IDDI, Biostatistical and eClinical Services for Clinical Trials

TRIAL DESIGN - RANDOMIZATION - DATA MANAGEMENT - BIOSTATISTICS
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Oncology

IDDI’s core therapeutic expertise is cancer research 

We have been involved in 12 market approvals of anti-cancer therapies.

Over the last five years IDDI has provided Biostatistics and eClinical solutions for 223 oncology clinical trials

  • IDDI’s team of statistical and clinical expert partners understand the key protocol design and operational and regulatory considerations in cancer clinical studies.

  • CRF design is essential: we make sure the data needed are there every time! Moreover, our Data Managers designing the CRFs for oncology studies have a thorough understanding of the disease area and its complexity: RECIST, specific data points, external data like biology/imaging. They are able to perform medical review where needed .

  • IDDI expertise lies in the right choice of endpoints, adequate definition of selection criteria, sensible use of assessment exams, state-of-the-art statistical planning, analysis and modeling  (tailored to oncology drug development needs). IDDI has all the technical solutions needed for effective long-term follow-up for survival data and a profound understanding of the regulatory intricacies of cancer drugs, from trial design to medical writing (protocol, CRF, CSR and manuscripts) which highlights just a few of IDDI’s assets in successful cancer data collection, analysis and reporting of trials.

 IDDI’s Notable Achievements in Oncology clinical trials:

  • Design and analysis of practice-changing clinical trials in oncology (e.g. Tournigand et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer. A randomized GERCOR study. J Clin Oncol 22: 229-237, 2004, > 1,750 citations)

  • Molecular profiling in oncology (Sotiriou et al. Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis. J Natl Cancer Instit 98: 262‑272, 2006, > 850 citations)

  • Independent validation of gene signatures in oncology (Buyse et al. Validation and clinical utility of a 70-gene prognostic signature for patients with node-negative breast cancer. J Natl Cancer Instit 98: 1183-1192, 2006, > 600 citations)

  • A Bayesian design for a seamless transition between Phase II and III. Data collected by a sponsor suggested a possibility of a differential treatment in subpopulations defined by levels of a biomarker. A Bayesian design has been developed, which allows the sponsor to conduct a randomized Phase II trial to corroborate the finding and to seamlessly continue to Phase III in the subpopulation, which benefits from the treatment. The design was consulted and accepted by FDA. 

 

Experience in Cancer Research Studies by Tumor Types (of trials over the last 5 years)

 

 Read IDDI White Paper : Challenging in Implementing Cancer Clinical Trials