Tag: adaptive design

Clinical Research: Phase 1 - Phase 4

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy. Adaptive...

Resources for Childhood Cancer Awareness Month

Premier Research is dedicated to helping patients and families around the world overcome the burden of debilitating diseases, such as a cancer diagnosis. Cancer is a leading cause of death for children and adolescents, and there are approximately 300,000 children diagnosed with cancer each year around the world.1 With the help of better therapies, more...

Considerations for Applying Adaptive Design Approaches to Early Oncology Studies

By utilizing accumulating data to modify the operating characteristics of an active trial in accordance with pre-specified rules, adaptive designs can make clinical trials more flexible, efficient, and informative than fixed-sample designs.[1] Adaptive design approaches can be applied across all phases of clinical development, including early oncology studies. These designs introduce real-time flexibility while a...

Minimizing Early-Stage Oncology Failures with Adaptive Design Approaches

Despite advances in our understanding of the complex genetic, molecular, and immunological factors which lead to cancer, the success and likelihood of approval rates for oncology remain low. According to a recent study performed by the Biotechnology Innovation Organization (BIO), nearly one-third of drugs entering phase 2 studies between 2006 and 2015 failed to progress....

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...

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...

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...

Adaptive Design Strategies in Rare Oncology

Traditional trials apply a frequentist strategy, which rely on the accuracy of pre-defined design assumptions (or inputs) to construct an effective design that yields robust final trial results. From first-patient-in to last- patient-out, trial execution proceeds without change, following a black box approach. While this strategy is common in clinical research, it is not well suited to...

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,...

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...