Q&A

Innovations For The Evolving Patient-Centric Clinical Trials Description

Source: Catalent
Innovations For The Evolving Patient-Centric Clinical Trials Description

Patient centricity is far more than a buzzword in the pharmaceutical industry. Patient-centric options are also extending to clinical trial design, with sponsors considering how clinical trial materials can be formulated, packaged, and delivered in a manner that is both efficacious, stable, and convenient for patients, clinicians, and caretakers alike.

A Q&A on this issue with Matt Blume, general manager, Catalent.

Patient centricity is an area of growing interest for clinical study sponsors, but what exactly is it?

Blume: I like to define it in two ways.  The first, more “text book definition” of patient centricity is health care that establishes a partnership between patients, practitioners, and families to ensure decisions about treatments respect the patient’s wants, needs, and preferences. Patients also have the support they need to make informed decisions about their own healthcare.

The second and more personal definition is, truly understanding the expectations that patients have for their treatments. This involves listening to their concerns and understanding what makes the course of treatment easier for the patients.  A lot of times, health care providers consult, show, and tell; they don’t always listen to ensure everything works for the patient. We really need to get that feedback and use that information to drive clinical trials.

Clinical studies have been conducted for decades, so why is the focus now shifting to patients?

Blume: I attribute a lot of this change to patients’ increased access to information. Over the internet, they can access forums with information about their condition and learn about treatment options that are working for other patients. There are several advocacy groups today that provide patient information and opportunities for patients to connect. Patients are becoming more and more involved in their own treatment decisions, and are asking their physicians and clinicians more questions.

This strong involvement of patients in their treatment options is starting to trickle upstream. And in response, clinical trial sponsors are asking, “What can we do to make the entire experience—trial and treatment—better for patients?”

Have you asked patients what they think about trials, and are they interested in giving feedback?

Blume: Yes. We were part of a focus group in July 2016 with 25 patients, and they were very interested in sharing their clinical trial experiences with us. The fundamentals of clinical trials are very routine and consistent for practitioners and clinical trial sponsors. But patients experiencing it for the first time may not always understand common protocols like blinding, placebos, product packaging, and the likes. When barriers make it hard for patients to take their medicine, they don’t hesitate to provide feedback. And, we as an industry need to listen.

Clinical trial participants typically display a high level of compliance since for many of them, the study represents their last chance to receive potentially life-changing treatment. Given this intrinsic motivation, why does patient centricity matter?

Blume: Patient centricity is not just about compliance. It’s also about convenience, simplification, and understanding.

For instance, some formulations for clinical trials don’t have a lot of stability yet, so they may arrive at clinical sites in very large blister wallets with doses that a patient must take three times a day for a month. When the patient needs to leave the house, and take the medication with him or her, that size could pose a problem. So, we not only need to think about the formulation, but also how patients are going to receive, transport, and even store it. 

One issue that came out of the July 2016 focus group was that some patients may even have trouble fitting large cartons of clinical trials materials in their refrigerators at home. Issues such as this one are really about the patient’s convenience as well as compliance.

Technology can also play a role in creating patient-centric solutions. People have busy lives. If patients were to use a smart phone app or dosing reminder message, it could really help someone who wants to be compliant remember to take their medication.  It’s a simple solution that supports convenience and compliance.

Like others in the industry, Catalent is also looking at the possibility of direct-to-patient delivery of clinical trial materials, which is a growing part of the clinical trials landscape. Such a service could absolutely help with clinical trial compliance, especially for home-bound patients or those who lack transportation.

What are some other examples of patient-centric changes or new solutions that have been introduced?

Blume: Years ago, when we started planning for clinical trials with the sponsors, we focused on things like product shipping. Today, we are shifting to thinking about how the medicine is going to be used, how sponsors are going to get product to the patient, how patients are going to use it, and how will they store it. These conversations are driving the way we provide materials today.

In addition, feedback groups, e-labels, and smart packages with dispensing information all help improve the patient’s experience with regard to materials and packaging.

Can innovations not used directly by patients be introduced “behind the scenes” that support a patient-centric approach?

Blume: Yes; some innovations support clinicians that are currently interacting with patients by developing ways to simplify the dispensing, handling, and storage of clinical trials materials. All of these areas ultimately benefit the patient. For instance, we’ve been applying a labeling technology, Peel-IDTM where part of the label will peel off and contain some of the medicine kit’s identification numbers. This makes it easier for the clinicians to identify which kit goes to which patient.

We are also thinking about how materials will be received, which can have a big effect on clinical sites. For instance, about five years ago, we sent a clinical site relatively large packages—60–70 pounds—fully loaded with refrigerated trial materials. While the materials arrived on time, some of the initial sites receiving materials provided the feedback that it was difficult to unload, unpack, and dispose of the packaging. To address this issue, we arranged for a specialty courier to help unpack and remove the boxes for later shipments.

We believe it’s very important for clinicians to have a positive experience with the trial as well.                                                                                         

What other stakeholders should be considered when designing patient-centric solutions?

Blume: When you look across the clinical trial landscape, you have the clinical trial sponsors, vendors, clinical staff, and the patients. Understanding how they tie together is key. Everyone is responsible for a different piece of the clinical trial puzzle. Very often, everyone focuses on their own part and may not understand everyone else’s pieces. The more we can get the communication between the pieces, the more it will help the clinical trial overall.

There’s also a hidden stakeholder to keep in mind: the surrogate that works between the patient and the clinician. This person might be a family member who often steps in to coordinate the patient’s care and provide encouragement. Anything we can do to create peace of mind for him or her is important.

For instance, we’re working on a clinical trials delivery service that ties closely to when patients have a need for medication. It can be extremely stressful for families if a dose were to be missed, which is especially the case for life-threatening diseases like cancer. Easing that concern is extremely important. Advocates can go a long way to ensuring a patient continues in a trial, and we want to be sure they have a positive experience as well.