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...
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...
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...
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...
DURHAM, N.C., June 13, 2016 — Premier Research is expanding its international organization of experts in rare disease amid continued growth in the field — especially in rare oncology, which has surpassed one-third of the company’s rare disease work. “Development of novel compounds for treatment of unmet medical needs historically has been overlooked by big pharma,...
There’s a lot to consider when investigating a novel and targeted oncology compound, and decisions you make early on can have profound and lasting implications. In this webinar, Premier Research shows how making sound decisions from the outset can improve your odds of long-term success. Oncology experts, Paul Hallenbeck and Luke Gill, Executive Directors for...