Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a sm...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2018-09-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865417301977 |
| _version_ | 1818486753185497088 |
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| author | Jiacheng Yuan Daniel Radecki Denise Bugarin Till Geib Jihao Zhou Jeen Liu |
| author_facet | Jiacheng Yuan Daniel Radecki Denise Bugarin Till Geib Jihao Zhou Jeen Liu |
| author_sort | Jiacheng Yuan |
| collection | DOAJ |
| description | This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations. Keywords: Adaptive design, Dose finding, Proof of concept, Seamless design, Budget saving |
| first_indexed | 2024-12-10T16:27:13Z |
| format | Article |
| id | doaj.art-772867899b184ebfb68560186063a376 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-10T16:27:13Z |
| publishDate | 2018-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-772867899b184ebfb68560186063a3762022-12-22T01:41:39ZengElsevierContemporary Clinical Trials Communications2451-86542018-09-01118388Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose findingJiacheng Yuan0Daniel Radecki1Denise Bugarin2Till Geib3Jihao Zhou4Jeen Liu5Corresponding author.; Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USAAllergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USAAllergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USAAllergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USAAllergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USAAllergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USAThis paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations. Keywords: Adaptive design, Dose finding, Proof of concept, Seamless design, Budget savinghttp://www.sciencedirect.com/science/article/pii/S2451865417301977 |
| spellingShingle | Jiacheng Yuan Daniel Radecki Denise Bugarin Till Geib Jihao Zhou Jeen Liu Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding Contemporary Clinical Trials Communications |
| title | Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding |
| title_full | Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding |
| title_fullStr | Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding |
| title_full_unstemmed | Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding |
| title_short | Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding |
| title_sort | seamless phase iia iib adaptive design with the same primary endpoint for proof of concept and dose finding |
| url | http://www.sciencedirect.com/science/article/pii/S2451865417301977 |
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