Clinical trials are becoming increasingly complex, driven by intricate study designs, the growing use of decentralized trial models, and the need to navigate diverse regulatory landscapes across numerous geographical locations. The risk of logistical issues not only affects the ability to conduct the study quickly and cost-effectively, but it also influences the validity of the data, not to mention impacts the patients who willingly participate in clinical trials.
For patients participating in the trial, logistical inefficiencies could result in missed treatments and disruptions to their care, which could reduce their confidence in the study, leading to high dropout rates or withdrawing altogether. This article considers how reliable RTSM solutions are in mitigating clinical trial risks.
What are the main bottlenecks to clinical trial efficiency?
- Clinical trial supply chain
- Patient engagement
- Data validity
- Regulatory delays
- Privacy and data security
- Emergency unblinding
Clinical Trial Supply Chain
The supply chain within a clinical trial is often complex, with multiple stakeholder involvement across different countries and regulatory landscapes. Without proper visibility and automation, the supply chain can become rife with issues, leading to delays and significantly increased costs.
Randomisation and Trial Supply Management (RTSM) tracks the movement of supplies, monitors site stock against recruitment rate, and ensures that investigational products are delivered to the right place, at the right time, and in the correct quantities.
Patient Engagement
Patient engagement is a key component of all successful clinical trials. Without participants, particularly in the context of large-scale randomized controlled trials, there would be no data. Without data, we do not have the evidence needed to drive innovation in healthcare and drug development.
Approximately 80% of clinical trials fail to meet patient recruitment targets and timelines, resulting in a loss of revenue of up to US $8 million per day for drug-developing companies.
RTSM systems are allowing clinical trials to become more patient-centric than ever before, enhancing participant recruitment, engagement, and retention rates with the integration of digital tools such as smartwatches and wearable devices helping to automatically collect data into RTSM systems, while the incorporation of user-friendly mobile apps and virtual consultations is allowing for ease of compliance for study participants.
Data Validity
Missing data in clinical trials can have significant implications on the validity, reliability, and interpretability of the results, having a significant effect on the validity of the inferences that can be drawn from the clinical trial, compromising the statistical inference by introducing bias to the study findings.
Modern RTSM systems provide trial management teams with seamless data integration, reducing the risk of manual input errors, and improving patient compliance and retention. With improved compliance monitoring and real-time data integration, RTSM platforms are providing digital dashboards that flag any inconsistencies or gaps in data collection early, allowing trial teams to intervene appropriately.
Regulatory Delays
Regulatory delays come in many shapes and sizes and present a major challenge for clinical trial sponsors and teams. From issues with ethical approval to compliance with regional regulations such as investigational drug distribution and adherence to transportation and labeling standards, there are many ways in which this can go wrong, affecting the entirety of clinical research.
RTSM can capture and track data by location, supporting varying regional regulatory requirements including complex labeling and protocol amendments. RTSM provides a comprehensive log of randomization, drug distribution, and site activity which provides an easily accessible and transparent audit trail while flagging potential issues in patient participation and logistics.
Privacy and Data Security
Handling sensitive patient information and trial data in clinical trials poses significant privacy and data security risks, with key legislation including GDPR and HIPAA influencing the management and storage of all study data in accordance with the law. In order to safeguard patients’ privacy and maintain the integrity of clinical research findings, this process must be free of error.
RTSM employs advanced encryption standards, with cloud-based security systems and role-based access controls helping to protect all patient data. Sensitive data can only be accessed by authorized individuals, reducing the risk of internal data breaches, and automatically complying with privacy standards.
Planning for the Unexpected
Reliable RTSM companies like Perceptive eClinical are making it easy to conduct large-scale clinical trials, with global delivery teams helping to coordinate clinical trials in over 100 countries worldwide including the US, Europe, Japan, and China. Not only do they influence logistical accuracy, but they mitigate disruption from risk, helping you to plan for the unexpected with over 200 risks and a catalog of best practices thathave supported over 4,700 trials.
Emergency Unblinding
Trial risk comes in all shapes and sizes. While emergency blinding is necessary to ensure participant safety in critical situations such as medical emergencies, it poses risks to the trials’ integrity and validity. Frequent emergency unblinding could compromise the study design, potentially reducing the statistical significance of trial data.
RTSM systems help to mitigate the risk of emergency unblinding in clinical trials by implementing controlled, secure, and well-documented processes with pre-defined authorization access, providing just one clear example of the system’s ability to perform partial unblinding and maintain trial validity.
Resources
BMJ. Potential impact of missing outcome data on treatment effects in systematic reviews: imputation study. https://www.bmj.com/content/370/bmj.m2898
The Journal of Medical Internet Research. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. https://pmc.ncbi.nlm.nih.gov/articles/PMC7673977/