As Arena International’s Outsourcing in Clinical Trials Europe conference gets underway this week in Barcelona, Spain, Clinical Trials Arena will shine a spotlight on how the outsourcing landscape continues to grow. From full service CROs to functional service providers, sponsor companies have relied on a variety of outsourcing models to help carry out their trials and get drugs to market. But how will the CRO landscape change as technological advances start to disrupt tried and tested business models? This week on CTA, we hope to provide the answers with articles that uncover the most pressing issues concerning outsourcing.
Be sure to visit CTA later today when Dr Craig Elliott of Clintec International speaks to CTA Editor Henry Kerali to explain why trial sponsors must take a data-driven approach when it comes to monitoring. On Tuesday, there’s a feature from Tufts CSDD’s Ken Getz, who examines the ever-changing CRO landscape, and draws close attention to how efforts to consolidate businesses will have a lasting impact on the industry.
Later in the week, Débora S. Araujo from Boehringer Ingelheim, reveals five key trends that are impacting clinical outsourcing. Meanwhile, Quibim’s Irene Mayorga Ruiz and Dr Raphaela Schnurbus of OPIS each explore how biomarkers and the role of data managers are affecting outsourcing practices. So as you can tell, a wide range of issues will be given the spotlight on CTA this week, so don’t miss out!
But first, catch up on some of CTA’s most recent stories delving into the challenges facing the outsourcing space… (click on the headline to finish reading).
For a pre-clinical stage small biotechnology company, the transition from being a totally research-driven organization to a more developmentally driven entity focusing on planning their first clinical trial the task can seem a bit daunting. As with all small grant and/or equity funded companies, cash flow is always a consideration. Not having the expansive budgets enjoyed by larger companies, it is essential that the clinical and regulatory process be completed in as efficient and cost-effective a way as possible.
Sponsors outsource their clinical trial activities for a variety of reasons; they may want to add geographic coverage, focus on other core activities, or simply realize cost and efficiency savings. But how does a sponsor decide what level of oversight is appropriate? Should certain functions always be outsourced? Never be outsourced? Finding the right balance of contracted versus in-house activities can make or break a clinical trial, not to mention the sponsor’s relationship with its providers.
In February 2016, the New York Times reported on the recall of the blood testing device used in the clinical trials of the popular anticlotting drug Xarelto. The recall raised questions about the validity of the data in the pivotal clinical trial (ROCKET AF), thus attracting the FDA’s attention as well. The specific issue was that the device, INRatio©, understated patients’ risk of bleeding. This potentially resulted in higher doses of warfarin and increased bleeding episodes in patients in the control arm of the study, a likely biased clinical trial result for Xarelto, and exposure of warfarin patients to unnecessary risk.
Over the past eight years, I’ve seen some trends with investigator brochures (IBs), which I view as very positive. They appear to be getting shorter, more clinically oriented, and increasingly similar to future package inserts. As one of the key tools to informing a clinical investigator about your product, I believe a clear and concise IB is essential to trial conduct. The IB is also essential to pharmacovigilance and is set in law as the go-to document for determining whether adverse events (AEs) are expected. Having a well-made IB helps sponsors comply with GCP guidelines and legal obligations in all regions.
As the Chief Scientific Officer of Vidasym, Ruth Wu-Wong has a hand in the development of two new drugs for chronic kidney disease and osteoporosis, with both in the clinical study stage.
Having conducted one trial in Australia for VS-505 (a novel phosphate binder derived from GRAS substances), one trial in the U.S. for VS-105 (a novel vitamin D receptor agonist), and another trial with a partner in China for VS-105, Wu-Wong has amassed experience shipping active pharmaceutical ingredients (APIs) and drug products among different countries.
In this Industry Viewpoint, Wu-Wong offers considerations to sponsor companies looking to conduct trials in China, and the challenges she’s come across.