The Consented Patient: Quintiles New Digital Patient Unit

In 2007, Quintiles formed iGuard.org, a separate entity and online consumer-targeted service that provides medication interaction checks. Now, four years and 2.5 million global registered users later, iGuard.org has since been renamed MediGuard.org and has been brought back into the Quintiles fold under its new Digital Patient unit. Announced early January, it unifies all Quintiles’ digital patient resources, which include MediGuard.org , www.ClinicalResearch.com, and the global Phase I volunteer databases. David Coman, Senior Vice President at Quintiles, will head the Digital Patient unit.

Applied Clinical Trials spoke with Elisa Cascade, Head of Operations for MediGuard.org since its inception. Cascade explained that the initial impetus for MediGuard.org was to figure out if it could have a consented relationship with the patient. As part of MediGuard.org, consumers are asked when they register if they want to receive information on research and education opportunities, along with accepting usual medical disclaimers. ClinicalResearch.com was developed as a Quintiles’ corporate communications outreach initiative to educate the public about clinical trials, as well as offer clinical trials search function by location and therapeutic area. Users are asked if they would like to be contacted for a study and registration information is then captured. There are over 165,000 registered users for ClinicalResearch.com.

In addition, the Phase I study volunteers that have been stored in a Quintiles’ database are also a part of the Digital Patient platform.

Cascade discussed the advantages of the unified Digital Patient resources over say, a claims database for finding potential participants into clinical trials, observational studies or disease management programs. “With AllScripts or whichever electronic medical records system you would choose, they know that Dr. X has 10 patients with a certain disease, but they have to find the doctor, engage that doctor, have the doctor find the patient, and engage that patient.” In contrast, to this physician-oriented model, Quintiles Patient Communities operate under a patient-oriented model. “We have a consented relationship with patients and reach out directly to them to introduce research opportunities.”

The Consented Relationship

Cascade believes that the original impetus for MediGuard.org worked. The company and database were able to establish their own relationship with a large group of patients. For over four years, MediGuard.org has provided its free medication monitoring service to patients that gives safety alerts, drug recalls, updates and checks for possible drug interactions. This service, says Cascade is objective, credible and has a built-in value and trust by the registrants. Also, because the registrants agree upfront to be contacted about clinical research and education, Cascade believes these factors change the likelihood that these registrants will participate in a trial.

Cascade says that 50% of Americans take medications, but only 8% of MediGuard.org users have ever participated in a clinical trial. The reason for this discrepancy is that over 2/3 of American’s are unaware of clinical trials. However, because they are consumers of medications, it may also make them more likely to at least be open to the idea of participation.

Identifying patients through the digital space, collecting protocol feasibility data, and screening patients for studies is at the core of what the Digital Patient unit will offer to both its internal patient recruitment department as well as external users. Quintiles’ patient recruitment department (formerly known as Access to Patients) facilitates participant recruitment and tools for the investigative site and respond specifically to the clinical operations departments. These activities would be around the overall recruitment process and retention, more likely around clinical trials. If the department determined a need for digital solutions to support their activities, it would go through the Digital Patient unit.

“Where we are going, in addition to clinical research, is activities in the observational studies and registries, as well as disease management and patient adherence programs,” explained Cascade. “We are enrolling patients directly again, rather than through the physician.” For example, Quintiles recently completed an observational study in Wales where they recruited 240 cholesterol patients in six weeks. Working in collaboration with NHS Wales and Swansea University, Quintiles was able to match patient-reported data with electronic health information in the SAIL data warehouse and to see if the medical claims submitted actually validated that these patients had cholesterol—which they did for 98% of the patients (and for the remaining cases it is unclear whether the patients were being untruthful, or if the medical records were incomplete).

Other examples include using the Digital Patient platform to improve medication compliance among chronic disease consumers. Currently, prescriptions for chronic medications drop off after month three, which is disruptive to the patient’s health.

The database was utilized by the Digital Patient unit recently to support a study that was submitted into Applied Clinical Trials for peer-review. A preliminary draft of the article appears online here. The data from the study suggests that age, condition and treatment satisfaction are the three most important factors to determine if a patient would become a participant in a clinical trial. The Digital Patient unit plans to continue these surveys and analysis to better inform behavioral decisions made by consumers.

Other plans for the near future is to add custom communities to the web site to better engage patients, and create clinical trial alumni communities that could help eliminate lost-to-follow up issues and cross participants over into observational and safety monitoring programs, which are increasingly required by the FDA and other regulatory authorities.