contributors; 1 Whats the problem with missing data?; 1.1 What do we mean by missing data?; 1.1.1 Monotone and non-monotone missing data; 1.1.2 Modeling missingness, modeling the missing value and ignorability; 1.1.3 Types of missingness (MCAR, MAR and MNAR); 1.1.4 Missing data and study objectives; 1.2 An illustration; 1.3 Why cant I use only the available primary endpoint data?; 1.4 Whats the problem with using last observation carried forward?
1.5 Can we just assume that data are missing at random?1.6 What can be done if data may be missing not at random?; 1.7 Stress-testing study results for robustness to missing data; 1.8 How the pattern of dropouts can bias the outcome; 1.9 How do we formulate a strategy for missing data?; 1.10 Description of example datasets; 1.10.1 Example dataset in Parkinsons disease treatment; 1.10.2 Example dataset in insomnia treatment; 1.10.3 Example dataset in mania treatment; Appendix 1.A: Formal definitions of MCAR, MAR and MNAR; References; 2 The prevention of missing data; 2.1 Introduction 2.2 The impact of "too much" missing data 2.2.1 Example from human immunodeficiency virus; 2.2.2 Example from acute coronary syndrome; 2.2.3 Example from studies in pain; 2.3 The role of the statistician in the prevention of missing data; 2.3.1 Illustrative example from HIV; 2.4 Methods for increasing subject retention; 2.5 Improving understanding of reasons for subject withdrawal; Acknowledgments; Appendix 2.A: Example protocol text for missing data prevention; Section X Subject retention; References; 3 Regulatory guidance - a quicktour 3.1 International conference on harmonization guideline: Statistical principles for clinical trials: E93.2 The US and EU regulatory documents; 3.3 Key points in the regulatory documents on missing data; 3.4 Regulatory guidance on particular statistical approaches; 3.4.1 Available cases; 3.4.2 Single imputation methods; 3.4.3 Methods that generally assume MAR; 3.4.4 Methods that are used assuming MNAR; 3.5 Guidance about how to plan for missing data in a study; 3.6 Differences in emphasis between the NRC report and EU guidance documents; 3.6.1 The term "conservative" 3.6.2 Last observation carried forward 3.6.3 Post hoc analyses; 3.6.4 Non-monotone or intermittently missing data; 3.6.5 Assumptions should be readily interpretable; 3.6.6 Study report; 3.6.7 Training; 3.7 Other technical points from the NRC report; 3.7.1 Time-to-event analyses; 3.7.2 Tipping point sensitivity analyses; 3.8 Other US/EU/international guidance documents that refer to missing data; 3.8.1 Committee for medicinal products for human use guideline on anti-cancer products, recommendations on survival analysis 3.8.2 US guidance on considerations when research supported by office of human research protections is discontinued |
| Record Nr. | UNINA-9910819122203321 |
|
O'Kelly Michael
|
||
| Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Cochrane clinical answers
| Cochrane clinical answers |
| Pubbl/distr/stampa | Wiley |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Evidence-based medicine
Clinical trials Evidence-Based Medicine |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | CCAs |
| Record Nr. | UNINA-9910295803003321 |
| Wiley | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Cochrane clinical answers / / Cochrane Innovations and John Wiley & Sons, Ltd
| Cochrane clinical answers / / Cochrane Innovations and John Wiley & Sons, Ltd |
| Pubbl/distr/stampa | New York : , : John Wiley & Sons, Inc., , 2012 |
| Descrizione fisica | 1 online resource |
| Disciplina | 610.724 |
| Soggetto topico |
Clinical trials
Evidence-based medicine Evidence-Based Medicine Randomized Controlled Trials as Topic |
| ISBN | 1-119-96948-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Clinical answers
CCAs |
| Record Nr. | UNINA-9910134799103321 |
| New York : , : John Wiley & Sons, Inc., , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The Cochrane database of systematic reviews
| The Cochrane database of systematic reviews |
| Pubbl/distr/stampa | Oxford, U.K. ; ; Vista, CA, : Update Software |
| Soggetto topico |
Medicine - Research - Statistical methods
Evidence-based medicine Clinical trials Systematic reviews (Medical research) Research Evidence-Based Medicine Randomized Controlled Trials as Topic Research Design |
| Soggetto genere / forma |
Periodical
Review Meta-Analysis. RU Database.$2LCGFT. Databases. Periodicals. |
| Soggetto non controllato | Medical Ethics & Philosophy |
| ISSN | 1469-493X |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
CDSR
Cochrane review |
| Record Nr. | UNINA-9910133835203321 |
| Oxford, U.K. ; ; Vista, CA, : Update Software | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
A comprehensive and practical guide to clinical trials / / edited by Delva Shamley, Brenda Wright, the Clinical Research Centre at the University of Cape Town, Cape Town, Western Cape Province, South Africa
| A comprehensive and practical guide to clinical trials / / edited by Delva Shamley, Brenda Wright, the Clinical Research Centre at the University of Cape Town, Cape Town, Western Cape Province, South Africa |
| Pubbl/distr/stampa | London, [England] : , : Academic Press, , 2017 |
| Descrizione fisica | 1 online resource (212 pages) |
| Disciplina | 615.50724 |
| Soggetto topico | Clinical trials |
| ISBN | 0-12-804730-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction to clinical trials / Brenda Wright -- Clinical trial phases / Brenda Wright -- Setting up of site, site assessment visits, and selection / Brenda Wright -- Regulatory requirements / Inge Vermeulen -- Contracts and agreements / Brenda Wright -- Protocol, informed consent documents, and investigator brochure / Brenda Wright -- Planning / Brenda Wright -- Recruitment and retention / Brenda Wright -- Training / Brenda Wright -- Data management / Annemie Stewart -- Investigational medicinal product (IMP) management / Wynand Smythe and Nicky Kramer -- Collecting, processing, and shipment of blood and urine samples / Brenda Wright -- Source document / Brenda Wright -- Screening, treatment, and safety follow-up visit / Brenda Wright -- Quality management / Brenda Wright -- Monitoring, close-out visits, and archiving / Brenda Wright -- Audits and inspections / Brenda Wright. |
| Record Nr. | UNINA-9910583073803321 |
| London, [England] : , : Academic Press, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
A concise guide to clinical trials
| A concise guide to clinical trials |
| Autore | Hackshaw Allan K |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Oxford, : Wiley-Blackwell, c2009 |
| Descrizione fisica | 1 online resource (225 p.) |
| Disciplina |
615.19
615.50724 |
| Soggetto topico |
Clinical trials
Clinical medicine - Research |
| ISBN |
1-4443-5666-6
1-282-13959-2 9786612139598 1-4443-1172-7 1-4443-1171-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | A Concise Guide to Clinical Trials; Contents; Preface; Foreword; 1 Fundamental concepts; 2 Types of outcome measures and understanding them; 3 Design and analysis of phase I trials; 4 Design and analysis of phase II trials; 5 Design of phase III trials; 6 Randomisation; 7 Analysis and interpretation of phase III trials; 8 Systematic reviews and meta-analyses; 9 Health-related quality of life and health economic evaluation; 10 Setting up, conducting and reporting trials; 11 Regulations and guidelines; Reading list; Statistical formulae for calculating some 95% confidence intervals; Index |
| Record Nr. | UNINA-9910146149303321 |
|
Hackshaw Allan K
|
||
| Oxford, : Wiley-Blackwell, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Soggetto topico
-
Clinical trials
(243)
- Clinical Trials as Topic (26)
- Drugs - Testing (25)
- Medicine - Research (11)
- Clinical medicine - Research (9)