During the past three decades, clinical trials have evolved to become major research methodology for clinical medicine. Many statistical principles have been applied to the design, conduct, and anlysis of clinical trials, and these statistical methodologies continue to evolve as we apply clinical trials to an increasing array of research settings.

From the Back Cover

Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented.

This book should be useful to anyone serving on a data and safety monitoring board, or planning to do so, for colleagues in academia, industry and governmental agencies, and for teaching students in biostatistics, epidemiology, clinical trials and medical ethics. No other text has as extensive a collection of cases which provide insight into the many issues, often conflicting, that must be examined before recommendations to continue or discontinue a trial can be made. While depth in statistical methods is not required, some familiarity with statistical design and analysis issues in clinical trials is helpful. The cases cover trials which were terminated early for convincing evidence of benefit, or for harmful effects. Cases with complex issues are also included. This series of cases should provide broad background information for potential monitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible.

The three editors have contributed two overview chapters as well as several case studies to go along with cases contributed by a distinguished group of colleagues experienced in the design, monitoring and analysis of clinical trials. Dr. David DeMets is currently Professor and Chair, Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison. He is past president of the Eastern North American Region (ENAR) of the International Biometric Society, a past member of the Board of Directors of the American Statistical Association and an elected Fellow. He recently received the Robert Gordon Lectureship Award, given by the National Institutes of Health, for significant contributions to the field of clinical trials. Dr. Curt Furberg, is currently Professor (and former Chair) of the Department of Public Health Sciences at Wake Forest University. Previously, he was Head of the Clinical Trials Branch and Associate Director of the Clinical Applications and Prevention Program at the National Heart, Lung, and Blood Institute. Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications and a former Assistant Director for Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three are past presidents of the Society of Clinical Trials. The editors have collaborated previously as coauthors of a text: the Fundamentals of Clinical Trials.

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

Store Description

Better World Books (https://www.BetterWorldBooks.com) is a for-profit, socially conscious business and a global online bookseller that collects and sells new and used books online, matching each purchase with a book donation. Each sale generates funds for literacy and education initiatives in the U.S., the UK, and around the world. Since its launch in 2003, Better World Books has raised $33 million for libraries and literacy, donated over 32 million books, and reused or recycled more than 397 million books.

Visit Seller's Storefront

Seller's business information

Better World Books Marketplace, Inc.
55740 Currant Road, Mishawaka, IN, 46545, U.S.A.

Sale & Shipping Terms

Terms of Sale

Better World Books (BWB) values your satisfaction and offers you returns within thirty (30) days after the estimated delivery date on most items. All returned items must be in the original condition; used items should include the SKU sticker located on the spine or back of the product.

If you have an incomplete, incorrect, or damaged shipment, please contact our Customer Care team via Abebooks contact seller options before proceeding with the return.Please keep in mind that because we deal mostl...

More Information

Right of cancellation

If you are a consumer you can cancel 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 CANCELLATION

Statutory Right to cancel

You have the right to cancel this contract within 14 days for any reason.

The cancellation 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 the last good or the last lot or piece.

To exercise the right to cancel, you must inform us, Better World Books, 55740 Currant Road, 46545, Mishawaka, Indiana, U.S.A., of your decision to cancel this contract by a clear statement (e.g. a letter sent by post, fax or e-mail). You may use the attached model cancellation form, but it is not obligatory. You can also electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". If you use this option, we will communicate to you an acknowledgement of receipt of such a cancellation on a durable medium (e.g. by e-mail) without delay.

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

Effects of cancellation

If you cancel 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 cancel with 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 us or Better World Books, 55740 Currant Road, 46545, Mishawaka, Indiana, U.S.A., without undue delay and in any event not later than 14 days from the day on which you communicate your cancellation 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 cancellation

The right of cancellation 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 cancel it once delivery had started.

Model withdrawal form

(complete and return this form only if you wish to withdraw from the contract)

To: (Better World Books, 55740 Currant Road, 46545, Mishawaka, Indiana, U.S.A.)

I/We (*) hereby give notice that I/We (*) withdraw from my/our (*) contract of sale of the following goods (*)/for the provision of the following goods (*)/for the provision of the following service (*),

Ordered on (*)/received on (*)

Name of consumer(s)

Address of consumer(s)

Signature of consumer(s) (only if this form is notified on paper)

Date

* Delete as appropriate.

Shipping Terms

Please allow 1-2 business days for order fulfillment.

Shipping rates within U.S.A.

Shipping rates within U.S.A.
Order quantity	4 to 8 business days	3 to 5 business days
First item	� 0.00	� 7.32

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.