infocusoct22

By Curebase How Co-Creation with DCT Vendors, Sponsors, and Sites Makes Participation in Decentralized Clinical Trials Easier For Sites In this guide, we reflect on the relationship between decentralized clinical trial vendors, sponsors, and virtual, traditional, and hybrid trial sites in the design phase of clinical studies. This comprehensive review illustrates how different site models can and should participate in clinical studies and how sponsors and DCT vendors can design studies to include site-friendly elements. The relationship that exists between sponsors, DCT vendors, and sites and how this relationship can be optimized for more mutually beneficial partnerships. The need for implementation of site support systems while participating in clinical trials and the ways in which DCT tools can make participation more frictionless for site staff. How site voices are missing in study feedback which can be used to better understand the burden sites face and to properly identify the proper site models needed for studies. Technologies and services DCT vendors can offer sponsors to better facilitate feedback cycles and support systems for sites participating in their trials.

By Kyle Given, Executive Vice President of Account Management, Transformative Pharmaceutical Solutions Whose favorite activity in a clinical trial is answering data queries? I would take a guess that the answer is a resounding “not me” for almost every site resource that has ever been involved in a clinical trial.  So why, then, is data management such a significant, and aggravating, part of the study coordinator’s responsibilities? Well, let’s start with the fact that patient data is voluminous and highly variable within and across patients. It is hard to keep it all straight, especially if a site may not be trained on certain data management concepts or provided with the same tools necessary to visualize that data.   Also, given resource constraints at many sites, data operations are often deprioritized, which builds up a backlog of data cleaning and potentially more queries. On the other hand, having high-quality, consistent, and reliable data is essential to answer each protocol’s efficacy and safety objectives with a high level of scientific rigor. Let’s start with the first issue, available resources. Most study coordinators are clinically trained – not trained to be data experts. This does not mean they do not have an awareness of the logical ways that clinical data interact, but they may not have the same level of knowledge and experience as a data manager that ultimately oversees the data quality in a clinical trial.   More importantly, clinical trial budgets often underestimate (or largely ignore) the amount of time that will be spent entering, curating, and cleaning patient data. It’s almost impossible to anticipate this volume of work before a trial starts. This leads to data cleaning being deprioritized at many sites with data query volumes increasing as a result.   The second challenge is that sites do not have effective data visualization tools to facilitate the review of large quantities of patient data. Most EDC or e-source platforms present the data one module at a time so the reviewer can only see a limited slice of data at any given point. They are set up for data entry, but not data review. In addition, the data is often captured in multiple systems, so cross-referencing data adds to the complexity of the review. Sponsors and CROs have medical and central data review teams that combine data across unique data sets and present the data over time so that a data reviewer can easily see inconsistent data… Furthermore, in many of these systems, they are now presenting the data using statistical signals so that outlier data can be flagged for the end user to review. Does it really make sense that the secondary reviewers of data have better tools than the primary reviewers of clinical data? There is a potential solution to this problem; sponsors could deploy centralized Data Operation Specialists (DOS) to remove the burden of data review and cleaning from the clinical trial site. This concept has already been deployed as a result of the pandemic when sites fell behind in data collection and cleaning activities. If this solution works well for an urgent situation, why not consider this a more permanent strategy that is deployed proactively?  Consider a reality where each site had a DOS that partnered with them to clean and process all of their clinical trial data with the best available data visualization software. Imagine a world where the site actually gets support to clean the sponsor’s clinical data, and the data gets captured and cleaned in real-time, thus avoiding a huge source of stress between sponsors and their clinical trial sites.  

By Liz Corcoran, Director, Research Strategy, Teckro and Jenn Weinberg, Director of Oncology, Teckro Advances in clinical development continue to drive efficiencies in the numerous and arduous processes involved in executing clinical trials. The changing technological landscape presents many opportunities to streamline further and capitalize on the ability of clinical trial practitioners to do more and do it faster and with greater accuracy. Even with this evolution, timelines are extending, staffing issues are mounting, protocols are becoming more complex, access to patients is more difficult, and costs are rising. As such, many patients still face long waiting periods for potentially lifesaving treatments.  A growth in resignations is leading to a shortage of qualified, experienced staff to conduct and monitor clinical research, resulting in further issues including lengthy onboarding periods. New clinical research staff are often not only new to clinical research itself but may not have the in-depth knowledge of a specific therapeutic area, which adds to the learning curve.   Difficulty filling open site and clinical research associate (CRA) positions is driving a subsequent delay in opening new studies, often leading to delayed or lower enrollment. Studies starting with no assigned clinical research coordinator (CRC) are becoming more common. The rising pressure on clinical trial teams means less time spent on research, less time with patients, and more effort to deal with the administrative, regulatory, and training deliverables. Experienced CRAs and Study Coordinators Are Resigning in Large Numbers   This burden is carried heavily by CRAs as well as sites. Between Q1 2021 and Q1 2022, the highest number of resignations was among those aged 40-60 with more than 10 years of experience. In previous years, employees in less tenured groups led in overall resignation rates. Between 2020 and 2021, that changed. The current resignation rate of employees with a 5-10 year tenure is 60% higher than in 2020. For employees with a 10-15 year tenure, it was 55% higher in 2021 than in the same period of 2020 (Source: Research & Insights Group Visier Inc 2021).   CRAs and CRCs play a pivotal role in clinical research management and execution. Sponsors rely heavily on both. Yet, while the roles are vital, the jobs are complex, arduous, and demanding. They face long, busy hours to complete time-intensive activities. CRAs are often overburdened and under-resourced. They must use multiple systems, technologies, and communication tools across the clinical trial lifecycle – all of which differ by the sponsor.   Many sites are asking sponsors for help to manage the issue of time and staffing, both to fill the resource shortage and to assist current staff with particularly time-consuming tasks such as data entry, regulatory and filing requirements. However, employing temporary workers is driving unexpected increases in the study’s budget as sponsors are financially responsible for the extra headcount. Hiring less experienced staff also requires further training and site oversight.   Helping Sites and CRAs Work Smarter    The clinical research industry needs to change the current way of working, to be smarter and more efficient with clinical staff time and the activities they are expected to complete. Using technology to smartly drive efficiency and really listening to sites’ requirements will help alleviate problems such as resource shortages. There should also be consideration given to what tasks can be executed remotely vs. onsite to positively impact CRA and site bandwidth. CRA time can be leveraged in more meaningful ways, such as improving site and patient experience.   Sponsors are also being creative in looking for solutions to their resource constraints, but not all make them a better or more attractive partner to sites:   Outsourcing different tasks to other countries has time zone implications and adds additional study team members who will contact sites for various reasons   Large and complex study start up teams can result in sites not knowing who to contact with questions or follow-up information   Outsourcing more roles to a CRO, who is also feeling the pain of increased resignations, can mean multiple turnovers in monitors throughout the course of a trial   Numerous vendors increase the “noise” and make it more difficult to complete tasks in the most efficient way possible    The increasing number of stakeholders is causing confusion at sites because they are often unsure who to contact. This is causing delays in response and turnaround time to complete tasks. Unfortunately, turnover at sites, CROs and sponsors is negatively impacting study timelines, budget, and ultimately quality.  Reducing CRA and Site Burden The continuous turnover of site staff and CRAs coupled with the need to do more with less, increases the importance of completing tasks in a timely, efficient manner. Everyone should have confidence that they are using the most current protocol and study reference material, all the while ensuring they have quick access to the correct tools and contacts. Let’s remember, looking for documents for more than a minute is longer than clinical trial staff have to spare! By streamlining communication, sites get their questions answered quickly. Monitors spend less time fielding site queries, reducing the cyclical rounds of communication. With Teckro, CRAs can monitor site engagement remotely and plan site visits effectively by sending important study updates, revising and refreshing documentation, and reducing the dependency on arduous paper trails – all while in transit. At Teckro we’ve built a clinical trial hub that delivers efficiency for site staff, monitors and CRAs with a unique integrated solution that helps relieve the burden of clinical trial monitoring, through simplified site communication and site management. Teckro links trial stakeholders to one another, to vital study content, and to meaningful trial data – all at the point of care. Ultimately, sites and CRAs need to learn to work together in new, smarter ways, to ensure that patient safety is maintained, and study quality is not compromised. As with any other successful relationship, transparency and good communication are key.     Giving CRA time back: learn how