Whitepapers

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

Abstract

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.

 

Sponsors are realizing the needs of patients result in benefits and this has lead to the rise of patient centric clinical trials.

 

Introduction

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.

Q&A

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.

Schroeder: Patient centricity is an industry buzzword right now garnering a lot of attention in the pharmaceutical community. Frankly, it means a lot of different things to a lot of different people. Specifically within the clinical trial community, we’re seeing people taking a step back from the traditional thinking of what’s most cost-effective or most immediate and really looking at the broader perspective of what’s most effective for the patient. As they’re starting to reevaluate that, they’re realizing that focusing on the patient ultimately leads to a lot of additional benefits that far outweigh the shortterm cost implications or perception that it may lengthen critical lead times.
Schroeder: Patient centricity leads to more focused clinical trials with better participant retention, better engagement with the study, and better adherence to the medication and protocol. Keeping more patients in a trial and them taking their treatments as per the protocol can significantly cut the time it takes to complete a study and improve the quality of the data it generates. These are huge benefits that substantially outweigh any considerations of short-term cost advantages of running less patient-centric trials.
Schroeder: A lot of people have traditionally gone for the most convenient way to deliver a product to the patient. This is not necessarily the most effective way to deliver a product to the patient. A bottle is a great example. A bottle provides convenient
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.

Schroeder: It gives patients a better chance of adhering to their medication and staying engaged in the trial. This could significantly benefit their health. For sponsors and CROs, this results in better study data, faster data gathering and ultimately more efficient trials.

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.

Schroeder: We’ve been specialists in package design for as long as we’ve been in the CMO space, which is over 50 years. Today we have a tremendously skilled team focused specifically in this area that makes sure we provide packaging that is as effective as possible. We engage our customers very early in the process as we’re starting to develop packaging for a study and ask questions. What is the typical patient like? What is their patient experience? How many medications might they be on? Might
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.
Schroeder: People are very engaged once we ask the right questions, but, quite commonly, there’s a disconnect between who’s developing the packaging and many of the other stakeholders. That’s one of the reasons why we really dig into trying to best understand what the environment looks like for the patient. By asking the right questions and engaging each of the key stakeholders, we factor in all the different things that need to be considered and the varying needs of all the different stakeholders.
Schroeder: Direct-to-patient trials are one innovative approach. Traditional clinical trials package up a product, label it for its destination, and then it sits in a warehouse until it is ultimately distributed. Typically drugs go from packaging and labeling, to the distribution center to the clinic. The clinic then administers the medicine to patients, who may have to return to the site frequently to receive the next dose, undergo tests, or provide information.

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.

Schroeder: It is much more convenient for patients and certainly alleviates a lot of the burdens they traditionally faced. Some patients today travel long distances to go to research hospitals for their clinical studies. Direct-to-patient trials really ease the burden and inconvenience of travel.

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.

Schroeder: Not much changes from a packaging and labeling perspective. The bigger changes are on the distribution side, particularly with biologics that need to be kept in a cold environment. You need to make sure you have a robust model that ensures products are in a cold-chain environment all the way to the patient’s home and that the infrastructure is in place to keep them refrigerated once they reach their destination. Also, patients need to be well-educated in how to use the product.
Schroeder: It will take a fundamental mindset shift for the industry to make sure that at every step they keep the patient’s interests at the highest level. Sometimes that mindset will create inconveniences for the people administering the study or add additional costs in the short-run.

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.

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