Title: Practical Considerations for Adaptive Trial Design and Implementation
Publisher: Springer New York
Publication Date: 2014
Language: English
ISBN 10: 149391099X
ISBN 13: 9781493910991
Binding: Gebunden
Condition: New

About this title

Synopsis

This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues facedin trial implementation.

Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.

About the Author

Weili He is a Director and Senior Principle Scientist of Clinical Biostatistics at Merck & Co., Inc. She has a Ph.D. degree in biostatistics. She has extensive experience in drug development, and has worked in many therapeutic areas over the years. Dr. He has been active both at Merck and in industry for initiatives relating to adaptive trials, with particular focus on adaptive trial design and implementation. She is a core member of the DIA Adaptive Design Scientific Working Group (ADSWG) and co-chair of the DIA ADSWG KOL Lecture series. Her research and collaboration with colleagues in various disciplines has led to over 30 publications in statistical and medical journals.

Jos� Pinheiro has a Ph.D. in Statistics from the University of Wisconsin – Madison, having worked at Bell Labs and Novartis Pharmaceuticals, before his current position as Head of Statistical Modeling in the Model-Based Drug Development department at Janssen Research & Development. He has been involved in methodological development in various areas of statistics and drug development, including dose-finding, adaptive designs and mixed-effects models. He is a Fellow of the American Statistical Association, former co-chair of the PhRMA working group on Adaptive Dose-Ranging Studies, former core member of the PhRMA working group on Novel Adaptive Designs and co-developer of the nlme library/package in S-PLUS and R for linear and non-linear mixed-effects models.

Olga Kuznetsova is a Senior Principal Scientist in the Late Development Statistics department of Merck & Co., Inc. She has a PhD in probability theory and mathematical statistics and more than 15 years of experience in clinical trials. In the last decade, her research interests centered around randomization techniques in clinical trials, in particular, addressing the randomization needs of adaptive design trials. Her collaboration with colleagues on randomization issuesresulted in more than 20 presentations and publications.

"About this title" may belong to another edition of this title.

Store Description

Online Handel nur mit Neub�chern

Visit Seller's Storefront

Seller's business information

Moluna GmbH
Engberdingdamm 27, Greven, 48268, Germany

Sale & Shipping Terms

Terms of Sale

Instructions for revocation/
Standard Business Terms and customer information/ data protection declaration

Revocation right for consumers
(A ?consumer? is any natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities.)

Instructions for revocation

Revocation right
You have the right to revoke this contract within one month without specifying any reasons.
The revocation period is one month...

More Information

Right of withdrawal

If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.

Information regarding the right of withdrawal

Statutory right to withdraw

You have the right to withdraw from this contract within 14 days without giving any reason.

The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.

To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.

To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.

Effects of withdrawal

If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).

We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.

We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.

We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.

We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.

You shall send back the goods or hand them over to moluna, Greven, Germany, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.

Exceptions to the right of withdrawal

The right of withdrawal does not apply to:

The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.

Shipping Terms

II. Kundeninformationen

Identit�t des Verk�ufers

Moluna GmbH
Engberdingdamm 27
48268 Greven
Deutschland
Telefon: 02571/5698933
E-Mail: abe@moluna.de

Wir sind nicht bereit und nicht verpflichtet, an Streitbeilegungsverfahren vor Verbraucherschlichtungsstellen teilzunehmen.

Informationen zum Zustandekommen des Vertrages

Die technischen Schritte zum Vertragsschluss, der Vertragsschluss selbst und die Korrekturm�glichkeiten erfolgen nach Ma�gabe der Regelungen "Zustandekommen des Vertrages" unserer Allgemeinen Gesch�ftsbedingungen (Teil I.).

Vertragssprache, Vertragstextspeicherung

3.1. Vertragssprache ist deutsch .

3.2. Der vollst�ndige Vertragstext wird von uns nicht gespeichert. Vor Absenden der Bestellung k�nnen die Vertragsdaten �ber die Druckfunktion des Browsers ausgedruckt oder elektronisch gesichert werden. Nach Zugang der Bestellung bei uns werden die Bestelldaten, die gesetzlich vorgeschriebenen Informationen bei Fernabsatzvertr�gen und die Allgemeinen Gesch�ftsbedingungen nochmals per E-Mail an Sie �bersandt.

Wesentliche Merkmale der Ware oder Dienstleistung

Die wesentlichen Merkmale der Ware und/oder Dienstleistung finden sich im jeweiligen Angebot.

Preise und Zahlungsmodalit�ten

5.1. Die in den jeweiligen Angeboten angef�hrten Preise sowie die Versandkosten stellen Gesamtpreise dar. Sie beinhalten alle Preisbestandteile einschlie�lich aller anfallenden Steuern.

5.2. Die anfallenden Versandkosten sind nicht im Kaufpreis enthalten. Sie sind �ber eine entsprechend bezeichnete Schaltfl�che auf unserer Internetpr�senz oder im jeweiligen Angebot aufrufbar, werden im Laufe des Bestellvorganges gesondert ausgewiesen und sind von Ihnen zus�tzlich zu tragen, soweit nicht die versandkostenfreie Lieferung zugesagt ist.

5.3. Die Ihnen zur Verf�gung stehenden Zahlungsarten sind unter einer entsprechend bezeichneten Schaltfl�che auf unserer Internetpr�senz oder im jeweiligen Angebot ausgewiesen.

5.4. Soweit bei den einzelnen Zahlungsarten nicht anders angegeben, sind die Zahlungsanspr�che aus dem geschlossenen Vertrag sofort zur Zahlung f�llig.

Lieferbedingungen

6.1. Die Lieferbedingungen, der Liefertermin sowie gegebenenfalls bestehende Lieferbeschr�nkungen finden sich unter einer entsprechend bezeichneten Schaltfl�che auf unserer Internetpr�senz oder im jeweiligen Angebot.

Soweit im jeweiligen Angebot oder unter der entsprechend bezeichneten Schaltfl�che keine andere Frist angegeben ist, erfolgt die Lieferung der Ware innerhalb von 3-5 Tagen nach Vertragsschluss (bei vereinbarter Vorauszahlung jedoch erst nach dem Zeitpunkt Ihrer Zahlungsanweisung).

6.2. Soweit Sie Verbraucher sind ist gesetzlich geregelt, dass die Gefahr des zuf�lligen Untergangs und der zuf�lligen Verschlechterung der verkauften Sache w�hrend der Versendung erst mit der �bergabe der Ware an Sie �bergeht, unabh�ngig davon, ob die Versendung versichert oder unversichert erfolgt. Dies gilt nicht, wenn Sie eigenst�ndig ein nicht vom Unternehmer benanntes Transportunternehmen oder eine sonst zur Ausf�hrung der Versendung bestimmte Person beauftragt haben.

Sind Sie Unternehmer, erfolgt die Lieferung und Versendung auf Ihre Gefahr.

Gesetzliches M�ngelhaftungsrecht

Die M�ngelhaftung richtet sich nach der Regelung "Gew�hrleistung" in unseren Allgemeinen Gesch�ftsbedingungen (Teil I).

letzte Aktualisierung: 23.10.2019

Shipping rates from Germany to U.S.A.

Shipping rates from Germany to U.S.A.
Order quantity	26 to 60 business days	26 to 60 business days
First item	� 42.49	� 42.49

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.

Detailed Seller Information