End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?

Author:

Degtyarev Evgeny1ORCID,Bolaños Natacha2,Brody Joshua D3,Buchbinder Aby4,Buyse Marc56,Fuchs Miriam1,Halabi Susan78,Hemmings Robert9,Masood Aisha4,Newsome Simon1,Saxton Claire10,Warwick Lorna11,Yateman Nigel A1,Zuber Emmanuel1

Affiliation:

1. Novartis Pharma, Basel, Switzerland

2. Lymphoma Coalition, Madrid, Spain

3. Hematology & Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA

4. Novartis Pharmaceuticals, East Hanover, NJ, USA

5. International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium

6. Interuniversity Institute for Biostatistics & Statistical Bioinformatics (I-BioStat), Hasselt University, Diepenbeek, Belgium

7. Duke Clinical Research Institute, Durham, North Carolina, USA

8. Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA

9. CONSILIUM Salmonson & Hemmings, Woking, UK

10. Cancer Support Community, Washington, DC, USA

11. Lymphoma Coalition, Management, Mississauga ON, Canada

Publisher

Informa UK Limited

Reference65 articles.

1. The saga of PI3K inhibitors in haematological malignancies: survival is the ultimate safety endpoint

2. FDA Guidance for Industry. Clinical trial endpoints for the approval of cancer drugs and biologics. December 2018. Available from: www.fda.gov/media/71195/download

3. Patient relevant endpoints in oncology: current issues in the context of early benefit assessment in Germany

4. ICH Harmonised Guideline. E8(R1) General considerations for clinical studies. [updated 2021 Oct 06]. Available from: www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ich-guideline-e8-r1-general-considerations-clinical-studies_en.pdf

5. ICH Harmonised Guideline. E9(R1) Addendum on estimands and sensitivity analysis in clinical trials. [updated 2019 Nov 20]. Available from: https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3