Extension Studies
Innovative designs bring efficiency to extension studies
Effective study designs that reduce complexity and cost while managing the burden for patients and physicians.
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Innovative designs bring efficiency to extension studies
Extension studies enable you to enroll patients from a parent clinical trial* and continue monitoring their disease progression, treatment success, and general health, allowing for a full study of long-term benefits and risks. But delivering studies over an extended timeframe poses challenges and can create complexity, often related to the operational aspect of data collection over time.
- Long-term follow-up studies, a type of extension study with longer than normal follow-up periods (e.g., 5+ years) which can add to operational challenges
- Growing demand for long-term follow-up studies that originate from the requirement of cell and gene therapy patients to be followed post-treatment for up to 15 years
IQVIA’s teams bring the expertise required to create innovative study designs that provide maximum value and reduce the burden for the sponsor or other stakeholders.
*In some cases, patients may be enrolled from post-approval use of a therapy
By rolling all operational efforts for multiple long-term follow-up studies into a single program, IQVIA’s teams can help deliver time and cost efficiencies
IQVIA’s understanding of stakeholder motivations allows the design to accommodate a fair level of burden for each. This does not always mean the lowest burden, but the best for the study and reasonable for the stakeholder.
Utilizing new real world data access options from IQVIA can provide operational advantages over more resource-intense site-based approaches
Governance activities centralized within regions streamlines activity and reduces project complexity, but requires deep knowledge of roles and requirements which IQVIA provides.
Long-term follow-up studies can be delivered efficiently with innovation and expertise
IQVIA can partner with you to deliver efficient, effective long-term follow-up studies that reduce complexity and cost while managing the burden for patients and physicians.
Our delivery expertise and innovative capabilities reduce complexity by providing efficient and feasible designs. Careful consideration needs to be given to the needs of each individual study and the operational challenges presented. Our teams are ready to discuss your needs and provide a design that meets yours and your stakeholders’ needs with confidence.