Patient-Centric Strategies for Successful Oncology Trials

Why the patient experience is a critical consideration

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset.

Enrollment and retention issues are all too common in complex oncology trials, and they can result in delays. Therefore, sponsors must take patient needs into consideration as early in the process as possible. Many of these patients’ conditions are disabling. Patient empathy is critical to creating an effective trial that maximizes enrollment and retention. Ultimately, a smooth trial process paves the way for the development of promising therapies that will continue to help more patients. In this blog we highlight three key considerations — increased patient access, reduced patient burden and managing logistical complexity — that center patients in complex oncology trials.

Increasing patient access

Complex oncology trials often take place in academic centers, as these areas have the resources and expertise needed to facilitate success. However, many patients do not live near these centers, which can make participation difficult. As a result, some patients are unable to participate in trials, which can lead to sponsors having difficulties meeting patient recruitment and diversity goals.

Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants. Some remedies include:

• Training and qualifying non-traditional, research-experienced sites — including community sites
• Increasing the collaboration between academic sites and community sites
• Alleviating the day-to-day barriers that patients face when accessing trials, like transportation and time away from work
• Implementing decentralized trial elements, including home health visits, wearables and more

Limited health literacy is one of the major factors that prevents patients from participating in trials, particularly for underserved and marginalized communities. Sponsors must have a deep knowledge of these issues and have insights into the everyday challenges a sick patient may experience. Building strong relationships with patient advocacy groups is a dependable path to gain that knowledge. These groups are valuable resources in increasing drug developers’ knowledge of what patients go through with their symptoms, and they often support the effort to increase health literacy and patient comfort with the clinical trial process.

Reducing patient burden

Oncology trials are often unique in their complexity due to rigorous regulatory and payor requirements. Oncology drug development lasts, on average, four years longer than most other drug development trials due to complex protocols and large study footprints. Researchers often employ cell therapy studies for oncology indications, and the U.S. Food and Drug Administration advises long-term follow-up studies for an additional 15 years after the end of these trials to monitor for any delayed adverse events. This places significantly more burden onto the participating patients. Some common challenges that patients face in oncology trial participation include:

• Being subjected to many blood samples and preparatory medical procedures
• Long and complex consent forms, presented to patients in early phases
• Frequent appointments and assessments conflicting with abilities, family and work responsibilities

Building a trial that is approachable for patients requires drug developers to build teams that are patient-centric. Understanding common patient struggles allows sponsors to know what requirements are feasible and where patients may need additional resources to participate. Everyone involved, from clinicians to biostatisticians, needs to keep the patient in mind, adding empathy to the patient experience wherever possible. This mindset ensures the implementation of solutions that facilitate the reduction of patient burden.

Digital and decentralized trial elements are effective tools in reducing potential strain on patients. A seasoned provider of contract research organization (CRO) solutions will infuse hybrid and decentralized solutions into studies, with experts that provide the breadth and depth of experience required to deploy mobile sites, wearables and more. They are also able to make common hurdles, like extensive consent forms, more approachable for patients. Collectively, this results in trial participation being more viable and less cumbersome for patients.

Balancing complex logistics with patient needs

In a survey of drug developers, patient recruitment emerged as their foremost concern, closely followed by trial complexity. These two issues are often intertwined, and both are prevalent in complex oncology clinical trials. Cell therapy trials are a good example of how complex oncology studies can be. There is a lot of competition in this area of drug development, and the regulatory landscape is increasingly dynamic. Supply chains and time constraints in cell therapy trials are especially intricate due to the use of live cells. Regulators and payors also demand a higher volume of data collection for these studies.

These intricacies affect both the drug developer and the patients participating in the trial. Patients are often required to undergo many assessments and tests because of frequent data collection. Due to complex logistics, it may be necessary to schedule a patient’s appointment at a specific time to ensure that the cells are not compromised by extended periods outside the freezer. These kinds of logistical needs may increase pressure on patients and result in patient retention challenges.

Certain approaches, like next-generation sequencing (NGS), enable the balance between centering the patient and needing copious amounts of data. Sponsors use NGS to find the patients needed for a trial without using as much of the patients’ time. They also use it to determine biomarkers that predict patient response, making it easier to prevent and manage toxicities associated with oncology therapies. This allows sponsors to facilitate better patient outcomes more quickly.

Data-driven and innovative approaches are necessary to prevent enrollment-related delays in early phase cell and gene therapy (CGT) trials. When sponsors focus on what data is necessary and plausible for patients, they can appropriately balance their needs with data requirements. Clear communication throughout the process further empowers patients to make informed decisions about their own care.

A partner in patient centricity

To set up complex oncology trials (like CGTs) for success, it is essential to collaborate with a team that has the necessary expertise. A seasoned provider of CRO services uses prior knowledge to narrow down the data necessary to collect, reducing patient burden. Making data-driven recommendations about logistics also frequently lowers sponsor operating costs. When a qualified CRO partner manages the administrative burden, it clears the way for an optimal patient experience.

The PPD™ clinical research business of Thermo Fisher Scientific’s expert teams have conducted over 160 immuno-oncology studies, more than 137 CGT studies and 263 early phase oncology studies, covering a wide range of tumor types and therapies. Our Cell and Gene Therapy Centers of Excellence have the experience necessary to provide end-to-end services and consistency to the oncology drug development process. Thermo Fisher Scientific’s Oncomine™ Solutions can return next-generation sequencing results in as little as 24 hours to streamline logistics and speed up the enrollment process. As a leader in early phase development oncology trials, we are dedicated to using our vast experience to enhance the patient experience and successfully bring new therapies to market.