The benefits of applying Direct-to-Patient (DtP) services to clinical trial and for commercial drug has been in the spotlight recently. For pharmaceutical manufacturers / sponsors and  researchers, DtP can offer competitive advantages, the opportunity to improve patient recruitment and reduce trial timelines, as well as potential commercial benefits.

Competition for Patients

For clinical trial sponsors, engaging the targeted number of eligible patients can be a challenge requiring a substantial investment of time and money. Failure to recruit on time also comes at a cost – delaying start-up or, even worse, forcing study cancellation. The end result? Valuable time and financial resources lost.

Offering patients an in-home treatment option helps dispel many of the objections normally associated with participating in a clinical trial – potentially swaying their decision among competitive studies.

Recruitment difficulties are often exacerbated by the following factors:

• A limited patient pool from which to draw, especially for rare diseases or orphan disease studies
• More rigorous patient exclusion criteria that further reduces the potential patient pool
• Investigator sites typically located closer to the research community than to patients
• Competitive studies by other sponsors vying for the same patients
• Lack of interest from potential participants
• Patients who are unwilling or physically unable to travel to sites
• Growing knowledge and empowerment within patient populations to choose their preferred treatment option

The flexibility posed by DtP opens up recruitment to patients who might otherwise be unable to participate, potentially offsetting the loss of patients excluded for other reasons.

On the commercial side, it may also offer a clear competitive advantage if other treatment options are available.

Competition for Investigator Sites

Just as traditional healthcare systems are stretched to capacity, a 2014 study sponsored by the U.S. Department of Health and Human Services (HHS) shows increasing competition for qualified investigators and sites. This is especially true in more popular therapeutic areas and for smaller sponsors who may not have existing relationships with quality investigator sites in all geographies.

A shrinking pool of investigators in the U.S. is expected to intensify competition as more and more trials in rare and orphan diseases are conducted. Meanwhile local recruitment challenges, the shift towards smaller trials, the growing complexity of protocols and the industry practice of spreading trials over more sites with fewer patients, among other factors, causes some sites to reconsider their own study participation.

While site visits are not completely eliminated from the study design, DtP reduces the burden on local site personnel and resources, potentially improving the ‘fit’ and making participation more accessible.

Improving Recruitment & Retention 

According to the HHS study, an estimated $2.28 billion is spent annually on patient recruitment and retention costs for studies. Despite this:

“Two-thirds of investigative sites fail to meet the patient enrollment requirements for a given clinical trial. Whereas in 2001 nearly half of all patients screened for clinical trials completed them, in 2010 less than one in four screened patients were retained for the duration of the clinical trial.”

While more recent estimates put the drop-out rate at 30-35%, the number is still concerning. It remains a key factor in jeopardizing research results, lengthening the duration of a study and increasing costs, to say nothing of the costs permanently lost on-boarding sites that enroll few or no subjects.

The DtP model has become a game-changer in this regard. Effectively eliminating many of the common barriers to participation significantly helps to stimulate patient recruitment and retention. Offering geographical flexibility and reducing much of the ‘inconvenience’ factor, the model eases and supports the patient’s ongoing participation in the trial. With improved retention comes higher adherence and, by extension, potentially better quality of life for the patient.

Reducing Costs
In addition to the cost savings associated with timely start-up and improved recruitment and retention practices, the DtP model may also favorably impact savings in facility costs normally associated with study sites. DtP may also result in faster completion times and fewer wasted drugs.

Commercial Considerations

For sponsors, the benefits of concluding a study earlier – with clear quantifiable research results – is the principal goal. Being first to market not only delivers a significant competitive edge against other therapies in development, it provides earlier product access to the broadest range of patients.

For approved therapies, patient convenience and adherence, potentially improved health outcomes and broader geographical distribution potential may also enhance long-term payer perceptions and commercialization efforts.

DtP brings with it a range of benefits, but it’s not just pharma manufacturers / sponsors and researchers that benefit. DtP can also improve the patient experience too. You can find out more about the benefits, challenges, and mechanics of DtP in our Direct-to-Patient e-book.