title: Adherence of non-pharmaceutically sponsored oncology trial protocols to the International Conference on Harmonization (ICH) guidelines in an academic institution outside the ICH jurisdictions and the impact of IRB implementation on this adherence.
abstract: OBJECTIVE
  To assess adherence of non-pharmaceutically sponsored trials (non-PSTs) to ICH protocol structure guidelines and to estimate the effect of implementing Institutional Review Board's (IRB) review on this adherence.
  
  
  METHODS
  This is a retrospective exploratory study where 60 non-PST clinical trial protocols (CTPs) were reviewed and halved to IRB-reviewed CTPs (IRCTPs) and non-IRB-reviewed CTPs (non-IRCTPs). Adherence score (AS) was calculated as the number of fulfilled items or sub-items divided by their total number.
  
  
  RESULTS
  Three adherence patterns were encountered: (1) items consistently present in both groups e.g. general and background information, objectives, inclusion criteria and intervention details, (2) items consistently absent in both groups and included contact information of investigators and trial sites, product accountability, randomization codes' management, interim analyses and many other statistical aspects, and (3) items variably present in both groups where the effect of IRB was verifiable. Trial site details, potential benefits, discontinuation and exclusion criteria, and follow up for adverse events were more encountered in IRCTPs than non-IRCTPs. Withdrawal criteria and monitoring of treatment compliance showed a reverse pattern (p<0.05 for all). The total AS, administrative AS and ethics AS for IRCTPs was 43%, 22% and 70% compared to 38%, 16% and 33% for non-IRCTPs (p<0.003, <0.001, 0.004), respectively. The scientific AS was 54% for both groups (p=0.87).
  
  
  CONCLUSIONS
  IRB-implementation at NCI-Egypt improved ethical and administrative sections of academic protocols. However, this improvement is modest and needs further actions including adoption of protocol templates. Scientific sections were as good after IRB-implementation as they were before that.
authors.affiliation: Department of Medical Oncology, National Cancer Institute, Cairo University, Egypt. azeeneldin@gmail.com
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Zeeneldin
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards* / Q000706:statistics & numerical data; D003226:Congresses as Topic; D019983:Guideline Adherence; D006284:Health Plan Implementation / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000706:statistics & numerical data; D006801:Humans; D007391:International Cooperation; D009369:Neoplasms / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D012955:Societies, Medical; D011795:Surveys and Questionnaires