In our April/May issue:
PEER-REVIEWED ARTICLES
Hematological Cancer Trials
Andrew Zupnick, PhD
Clinical studies for blood-based cancers such as leukemia, lymphoma, and myeloma require an understanding of what has become an increasingly complex treatment paradigm. This report examines that evolution and the nuances involved in successfully conducting hematological malignancy trials.
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Adaptive Solutions in Oncology
Dirk Reitsma, MD, Austin Combest, Jürgen Hummel, Ashley Simmons
Although anticancer agents account for nearly 25% of all drugs in development, statistics still point to high attrition rates for experimental oncology treatments. Adding further burden are the complex trial demands for targeted therapies in the cancer setting. Adaptive trial design offers opportunities to improve these odds, as this article—comparing adaptive design with conventional oncology study approaches—illustrates.
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Molecular Imaging Momentum
Ashwin Shetty, MD
As the influx of studies for molecular-targeted drugs advances the role of imaging in cancer trials, emerging techniques and technologies in measuring tumor response are examined.
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Forecast Formula for Enrollment
Gen Li, PhD
Author presents a novel statistical method for potential reliable forecasting of clinical trial enrollment rate. It involves calibrating the site activation process with site enrollment performance to uncover the sometimes elusive patterns in trial planning and execution.
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NEWS
View From Washington: Jill Wechsler gives a status update on U.S. legislative provisions in the works to stimulate biomedical R&D.
View From Brussels: Peter O'Donnell explores the likely fallout from the media’s recent criticism of Europe’s Innovative Medicines Initiative.
Global Report: Philip Ward reports on efforts in Europe to boost understanding of medical device development.
Regulatory Reform: A look at the increased push among FDA and sponsors to embrace patient focused drug development in study design.
Oncology Outlook: New ASCO study draws attention to cancer care delivery challenges.
Drug Review: Comparing the nuts and bolts of FDA’s four expedited drug approval pathways.
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CLINICAL TRIAL INSIGHTS
Debunking Innovation Investment Myth
Ken Getz
Study shows that the pharma industry’s contributions to R&D extend well beyond the applied area of clinical testing. |
CLOSING THOUGHT
The Psychology of Cancer
Moe Alsumidaie
The use of validated and licensed psychiatric scales can help assess the impact and progression of suicidal ideation in cancer clinical trials. |
