Making Clinical Trials More Effective By Keeping Focus On The Patient – A Q&A with Justin Schroeder, Executive Director, Marketing, Business Development and Design, PCI Pharma Services
The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and inconvenience patients. Today, priorities are changing as sponsors realize studies designed around the needs of patients also result in benefits to other stakeholders. This has led to the rise of patient-centric clinical trials.
The burdens of clinical trial participation are well-known. Traveling to trial sites, complying with medication regimens, and undergoing procedures all place strains on patients, leading some people to drop out and others to not comply with the protocol. What is changing is the willingness of sponsors to redesign their studies around patients and the recognition of how this benefits everyone.
Sponsors’ changing attitudes are underpinned by evidence the current system is flawed. According to a survey of 3,150 people by the Center for Information and Study on Clinical Research Participation, more than one-fifth of trial subjects find the experience somewhat or very stressful. Asked what they liked least about the experience, people cited the location of the medical center, the time-consuming nature of study visits, and the cumbersome procedures they had to follow.
The consequences of these experiences extend beyond patients. Sponsors need people to want to enroll in trials and take their medication per protocol if they are to gather high-quality data as fast as possible. Yet, trials designed without considering the needs of patients are unlikely to achieve optimal enrollment, retention, and compliance rates.
Recognizing this, sponsors are increasingly building the patient perspective into all aspects of their clinical trials.
Sponsors that take the time to design patient-centric clinical trials are rewarded with significant mid- to long-term benefits, according to Justin Schroeder, PCI Pharma Services. In this Q&A, Schroeder discusses the benefits of patient-centric clinical trials, the role packaging can play, and why it is worth incurring up-front costs and inconveniences to put the patient at the center of studies.
protection for tablets during delivery, but such simple packaging is not most effective for patients.
Instead, companies can use packaging to increase adherence. Packaging that provides medication in a calendarized unit dose format shows patients exactly how they’re supposed to take it on that particular day, or that morning, evening, with or without food, et cetera. When utilizing compliance prompting packaging, it’s very well laid out for them so they can track their progress and keep to the regimen.
Some packaging has additional areas where patients can capture notes such as how they feel or side effects they may be experiencing. There’s even packaging now that is interactive, so the patient can capture information and provide that to the clinician or send back information literally through the package or via interaction with their smartphone. This provides real-time information for the people administering the study. This type of data is powerful, particularly in a scenario such an adaptive study, whereby the data can be acted upon much more quickly than a traditional study where data may lag substantially and key opportunities are missed.
Also, the doctors and clinicians who administer the study benefit from having consistent patient populations that are educated and have the best chance to receive better health. It’s a situation where everybody wins.
they have dexterity issues or be experiencing some form of neuropathy? Are they men, women? Are they young? Are they old? Will the drug be self-administered or given by a caregiver? There are a lot of factors that go into making sure the package is as effective as possible. A lot of those factors play into whether someone gets engaged with their packaging or alternatively gets turned off by their packaging. We certainly know that bad packaging can drive people away from taking their medication.
In the direct-to-patient model, the medication is delivered to the patient so it’s quite convenient for them. It can be a scheduled delivery. At that time other information can be gathered if that’s part of the study. Some studies feature in-home nursing to check vital signs, answer questions and otherwise engage with the patient. Other studies handle everything virtually through smartphones or web portals. Either way, in this scenario a lot of things that traditionally happened in clinic are now happening in the home environment.
The follow-through from that is direct-to-patient trials may yield better patient recruitment and engagement, better patient retention, and may accelerate subject enrollment by giving sponsors access to larger patient populations.
Over a longer time frame, the benefits and financial impact far outweigh any of the short-term costs. There’s a lot of value to be gained for sponsor companies, CROs, and suppliers in making sure they keep patients’ interests front and center.