According to a story from BioPharma Dive, an ongoing discussion in medical circles, both rare and otherwise, is improving the design of clinical trials. Clinical trials are an important tool for thoroughly testing experimental drugs for safety and effectiveness before they are approved for public use. In recent years, the design of trials has come under scrutiny for a variety of reasons, such as highly specific inclusion criteria, the use of outdated endpoints, and more. In this story, we will discuss an example of clinical trial that was improved using the latest research to responsibly expand inclusion criteria ensure that all protocols were relevant, necessary, and based on valid data.
Modifying Inclusion Criteria With Data Input
A drug company is planning to develop a treatment for diabetic kidney disease. To do so, the company would develop a Phase II trial for patients with chronic kidney disease, type 2 diabetes, and macroalbuminuria. The initial draft for the trial called for patients with a urinary albuminto-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) within a certain range. These are common measures for kidney disease and macroalbuminuria, but an analytical model determined that recruitment for the trial would be too strict as there are very few type 2 diabetes patients that would meet the listed parameters. This was determined though extensive analysis of patient data.
Further calculations determined that only minor tweaks would be necessary to the parameters for UACR and eGFR to more than double the number of patients that would meet the eligibility criteria for the clinical trial. These changes would not compromise the overall goals of the study. So far these revised criteria have allowed for recruitment to occur at a rate that was greater than the study investigators originally expected.
Why Incorporating Up to Date Information Matters
While this may seem like a simple solution to improving the study design, many designers do not take into account the latest data and are content with using eligibility criteria from a prior trial for a similar disease or simply set criteria that seem within reasonable range but lack real scientific backbone. Using up to date data is critical as new research and care standards are being introduced at a rapid rate. Utilizing the latest data can go a long way to improving the effectiveness of a trial, ensuring that it is open to a greater swathe of patients, and improving the value of its findings.
