Oncology & Hematology

Clinical Research: Phase 1 - Phase 4

Considering iRECIST Guidance in Evaluating Solid Tumors

In evaluating patient response to treatment of solid tumors, the nearly decade-old RECIST 1.1 guideline remains the gold standard. But the implementation earlier this year of the iRECIST guidance is focusing attention on how the many wide-ranging approaches to tumor assessment interrelate, and how they rank in relevance — today and looking forward. It all...

Consulting

Webinar Explores Expanding Role of Immuno-Oncology Drugs

DURHAM, N.C., MAY 23, 2017 — Interleukin-2, interferon, and other immune-modulating agents have long been used to treat some solid malignancies, but their efficacy is generally limited to immunogenic cancers such as melanoma and kidney cancer. Until now. Today, multiple immuno-oncology pathways are under development, and we’ll explore this promising trend in a webinar on...

Consulting

Process and Regulatory Changes Making Rare Cancer Drug Development More Efficient

The study of rare cancers poses special challenges for drug developers, who often must draw on their experience in both oncology and rare disease. Careful consideration of clinical trial design and regulatory pathways can help increase the likelihood of success in rare oncology clinical trials. Researchers studying rare cancers must call on expertise in both...

Clinical Research: Phase 1 - Phase 4

The Biggest Hurdles in Rare Oncology Research (And How to Overcome Them)

Translational research has the potential to help all patients, but the principles behind bench-to-bedside research hold special promise for patients with rare diseases — many of which have no standard treatments. Here’s how changes to the way rare oncology studies are performed are getting treatments to the patients who need them at a faster rate. What Makes...

Consulting

5 Endpoints for Rare Oncology Trials

In general, greater certainty about the clinical benefit of a drug correlates with an increased time to achieve needed results — the best evidence can take years of careful follow-up. But an unnecessarily long time to market isn’t good for sponsors and patients alike. This is especially true for patients battling rare cancers: With many of these conditions lacking standard treatments,...

Consulting

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...

Medical and Regulatory Affairs

Rapid Change, Real Promise: The Future of Rare Oncology Research

As our understanding of the genetic and molecular basis of cancer advances, rare oncology research is accelerating at an unprecedented pace. In fact, in 2014, more than 40 percent of U.S. Food and Drug Administration’s orphan drug designations were for rare cancers. Moreover, the trend toward increasing international cooperation among big pharma, biotech, and academia...

Patient and Stakeholder Engagement

Rare Cancer Research from the Patient’s POV

The purpose of clinical research is ultimately to help patients. That may sound obvious, but all too often we forget the human side when it comes to clinical trials. For patients with rare cancers, taking their perspectives into consideration is invaluable to quality research. But what specific unmet needs do rare oncology patients have? What...

Clinical Research: Phase 1 - Phase 4

Maximizing Success in Early Stage Oncology Trials

The success rate of investigational compounds eventually approved for clinical use in cancer remains the lowest among all diseases. Of the more than 750 drugs currently under development for the treatment of cancer, it is predicted based on past performance that only a few will ultimately demonstrate sufficient efficacy and safety for regulatory approval and...

Medical and Regulatory Affairs

8 Programs That Get Rare Cancer Treatments to Patients Faster

A variety of factors can make it difficult to conduct traditional full-scale clinical trials for new treatments of rare cancers. Consequently, because so little information is available, treatments for rare oncology patients are inadequate or nonexistent. Luckily for both patients and researchers, the FDA and the European Medicines Agency (EMA) have introduced regulations that expedite review and approval of certain investigative drugs. Expedited FDA...