Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs continue to acquire smaller competitors, can sponsor companies expect to benefit from this development?
The past several years have brought significant changes to the clinical trial landscape. Mergers and acquisitions, new players, the rapid proliferation of technology, increased patient advocacy, and new regulatory guidelines have added to the complexity of trials and burdened resource-strapped leaders with additional challenges and risks.
The social, demographic, and economic environments in which the global pharmaceutical industry operates are transitioning. Developed economies with ever-rising healthcare costs are looking to curb healthcare expenditures, and payer demand is moving toward a reimbursement model based on healthcare outcomes. Declining R&D productivity and the looming patent cliff are threatening the sustainability of the current pharma industry business model. Emerging markets — specifically India, given its large domestic market, product development skills, and scientific man power — offer a solution to the global pharma industry to address the challenges of growth and innovation.
With the age of remote clinical trials upon us, it bears asking: What do these trials mean for the common business-related tasks of clinical trials? One under-emphasized place of change will likely be investigator site budgets.
RTSM software developed with an agile methodology and built on a modern technology stack dramatically accelerates the study start-up process and mid-stream adjustments. Customers are able to see and interact with the system before approving specifications and changes can be made quickly, without impacting study progress. The use of agile software in clinical trials enables customers to streamline internal processes and spend time on other high-value activities critical to the success of their studies.
There is a dazzling array of quality initiatives within the clinical trials sector all looking to move the needle from paper-based methods or single point solutions to a more integrated, non-siloed approach to study conduct. These efforts, may be rooted, at least somewhat, in work started nearly 20 years when the Institute of Medicine published To Err is Human, a call-to-action to improve safety in our healthcare system by linking it to greater quality. That seminal work was followed by various reports recognizing the urgent need to transform the clinical trials enterprise by focusing more intently on quality, which leads us to today’s sharp focus on this subject.
The sharpening focus on quality management is fueling greater use of standardized metrics to optimize clinical trial performance. Stakeholders are embracing this trend through growing adoption of cloud-based technologies, such as clinical trial management systems (CTMS), source data, and the electronic trial master file (eTMF). The information they generate is flowing into data analytic tools, and with this capability, standardized metrics are gaining mainstream status.
FDA recently released a snapshot report showing the diversity of clinical trial participants in studies conducted in 2015 and 2016. Out of over 31,000 patients who participated in clinical trials for novel products in 2016, 48% of the study participants were women, which was an increase from 40% in 2015. An increase in clinical trial participation of African Americans was also observed from 2015 to 2016 (i.e., 5% in 2015 vs. 7% in 2016). However, Asian subject participation in clinical studies decreased 1% between 2015 and 2016 (from 12% to 11%, respectively). Overall, the trend towards increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.
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CROs are increasingly responsible for a broad range of study management activities. Don’t burden your study teams with unnecessary manual tasks and workarounds that ultimately prevent the development of smart work solutions by using an outdated CTMS that simply cannot keep pace.
Mitigate the risk of significant financial investment and time by selecting a system with the ability for phased implementation of the full system configuration.
To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design. The goal is to be able to respond appropriately to any surprises or issues that could not only jeopardize your study but also potentially delay your product’s development and launch.
This article identifies the ‘low-hanging fruit’ of site optimization that, if reached for early, can replace previous time-intensive, manual methods and deliver significant cost, time and data quality benefits with minimal investment and disruption.
September and October are historically some of the best times for clinical trial recruitment.