Clinical trials are a critical part of the drug development process, but they can be time-consuming and costly. Data intelligence can be a great tool for planning clinical trials to stay on budget and on schedule. In this post, we explore how we can evaluate feasibility estimates from CROs and how we can use them to make informed decisions. We also discuss what data can help us optimize country selection for our clinical trials, utilize experts, and get early warning signals that patient recruitment may be slowing down before it really does.
A Comprehensive Approach to Clinical Trial Feasibility
The TrialHub Database is an ecosystem that helps to understand what makes clinical trials successful. Trial Hub takes a holistic approach to feasibility: it includes patient interests, site feasibility, assessment of competing trials, and more. Sponsors as well as CROs gain with this information a comprehensive understanding of what it takes to write the right protocol, select the best recruiting sites, and understand all crucial parameters that have a direct influence on patient recruitment. Getting a realistic estimation of patient recruitment rates in clinical trials is the key to staying on budget and on schedule and delivering better therapies to patients.
Bridging the Gap Between Sponsors and CROs
The optimal approach to clinical trial feasibility is if it is a collaborative effort between sponsors and CROs. Data-driven insights using specialized databases can help sponsors and CROs in planning successful clinical trials. We can compare how other clinical trials have performed in similar situations which gives us an unbiased view of the probability of success of our trial setting. With that view sponsors and CROs can make better decisions and avoid budget and timeline overruns. In addition, Trial Hub also provides early warning signals to identify potential bottlenecks in recruitment. For example, the system can monitor the sites involved in your trial and inform you if they start participating in competing trials. This allows sponsors and CROs to take proactive action to keep their clinical trials on track.
Maximizing Clinical Trial Success Through Careful Country Selection
Selecting countries where sponsors also plan to market their therapeutics is an approach that may not always result in the most efficient patient recruitment process. The optimal approach is a balance between market-access countries and the best recruiting countries. Additionally, utilizing expert analysis can help sponsors optimize their country selection. TrialHub provides access to this local expertise through experts who understand the local standards of care in the selected countries, and ensure that the protocol aligns with it. This avoids many protocol changes during the trial.
Utilizing Data to Identify and Overcome Clinical Trial Delays
Clinical trials oftentimes face delays. In these situations, it is important to identify the root cause of the delay and develop a plan to overcome it. Comparing the performance of similar clinical trials with TrialHub and their respective trial setting, we can understand the root cause and what needs to change to get back on track. This can include expanding to additional countries or sites, increasing marketing efforts, or adjusting the protocol.
Summary:
Data intelligence can be used to help plan clinical trials that stay on budget and on schedule. This involves evaluating feasibility and making informed decisions, optimizing country selection, utilizing experts and quality management systems, and getting early warning signals for potential slowdowns in recruitment. Contact one of our representatives if you are interested to learn more about data-driven feasibility approaches.
