Adaptive Clinical Trials: Overview of Phase III Designs and Challenges

Therapeutic Innovation & Regulatory Science
Jeff MacaPaul Gallo

Abstract

Adaptive designs use accruing data to make changes in an ongoing trial according to a prespecified plan and potentially offer great efficiencies for clinical development. There are many types of adaptive designs and many trial aspects that could in theory be adapted. However, the scope of adaptive designs with relevance in confirmatory trials is narrower, and in addition, extensive pre-planning is needed and various types of challenges need to be addressed in order to use these designs in this stage of development. Nevertheless, with careful planning, there are opportunities for these designs to offer important benefits even in the confirmatory stage of development. We provide an overview of adaptive designs that have relevance for confirmatory trials and discuss considerations that may affect whether they should or should not be used in particular trials or programs as well as the challenges that need to be addressed.

References

Apr 21, 2001·Biometrics·W Lehmacher, G Wassmer
Mar 11, 2003·Statistics in Medicine·Christopher Jennison, Bruce W Turnbull
Dec 4, 2003·Statistics in Medicine·Meinhard Kieser, Tim Friede
Apr 2, 2004·Statistics in Medicine·Y H Joshua ChenK K Gordon Lan
Nov 20, 2004·Statistics in Medicine·A Maitournam, R Simon
Jun 29, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Robert J Temple
Jun 29, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Boris Freidlin, Richard Simon
Nov 11, 2005·Clinical Trials : Journal of the Society for Clinical Trials·Richard M Simon
Sep 16, 2006·Biometrical Journal. Biometrische Zeitschrift·Frank BretzWilli Maurer
Aug 11, 2007·Pharmaceutical Statistics·Sue-Jane WangH M James Hung
Jul 30, 2008·Biometrical Journal. Biometrische Zeitschrift·Jack Bowden, Ekkehard Glimm
Feb 4, 2009·Circulation·Cyrus MehtaJames H Ware
Feb 12, 2009·Statistics in Medicine·Frank BretzMartin Posch
Mar 7, 2009·Statistics in Medicine·Werner BrannathAmy Racine-Poon
Apr 10, 2009·Biometrical Journal. Biometrische Zeitschrift·Sue-Jane WangRobert T O'Neill
Jan 19, 2010·Pulmonary Pharmacology & Therapeutics·Peter J BarnesDavid Lawrence
Sep 8, 2010·Biometrical Journal. Biometrische Zeitschrift·Ionut BebuVladimir Dragalin
Mar 25, 2011·Statistics in Medicine·Caroline Tournoux-FaconPascale Tubert-Bitter
Apr 26, 2011·Journal of Biopharmaceutical Statistics·Gernot Wassmer
Apr 26, 2011·Journal of Biopharmaceutical Statistics·Cyrus R Mehta, Ping Gao
Nov 23, 2011·Statistics in Medicine·Cyrus R Mehta, Stuart J Pocock
Jun 30, 2012·Statistics in Medicine·Máximo Carreras, Werner Brannath
Jan 1, 2013·Stat·J GertheissA-M Staicu

❮ Previous
Next ❯

Citations

Nov 1, 2015·Therapeutic Innovation & Regulatory Science·Harold E GlassPhuong Tran
Nov 16, 2019·Pharmaceutical Statistics·Daniele De Martini
Apr 25, 2017·Expert Review of Clinical Pharmacology·François Curtin, Stephane Heritier
Sep 1, 2016·Journal of Immunology Research·Alison SmithFrank-Peter Theil
Dec 6, 2020·Trials·Julia M EdwardsSteven A Julious

❮ Previous
Next ❯

Software Mentioned

ADDPLAN

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

© 2022 Meta ULC. All rights reserved