Protocol Adherence in Vaccine Clinical Trials with TrialPal
Table of Contents Patient adherence and data accuracy are non-negotiable in vaccine clinical studies. Inadequate reporting can jeopardize regulatory submissions, raise expenses, and postpone the conclusion of studies. However, many vaccine clinical trials are plagued by low adherence rates and ineffective data collection, which can result in insufficient safety monitoring and possible protocol violations. […]
Electronic Patient-Reported Outcomes in Clinical Trials
Table of Contents “Utilizing ePROs not only facilitates better data collection but also contributes to improved quality of care and patient safety”. “FIdec achieved over 98% patient adherence using the proper ePRO” ePRO stands for electronic Patient Reported Outcomes. This system allows patients to report their health status, symptoms, and quality of life using digital […]
Phase I Vaccine Trials & ePRO: Ensuring Patient Safety
Table of Contents When developing new vaccines, patient safety is paramount. Phase I vaccine trials determine safety and efficacy before public release. Data collection is crucial for evaluating the vaccine’s performance. Electronic Patient Reported Outcomes (ePRO) are valuable tools in ensuring patient safety during Phase I vaccine trials. This article explores the importance of […]
4 Key Benefits of AI & Machine Learning in Clinical Trials
Artificial intelligence (AI) and machine learning (ML) herald a new era of regulatory operations in clinical trials. These advanced technologies are revolutionizing how companies manage regulatory data, predict outcomes, and ensure compliance, ultimately leading to greater efficiency and accuracy. From the IQVIA article published on its website on June 10, 2024, we would like […]
How to include an ePRO in your protocol design
From the ideation of the scientific question, sponsors can consider integrating ePRO tools in protocol designs. Decentralized and hybrid clinical trials can widen the data points and make the most of each trial. Here we share five steps to introduce an ePRO into a protocol: Define the objectives an ePRO tool can address: Identify the […]
What is ePRO, Electronic Patient-Reported Outcome?
What is electronic patient-reported outcomes (ePRO)? ePRO stands for “Electronic Patient-Reported Outcomes.” It is a tool that allows patients to record electronically and submit their health outcomes digitally using devices such as smartphones, tablets, or computers. Electronic patient-reported outcomes (ePRO) is an innovative tool that transforms how data is collected and analyzed in clinical trials. […]
Electronic Clinical Outcome Assessment (eCOA): What is and Who Uses it?
Table of Contents The global eCOA market is poised for significant growth in the coming years. Grand View Research shows the market is expected to reach $20.5 billion by 2028. eCOA (electronic Clinical Outcome Assessment) uses electronic tools and technologies to collect and evaluate patient outcome data in clinical trials and clinical research. It allows […]
Adherence Reporting in Vaccine Trials: [+98% Adherence Rates]
Poor patient reporting adherence can prolong the trial duration by increasing the time required to gather complete and accurate data. This can extend the overall cost of the trial while burdening the study team and site, and compromise future submissions. Patient reporting adherence facilitates the early identification of symptoms and risk factors, prevents dropouts, […]
Differences and similarities between an eCOA and ePRO
Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are two types of electronic data collection methods. While they may seem similar, there are some differences between them that are important to acknowledge. ePRO involves patients reporting their own health outcomes directly to their healthcare provider or research team. This is usually […]
Rising Equity in Clinical Trials and Emerging Countries Through Tech
An FDA 2020 report (1) has shown a 28% decrease in underrepresented populations in United States clinical trials compared to 2018. Moreover, the 2022 FDA guidance for the industry to improve underrepresented racial and ethnic participants’ enrollment is a call to action to get clinical data that really reflects the diversity of the population expected […]
