4 Hurdles to Successful Decentralized Trials – And How to Overcome Them

Robert Geckeler, MBA. — ScienceMedia Product Director

Robert Geckeler, MBA. — ScienceMedia Product Director

  • September, 2021

In the same way that global businesses were forced to adopt remote work when traditional in-office work was disrupted during the pandemic, clinical research operations were likewise forced to rapidly apply remote approaches that might previously have only been planned or in the process of being piloted. In the wake of the pandemic, Decentralized Clinical Trials (DCTs), and their near cousins that apply a hybrid approach of in-person and remote visits, are increasingly seen as a viable solution for the conduct of clinical trials. As DCTs continue to rise in prevalence, so too do the number of technologies and innovative tools that are designed to help make DCTs run smoothly. According to a Sites NOW "State of the Clinical Workforce" survey, sites are embracing virtual solutions for managing studies. As many as 61% of sites now plan to use remote coordinators, whereas this number was only around 15% prior to the pandemic. Underscoring this trend, 93% of sites also reported that they would allow sponsors or CROs to conduct remote monitoring, compared to 74% pre-COVID.

As the number of trials disrupted by the pandemic has leveled off and studies resume more normal operations, some challenges remain. Even with experience gained during the pandemic, many sites are still early in the learning curve when it comes to the adoption of remote practices. Luckily a new tool, like mobile education platforms focused on the specific needs of DCTs, are available to facilitate decentralization by providing training that is optimized to target the training needs of site staff, patients, and home healthcare providers.

High-quality, study-specific education delivered through a cutting-edge platform that monitors comprehension and ensures compliance can offset the risks that accompany DCTs. In addition to the benefit of shortened startup timelines that can result from having on-demand, just-in-time training, targeted education can help streamline recruitment and enrollment procedures and help ensure data integrity through improved adherence to protocol requirements.

Minimizing the Impact of Site Staff Turnover

A key challenge facing Sponsors today is the high rate of turnover seen in both contract research organization (CRO) staff and site operations staff. This turnover is disruptive and can have a significant impact on an ongoing clinical trial by introducing inefficiency, increased cost and, critically, by posing a risk to data quality. One of the biggest concerns for effective study management is how to mitigate the impact of study workforce turnover by quickly onboarding and adequately training new staff.

Mobile educational platforms have the promise and power to address this challenge. The on-demand training delivered by these platforms allow study team members to be quickly educated on key study requirements and procedures and ensures that the training received by replacement staff coming on mid study is the same high-quality education that was available at the beginning of the trial.

Improving Protocol Compliance

Given the degree of turnover in study staff and the potential for variability during more direct training sessions such as those tied to site initiation visits, the potential for gaps in protocol knowledge and understanding is high. Compounding that is the problem of learning retention in the absence of lesson reinforcement. Together, these risks pose a threat to protocol compliance and, in turn, to the integrity of the study.

Study staff who are adequately trained are more likely to fully understand protocol requirements and to implement study procedures without deviating from those standards. Improvements in protocol compliance have the potential to translate into reduced rates of data variation and loss, thereby impacting the overall quality of the study. Enhanced protocol understanding also has the potential to improve screen failure rate and the number of non-evaluable patients, as sites correctly apply inclusion and exclusion criteria. In addition, informed study staff will be better equipped to answer patient questions, provide context for study procedures and help guide patients on their study journey, thereby improving the patient experience. Educational platforms tailored to support DCTs can effectively "de-risk" common mistakes by ensuring that all site staff are knowledgeable and have the tools they need to be successful.

These educational platforms not only deliver the content required to train study staff, but do so in a way that applies adult learning best practices to improve the effectiveness of the lessons while also making them more engaging. The platforms also capture training records to provide real-time evidence that required training has been successfully completed. In addition to tailoring lessons based on role, so that required learning is appropriate for individual study team members, these platforms can apply analytics that offer insight into the level of comprehension of required study material. Data on how effective the training was for site staff can provide an alert regarding potential problem areas and can guide the delivery of supplemental training.

Patient Recruitment and Enrollment

The proliferation of mobile technologies has shifted some additional responsibility onto patients, requiring them to follow specific timelines and undertake activities required by the study protocol that might previously have been completed at the study site. Not all patients are equally prepared for this task, however. But specialized training modules designed specifically for patients and caregivers can help guide enrolled patients through their responsibilities as a study participant, particularly when delivered through an intuitive, easy-to use mobile platform. Using an on-demand training system and dividing lessons into concise and manageable concepts, learners can work at their own pace when it is convenient for them. This proven concept of microlearning uses small units of curriculum to focus learning and then reinforce lesson comprehension and retention through the process of repetition.

This microlearning approach can also help streamline patient recruitment and enrollment, using topical modules to raise awareness of the study, provide an overview of clinical trial basics and the informed consent process, and finally supplement the ICF itself. Most ICFs are lengthy and can be challenging for patients to follow. Providing a companion explainer ensures that patients have both an adequate understanding of the trial and their responsibilities as a participant. Ultimately, setting proper patient expectations can help reduce the risk of subsequent withdrawal.

With proper education and training, prospective patients can be efficiently guided through the recruitment and enrollment process using engaging content that fits in the palm of their hand — anywhere in the world.

Ensuring Regulatory Approval

The operational complexities of clinical trials can lead to protocol deviations which, if significant, can impact the overall integrity of a study. Minor deviations can introduce data management-related delays that can push out timelines for study closeout and data analysis. Modern, mobile training platforms allow the study team to verify and monitor that each individual involved in the conduct of the trial understands and comprehends the protocol, thereby minimizing the risk of protocol deviations.

Mobile education platforms have the potential and power to improve site performance, reduce site burden, manage risks, and enhance both the quality of study data and the patient experience. Together, these benefits work to ensure on-time study completion with an improvement in data quality.

Robert Geckeler, MBA. — ScienceMedia Product Director

Prior to joining ScienceMedia, Mr. Geckeler logged over 25 years in the pharmaceutical industry working on the clinical development across a wide range of product formats and therapeutic areas. Most recently, Robert served as the Chief Development Officer for Sitka Biopharma and as a board member for Cerion NRx. In addition, Robert previously led client services and product expansion at OneHealth, an online and mobile platform that used social networking, coaching, and disease management programs to support users with chronic medical conditions. Robert has a B.A. in Biology from Washington University in St. Louis and an MBA from San Diego State University.

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