Tag: rare oncology

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...

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 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....

Consulting

From Lab to Bedside: February 28 Webinar Examines Treatment of Rare Cancers

DURHAM, N.C., FEBRUARY 22, 2017 — Premier Research will share new insights on rare oncology drug development at a webinar on Tuesday, February 28. From Laboratory to Bedside: Expediting Development of Novel Rare Cancer Treatments (11 a.m. EST / 4 p.m. GMT / 5 p.m. CET) will examine how new processes and regulatory pathways are...

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...

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...

Clinical Research: Phase 1 - Phase 4

Innovations in Rare Oncology Trial Design

A rare cancer is often defined as one with an incidence of less than 15 per 100,000. The patient populations of these conditions are so small that traditional clinical trial design strategies can be unfeasible. But, with such a low incidence, just why is rare oncology research so important? Why Rare Oncology Needs Innovation Keep in mind...

Clinical Research: Phase 1 - Phase 4

Rare Oncology Research in the 21st Century

Speakers: Sachin KulkarniExecutive Director, Strategic Development, Oncology & General MedicinePremier Research Juliet M. MoritzExecutive Director, Strategic Development, Rare DiseasesPremier Research Study of rare cancers tends to look more like rare disease research than standard oncology research. This webinar will highlight some of the challenges in designing and conducting trials for rare cancers and explore positions...