The importance of good protocol and instrument design for clinical outcome assessments
Many factors contribute to the success of a clinical trial. These can vary depending on the phase, therapeutic area and indication. However, the bedrock of a successful clinical trial is a well-designed protocol with reliable and valid measurements of biomedical and health-related outcomes. A well-written protocol ensures that good quality data is collected. More specifically, clinical trial data must be of sufficient quality to enable meaningful comparison, have adequate scientific rigor and satisfy regulatory standards. Put simply, a clinical trial is only as good as its data.
Clinical trials data fall into two main categories: biomarkers and clinical outcome assessments (COA). Biomarkers measure characteristics, for example, blood pressure that indicates biological or pathologic processes or responses to intervention. COAs describe or reflect how an individual feels, functions, or survives. Although generally more subjective in nature, COA can and should be subject to scientific rigor and the application of science can make for a better patient experience and improved data quality.
As technology has evolved and become more present in our daily lives, the ability for technology to improve clinical research has grown. At Clario, we see these benefits every day across our clinical trial management platform. The collection of COA electronically (eCOA) has been a game changer in clinical research. eCOA has facilitated decentralization of trials and hybrid clinical models by making data available to sites and monitors in real time and enhancing the ability to get information from patients in diverse environments. We can integrate this information better and with less effort because of the increased data quality and the ability for validation or adjudication. Electronic data collection allows for custom programmability, date and time stamping, prevention of data omissions and restrictions of data entry to prevent retroactive or forward completion or the review of previously recorded data. As a result, eCOA datasets are more reliable, accurate, and complete as compared to paper COA.
eCOA designs include alerts and compliance triggers to make sure we’re collecting the data that we need.On the backend, we can benchmark the data received from patients with metadata or data from connected devices, creating a robust assessment of the clinical outcomes.The availability of modern technology, including smartphones and tablets in the home, has enabled electronic patient reported outcomes (ePRO) to provide patients with greater flexibility and input in their participation in clinical trials. Clinical trials now routinely offer participants the option of using their own smartphone to enter study data (a method called BYOD—or bring your own device).
It’s easy to get excited about the promise of technology in clinical trials.If you had told us 20 years ago that there was a way to avoid the hundreds of hours and massive room for error introduced by the manual data entry process that would have been cause for celebration.
This post was originally published on here
