Patient Centricity: Nice buzzword – Now how do you implement?

In the US, pharmaceutical and biotechnology companies sponsor the majority (75%) of clinical trials. In total, these companies spent approximately $40 billion on clinical research in 2014. [1]
Clinical trials such as these are the first point of interaction between a patient and a sponsor company. In spite of this, clinical teams frequently overlook this fact when planning the scientific and operational components of clinical trials. The result is burdensome trial protocols, avoidable inconvenience on patients already in a challenging situation, and, therefore, unhappy patients, low recruitment and high dropout rates.

The aim of patient-centric clinical trials is to decrease the burden of participation by making it as convenient and pleasant as possible, and, thus, to aid in tackling such issues. While terms such as “patient centricity” and “patient-centric trials” have become industry buzzwords and made their way into various publications and presentations, there is still much to do when it comes to implementation. Integrating the patient perspective into clinical trial planning and activities is not an easy task, but can be well worth the investment. Throughout the trial design, recruitment, and even during the active retention phase, thoughtful understanding of the needs of study participants is essential to the establishment of patient-centric practice. By incorporating in-home, alternate site or remote visits within the trial design, sponsors can create and manage patient-centric programs that lessen the burdens on the participants and improve overall results.

When 100 clinical trial site staff were asked about their experiences with enrollment and retention, about 75% of respondents said they failed to meet enrollment targets between 5-25% of the time, 16% reported failing more than 25% of the time. [2] Subject enrollment can be problematic because patients will choose not to enroll in a clinical trial for any number of reasons. To enhance the probability of meeting enrollment targets, one of the best decisions sponsors can make is to allow trial participation to be easy, making it convenient for patients to enroll and stay involved. A patient’s greater engagement, through uncomplicated trial participation, can not only contribute to improved health outcomes, but it may also allow for elevated return on investment throughout the life cycle of a product or portfolio.

Likewise, each year thousands of patients drop out of clinical trials for any variety of reasons. Though some dropouts are a result of uncontrollable circumstances, many others are preventable. With over 85% of trials failing to retain enough patients [3], it is clear more can be done to boost subject retention. Poor patient retention can adversely affect a trial by lengthening timelines, adding cost, introducing risk to the interpretation and validity of study data, and delaying product approval. Therefore, it has become critical for sponsors and sites to proactively address patient retention in clinical trials.

Growing pressures within the clinical trial industry present many challenges in getting a drug or device to market, such as:

• Longer studies with frequent site visits and more complex trial protocols can be time consuming, inconvenient, and unpleasant—a significant barrier to patient enrollment and retention.
• Challenges to specific patient populations can prevent or reduce patient participation: the elderly, immobile patients, those too frail or too progressed in their disease state to travel, individuals who live too far away from sites, pediatric patients and their caregivers, patients who are actively employed, students, or those who travel frequently or have seasonal homes.
• Increasing FDA pressure to include the appropriate “intent to treat” patient population adds further challenges to the traditional (non-remote) patient site visit model.

Therefore, alternatives to the traditional patient site visit model need to be considered.  For example, integrating clinical trial expertise with in-home nursing to bring the trial to patients wherever they live, work, study or vacation.  In fact, for over a decade now the in-home study services movement has been at the forefront of direct-to-patient, in-home and alternate site clinical services, mobile nursing, ambulant care services, virtual trial and remote monitoring for clinical trials.

For each study, proper logistical planning experience and processes help ensure the right clinician is in the right place at the right time with all of the support and materials they need, including thorough training in the trial protocol.  Experienced in-home clinical service providers are well positioned to identify risks early in the process so challenges can be optimally managed or completely avoided.

By changing the place of the clinical trial to the patient’s home, office or destination, study sponsors are better equipped to in quicken the pace of their trial by improving enrollment and retention.  The in-home visit has effectively transformed the face of clinical trials by associating the clinical trial process with a place of comfort and convenience, with caring and compassion delivered by the homecare clinician.