Patient-centric, direct to patient (DtP) clinical trials are an important alternative to traditional clinical studies for biopharmaceutical companies. 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 to administer the investigational medicinal product, deliver clinical support, measure vital signs, prepare laboratory samples, and ensure safety.
Here are three reasons to consider DtP trials when designing your next study.
1. Direct-to-Patient Trials Expand the Available Patient Pool
Today, nearly 80 percent of clinical trials fail to meet enrollment deadlines. Patient groups can be difficult to find for rare or orphan diseases.
DtP can be a useful model for sponsors seeking to recruit patients faster and increase the chance of participating for patients who are:
- Seriously ill or disabled
- 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 clinical trial site that makes regular visits difficult
In addition, a DtP trial that offers access to the most knowledgeable investigators, without the need to travel, can be very attractive to patients seeking care.
2. Direct-to-Patient Trials Are Attractive to Sponsors.
For sponsors, DtP trials can bring the drug to the marketplace faster by:
- Creating a wider pool of patients (including those unable to reach most study sites or those in outpatient care) by bringing the site of the study directly to them
- Reaching investigators and specialized sites who can study rare diseases
- Attracting more patients to trials that may be in competition with other trials
- Increasing the number of evaluable patients who have complete data records
DtP trials can also reduce a site’s financial burden, save time, improve data collection, and reduce the costs associated with overproducing IMP.
3. Direct-to-Patient Trials Are the Future of Clinical Studies
With biopharmaceutical companies facing increased pressure to recruit and retain available patients and improve data collection in the face of ever-changing regulatory requirements, the cost of drug development is increasing. Sponsors must find new ways to recruit, enroll and engage patients, while at the same time meeting all regulatory requirements, and accelerating development. DtP trials fundamentally change the design and execution of running a clinical trial, with touchpoints spanning the full spectrum of delivery requirements.
As more sponsors execute DtP trials, they will want to seek experienced partners who can design and execute on the promise of these patient-centric studies.
For more information on Direct to Patient clinical trials, download our white paper https://informatics.parexel.com/informatics-white-papers/direct-to-patient-white-paper Assuring Success in Direct to Patient Studies: Key Considerations.