Immunology and Rheumatology
PPD’s Experience In the past five years:
Our people, our expertise and our resources are what bolster our distinctive services. Consider PPD’s use of a proprietary database that contains highly detailed data on rheumatology/immunology clinical trials conducted around the world. A special PPD team, dubbed “POTO” for protocol optimization and trial optimization, includes physicians with clinical experience as well as a wide array of experts who have designed and operated numerous clinical trials. The team uses this database to help provide evidence-based recommendations to a customer hoping to conduct a clinical trial.
There are many examples of how POTO helps streamline protocols, including a customer whose clinical trial participants need four years of follow up post-completion of the Phase III trial. PPD was able to demonstrate to the customer how a long extension and frequent assessments of the study population were increasing study complexity and cost and reduce the follow up in half along with timing of assessments. Regulatory agencies readily approved the new protocol, agreeing that this is what should be done.
PPD’s capabilities extend across the full development spectrum including:
Accelerated Enrollment Services (AES) — offers patients and sites that offer just-in-time testing
Evidera — provides real world evidence, optimizes patient access with evidence of value, effectiveness, and safety
“At the end of the day, the customer isn’t really ‘buying’ the company, they are buying a connection to the people who are represented at the table. [People] want partners who are personable, very approachable, who can answer questions in a way that lets them know they understand their needs and can come up with innovative solutions—and that they do all of that with energy and dedication.”
EXCEEDING EXPECTATIONS by Completing Study Ahead of Schedule
Case study: Patients with moderate/severe rheumatoid arthritis: 10 sites activated in real time, 560 subjects screened in five weeks, study completed six weeks ahead of schedule.
Case study: An exceedingly debilitating disorder in which muscle and connective tissue are gradually replaced by bone is known as an “ultra” rare disease — it affects only about 800 people worldwide. No treatment existed for this genetic disease, fibrodysplasia ossificans progressiva (FOP), until PPD successfully managed a Phase III study as part of a process leading to regulatory approval. Despite the scarcity of patients, PPD was able to execute the trial with only 15 sites in 11 countries, instead of the 21 believed necessary. “And we over-enrolled — 107 patients instead of the 80 required – and completed enrollment three months early.” — Annette Schuerman.
Over the past five years, PPD has conducted clinical trials in:
- Rheumatoid arthritis
- Lupus (all types)
- Psoriatic arthritis
- Food hypersensitivity
- Ankylosing spondylitis
- Giant cell arteritis (GCA)
- Juvenile arthritis
- Systemic scleroderma
- Sjögren’s syndrome
- Raynaud’s phenomenon