Executive Summary
Our team at ethica CRO managed a series of investigator-initiated trials (IITs) for a US-based pharmaceuticals company. The main objective of these trials was to demonstrate the efficacy of botulinum toxin (BTX) for a number of off-label indications for aesthetic applications, as BTX was only approved for the treatment of glabellar lines at the time. Another purpose of these IITs was to enhance understanding of the effects and impacts of this drug, such as patient satisfaction, diffusion, duration of action, and social perception, among other factors.
We provided a full range of clinical trial management and data management related activities for approximately 25 IITs. By assembling a dedicated clinical management team, ethica CRO managed to efficiently and effectively manage a large portfolio of IITs.
Essentially, ethica CRO functioned as the Investigators’ Clinical Operations and Biometrics departments by providing full support for clinical development, study management, data management, and biostatistics. In parallel, we ensured compliance with ICH-GCP and HIPAA regulations. Our efforts led to numerous scientific publications that demonstrated the feasibility of BTX for several off-label cosmetic indications, thus providing peer-reviewed manuscripts for pharmaceutical company’s team of Medical Science Liaisons (MSLs).
About the Client
Our client was a US-based pharmaceuticals company that specialized in developing and manufacturing products for medical aesthetics, neurology, eye care, and gastroenterology.
The Challenge
Investigator-initiated trials (IITs) are useful in determining the effectiveness and safety of a drug or device in real-world settings in order to address questions faced by clinicians in their day-to-day practice. However, as IITs are conducted by physicians and/or institutions primarily focused on clinical care, such studies often fail to meet their objectives due to shortcoming related to regulatory compliance, oversight and monitoring, study personnel training, inappropriate statistical techniques, and data management.
Pharmaceutical companies are often conflicted between their desire to finance IIT programs and their concern as to whether their investment will lead to meaningful and viable data regarding their products.
The Solution
ethica CRO simultaneously conducted numerous BTX IITs within a wide variety of aesthetic indications and proof-of-concept pilot studies. These studies also required significant investigator training and organization between sites located across the US, Canada, South America, Australia, New Zealand, UK, and Belgium.
We assembled a dedicated team within ethica CRO to oversee and manage all BTX trials. This group consisted of a project management team, with clinical trial associates, biostatisticians, and data management personnel, all of whom demonstrated a great deal of flexibility and urgency in responding to the fast pace of these projects.
While study Investigators maintained overall responsibility of their studies, ethica CRO essentially functioned as the Investigators’ clinical department by providing full logistical support to assure that all studies progressed in compliance with the study protocol and ICH-GCP.
The Results
ethica CRO proceeded to successfully manage a large portfolio of studies in support of our client’s IIT research initiatives. The completion of this series of IITs resulted in numerous peer reviewed publications, as well as podium and poster presentations that provided unique clinical insights into the use of BTX for several off-label indications. Salient pharmacodynamic information was also developed that highlighted duration of action, diffusion, and tolerability.
Several studies produced such promising and viable data that full clinical research programs following the traditional FDA regulatory approval path were initiated, subsequently leading to labelling changes and lucrative new streams of revenue.
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