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Tag: adaptive design

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The Role of Adaptive Trial Designs in Early Oncology Studies: Optimizing Flexibility and Agility

Targeted therapies and immunotherapies have changed not only cancer treatment paradigms, but also historical approaches to clinical trial design, especially in early development. Traditionally, early phase oncology trials have been focused on dose optimization, toxicity, and broad response signals. However, with the growth of personalized medicine, many early phase studies also place emphasis on identifying...

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Clinical Research: Phase 1 - Phase 4

How Adaptive Design Clinical Trials Uphold These 3 Core Ethical Principles

In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report, which has since become a pivotal document in medical research ethics. This report pointed to three unifying ethical principles that must be followed in clinical research: respect for persons, beneficence, and justice, which are considered fundamental for...

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Clinical Research: Phase 1 - Phase 4

4 Potential Advantages of Adaptive Design

Adaptive design is a type of clinical trial methodology that incorporates prospectively planned opportunities for modification of one or more aspects of a study’s design or its hypotheses based on interim analysis of study data. Explicitly planning these pre-specified changes helps to maintain scientific integrity while also introducing greater flexibility in the clinical research environment. The major...

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Consulting

Adaptive Design Strategies in Rare Oncology

Traditional trial design use only a priori inputs to obtain final trial results. From first patient in to last patient out, trial execution proceeds without change, following a black box approach. While a standard for clinical research, this strategy doesn’t always suit rare oncology research, which must contend with very small patient populations that are often difficult to treat....

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Clinical Research: Phase 1 - Phase 4

Ethical Considerations in Adaptive Design Clinical Trials

What happens when a widely recognized advance in clinical trial design poses ethical questions? Find out in Premier Research’s webinar, Ethical Considerations in Adaptive Design Clinical Trials. The hour-long event examines particular design adaptations and discusses the ethical obstacles they present — and potentially resolve. Jennifer Nezzer, Director of Biostatistics, and Dr. Thomas Laage, Director of Product Development Consulting,...

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Study Design

Adaptive Design: Premier Research Participates in a Talk on Benefits, Risks, and Ethics

DURHAM, N.C., May 13, 2016 — A potent mix of benefits, risks, and ethical questions confronts researchers conducting novel adaptive design clinical trials. Dr. Thomas Laage, Senior Medical Director, Premier Research, explored this complex challenge in a webinar with members of the DIA Adaptive Design Scientific Working Group. Dr. Laage, with several co-authors of the...

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Data Management & Biostatistics

The Ethical Challenges of Adaptive Design: Join a Premier Research Webinar Nov. 19

PHILADELPHIA, November 10, 2015 — What happens when a widely recognized advance in clinical trial design poses ethical questions? Find out Thursday, Nov. 19, at a complimentary Premier Research webinar, Ethical Considerations in Adaptive Design Clinical Trials. The hour-long event, starting at 11 a.m. EST / 4 p.m. BST / 5 p.m. CET, will examine particular...

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Patient and Stakeholder Engagement

Premier Research’s New Rare Disease and Orphan Drug Survey Accentuates Difficulty of Recruiting Patients and Motivating Patients to Take Part in Study

A new survey of clinical trial decision makers commissioned by Premier Research and involving 50 biotech and pharmaceutical firms in North America and Europe reveals that more than two-thirds (69%) of respondents said that among the most difficult factors in recruiting patients into a rare disease clinical trial was not only finding and motivating patients to join and remain in trials, but identifying and setting up investigative sites for studies.

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