Patients CAR T-cell Therapy Patient Perspectives

Cancer patients’ lived experiences on their pathway to CAR-T cell trial participation

To gain a deeper understanding of journeys before, during, and after CAR-T therapy for hematological malignancy, we gathered insights and feedback from patients, caregivers and healthcare professionals (HCPs).

Follow our patients on their pathway to CAR-T trial participation.

Literature review

of CAR-T and related clinical trial challenges, internal Parexel presentations

Qualitative HCP in-depth interviews

Hematology/Oncology Clinical Trial Coordinator, Parexel Medical Directors and Parexel Nurse Advisor

Quantitative surveys

patients familiar with or who have received CAR-T therapy for their hematological malignancy

Qualitative patient and caregiver in-depth interviews

patients who have received CAR-T in a clinical trial

Kristina Reeder

Director, Patient Engagement, Head of Patient and Site Insights, Parexel International

Kristina Reeder Director, Patient Engagement, Head of Patient and Site Insights, Parexel International

With over 20 years of experience in clinical research, including patient innovation, decentralized clinical trials, strategy, patient recruitment, retention, site engagement and feasibility, Kristina is dedicated to bringing a thorough understanding of the patient journey and the patient voice to the entire spectrum of research services. She has performed postdoctoral research studies in human behavior and has a BS in Human and Organizational Behavior and Communication Studies. In addition to being a former contributor to diversity and inclusion services, DCT solutions, and member of the DTRA and CISCRP, she is the author of many trade articles and abstracts.

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Our Methodology

Regulatory Strategies

Report Home

YES

Do you have a referral from a HCP?

YES

Start your journey

Are you based near a CAR-T trial site?

Do you meet the inclusion/exclusion criteria within the specified timeframe?

YES

Are you financially able to travel, hire caregivers, and/or be absent from work?

YES

Can you rely on a dedicated caregiver?

YES

Restart Journey

You’re excluded from trial enrollment as you can’t meet the high clinical and personal barriers to entry.

After appropriate HCP referral, patients can often face hurdles in meeting trial participation requirements and provisioning the required financial and personal support.

You’re excluded from trial enrollment as there is a lack of HCP awareness.

CAR-T therapy is still a novel treatment, so referrals can be limited. Trial locations are at prominent academic research centers, restricting access to wider patient populations.

Restart Journey

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Restart Journey

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Restart Journey

You’re excluded from trial enrollment as there are strict inclusion and exclusion criteria.

After appropriate HCP referral, patients can often face hurdles in meeting clinical criteria and/or running out of time while healthy enough to enroll.

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Restart Journey

You’ve met the requirements to enroll in the trial.

Once patients embark on the trial, their experience is as important as the treatment itself. Patients face a range of challenges that can impact overall success.

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After the trial, there are many possible outcomes depending on clinical and patient experience factors. Patients’ journeys are singular, and the factor in common for all cell and gene therapy trial participants is that their pathway to, and following treatment, is unique.

What we learned about the patients’ experiences on their CAR-T treatment pathway...

Patients accessing CART-T therapies usually don’t have other treatment options:

Because many cell and gene therapies are still in their infancy, they are typically studied in people who have exhausted other care options.

The caregiver’s perspective:

"People are too beat down physically by the time they get to CAR-T for the process to work. And we do see there's just better results of people a little bit younger and a little bit healthier and they have a little bit less tumor burden.”

There is a big financial impact on patients accessing cell and gene therapies:

Many treatment regimes involve long inpatient or local stays (including for follow-ups), making it financially restrictive for some patients.

The patient’s perspective:

“The only thing that it's cost me is not being able to work. I've lost income from not being able to work. As far as cost, from what I'm understanding, this is a trial and I have to put no out-of-pocket money for the trial or my insurance does have to pay for this.”

Personal support plans for patients are a must-have:

The testing, preparation, inpatient and follow-up requirements for cell and gene therapy patients is intensive, so a personal support plan is essential.

The HCP perspective:

“We do quite a bit of work in the background to bring the families together and to make them understand what degree of support is needed.”

Site staff are critical support for patients:

Because of the complexities of the patients and the procedures, the ‘user experience’ site staff provide is critical to seamless execution.

The patient’s perspective:

“By explaining it to me, at least I knew what I was in for...if it's explained well, then they're going to understand it. And some people get it explained real well and some don’t.”

Post-trial support is imperative:

Survivors of CAR-T may not know how to adjust to being “cured".

The caregiver perspective:

"A lot of people have been through the ringer, the cancer ringer...then they get through CAR-T and pretty much, they're in remission, so now, they've been a full-time patient for years, so now what? What do you do...how do you return to normality?“

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What we learned about the journey to CAR-T therapy...

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The HCP’s perspective:

“There is socioeconomic disparity between those that can go through CAR-T and those that financially or logistically cannot.”

Socioeconomic factors and complex inclusion/exclusion criteria prevent patient participation:

Complex inclusion/exclusion criteria and a lack of access to resources can preclude potential study participants, especially from underrepresented populations.

The caregiver’s perspective:

"The FDA approves these trials…and the doctor cannot deviate from the protocol. An example I'll give is the bone marrow biopsy. In the three times she had Lymphoma, she never had any positive bone marrow, and because of the protocol she had to get four different bone marrow biopsies...it got to be too much.“

Patients’ diagnostic and treatment journeys are unique:

Diagnostic and treatment journeys leading to consideration of a CAR-T therapy vary significantly from person-to-person.

What we learned about access to, and engagement with CAR-T trials...

The HCP’s perspective:

“Referring physicians can misidentify candidates that are not appropriate and under identify appropriate patients which may explain why the uptake of CAR-T has been so slow and less than gratifying.”

A lack of awareness from HCPs impacts patient referrals:

Cell and gene therapies are still in their infancy, so referring providers may be less familiar with, or less confident in recommending CAR-T due to restrictive location access. This can directly impact patients’ awareness of CAR-T as a care option.

The HCP perspective:

“Scientists tend to create the proposed protocols for patients based on statistical probabilities, powering of numbers, and desired primary and secondary outcomes. Someone else needs to look at it from the patient experience perspective.”

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Download the Executive Summary

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals is doing everything humanly possible to design and deliver clinical trials with patients in mind, increasing access and participation and making every phase of the clinical trial process more efficient. We work With Heart™ every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit us at www.parexel.com.

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Our Methodology

Literature review

of CAR-T and related clinical trial challenges, internal Parexel presentations

Qualitative HCP in-depth interviews

(4): Hematology/Oncology Clinical Trial Coordinator, Parexel Medical Directors and Parexel Nurse Advisor

Quantitative surveys

(104): patients familiar with or who have received CAR-T therapy for their hematological malignancy

Qualitative patient and caregiver in-depth interviews

(5): patients who have received CAR-T in a clinical trial

What we learned about access to, and engagement with CAR-T trials

The Results

A lack of awareness from HCPs impacts patient referrals: Cell and gene therapies are still in their infancy, so referring providers may be less familiar with, or less confident in recommending CAR-T due to restrictive location access. This can directly impact patients’ awareness of CAR-T as a care option.

Referring physicians can misidentify candidates that are not appropriate and under identify appropriate patients which may explain why the uptake of CAR-T has been so slow and less than gratifying.

The HCP’s perspective

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