Despite expert design and thoughtful planning, all studies will encounter risks and issues. How well these risks and issues are managed directly correlates to how well a study is run. But tracking issues and their mitigating actions can be a cumbersome and inefficient process.
To gather insights about how to solve this ongoing problem, we met with study teams, representatives from multiple functional areas, oversight teams and clients. See how these critical insights were used to design a flexible system centered on operational and quality excellence. Continue reading
Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry. Xcellerate Trial Design was recognized for its innovative approach to improving site selection, forecasting resource demand and optimizing of clinical trial design. Continue reading
Emerging Markets in Clinical Trials: Romania Delivers Pivotal Boost in Enrollment in Challenging Indication
Intense competition for investigators and patients in traditional clinical research markets has enabled emerging regions such as Central and Eastern Europe, Russia and the former USSR to play an increasingly prominent role in the quest for high-quality clinical trial data. While well-established markets across Western Europe and the U.S. continue to play an important role in clinical research, it has become crucial to leverage the untapped patient and investigator potential of these emerging markets to ensure sufficient and timely enrollment. Continue reading
Choosing where to conduct a global clinical trial is a critical strategic decision that can impact an entire drug development program, including patient recruitment and retention, the speed of execution, and ultimately your marketing plan. Many factors must be taken into account when selecting countries, however, the relative importance of each factor will vary depending on clinical trial design, the therapeutic area being studied, and your overall development strategy. For instance, while one study may rely on access to naïve patients or include a comparator arm, other conditions may require a more complex trial design and more robust clinical infrastructure, such as availability of specialized imaging capabilities. Continue reading
Early clinical research continues to be a high stakes industry requiring increasingly complex studies, procedures, and protocol designs all of which take longer to complete, which in turn drives up cost. The introduction of combined protocol designs—also called umbrella protocols—is gaining popularity among drug developers as a way to bring the first subject visit for the all-important proof-of-concept study forward by months, as well as saving significant cost.
When a large multinational client asked Covance to conduct a Phase III trial on a promising new colorectal cancer drug, their rigorous patient selection criteria initially caused some concern. How long would it take to identify, recruit and retain sufficient qualifying patients? After all, a recent study published by the Tufts Center found that, although 90% of clinical trials worldwide meet their patient enrollment targets, the trade off is that drug developers typically need to nearly double their original timelines to reach those targets.* Continue reading
Updated: The infographic was replaced on 12-Feb.
If you are a procurement or operations professional responsible for delivering successful clinical trials, you will be under constant pressure to keep your budgets in check and meet study deadlines, to ensure your company’s drugs make it to market before the competition.
As you know, it costs on average $50K to activate a single site, regardless of its final performance. Some ‘waste’ may be inevitable but a recent study from Cutting Edge Information* showed that, between 2008 and 2011, per-patient clinical trial costs rose by an alarming 70%. 46% of this increase is attributed to patient enrollment: some sites never manage to enroll a single patient; even worse, others wait for a long time and eventually recruit one patient but still have to expend resources and supplies until the patient completes the study or withdraws. Continue reading
With Alzheimer’s disease increasing across the globe, the demand for preventative, disease-modifying, and curative treatments is mounting. However, there remain several obstacles, including a high failure rate in Alzheimer’s disease clinical trials.
Given the pressing need for Alzheimer advances, Covance recently surveyed 100 of the most experienced investigators (throughout 25 countries) involved in Alzheimer’s research to gain perspectives that may be critical in planning for successful trials in the future. The majority of investigators included were physicians from large academic institutions, hospitals, and clinics, including neurologists and psychiatrists. Also represented were physicians with a specific focus on Neurogeriatrics, Clinical Pharmacology, and other related specialties. Continue reading