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

Patient Pathways

Patient B

  • Does have a referral from a HCP
  • Does not live near a CAR-T trial site
  • Is not financially able to travel, hire caregivers, and/or be absent from work
Patient Outcome

Patient B is excluded from trial enrollment as they 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.

What we learned about the journey to CAR-T therapy

1. 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.

The FDA approves the 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.

The caregiver's perspective

2. 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.

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

The HCP's perspective

 

Our Methodology

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

4 Qualitative HCP in-depth interviews
Hematology/Oncology, Clinical Trial Coordinator, Parexel medical Directors and Parexel Nurse Advisor

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

5 Qualitative patient and caregiver in-depth interviews 
patients who have received CAR-T in a clinical trial 

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Learn more about Parexel's cell and gene therapy research

At Parexel, we deliver innovative trial designs, built on a deep understanding of the patient journey. Our Cell and Gene Therapy Center of Excellence aggregates best practices from across the development lifecycle to help our customers navigate frequently changing regulatory hurdles and accelerate the treatment journey to patients. Parexel supports sponsors to take control of their regulatory path and reduce compliance risks to deliver a faster, smarter route from proof of concept to marketing authorization. 

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