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Design Issues of Randomized Phase II Trials and a Proposal for ...


Design issues of randomized phase II trials and a proposal for ...

Future progress in improving cancer therapy can be expedited by better prioritization of new treatments for phase III evaluation. Historically, phase II ...

Design Issues of Randomized Phase II Trials and a Proposal for ...

We present our own explorations into the possibilities of developing “phase II screening trials,” in which preliminary and nondefinitive randomized comparisons ...

Design Issues of Randomized Phase II Trials and a Proposal for ...

We present our own explorations into the possibilities of developing “phase II screening trials,” in which preliminary and nondefinitive randomized comparisons ...

Design issues in randomized phase II/III trials - PubMed

Two key considerations in designing a phase II/III trial are whether to suspend accrual while the phase II data mature and the choice of phase II target ...

Design Issues of Randomized Phase II Trials and a Proposal for ...

There has been a long-standing interest in using phase II trials with randomization against a standard-treatment control arm or an additional experimental arm ...

Randomized Phase II Designs - Clinical Trials - AACR Journals

Where the randomized phase II selection design is appropriate, it can be conducted with modest sample size. For example, Simon et al. show that ...

Randomized Phase II Trials: Time for a New Era in Clinical Trial ...

The design of a clinical trial is largely driven by three statistical parameters: (1) α, the type I error or probability of a false-positive result, (2) β, the ...

An Overview of Phase 2 Clinical Trial Designs

Randomized phase 2 trials with a control arm are preferred. Single-arm designs are an option for trials with novel agents with promising ...

Design, power, and alpha levels in randomized phase II oncology ...

The statistical plan of a phase II trial should balance minimizing the premature termination of potentially beneficial therapies (i.e. false ...

The Design of Phase II Clinical Trials Testing Cancer Therapeutics ...

The Task Force agreed that randomization was generally required to evaluate the efficacy of combinations of agents (e.g., for approved drugs and ...

Design of phase II oncology trials evaluating combinations of ...

One solution to this problem is to use a randomized comparative trial in which the combination of interest is compared with 1 or both of its component agents, ...

A Bayesian pick-the-winner design in a randomized phase II clinical ...

To balance unknown confounding factors, randomization is implemented to assign patients to the two treatment arms. For each treatment arm, a ...

Review of Perspectives on the Use of Randomization in Phase II ...

Historically, phase II oncology trials assessed a treatment's efficacy by examining its tumor response rate in a single-arm trial. Then, ...

Phase II design: history and evolution - Chinese Clinical Oncology

In the setting of the randomized trial, the usual limits for type I and type II errors may be relaxed; in fact, usage of type I error of 0.20 may be considered ...

Design, power, and alpha levels in randomized phase II oncology ...

The statistical plan of a phase II trial should balance minimizing the premature termination of potentially beneficial therapies (i.e. false negatives) and ...

An Overview of Phase 2 Clinical Trial Designs

A controlled randomized phase 2 trial, ideal in. 24. Statistics for the People. International Journal of Radiation Oncology Biology Physics. Page 4. many ...

Randomized phase II trials with a prospective control

These designs are randomized phase II trial analogs of Simon's designs that were proposed for single‐arm phase II trials allowing for early termination of ...

Are There Circumstances in Which Phase 2 Study Results Should ...

Selection of the experimental novel therapy arm for randomized studies is generally obtained from phase 2 investigations. The randomization ...

Design issues of randomized phase II trials and a proposal for ...

instance of · scholarly article ; title. Design issues of randomized phase II trials and a proposal for phase II screening trials (English).

Randomized Phase II Designs - OUCI

We review the arguments for and against the use of randomization in phase II studies, the situations in which the use of historical controls is preferred, and ...