Direct-to-patient clinical trials may offer a solution for patient enrollment and retention woes.
As patient-centricity sweeps across healthcare sectors, it’s no surprise that interest in a direct-to-patient clinical trial model is increasing. Clinical trials have long struggled to recruit and retain patients; according to one estimate, it costs $2.6 billion to bring a drug to market, and much of that cost is accrued during the patient recruitment stage.
Further, 90% of clinical trials struggle to hit enrollment targets, and each additional day that a trial is delayed can cost sponsors up to $37,000 in expenses. Even meeting enrollment targets can’t guarantee that the trial will go without a hitch; it’s estimated that clinical trial dropout rates are as high as 30%.
Because inconvenience of travel is the leading reason why patients drop out of trials, clinical trials that are able to travel to patients may find that doing so can prevent dropout, increase enrollment, and bring a drug or treatment to market far more efficiently. For this reason, direct-to-patient clinical trials may be a solution to many sponsors’ and CROs’ recruitment woes.
How Direct-to-Patient Trials Work
In direct-to-patient trials, there’s no need for investigator sites. Instead, doctors visit patients in their homes, and patients receive their medications in the mail. Companies like Science 37 are experimenting with means of optimizing direct-to-patient trials, offering a cloud-based mobile platform called the Network Oriented Research Assistant (NORA) to connect patients, researchers, and health professionals.
The combined convenience of mobile technology and at-home treatment may compel more patients to both enroll in clinical trials and continue them through to the end, especially in geographic areas where clinical trial sites are scarce or for trials that treat patients with limited mobility. According to an early study, retention rates for direct-to-patient trials are as high as 95%.
The Complications of Direct-to-Patient Trials
Of course, the direct-to-patient model isn’t a good fit for every clinical trial. Long-term trials, trials that don’t rely on large medical equipment, and trials that cater to patient bases that are disabled, geriatric, pediatric, or potentially lacking transportation are especially well-suited to the model.
However, sensitive or temperature-controlled medications likely aren’t a good fit for the model unless an in-home storage solution is possible. If the treatment must be administered by a healthcare professional, trials must ensure that those accommodations can be met. Further, if any equipment is necessary that cannot be easily transported to the patient’s home, a direct-to-patient model may not work.
Sponsors and CROs should also be aware of any regulations surrounding at-home care. For example, in some countries, only licensed physicians are allowed to draw blood from patients under the age of 18 in their homes. There may also be specific regulations concerning drug dispensing for in-home use.
For trials that meet this set of guidelines, a direct-to-patient model may be a good option for speeding enrollment and increasing patient retention. However, whether or not a trial can make use of an at-home model, digital marketing is an excellent and cost-effective means of reaching patients.
Direct-to-patient trials may be a ways off, but CROs and sponsors can reach patients who are actively seeking treatment options now with a polished paid media strategy, including PPC tools like Google Ads and social media ads. Only 11% of clinical trials currently use social media to recruit patients, but Facebook ads can help trials reach patients who have joined groups or liked pages related to a given condition. Meanwhile, PPC ads can help CROs and sponsors reach patients who are actively searching for novel care options.