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Four Important Considerations for Successful Direct-to-Patient (DtP) Study Implementation

July 6, 2016
Posted by: Joe Martinez, RPh, PDE, PPC

The practice of pharmacy has always centered on the patient.   Lately, however, ‘patient-centricity’ is gaining more visibility and momentum in the media, clinical industry and with regulatory authorities as a way to improve trial enrollment, patient retention and study outcomes.

Direct-to-Patient (DtP) protocol not only places the patient at the center of the research process, it also takes it one step further by engaging the patient more directly.  As an example, by sending medication directly to the patient’s home,  DtP serves as a proactive channel to help overcome geographical challenges in trial operations and logistics and positively influence patient enrollment and retention.

Many clinical trials continue to over-enroll because, according to a Tufts Study, 37% of sites under enroll, while 11% do not enroll even one patient. (1)  In addition, results from data released at the 2013 ISPE Annual Meeting on clinical research initiatives show that 78% of patients indicated it would be either “very helpful” or “somewhat helpful” to have their study medication delivered to their homes. (2)

Understanding that the use of DtP protocol will continue to increase, clinical trial sponsors should be aware that there are four main areas of interest to consider in order to conduct a successful DtP shipping study. These include:  1) regulatory issues, 2) good clinical practices, 3) privacy laws and 4) good distribution practices.

Regulatory Issues

Policies and acceptable processes vary by country and it is advisable to begin a dialogue with the appropriate regulatory authority early in the trial planning process to create an open communication channel, review existing and new pharmacy and clinical study regulations, as well as to discuss filings and any other concerns.

Good Clinical Practices

It is extremely important to develop a clear investigation plan to address the specifics of DtP, and to also consider a hybrid approach with an option for the patient to opt out.  This will encourage patient compliance, accountability and confidentiality.

Privacy Laws

The law is the law and we need to know, respect and follow it, especially when it applies to patient privacy.  Understanding the appropriate guidance to comply with local and global data protection laws is crucial. And it is important to remember that each region may have its own set of regulations. In the US there is protected health information, the EU has the Data Protection Directive 95/46/EU, while Asia-Pacific and Latin America also have their own set of rules.

Good Distribution Practices

Finally, in order to conduct a successful DtP shipping study, it is essential to plan and organize a well-documented supply chain and process to ensure chain of custody.  This will help to support compliance, assess risk and recall management as required.

It is clear that more trials will include a Direct-to-Patient component to address the ongoing challenges of patient enrollment, retention, compliance and outcomes. 
The potential benefits of DtP may be recognized after addressing the regulatory and operational concerns specific to the patient, product and disease being treated.  In addition, a reduced number of clinical study sites may provide the added benefit of decreased trial costs,  increased overall operational efficiency and enhanced data collection. 


1. Tufts Center for the Study of Drug Development, “New Research from Tufts (CSDD) characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices,” News, January 15, 2013, http://csdd.tufts.edu/news/complete_story/pr_ir_jan- feb_2013

2. Released at the 2013 ISPE Annual Meeting during an executive session on ISPE Research Initiatives; URL: https://www.ispe.org/patient-initiative/2013novreport.pdf
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