Investigator Initiated Trials (IIT)
Investigator-initiated trials (IIT) are unique in that the clinician is both sponsor and investigator.
Carefully planned and executed IIT strategies provide quick proof-of-concept data and accelerate drug and device development. IITs provide expanded product knowledge regarding safety and efficacy. New ways of using approved therapeutic products are often identified by physicians, resulting in improved treatment outcomes for patients.
Advantages of IITs versus industry-sponsored studies:
Faster identification of new applications and indications by experienced clinicians
Access to independent publishable product efficacy and safety data
Minimal to no internal resources required for study management
Capitalize on ethica CRO’s experience to develop your next IIT
IITs provide numerous benefits but beware of risks if:
Avoid the pitfalls but maintain control and oversight of your IIT. Entrust regulatory submissions, logistics setup and maintenance, data management, and biostatistical support to ethica.
ethica’s Approach to Managing Rigorous IITs
ethica CRO provides reliable, customized support for IITs. Investigators can count on ethica to develop ICH-GCP-compliant study protocols. Services are delivered without ever jeopardizing Investigator independence or OIG compliance. Trust ethica for a satisfying and rewarding experience.
ethica CRO provides a full range of clinical study management services tailored to meet the logistical demands of your IIT:
- Essential documentation development
- CRF development
- Database development
- Participant enrolment strategies
- Regulatory submissions
Study maintenance activities
- Remote and on-site monitoring
- eTMF maintenance
- Safety reporting
- Data management
- Statistical analysis
Study closure activities
- Data resolution and reconciliation
- Product and samples accountability
- Study reporting
- Manuscript review
ethica CRO’s IIT Experience
ethica has completed more than 70 IITs, studying drugs and devices in numerous indications. Through its national and international research standards compliant quality systems, multilingual team, and network of international experts, ethica’s IIT experience spans four continents.
Case Study – How ethica CRO managed a rigorous multinational IIT program to expand knowledge of BTX for aesthetic applications
A US-based pharmaceuticals company contracted with ethica CRO to manage a series of IITs. The main objective of these trials was to demonstrate scientifically the efficacy of botulinum toxin (BTX) for a number of off-label indications for aesthetic applications. Another objective was to better understand the impact of treatment on patient-reported outcomes regarding personal satisfaction, quality of life, and social perception. This research would support increasing the number of approved uses for BTX.
ethica CRO provided a full range of clinical and data management services for more than 20 BTX IITs and assisted Investigators located across the US, Canada, Brazil, Argentina, Australia, New Zealand, UK, and Belgium. ethica’s dedicated clinical project managers, clinical trial associates, biostatisticians, and data management personnel functioned as the investigator’s clinical operations and biometrics team. These professionals ensured regulatory compliance and provided full support for study conduct, clinical development, study management, data management, and biostatistics.
ethica’s hard work resulted in numerous scientific publications that expanded on BTX’s dosage, diffusion, and duration of action. The studies provided insight on the meaningful impact of BTX on patients’ quality of life (QOL), demonstrating the feasibility of BTX for several new aesthetic indications. This led to a series of scientific presentations at dermatology symposia, and peer-reviewed manuscripts that supported the client’s team of Medical Science Liaisons (MSLs) in providing truthful, accurate, balanced, non-misleading, and non-promotional scientific and medical information about BTX.