We have a database containing the contact information of more than two thousand treating physicians (out-patient department, private hospitals, regional hospitals) with whom agreements on recruitment of patients for participation in clinical trials have been signed. See below a real-life example of improvement in enrollment of a rare type of breast cancer study before and after implementation of Cromos Pharma’s referral sites strategy.
Commitment to patients: according to the clinical protocol requirements a 24-hour spirometry assessment had to be performed for COPD patients. Due to the fact that a number of procedures were to be performed at night, many non-resident patients refused to visit the clinical site at the fixed timeframes, which caused multiple repeated protocol deviations. Cromos Pharma assisted the Sponsor in retaining patients through implementing initiatives such patients’ reimbursement for travel, accommodation if required, breakfast vouchers and other tools designed to remove obstacles, all of which resulted in a significant reduction in the rate of patient drop-outs.
DTC outreach: Cromos Pharma supports patient recruitment in clinical trials by means of publishing informational announcements on medical forums and through other appropriate media. Such announcements may be used to inform and invite patients to participate in rare disease clinical trials (e.g. bulimia nervosa; growth hormone deficiency).
Investigator’s materials: Cromos’ development of portable mini-protocols, inclusion/exclusion criteria cards has helped to reduce the number of screen failure rates.
Booster visits: Cromos Pharma has been involved in a number of rescue and urgent studies, including an ongoing protocol with arterial hypertension indication that had unsatisfactory delayed patient recruitment. After the analysis of the current situation it was agreed to perform extra booster visits to sites which lacked proper oversight by the PI. Cromos Pharma developed a site recognition program which was effective in speeding up patient recruitment by >30% on average, allowing the study to meet protocol targets.