Early Access Provision for Innovative Medicinal Products in Oncology: Challenges and Opportunities.
作者信息
Krendyukov Andriy
机构信息
VP Head Global Medical Affairs, Apogenix AG, Heildelberg, Germany.
出版信息
Front Oncol. 2020 Sep 2;10:1604. doi: 10.3389/fonc.2020.01604. eCollection 2020.
Abstract
摘要
相似文献
1
Early Access Provision for Innovative Medicinal Products in Oncology: Challenges and Opportunities.
Front Oncol. 2020 Sep 2;10:1604. doi: 10.3389/fonc.2020.01604. eCollection 2020.
2
[Chapter 2. Clinical trials of advanced therapy medicinal products: which future for the European regulation].
J Int Bioethique Ethique Sci. 2018 Jul 20;29(2):35-51. doi: 10.3917/jibes.292.0035.
3
[Innovative medicinal products: the new criteria of the Italian Medicines Agency.].
Recenti Prog Med. 2018 May;109(5):261-262. doi: 10.1701/2902.29243.
4
Compassionate use of drugs and medical devices in the United States, the European Union and Japan.
Regen Ther. 2016 Feb 15;4:18-26. doi: 10.1016/j.reth.2015.11.002. eCollection 2016 Jun.
5
A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC).
Ther Innov Regul Sci. 2019 Mar;53(2):243-248. doi: 10.1177/2168479018759659. Epub 2018 Mar 8.
6
Access to innovative medicines for metastatic melanoma worldwide: Melanoma World Society and European Association of Dermato-oncology survey in 34 countries.
Eur J Cancer. 2018 Nov;104:201-209. doi: 10.1016/j.ejca.2018.09.013. Epub 2018 Oct 31.
7
Characterizing expanded access and compassionate use programs for experimental drugs.
BMC Res Notes. 2017 Jul 28;10(1):350. doi: 10.1186/s13104-017-2687-5.
8
Physician perspectives on compassionate use in pediatric oncology.
Pediatr Blood Cancer. 2019 Mar;66(3):e27545. doi: 10.1002/pbc.27545. Epub 2018 Nov 8.
9
What do patients with unmet medical needs want? A qualitative study of patients' views and experiences with expanded access to unapproved, investigational treatments in the Netherlands.
BMC Med Ethics. 2019 Nov 9;20(1):80. doi: 10.1186/s12910-019-0420-8.
10
[Compassionate use of non-approved medicinal products. Legal basis and guidelines].
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2009 Apr;52(4):439-43. doi: 10.1007/s00103-009-0829-1.
引用本文的文献
1
Characteristics and availability of medicine early access programs and donations in Slovenia.
Oncologist. 2025 Jul 4;30(7). doi: 10.1093/oncolo/oyaf092.
2
Interactions between Australian cancer physicians and the pharmaceutical industry: a qualitative study.
BMJ Open. 2023 May 26;13(5):e065719. doi: 10.1136/bmjopen-2022-065719.
3
Treatment patterns, adherence to international guidelines, and financial mechanisms of the market access of advanced breast cancer therapy in Bulgaria.
Front Public Health. 2023 Mar 3;11:1073733. doi: 10.3389/fpubh.2023.1073733. eCollection 2023.
4
Early access provision: Awareness, educational needs and opportunities to improve oncology patients' access to care.
Front Oncol. 2022 Oct 26;12:714516. doi: 10.3389/fonc.2022.714516. eCollection 2022.
5
Early Access to Medicines: Use of Multicriteria Decision Analysis (MCDA) as a Decision Tool in Catalonia (Spain).
J Clin Med. 2022 Mar 1;11(5):1353. doi: 10.3390/jcm11051353.
本文引用的文献
1
Evolving Communication with Healthcare Professionals in the Pharmaceutical Space: Current Trends and Future Perspectives.
Pharmaceut Med. 2020 Aug;34(4):247-256. doi: 10.1007/s40290-020-00341-0.
2
Critical Factors Shaping Strategy Development of an Innovative Medicine in Oncology.
Pharmaceut Med. 2020 Apr;34(2):103-112. doi: 10.1007/s40290-020-00328-x.
3
Early access to health products in France: Major advances of the French "Conseil stratégique des industries de santé" (CSIS) to be implemented (modalities, regulations, funding).
Therapie. 2019 Feb;74(1):103-117. doi: 10.1016/j.therap.2018.12.002. Epub 2018 Dec 13.
4
Impact of Expanded Access on FDA Regulatory Action and Product Labeling.
Ther Innov Regul Sci. 2017 Nov;51(6):787-789. doi: 10.1177/2168479017707800. Epub 2017 May 3.
5
Fair, just and compassionate: A pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials.
J Med Ethics. 2018 Nov;44(11):761-767. doi: 10.1136/medethics-2016-103917. Epub 2018 Jul 7.
6
A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.
JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618.
7
Gene Therapy for Adenosine Deaminase Deficiency: A Comprehensive Evaluation of Short- and Medium-Term Safety.
Mol Ther. 2018 Mar 7;26(3):917-931. doi: 10.1016/j.ymthe.2017.12.022. Epub 2018 Jan 4.
8
How Often Are Drugs Made Available Under the Food and Drug Administration's Expanded Access Process Approved?
J Clin Pharmacol. 2017 Oct;57 Suppl 10:S136-S142. doi: 10.1002/jcph.960.
9
Ethics review in compassionate use.
BMC Med. 2017 Jul 24;15(1):136. doi: 10.1186/s12916-017-0910-9.
10
The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications.
J Pharm Policy Pract. 2017 Feb 21;10:10. doi: 10.1186/s40545-017-0100-3. eCollection 2017.
Zotero 插件