There were numerous articles in January 2018 that covered a wide range of topical issues. For one, January featured a spotlight on Data Strategies, which covered a variety of topics including GDPR. Click here to read our exclusive articles. But beyond data management, here are five of the best stories you might have missed… (click the headline to finish reading the story)
As clinical studies and demand signals become more complex, and supply networks and operations more diverse, the need for supply chain organizations to ‘do more with less’ continues to be an emphasis. Those groups which set themselves up for success in this dynamic landscape are rewarded with competitive advantage and better outcomes for patients. The following article outlines approaches to the necessary demand and supply planning, modeling, and execution required to achieve and sustain high-level clinical supply chain performance.
An ineffective enrolment strategy can have huge consequences on a study, with delays costing sponsors obtuse amounts of operational costs and lost opportunity costs. More than half of clinical trials do not enlist participants within the initially forecasted timelines, and nearly half of selected sites fail to meet their recruitment targets, while 10 percent fail to recruit any patients. Patient recruitment and site selection are two of the biggest operational issues that can have significant impact for smaller companies in particular who tend to have fewer resources.
We have all probably heard someone mention that a patient-centric approach in clinical trials is time consuming. We can surely find enough reasons to back this up. We can also find enough reasons explaining why we need to postpone adapting policies to accommodate a more patient-centric approach.
We all know the importance of a complete clinical trial dataset, but ensuring all events are captured while accounting for every patient is often left until the end of a study. By then, retention activities should be referred to more accurately as a rescue effort. The efforts needed to locate missing patients become labor-intensive initiatives and come at a high cost both financially and scientifically. The activities are undertaken by trialists who are juggling many close-out activities or by vendors who often charge a premium since they know how critical a robust dataset is to a trial’s success. Based on experience with numerous large outcome trials, retention should be planned from end-to-end during a project and should be monitored by skilled staff that are committed to the success of the project.
Pediatric clinical trials are unique in that not only do you need to consider the patient, but also the caregiver of the preparation, dosing and administration of investigational products.
When planning clinical supplies, there are also other factors relating to neonates, infants, children, and adolescents that do not normally apply to adult populations.
This article will present factors to consider when designing supplies for caregivers, having critical discussions and communications with the physicians responsible for protocol development, and ensuring that solutions are considered for situations likely to occur in the trial.
PHOTO CREDIT: Rob Nguyen