IDDI, Biostatistical and eClinical Services for Clinical Trials

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IDDI’s second therapeutic area is ophthalmology

We have partnered with Eyetech and played a major role in the market approval of Macugen, the first compound approved in age-related macular degeneration.

This drug was going to enter a phase II dose-ranging trial in order to determine the dose to use in phase III trial. IDDI proposed to jump ahead and test a dose-effect hypothesis in two pivotal phase III trials, using appropriate statistical methodology to adjust for multiple testing (simulations showed a step-up procedure to be slightly preferable to a closed-test procedure). Although the two trials were far larger than if a single dose study had been conducted, this bold approach resulted in a gain of at least one year of clinical development. The drug has received approval by the FDA (Food and Drug Administration).

  • Since then, we have designed, collected, analyzed and reported on clinical trials in ophthalmology for more than 99 ophthalmic trials to date.
  • Over the last 5 years, IDDI has provided biostatistics and eClinical solutions in 28 ophthalmic trials.

IDDI Expertise

  • IDDI’s team of biostatistics and clinical experts and partners understand the key protocol design and operational considerations in ophthalmic studies.
  • CRF design is essential: we make sure the data needed are collected! Moreover, our Data Managers designing the CRFs for ophthalmology studies have a thorough understanding of the disease.
  • The clinical endpoints are well known by our statisticians in order to perform the analyses in the most efficient manner.

Experience in Ophthalmology ( % of trials over the last 5 years)