“Participant safety is the primary responsibility of those undertaking clinical research,” write Helen E. Higham and fellow researchers in a 2023 article in the British Journal of Clinical Pharmacology. Patient safety risks can arise in nearly any situation or task during early phase clinical trials — including the planning phases before participants have been recruited.
To reduce the risk of errors, maintain regulatory compliance, and improve communication, a single source of information and task tracking can help. AnjuEPS is an eSource solution designed and developed by early phase clinical trial experts to address the need to maximize patient safety during these crucial trials.
Patient Safety Issues in Early Clinical Trials
Safety is the primary focus of early phase clinical trials. The purpose of a phase I trial is to evaluate the safety of a therapy or treatment and to recommend dosing guidelines for a later phase II trial.
The design of phase I trials thus has a significant impact on later trials, write Alyssa M. Vanderbeek and fellow researchers in BMC Medical Research Methodology. When safety data is collected in a clear, complete, and accurate manner, using a single source of truth for capture and analysis, a more complete picture of the drug’s safety and potential dosing features emerges for use in later phases.
Early phase clinical trials also play a crucial role in drug development because phase III randomized controlled trials “are not always feasible, are expensive, can be prolonged and can be limited in generalizability,” write Harriette G.C. Van Spall and fellow researchers. Early phase clinical trials, meanwhile, can be valuable for generating proof of concept and real-world evidence.
To streamline dose-finding tasks, some sites combine phase I and phase II clinical trials. In one study of such trials, however, Guillermo Villacampa and fellow researchers found that “the overall reporting quality of early phase dose-finding trial protocols is suboptimal (65.1%).” Early phase clinical trials need more complete, transparent solutions to ensure patient safety and produce more rigorous, reproducible results.
Using eSource Solutions to Enhance Patient Safety
Villacampa et al. found that while the overall reporting quality of early phase dose-finding trial protocols was 65.1 percent, the reporting quality of each individual item varied from 9.4 to 100 percent. This high variability stems from a number of factors, many of which can be addressed with an eSource solution designed to improve the completeness and accuracy of early phase clinical trial data.
Using an eSource solution as a “single source of truth” can also lead to better data analysis — and better decision-making if critical safety events occur.
For example, many early phase clinical trials implement protocol-specified rules that will stop the study if a predetermined number of safety events is exceeded, write researchers Michael J. Martens and Brent R. Logan. Statistical models and other methods of data analysis can help clinical trial teams identify when this threshold is approached or exceeded. When information is gathered within a single eSource solution, alerts can be raised and decisions made promptly, before safety event numbers rise unnecessarily.
Incorporating an eSource solution into human efforts during an early phase clinical trial can be particularly powerful. In studying safety measures during a COVID-19 clinical trial, Higham et al. found that “human capacity for recognizing problems and adjusting behaviours and actions in the moment will almost always prevent an accident rather than cause one.”
Yet humans may need help recognizing problems so they can adjust behaviors and actions accordingly. An eSource solution that flags missing or potentially incorrect information, or one that uses role-based access to focus users’ attention on the items they are authorized to interact with, can help human clinicians spot potential problems and adjust to protect patient safety.
How AnjuEPS Helps Support Patient Safety Efforts
AnjuEPS is an eSource solution designed and developed by experts in early phase clinical trials. Built-in solutions within AnjuEPS help support patient safety efforts throughout early phase clinical trials.
AnjuEPS supports direct data capture by clinic staff, both at the bedside and through wearable medical devices. By providing time-based dosing information to clinic staff, AnjuEPS supports staff efforts to avoid deviations from protocol — reducing the risk of safety issues.
Additional AnjuEPS features include:
- A configurable recruitment module allowing clinical trial teams to collect everything from basic demographic information to complex medical and medication histories. Data is accessible in one location through a single interface, making it easier to identify safety information relevant to each patient.
- Flexible search tools allow site recruitment teams to search for qualified trial volunteers based on stored information or previous study data. Clinical trial teams can ensure their recruitment information reaches patients who offer a good fit for the study.
- One-stop communications capabilities allow clinical trial teams to communicate more effectively with participating patients. Appointment reminders, emails, mail merge tools, and SMS message support allow researchers to send essential information to the right audience at the right time.
- A pharmacy module assists teams to manage drug and supply inventory, track chain of custody, and address dose labeling and study treatment plans within a single system. Pharmacists can manage treatment details and provide necessary information and instructions for a variety of dosing scenarios. The included packaging workflow allows users to package and print sample labels while maintaining a full audit of approvals and the printing process.
- Laboratory integration for faster, more complete Safety Lab Results reviews. Review Safety Lab Results directly within AnjuEPS when our eSource solution is integrated with your laboratory information management system (LIMS). AnjuEPS can send HL7 lab orders and import test results for physician review, and helps ensure that critical patient safety data is protected and accessible within a single interface.
Patient safety is a must in early phase clinical trials. By capturing medical device data, tracking patient information, and providing robust tools for pharmacists and physicians, AnjuEPS helps early phase clinical trial teams provide the safety their patients need and that regulators demand.
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Authored by Laura Acosta, VP of Product Management, eClinical Division
Laura Acosta, VP of Product Management for Anju’s eClinical Division, brings over 25 years of experience in life sciences software, including significant roles at Oracle Health Sciences. With academic credentials from Boston University and Tufts University in Computer Science, Laura excels in navigating the complexities of eClinical solutions. Her commitment to continuous learning and innovation has earned her recognition as a trusted leader in the field. Connect with Laura on LinkedIn to explore her expertise further.