title: Predictive value of clinical judgment of tumour progression in phase II trials.
abstract: BACKGROUND
  The diagnosis of tumour progression or progressive disease (PD) is a key element for designing and interpreting contemporary phase II trials. In some cases, PD is stated by the physician and is not formally confirmed by imaging.
  
  
  OBJECTIVE
  In this study, we intend to analyze the value of the PD based on clinical judgment and the risk of overestimating the occurrence of PD by clinical judgment.
  
  
  METHODS
  We have conducted a single-centre retrospective study to analyse the diagnostic accuracy of this clinical judgment compared to planned imaging including all patients enrolled in our institution in phase II trials investigating systemic treatments for advanced solid tumours between January 2008 and November 2010.
  
  
  RESULTS
  The positive predictive value (PPV) and the specificity of clinical judgment of PD was very high (>90%).
  
  
  CONCLUSIONS
  According to this study, the clinical judgment of PD is highly predictive of radiological PD as assessed, for example, by RECIST. Physicians do not overestimate PD occurence. Clinical judgment of PD could be taken into account in the definition of PD.
authors.affiliation: Centre Oscar Lambret, Lille, France.
authors.forename: Nuria
authors.initials: N
authors.lastname: Kotecki
authors.forename: Nicolas
authors.initials: N
authors.lastname: Penel
authors.forename: Antoine
authors.initials: A
authors.lastname: Adenis
authors.forename: Charles
authors.initials: C
authors.lastname: Ferte
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Clisant
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007600:Judgment; D053208:Kaplan-Meier Estimate; D008297:Male; D009369:Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D016896:Treatment Outcome