Protocol & Feasibility Clinical Trial Simulation

Protocol Feasibility & Clinical Trial Simulation

Patient Centricity Starts with Engaging Patients at the Protocol Design Phase

How can UBC help?

UBC is an expert in conducting market research to help sponsors gain insights from patient populations. Using a qualitative research approach, either in-depth interviews or focus groups, sponsors hear feedback on their study design directly from patients. Our moderator probes on potential challenges to study participation – delving into the study assessments, visit schedule, and PROs or other requirements of the patient – giving sponsors insight even before the protocol is finalized.

Why is this important?

UBC’s semi-structured, exploratory approach can reveal unanticipated patient concerns early on, before the study starts. By engaging patients to provide up-front input, sponsors can make decisions about protocol design that will optimize patient enrollment and help to ensure retention over time.

What is UBC’s approach?

UBC customizes the qualitative research design and methodology to meet the sponsor objectives. To start, our moderators develop a rapport with patients. This allows for thoughtful and candid patient feedback on study design and participation. For example, the moderator can probe on informed consent, study procedures, product administration, and other barriers to enrollment and compliance.

How does clinical trial simulation work?

For sponsors seeking a more in-depth understanding of how their study might be conducted at a research site, UBC can bring together medical personnel to act as the principal investigator, study coordinator and patient participants. By simulating key elements of the study design, sponsors can see how the events of the study will unfold in real life. These include everything from Informed Consent to e-diary use, with the research participants going through each step of the process. The trial simulation is followed by in-depth patient interviews to probe on reactions to the study as presented. The sponsor’s core team is able to observe and provide input throughout. UBC has deep experience in iterative qualitative research that allows each simulation and interview to present an improved version of the last based on live team input.

Why work with UBC for protocol feasibility?

UBC has conducted more than 900 in-depth qualitative research interviews for more than 65 studies. We offer sponsors full-service, qualitative and quantitative market research capabilities and have experience conducting this research in more than a dozen therapeutic areas, including oncology, neurology, and rare diseases.

Contact us

Put our protocol and clinical trial simulation experts to work for your next study. Contact us to learn more.

 

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