Recruiting and retaining patients is one of the biggest challenges biopharmaceutical and medical device companies face when they start a clinical trial.
Today, nearly 80 percent of clinical trials fail to meet enrollment deadlines. According to the Tufts Center for the Study of Drug Development, 11 percent of sites in a given trial fail to enroll a single patient and 37 percent of all sites under-enroll.
Enrollment failures are expensive. The average cost of bringing a new drug to market exceeds $1 billion, so each day a drug is delayed translates into as much as $8 million in lost revenue.1
Direct-to-patient (DtP) studies offer a compelling alternative to the traditional clinical trial structure.
In DtP clinical trials, drug therapies and medical equipment are delivered and administered in a patient’s home. Patients may take the medications themselves or rely on a home care provider for clinical support, measuring vital signs, preparing laboratory samples, and ensuring patient safety.
DtP trials are enabled by e-clinical technologies that help improve patient compliance, enhance patient safety, and make remote DtP trials possible. Clinical trial management systems, electronic data capture (EDC), interactive response technology (IRT), electronic clinical outcome assessments (eCOA), and patient e-diaries replace paperwork, manual processes, and frequent site visits.
E-clinical technologies also enable off-site monitoring and patient recruitment, as well as engagement during the course of the study, communication with investigators and sites, patient randomization, supply and logistics tracking, and data collection.
DtP clinical trials may be attractive for patients and their families since they do not involve travel to investigational sites. This is helpful for patients who are too unwell to travel or live a great distance from clinical sites.
For sponsors, DtP trials can bring the drug to the marketplace faster because they create a wider pool of patients by bringing the site of the study directly to them. They may attract more patients to trials already in competition with other trials. And, they increase the number of evaluable patients who have complete data records.
For more information on Direct to Patient clinical trials, download our white paper Assuring Success in Direct to Patient Studies: Key Considerations.
 “Impact Report,” Tufts Center for the Study of Drug Development, January/February 2013, http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf.