07.May.2013

The first milestone in phase II trial in breast cancer reached by OCT

OCT has reached the first milestone in data cleaning in phase II trial in breast cancer

March 2012 OCT started a comparative multicenter randomized two arm phase II clinical study to investigate the safety, tolerability and antitumor activity of the investigational drug versus a reference drug in metastatic breast cancer subjects. The aim of the trial was to compare progression-free survival of patients due to the treatment with the investigational drug, as well as to compare overall toxicity and time-to treatment response, with the same indicators values in patients receiving traditional therapy.

19 sites have been opened in Russia and the USA, 153 patients have been enrolled and randomized 4:3. According to the study design, arm-1 patients are treated with the investigational drug, while arm-2 subjects are receiving commercially available therapy. After several treatment cycles, patients from the second arm  crossover to start getting treatment from arm-1, on the assumption of disease progress. 

By now, 25 patients from the second arm have been transferred to the group under the investigational drug treatment, after the traditional drug had turned out to be ineffective. All the data concerning those 25 patients have been collected, cleansed and provided for statistical manipulation, which was commemorated as the first milestone achievement. Our clinical research associates keep collecting data from the rest of the second arm 40 patients. 

With an in-house clinical data management (DM) department, OCT has gained a serious experience in DM services provision. Our skillful team of data managers and programmers has created a DM platform that is CDISC ODM standards-compliant, which guarantees auditable GCP quality results so that our clients can be assured that study data is being managed properly. Our data managers work with both paper-based and web-based CRFs, depending on the sponsor’s requirements. OCT provides the whole range of services connected with data management, including: 

  • CRF design for clinical study
  • Database design and programming
  • Site team, CRAs and sponsor/project team DM trainings
  • Real-time blind and independent double data entry
  • Data cleaning
  • Data coding (using MedDRA, Version 15, and WHO DRUG ATC/DDD dictionaries, or client’s custom dictionary)
  • Automated and manual capabilities for import, export, and interchange of clinical data with other systems  
  • SAE/AE reconciliation
  • SAS programming and validation
  • Statistical reports

OCT is eager to provide the whole range of services for your phase I to IV clinical trials, from initial consulting to data management support and statistical reports provision.