Patient Support Services

Case study

Patient Support Services Boost Recruitment in Study for Progressive Supranuclear Palsy: Recruitment Completed Over Three Weeks Early

The Challenge

One sponsor needed to recruit nearly 500 patients for a pivotal registration study in progressive supranuclear palsy (PSP) – a Herculean task given the rarity of the disease; PSP is found in only 9 out of every 100,000 people. To add to the challenge, the protocol was extremely involving for patients and their relatives, requiring numerous assessments at each visit. Indeed, as it was initially conceived, one visit would have required patients to be on site at the clinic for nine consecutive hours. Such demands would be taxing for any patient, but particularly onerous for PSP patients who have issues with balance and vision.

The Solution

In order to cast the patient recruitment “net” as wide as possible, the sponsor ran the study in 90 sites across 15 countries. ICON worked with the sponsor to revise the protocol in ways that would ease the patient burden and to develop a global patient recruitment and support strategy that was adapted to the needs of each country and site.

Each site was offered a menu of patient support services that could be employed as appropriate given that site’s local culture, ethics committee requirements, and patient population. Sites were able to decide which services would work best for their patients.

Among the most popular services were reimbursement of patients’ travel expenses (including for those who failed the screening process), travel logistics support, and home health services such that certain assessments could be performed by a home health nurse rather than in the clinic.

ICON’s Value Add

  • Full menu of patient support services, including patient education and engagement as well as financial, educational, and clinical services
  • Flexibility to adopt services by country and site
  • Coordinated communications across numerous vendors
  • Site consultation and training on patient services
  • Familiarity with country-specific considerations

The Outcomes

The available patient support services varied by country and the uptake differed by sites and patients, creating some operational complexity. However, this flexible approach was well worth it for the results it generated. Roughly, a third of sites (33) elected to use the home health services, which cut the number of site visits by more than half; 8 out of 15 scheduled visits could be performed in the safety and convenience of the patient’s home.

Due to ICON’s flexible strategy and carefully managed, patient-centric approach, recruitment was complete more than three weeks ahead of plan, which saved the sponsor an estimated $700,000 in operating costs.

  • $700k

    in operating costs saved. As recruitment was completed 3 weeks ahead of plan.

“It has been an honor partnering with ICON. Thank you for your commitment to the patients. I truly believe that we will one day bring effective therapies to the PSP community.”

Medical director, Global Biotech Company

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