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Looking for a 'paradigm shift' in patient recruitment and retention on an international level
World Courier MyCubixx unit
World Courier (London) has a global network (with 140 offices in 50 countries) of couriers and delivery services primarily for clinical trial management. Medical Research Network (MRN; Milton Keynes, UK; US HQ in Skokie, IL) has established a model of a “clinical trials support organization” over the past decade, handling over 150 trials set up to service patients in their homes. Now, by partnering with each other, the companies hope to offer a relatively innovative approach to clinical trials with a focus on home-based patient access.
“Patient recruitment and retention are the two biggest pain points for trial sponsors,” notes Sam Herbert, COO of World Courier. “It’s a challenge when a sick patient has to go to a clinic several hours away for an infusion, when starting or continuing a trial. By eliminating that step, we’ve seen cases of a near-doubling in patient recruitment success, and retention in some cases as high as 95%.”
The home-based approach has significant challenges: For specialty-pharmaceutical injections, a nurse generally has to be available, so the delivery of the drug needs to be coordinated with the arrival of the nurse. Sending multiple drug samples to multiple locations, rather than to one investigator site, is another. World Courier, says Herbert, is engaging with other parts of the AmerisourceBergen organization (of which it is a subsidiary): US Bioservices for infusion nurses is one example; another is MyCubixx, a box-sized refrigeration unit (recently developed to service hemophilia patients in their homes) that maintains a stock of drug at a verified temperature, and, through RFID-based labeling, verifies arrival and consumption of doses. Having the storage unit at the patient’s home provides some flexibility for scheduling nurse calls. All of these services, obviously, can provide the validation necessary for ensuring a successfully conducted trial. (MRN also maintains a network of nurses, and some related operational services.)
There have been instances of setting up home-based trial networks; recently, the Guardian Research Network founded in South Carolina for oncology trials; and back in 2011 Pfizer sponsored a broad-based trial, Research on Electronic Monitoring of OAB Treatment Experience, or REMOTE (cute, huh?) but, according to press reports, recruitment problems torpedoed the effort. This year, Sanofi has set up a so-called “virtual” trial in Europe, said to be the first to occur in that region.
UPDATE: Graham Wylie, CEO of MRN, provided some additional insights on the home-based trial process, noting that “virtual trials” like those attempted by Pfizer or Sanofi are explicitly done without HCP involvement in the patients’ homes; the idea is to get useful data directly from the patient. MRN’s setup, which has been used over 100 times in multiple countries, involves nurses or other HCPs being present at the patients’ homes, to either administer the trial drug, draw blood samples or other clinical data, and help guide the patient in drug use. “The nurses are trained in Good Clinical Practices (GCPs), which vary country by country,” he notes. MRN has a variety of levels of service, from basic drug administration and blood work, to managing trials of rare diseases or pediatric trials, to complex infusions or injections of specialty drugs. As noted, besides the ability to bring in trial recruits and obtain validatable test results, the service has a profound effect on patient retention. “Trial sponsors usually aim for 80% retention and believe they’ve accomplished a significant goal with that; our retention rates are as high as 98%,” he says.