In a gene therapy trial, a competitive trial landscape; the availability of approved therapies; and the complexity of the trial put site engagement and enrollment at risk. Working with the sponsor and sites to discuss how this trial differed from others in the therapeutic area, what the potential long-term benefits and risks were to warrant the complexity, and training the sites on how to discuss this with their patients allowed Rho to enroll each cohort on-time.
In a cellular therapy trial, when insurance approvals for assessments not covered by the trial were delaying, and in some cases hindering, enrollment, Rho worked with the sites on best practices for approaching the insurance companies about these procedures. This led to a dramatic increase in approvals from the insurance companies, which led to faster patient enrollment.
In a Natural History Study, we were able to reduce data entry by the site, which lessened the burden on site staff. We did this by having data which had already been collected for a patient registry transferred to Rho for use in the study’s database. We also pulled key data points, for which we knew there would be a high volume of data, from the site’s electronic medical records instead of having the site staff enter them.