Immunology Case Study

Patient-Centricity is Central to Recruitment and Compliance
Challenge

A specialty biopharmaceutical company targeting the plasma replacement for the treatment of hemophilia and immune deficiencies contracted with ARG to perform comprehensive CRO services for two different Phase III studies. Regulatory requirements included an audit mid-way through the process. The Sponsor faced difficulties both recruiting patients and then ensuring compliance.

Solution

Because of our relationships and experience in these therapeutic areas, we able to not only meet recruitment targets but also ensure patient compliance. This was accomplished in several ways: use of specialized home health providers, daily interactions with the patients via our Study Champion, and a unique understanding of the patient experience in these disease states.

After successfully completing an audit of protocol design, conduct, monitoring, data management, and quality assurance processes, ARG won preferred provider status.

We have also found that providing this as an option has been a great recruitment tool for sites.

Study Champion In Immunology Trials

In terms of patient-customer service, this role will provide an unprecedented level of patient support, and build a bridge of continuity for sites and home health care nurses.

The Study Champion will be an expert in the systems and tasks for study participants, a one-stop-shop for patient support.

This could include working closely with advocacy, community and physician outreach to aid in patient recruitment efforts, providing travel and lodging concierge services, assisting in navigating the complex study information including logistics, dosing, and technologies, providing valuable patient feedback allowing both sites and sponsors to take corrective action sooner.

This change will ensure that the study participants have a dedicated team member to support them during their time in the study, thereby, decreasing the number of people a participant must go through in order to obtain the support that is needed. This strategy will ultimately lead to greater compliance, satisfaction, and retention.

Moving Forward

Sponsors are realizing that there is no one-size-fits-all option for operationalizing clinical trials in immunology. The right partner is the right CRO for your trial, one that is patient-centric, has the relationships within the treater communities, and the technical know how to get the job done. Equal expertise is multiple functional areas clearly demonstrates team experience, commitment, and execution.

Your trial should enjoy high visibility in your CRO’s building, and ARG’s senior leadership are deeply involved in overseeing projects. Paul Bishop, CEO, founded ARG in 2004, maintains a close relationship with the Clinical Immunology Society (CIS) and American Academy of Asthma, Allergy & Immunology (AAAAI )and has been involved in Immunology development for over 20 years.