news roundup

Almac and EORTC Collaborate on Tumor Profiling

The European Organization for the Research and Treatment of Cancer (EORTC) has selected Almac Diagnostics as its preferred partner for molecular profiling of cancer patient samples collected by EORTC clinical trials, including SPECTA (Screening Patients for Effective Clinical Trial Access), a pan-European Cancer network. Almac Diagnostics will receive and process patient samples across multiple disease types from various locations across Europe, from its facility in Craigavon, Northern Ireland.

Tufts CSDD Finds No Difference in Approval Times for 505 (b)(2)

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times, according to Tufts CSDD. Specifically, Tufts found the percentage of 505(b)(2) drugs approved on the first review cycle was substantially lower than for all NMEs.

CROS NT Acquires for Expanded Data Expertise

CROS NT, previously a biometrics-only CRO, announced the acquisition of the clinical division of PM Clinical Limited, which expands CROS NT's service offerings by adding regulatory consultancy, study design, feasibility, clinical project management and monitoring.

Take the Clinical Endpoints Adjudication Survey!

The survey will evaluate how endpoint adjudication is impacting study design, and uncover operational challenges with endpoint adjudication and endpoint adjudication outcomes.

Articles

The Growing Role of Performance Incentives

The expanding role of incentives is a healthy trend in an industry defined by high costs and the pressure of project deadlines, and these agreements between drug makers and their clinical research providers have matured significantly in recent years — to each party's mutual benefit.

Embracing the Rising Prominence of Patient Advocacy

This article offers a historic retrospective on the rise of patient advocacy groups and their effect on the drug development process.

Oncology

Uphill Work to Realize the Dream of Rare Disease Treatment

Recent rare disease symposium in the EU brought to light the very real challenges between patients, payers, reimbursement strategies and regulatory authorities in developing and providing for treatments for rare disease.

Developing New Endpoints in Immuno-Oncology Studies

The unique mechanism of action of immuno-oncology treatments necessitates rethinking of traditional clinical trial endpoints--usually overall survival. However, achieving that endpoint requires years of study and would delay the approval of life-saving or extending treatments. Thus, drug developers are using surrogate endpoints to monitor the effectiveness of immunotherapies.

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Lisa Henderson
Editor in Chief
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