Drug Companies Adopting Patient-Centricity When Designing Clinical Trial Protocols
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--The healthcare industry is experiencing a shift toward patient-focused care, and clinical trials are no exception.
“If a protocol is focused on making participation as easy as possible for the patient, doctors will feel more comfortable encouraging their patients to enroll.”
Cutting Edge Information published a new study titled, “Clinical Development and Trial Operations: Protocol Design and Cost Per Patient Benchmarks,” which found that protocol design should be centered on the patient, on providing exceptional care and lessening the burden of participating in research. When designing protocols, clinical research teams should put themselves in the patient’s shoes. Teams can identify and address weaknesses by walking through each step of the process and questioning the likelihood of a patient feeling comfortable participating.
Clinical research teams can develop a patient-centric approach by:
• Identifying patient motivation
• Using technology to develop protocol simulations and to foster a sense of community
• Incorporating feedback from doctors
“A majority of patients discover the opportunity for clinical trials from their doctor, so it is important that teams develop a protocol that doctors can rally behind,” said Ryan McGuire, research team leader at Cutting Edge Information. “If a protocol is focused on making participation as easy as possible for the patient, doctors will feel more comfortable encouraging their patients to enroll.”
Patient retention rates offer researchers deeper insight into the protocol, revealing whether or not teams were successful at adapting requirements to suit patients. The study discovered that trials in Phase 2 and beyond regularly encounter a retention rate of roughly 87%. Designing protocols with the idea of maintaining a high level of patient retention will also boost recruitment. A trial that patients are likely to participate in through to the end is almost certainly a trial with a patient-centric protocol.
The study “Clinical Development and Trial Operations: Protocol Design and Cost Per Patient Benchmarks,” (http://www.cuttingedgeinfo.com/research/clinical-development/trial operations/) is designed to help clinical operations groups staff and fund their trial teams using key performance indicators, such as patients per CRA and sites per CRA. As well as create clinical trial protocols that balance scientific needs and patient needs.
Use this report to:
- Make budgeting decisions based on per-patient cost benchmarks.
- Adopt a patient-centric approach to protocol design and patient recruitment/retention.
- Find the right balance between in-house resources and outsourced expertise.
- Develop criteria to select the right vendor/CRO.
For more information about clinical benchmarks, contact Cassie Demeter at 919-403-6583.