EqualClinic I Pharma Solutions I QA Package I Center Validation I Patient Validation I Data Collection
  EqualEstro - Pharma Solutions  
  How can you ensure  
  • Patient safety? Differences in treatments will effect survival, relapse rates and morbidity.
  • Detection of drug effect? The variability in radiation therapy can drown out the signal from the drug.
  • Minimal costs? Increasing patient populations to achieve sufficient power to compensate for this variability increases the cost of the trial.
  • Credibility of the results? Regulatory bodies are focusing more today on the quality and comparability of the radiation therapy provided in clinical trials.
  Hazard of protocol deviation  
  The graph demonstrates the differences in loco-regional control for patients included in the HeadSTART trial. These patients with advanced head & neck cancer were treated with chemo-radiation therapy with or without the test drug. A retrospective analysis showed that in 11% of the cases there was a deviation from the radiotherapy protocol leading to adverse impact on tumour control. This leads to a 20% loss of loco-regional control for these patients after one year compared to patients who received radiotherapy according to protocol.  
  * Rischin D, Peters L, O’Sullivan B, Giralt J, Yuen K, Trotti A, Bernier J, Bourhis J, Henke M, Fisher R, Trans-Tasman Radiation Oncology Group. Phase III study of tirapazamine, cisplatin and radiation versus cisplatin and radiation for advanced squamous cell carcinoma of the head and neck. J Clin Oncol (Meeting Abstracts) 2008 26: LBA6008.