Enabling better access to kidney disease trials
March is National Kidney Month, and we at Labcorp are committed to improving the renal health of patients worldwide. The field of nephrology clinical research has been steadily adding new interventional trials over the last five years at an average pace of 176 trials per year. This activity reflects the continued interest in and importance of developing new drugs to treat renal disease. The recent approvals of Farxiga® (dapagliflozin) and Kerendia® (finerenone) have also moved the field forward with new treatments to delay kidney disease progression. However, the operational conduct of kidney disease studies—whether they be for chronic kidney disease or rare renal diseases such as IgA nephropathy or focal segmental glomerulosclerosis—remains challenging due to low recruitment rates, a widely competitive geographic spread and long development timelines. Within the Operational Strategy and Development Group at Labcorp, we are deploying various tactics to improve the efficiency of renal studies by focusing on the patient.
Patient-centricity is not a new concept, but many studies still fail to fully consider how protocol design impacts patient acceptance. Studies with the same patient population can recruit at very different rates depending on the complexity of the schedule of events, the frequency of office visits and the flexibility within the entry criteria. At Labcorp, our breadth of experience, along with deep expertise from medical, strategy and operational perspectives, enables us to streamline protocols and maximize recruitment without impacting the scientific value of the study. In some cases, we have seen streamlined protocols provide up to two times higher recruitment rates in the same patient population.
The growth of digital technology combined with the influence and needs created by the COVID-19 pandemic have produced a wealth of capabilities to bring the study to the patient. At our disposal are electronic consenting, telehealth, mobile clinical services (MCS), direct-to-patient drug shipments, targeted web-based outreach, mobile health units, wearable devices and electronic patient-reported outcomes, with continuing advances on the horizon. The availability of technology, however, needs to be considered in conjunction with strategic application. Some studies benefit from MCS alone, particularly those enrolling patients with difficult school and work schedules or those limited in their ability to travel. Other studies need to pair MCS with telemedicine and direct-to-patient drug shipments due to geographical limitations as might occur in rare disease trials. Strategically matching technology to trial design is required to maximize patient access and when matched correctly offers the possibility to improve recruitment, retention and patient satisfaction.
March is National Kidney Month and Labcorp recognizes the value of access to nephrology clinical trials as one of the most critical elements in speeding the development of new treatments.