Risk-based monitoring (RBM) has recently emerged in the pharmaceutical industry as a way to reduce the costs of clinical trials while maintaining, or even improving, site protocol compliance and communication. In traditional trials, sponsors visit clinical sites frequently — often every four to eight weeks. However, these in-person site visits and monitoring strategies account for a large percentage — a suggested 30% — of clinical trial costs. A risk-based monitoring strategy — especially when combined with in-person visits — conserves time and staffing resources while still enforcing good clinical practices. Continue reading
Clinical research associates (CRAs) are a crucial part of a company’s clinical trials staffing. CRAs often work as a liaison between the company and investigator sites, ensuring that the trials run smoothly. As such, CRA responsibilities range from tracking patient consent forms to monitoring patient data and visiting investigator sites. Cutting Edge Information’s recent study on clinical trials finds that when recruiting CRAs, companies consider a number of qualities, including: Continue reading
Patient recruitment isn’t just human subjects. Cutting Edge Information has conducted a number of clinically focused projects, examining an array of industry challenges. How companies recruit for their clinical trials — including what works and what doesn’t — is a hot topic for clinical stakeholders. A recent CEI study on patient recruitment highlights the percentage of companies conducting activities and who specifically —trial site, sponsor or CRO — is coordinating these activities. Continue reading
As clinical research monitoring strategy moves toward a risk-based approach, creating a dedicated team to define a risk-based monitoring (RBM) strategy and oversee the management of RBM on a per trial basis is beneficial. Dedicated risk-based management teams are able to prioritize a well-executed monitoring strategy, protecting essential elements of the trial while maximizing limited resources. Continue reading
Phase I clinical trials are supposed to be the quickest, easiest trials with the simplest question in mind: will the drug harm the patient? No? Good, then you may proceed. However, sometimes the trials are not as straightforward as all that – there can be problems in recruiting, sites can drop out, etc. For many companies, a good way to expedite Phase I trials – and save a little money – is to use contract research organizations (CROs) to administer the trial. In fact, surveyed drug companies outsource 70% of Phase I trial costs. Continue reading
Getting safety data correct the first time is essential to keeping drug development on schedule and avoiding potentially costly overruns. Several recent cases in which regulators requested additional drug safety data upon review of products new drug applications (NDA) demonstrate just how costly these overruns can be. Fulfilling these requests can delay final approval for years — costing companies millions for additional studies and hundreds of millions in lost revenues. Phase 3 safety data is a particularly important consideration for preventing these costs. Continue reading
One of the characteristic symptoms of schizophrenia is patients inability to differentiate among important and unimportant stimuli in their environments. Researchers attribute this symptom to a “P50 Auditory Gating deficit.” After individuals hear sounds, their cochleae typically form small electrical voltage potentials (auditory evoked potential) that are transmitted from their cochleae to their cortices. P50 represents the period from 20–70 milliseconds after patients hear a sound, but before the impulse reaches their cortices, allowing their brains to process it. When the P50 period becomes disrupted, the amplitude of the auditory message becomes reduced, making it harder for patients to process the now-quieter message. Continue reading
Often, news surrounding the clinical development process seems pretty grim. R&D budgets are being slashed, promising new compounds fall short in late-stage trials, patients struggle to find and enroll in a study that has the potential to heal them. Despite all of these challenges, there is a great deal of hope within the clinical pipeline. Researchers are moving closer and closer to finding cures and therapies for debilitating diseases such as malaria and hepatitis C. An increased focus on patient-centricity helps recruit and retain patients who often may not have an opportunity for care. And even within the costly world of clinical trials, innovative developments are improving the bottom line. One such innovation is risk-based monitoring (RBM). Continue reading
This Thanksgiving, let’s all put down our forks and thank clinical trial third-party vendors performing critical clinical tasks for life sciences companies. Life science companies can be especially thankful for those contract research organizations and specialized support firms offering turnkey solutions, handling everything from site selection to study monitoring.
Almost all companies surveyed in the new report, Clinical Development and Trial Operations, hire third parties to conduct some aspect of their clinical trials. Vendors offer expertise to ensure trials run efficiently and yield accurate results. Companies may contract these vendors to conduct a specific trial task, one phase or a larger part of the overall clinical trial. Whatever the task, these vendors help accelerate trials, providing accurate data to more quickly win regulatory approval and bring new products to market.
Let’s Give Thanks for Clinical Trial Third Party Vendors (click infographic for higher resolution)
The ASCO abstracts are out! Well most of them — some of the most exciting will be kept under wraps until the conference begins early next month. One of those generating the most buzz is Abstract #4, “Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The Phase III DECISION trial.” Continue reading