Many Clinical research organizations such as Veristat invest a lot of time, money, and intellectual capital to ensure the success of clinical trials. But why do most of them fail? The purpose of holding a clinical trial is for drug developers to ensure that a drug or a medical device is safe for human use. But what are some reasons why clinical trials fail? Let’s find out.
Successful clinical trials require productive teams and proper clinical trial planning at all times. All team members must ensure that they perform their roles exceptionally. However, most teams lack motivation or lack sufficient knowledge of the products being investigated. Some teams also have an unbalanced team hierarchy, leaving the team members unsure of who to answer to.
Inadequate understanding of how medical products interact with the body
Clinical trial failures could also be due to a poor understanding of how the body interacts with an investigational product (i.e., pharmacodynamics and pharmacokinetics). even then, these interactions will vary widely especially between humans and animals, between patients and healthy subjects, and between groups from different demographics.
The complexity of protocol and data quality
This occurs when you are trying to answer too many questions in one trial. There are many protocol amendments, which is an indicator of the protocol’s overcomplexity. Lack of data quality monitoring measures during a study will lead to unwanted consequences. Miscalibration of measuring devices and misinterpretation of measurement methods might negatively influence the clinical trial outcome.
Tips for clinical trials to succeed
Most issues that cause clinical trial failures can occur at any phase of clinical development. So how then can we avoid trial failure? Here are some tips:
Invest in quality data from the beginning
Most CROs fail to invest in clinical data strategies from the beginning. This includes the entire project, including the postmarket phase. Data is the greatest asset for the clinical trial, so companies should always invest in a clinical data team with exceptional experience in database management and building.
Hire experienced personnel
One of the best ways to ensure the trials’ success is to hire a team with relevant experience. The project manager should have experience in running a clinical trial. Consider involving a biostatistician on your team from the beginning of your project. They can study the clinical design and suggest hypothesis testing and analysis. Statisticians play a vital role in protocol development, design, monitoring, data management, and reporting. Biostatisticians can also apply trial design methods such as adaptive trial design to make significant changes in the studies while reducing the study timelines.
Use Technology such as EDC for risk-based monitoring
Electronic Data Capture (EDC) helps keep the trial costs under control when different options are available. Implementing EDC in a medical device trial provides immediate feedback, easy access to trial information, and high data quality. Risk-based monitoring uses on-site and centralized remote monitoring by coordinating both of them. Risk-based monitoring activities are supported by reporting tools that enable verification and offer trigger alerts in case of inconsistent data.
Every clinical trial has its unique challenges. It is up to the project managers to develop ways to solve the challenges and reduce the chances of the trial failing.