Opportunities for Patients and Sponsors: Direct to Patient Trials

February 14, 2018 Cornelia Truemner

Patients seeking care may find direct-to-patient (DtP) clinical studies more attractive than traditional studies. Sponsors may find DtP trials can accelerate patient recruiting and increase engagement during the course of the study.

In DtP 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 safety.

DtP studies increase the chance of participating for patients who are:

  • immobile or disabled (for example, those with respiratory or mobility issues)
  • in need of support to visit a site (for example, children and those with Alzheimer’s, motor neuron diseases, or any disorder that would impact one’s mental capability)
  • already being treated through outpatient care
  • able to participate only if site visit requirements are minimal
  • already being treated with trial materials, or who require equipment that is heavy, challenging to transport, or dangerous
  • living a distance from the study site that makes regular visits difficult

DtP trials are highly patient centric. They can be designed to leverage mobile applications and social media to attract and qualify patients.

Many patients already use activity trackers and health-tracking applications on their smartphones> They will be comfortable with the next generation sensors, wearables and mobile applications that might be used in a trial to monitor health or increase engagement with the sponsors, investigators, or trial site. Studies designed around technologies familiar to consumers could motivate more people to participate.

Educational materials distributed during the trial’s onset can help patients understand the important role they play in drug development. Materials distributed throughout the study can further educate patients, help answer questions and remind patients of their responsibilities, while keeping them engaged.

Direct-to-Patient Can Improve Recruiting for Sponsors

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. This includes patients unable to reach most study sites or those in outpatient care.

DtP studies also can extend the reach of specialized sites and investigators – especially for rare diseases for which there are only a few experts. DtP trials may attract more patients to trials already in competition with other trials and increase the number of evaluable patients who have complete data records.

The DtP model can be used to improve patient retention by developing and delivering educational materials and answering patient questions throughout the course of the study. 

Finally, DtP trials can also reduce a site’s financial burden, save time, improve data collection, and reduce the costs associated with overproducing the investigational medicinal product (IMP).

For more information on Direct to Patient clinical trials, download our white paper Assuring Success in Direct to Patient Studies: Key Considerations.

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Direct to Patient Clinical Trials Could Overcome Challenges of Recruiting Patients
Direct to Patient Clinical Trials Could Overcome Challenges of Recruiting Patients

Direct to Patient Clinical Trials Could Overcome Challenges of Recruiting Patients