For clinical operations and development clinical feasibility teams, diversity equity and inclusion and health equity leaders, as well as health economics and outcomes research (HEOR) teams, it is essential to understand the considerations when integrating data to help ensure inclusive and equitable compliant clinical trials that increase trust among patients, pharma, and study participants.
Data networks are valuable to inform clinical trials with insights and analyses such as patient population selection criteria, site selection criteria, site performance evaluation criteria, Principal Investigator (PI) selection criteria, and incorporating population health efforts into informing trial selection.
Patient Population Selection Criteria
The first step towards a more equitable clinical trial is selecting the right patient population. When selecting a patient population it is important to consider all demographic factors such as age, gender, race and ethnicity, socio-economic status, education level, and geographic location. It is equally important to consider factors such as patient preferences, medical history and disease burden.
Site Selection Criteria
When selecting sites, it is important to consider factors such as location (is the site close enough to the patient population), infrastructure (do they have the necessary equipment and personnel to conduct the trial), experience (are they familiar with conducting trials in a compliant manner) and cost (are their fees reasonable).
Site Performance Evaluation Criteria
Once sites have been selected for a clinical trial, it is important to evaluate their performance. Factors that should be considered when evaluating performance include recruitment rates of patients from target populations, adherence rates of patients enrolled in trials and data quality from participating sites.
PI Performance and Selection
It is also important to consider the performance of principal investigators (PIs) when selecting sites for a clinical trial. PIs should be selected based on experience in conducting trials, meeting recruitment goals and providing data that meets quality standards. PIs with diverse backgrounds and experience should be given preference when selecting sites to ensure an inclusive trial design.
When selecting sites for a clinical trial, it is critical to consider the patient population being targeted by the study. Factors such as age range, ethnicity, gender and socioeconomic status should all be taken into account when selecting locations and recruiting patients for a clinical trial. Additionally, consideration should be given to ensuring that vulnerable populations are not excluded due to language or cultural barriers.
Finally, it is important to consider how population health efforts can inform trial selection and HEOR research. This includes understanding which patient populations are most likely to benefit from the drug being tested, and incorporating those populations into the trial design.
This understanding of how data networks can empower clinical trials has led to many new initiatives and regulations aimed at increasing the representation of diverse patient populations in clinical trials.
We need to ensure that all stakeholders have access to data to inform their decision-making when it comes to inclusion and equity in clinical trials. Therefore, data networks can be powerful for understanding disparities in access to care, which can lead to more equitable enrollment criteria when selecting sites and PI’s for a successful trial.