When individuals participate in clinical trials and research, they invest their time and energy for the sake of scientific advancement, knowledge, and the greater good. This is why there has been an ongoing debate in the scientific world about the utility of returning research results to participants. Time and again, several empirical studies have shown that these…
Training is often considered a prerequisite and one of the essential components of clinical research. With proper training, researchers understand all the ethical implications of the study and stay compliant with all the regulations throughout the study. To that end, the training aims to teach the researchers about all the steps of the research, from…
In the last decade, many clinical trial sponsors have shown keen interest in transitioning from paper to e-source to further strengthen the model of decentralized clinical trials. But even a decade later, the adoption has been slow and requires clinical trial organizers to accelerate the process by eliminating the limitations. The good news is that…
As per a study, randomization and blinding in research, despite their numerous benefits, are underutilized tools in non-pharmaceutical trials. While clinical trial organizers and researchers acknowledge the benefits of randomization and blinding, not many have been keen to implement the protocol in research studies for a long time. However, after 2020, when decentralized clinical trials,…
Remote data collection in modern decentralized clinical trials has allowed research sponsors to eliminate various barriers and improve data quality. Gathering accurate and real-time data from a diverse pool of clinical research participants is now possible with remote data collection. But to fully leverage this tech-supported clinical trial model, researchers must know the different data…
As more advanced technology is used in clinical trials and studies, the chances of incidental findings have also increased manifold. Incidental findings can be potentially relevant during the course of the research, but they fall outside the primary scope of the study. These findings may be anticipated or unanticipated, and sometimes researchers even seek them…
In recent years of modernized clinical trials, patient centricity has become a top priority for a vast majority of clinical trial sponsors. Allowing clinical trial organizers to avail numerous benefits, the concept of patient centricity has also given a boost to the idea of decentralized clinical trials. But ensuring patient centricity in clinical trials is…
In the worldwide clinical trial industry, new privacy regulations emerge at regular intervals, with added guidelines provided by the states. Since endpoint adjudication committees (EACs) have to review data received from all over the world, they have to stay on top of all the developments and changes in the regulations across the world. In this blog,…
Study startup is an overwhelming, time-consuming, and occasionally frustrating component of the entire research process. It is notoriously prone to delays and can derail subsequent research activities. To ensure a seamless, swift, and successful study startup process, all stakeholders must cooperate carefully to get the study up and running. Here is a comprehensive checklist to help…
Inform consent is the process of informing potential participants on the key elements of a study so they can make an informed decision on their participation. The informed consent process is central to the ethical conduct of any study, and stakeholders should pay special importance to creating a robust form that complies with relevant rules and…