Small and midsize biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. Here are five reasons why the APAC region may be a good fit for your global clinical trial.
Unfortunately, not all oncology trials succeed. In fact, the phase success and likelihood of approval (LOA) rates for oncology are the lowest across major therapeutic areas. Although there are many reasons for these relatively poor success rates, issues determining dose, schedule, and regimen in early-phase trials are among the most prominent.
Selecting a safe starting dose must be balanced against the proportion of patients treated at subtherapeutic doses. This is important for agents that demonstrate minimal toxicity in preclinical testing or for drugs that are unlikely to reach maximum tolerated dose. This approach has the potential to reduce the number of dose escalations while preventing patients from being treated at overly toxic doses that lack incremental biological activity.
It’s always been true: every trial is a learning experience. Each one is different, and each one presents new challenges. Learn how a CRO helped one company overcome an early patient screening failure rate of 70 percent as well as assisting with instituting new protocols and renegotiating contracts as the study experienced a major change of direction.