Our experts discuss a new way of thinking about clinical development and delivery.
Study planning is a huge part of what we do in the CRO industry. Study planning, however, can get bogged down by inefficiencies and challenges encountered during patient enrollment. PPD has developed its newest trial delivery solution, PatientAdvantage, to respond to those challenges and bend the cost and time curve of drug development, optimizing value in delivering life-changing therapies to improve health.
PatientAdvantage provides PPD with the ability to address the two core issues impeding more productive clinical trials:
Issue #1: Traditional site selection is flawed; there are too few investigators conducting many of the clinical trials.
Issue #2: Investigator sites cannot be depended on to find enough patients.
Like any major CRO, PPD leverages de-identified patient data to aid in protocol feasibility, trial simulation and site selection. When it comes to selecting sites based on their proximity to the community of patients outside active practices, the difference lies in our ability to leverage fully identified and permissioned patient data to recruit those potential candidates directly.
PatientAdvantage: central control, central accountability
PatientAdvantage represents our global clinical development services optimized with the combined service offerings available from PPD’s Accelerated Enrollment Solutions (AES) business unit. AES owns delivery of the key ingredients of clinical trials: patients and sites. To start, we identify the number of patients we can recruit from a certain population with our proven enrollment models. We then apply this population to our wholly owned network of sites. Those sites, with known patient access based on country level feasibility, are selected for participation, taking advantage of flexible resourcing models that allow for a greater capacity to screen high volumes of referrals. By effectively replacing low-enrolling sites with top-performing sites, and at the same time infusing those sites with even more patients, enrollment rates are increased while the number of sites required to accommodate the patient volume is reduced. Additional top-performing traditional sites can be added as needed and supported with patient enrollment. This scalability is baked into PatientAdvantage and leaves ample room within the model for maintenance of relationships with preferred sites and important key opinion leaders.
Furthermore, we have direct access to our sites’ patient appointment calendars to arrange for patient screening visits once the patient has successfully completed the online or call center pre-screener. This allows for central control of capacity and throughput, rather than distributing accountability for enrollment throughout hundreds of independent sites.
Identified patient data: connecting who and where
Sites often cannot enroll the number of patients needed for clinical trials. The PatientAdvantage solution overcomes this challenge by tapping into the group of patients in the community who are beyond the reach of traditional research sites. PatientAdvantage integrates access to the only clinical repository of more than 20 million people who have pre-screened for clinical trials, which is supplemented by more than 100 million households that have permissioned PPD to contact them directly for clinical trial opportunities. Although de-identified data can single out institutions with access to specific patient populations, additional effort is required to convert this data into randomized subjects, and this does not allow for direct recruitment of patients. PatientAdvantage uses fully identified patient data to locate where motivated trial candidates live (which aids in superior site selection) to rapidly recruit people with the targeted disease.
The result is PPD’s capability of providing qualified referrals to research sites, including participating independent research sites, and improved data quality, which streamlines trial conduct and the entire clinical research and submission process.
Bending the time and cost curve with the power of PatientAdvantage
With PatientAdvantage, recruitment efforts focus on identifying qualified patients directly from the general population, with less reliance on site-acquired patients to enroll a study. Using unmatched access to fully identified trial candidates, we model the ideal patient for each treatment area and generate clear, compelling trial messaging. By converting referred study candidates to randomized patients through a combination of people and technology, we achieve higher than average conversion ratios at the site level.
PatientAdvantage significantly reduces timelines and site footprint and can provide up to 100 percent of the total patients required for a trial, thereby increasing speed, cost savings, and data quality and ultimately delivering timeline and budget certainty.
Combining PPD’s global clinical development services with unique, proven data strategy and capabilities, PatientAdvantage offers sponsors of clinical research the patients needed, in less time, with fewer sites, and under fully accountable commercial terms.