Real-World Evidence in Medical Product Development (Paperback)
Weili He
Sold by Grand Eagle Retail, Bensenville, IL, U.S.A.
AbeBooks Seller since 12 October 2005
New - Soft cover
Condition: New
Ships within U.S.A.
Quantity: 1 available
Add to basketSold by Grand Eagle Retail, Bensenville, IL, U.S.A.
AbeBooks Seller since 12 October 2005
Condition: New
Quantity: 1 available
Add to basketPaperback. This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases. This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.
Seller Inventory # 9783031263309
This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.
Weili He
Dr. Weili He has over 25 years of experience working in the biopharmaceutical industry. She is currently a Distinguished Research Fellow and head of Medical Affairs and Health Technology Assessment statistics at AbbVie. She has a PhD in Biostatistics. Weili’s areas of expertise span across clinical trials, real-world studies and evidence generations, statistical methodologies in clinical trials, observational research, innovative adaptive designs, and benefit-risk assessment. She is the lead or co-author of more than 60 peer-reviewed publications in statistics or medical journals and lead editor of two books on adaptive design and benefit-risk assessment, respectively. She is the co-founder and co-chair of the American Statistical Association (ASA) Biopharmaceutical Section (BIOP) Real-world Evidence Scientific Working Group from 2018 to 2022. Weili is the BIOP Chair-Elect, Chair, and Past Chair from 2020-2022. She is also an Associate Editor of Statistics in Biopharmaceutical Research since 2014, and an elected Fellow of ASA since 2018.
Yixin Fang
After he received his PhD in Statistics from Columbia University in 2006, Yixin Fang had been working in academia before he joined AbbVie in 2019. Currently, he is a Research Fellow and Director of Statistics in Medical Affairs and Health Technology Assessment Statistics (MA&HTA Statistics) at AbbVie. Within MA&HTA Statistics, he is Head of the therapeutics areas (TAs) of Eye Care and Specialty and Head of Causal Inference Center (CIC). In this role, he is involved with the design and analysis of Phase IV studies and real-world studies in medical affairs and leading HTA submissions in the TA of Eye Care. In addition, he is active in the statistical community with over 100 peer-reviewed manuscripts and his research interests are in real-world data analysis, machine learning, and causal inference.Hongwei Wang
Dr. Hongwei Wang has close to 20 years’ experience working in the biopharmaceutical industry. He is currently a Research Fellow and Director at Medical Affairs and Health Technology Assessment Statistics of AbbVie. Prior to that, Hongwei worked at Sanofi and Merck with increasing responsibilities. He has been leading evidence planning and evidence generation activities across various therapeutic areas in the fields of real-world studies, network meta-analysis and post-hoc analysis with a mission to support medical affair strategy and optimal reimbursement. Hongwei received his PhD in Statistics from Rutgers University, conducts active methodology research and their applications to different stages of drug development. He serves as coauthor of about 40 manuscripts in peer reviewed journals and over 100 presentations at scientific congresses.
"About this title" may belong to another edition of this title.
We guarantee the condition of every book as it¿s described on the Abebooks web sites. If you¿ve changed
your mind about a book that you¿ve ordered, please use the Ask bookseller a question link to contact us
and we¿ll respond within 2 business days.
Books ship from California and Michigan.
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 without giving 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, Grand Eagle Retail, 26C Trolley Square, 19806, Wilmington, Delaware, U.S.A., 1 (302) 261-2674, 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 Grand Eagle Retail, Grand Eagle Retail c/o Kable Product Services, 4275 Thunderbird Lane, 45014-45, Fairfield, Ohio, U.S.A., 1 (302) 261-2674, 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:
Model withdrawal form
(complete and return this form only if you wish to withdraw from the contract)
To: (Grand Eagle Retail, 26C Trolley Square, 19806, Wilmington, Delaware, U.S.A., 1 (302) 261-2674)
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.
Orders usually ship within 2 business days. All books within the US ship free of charge. Delivery is 4-14 business days anywhere in the United States.
Books ship from California and Michigan.
If your book order is heavy or oversized, we may contact you to let you know extra shipping is required.
| Order quantity | 6 to 16 business days | 6 to 14 business days |
|---|---|---|
| First item | £ 0.00 | £ 0.00 |
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.