Overcoming Clinical Trial Design Challenges in a Phase I/II Phase Myelodysplastic syndrome study

Study Description

A phase I/II open-label, multi-center, dose-finding, safety, efficacy study on patients with higher risk myleodisplastic syndrome (MDS) and untreated acute myeloid leukemia (AML) who are ineligible for induction chemotherapy​.

IDDI as the Biometry Partner to Ensure Data Quality

  • IDDI had been selected earlier for the review of previously collected outputs and for the Biostatistics support of the Sponsor’s program including the generation of clinical trial designs, protocols and statistical analysis plan development. In this particularly important phase, the Sponsor benefited from IDDI’s consultants rich experience in oncology, clinical trial design and relationship with regulatory authorities including pre-IND meeting package submission.
  • The Sponsor selected IDDI as the full biometric partner including eClinical tools (EDC & RTSM), data collection, data cleaning and data analysis. It was important to have these tasks executed by one vendor to ensure data quality and coherence with trial design.
  • Sponsor selected another vendor for Clinical and Medical monitoring, ensuring a clear separation of tasks.

Multiple challenges

  • Fast access to all collected data including eCRF, lab data, RTSM, external systems, etc.
  • Complex protocol design and specific data collection requirements combined to ease site burden
  •  Covid-19 implementaton

Results

  • FAST IMPLEMENTATION OF A COMPLEX CLINICAL TRIAL DESIGN THANKS TO INTEGRATED TECHNOLOGY
  • EASY AND PRECISE DETERMINATION OF PHASE II DOSE
  • COORDINATED IDENTIFICATION AND  RESOLUTION OF MISSING DATA DUE TO COVID-19
  • COHERENCE BETWEEN SDTM AND ADaM DATASETS

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CASE STUDY : Overcoming Clinical Trial Design Challenges in a Phase I/II Phase Myelodysplastic syndrome study

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