Patient recruitment is a crucial step in the success of any clinical trial. The ability to enroll an adequate number of qualified participants not only impacts the timeline but also the validity and reliability of the trial results. However, recruiting…
Good Clinical Practice (GCP) guidelines are a cornerstone of clinical research, ensuring that trials are conducted ethically and scientifically, with the rights, safety, and well-being of participants as a priority. The International Council for Harmonisation (ICH) has recently released an…
The integration of real-world data (RWD) into biostatistics is revolutionizing the field of clinical research. Real-world data refers to health-related information collected from a variety of sources outside traditional clinical trials, such as electronic health records (EHRs), claims and billing…
Decentralized clinical trials (DCTs) have gained significant traction in recent years, driven by advancements in technology and the need for more patient-centric approaches. Unlike traditional trials, which require participants to visit central sites, DCTs leverage digital tools to collect data…
The European Medicines Agency (EMA) plays a critical role in the regulation and approval of clinical trials within the European Union. In recent years, the EMA has updated its requirements for clinical trial submissions to ensure that trials are conducted…
Missing data is a common challenge in clinical trials that can compromise the validity and reliability of statistical analyses. Effective methods for addressing and imputing missing data are essential to ensure robust and reliable results. This article explores best practices…
Clinical trials are the backbone of medical research, playing a crucial role in the development of new therapies and treatments. Traditional trial designs, while effective, often come with limitations such as long durations, high costs, and rigid structures. In recent…
The integration of digital health technologies (DHTs) into clinical trials represents a significant advancement in the field of medical research. From wearable devices to mobile health apps, these technologies offer new ways to collect data, monitor patient health, and improve…
Machine learning (ML) is transforming various industries, and clinical research is no exception. The application of ML in clinical trial data analysis offers the potential to enhance data accuracy, uncover new insights, and improve the efficiency of clinical trials. This…
