An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.

OBJECTIVES: To investigate the frequency of interim analyses, stopping rules, and data safety and monitoring boards (DSMBs) in protocols of randomized controlled trials (RCTs); to examine these features across different reasons for trial discontinuation; and to identify discrepancies in reporting between protocols and publications. STUDY DESIGN AND SETTING: We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada. RESULTS: Of 894 RCT protocols, 289 prespecified interim analyses (32.3%), 153 stopping rules (17.1%), and 257 DSMBs (28.7%). Overall, 249 of 894 RCTs (27.9%) were prematurely discontinued; mostly due to reasons such as poor recruitment, administrative reasons, or unexpected harm. Forty-six of 249 RCTs (18.4%) were discontinued due to early benefit or futility; of those, 37 (80.4%) were stopped outside a formal interim analysis or stopping rule. Of 515 published RCTs, there were discrepancies between protocols and publications for interim analyses (21.1%), stopping rules (14.4%), and DSMBs (19.6%). CONCLUSION: Two-thirds of RCT protocols did not consider interim analyses, stopping rules, or DSMBs. Most RCTs discontinued for early benefit or futility were stopped without a prespecified mechanism. When assessing trial manuscripts, journals should require access to the protocol.

A New Symptom, 'Palinendophonia', Associated with Pure Verbal Palinacousis Induced by a Right Inferior Temporal Lesion.

We describe the case of a patient with pure verbal palinacousis and perseveration of inner speech after a right inferior temporal lesion. The superior temporal lobe, including the superior temporal sulcus and the interhemispheric connection between the 2 superior temporal lobes, explored by tractography, were preserved. These regions are involved in voice processing, verbal short-term memory and inner speech. It can then be hypothesised that abnormal activity in this network has occurred. Palinacousis and 'palinendophonia', a term proposed for this symptom not previously reported, may be due to common cognitive processes disorders involved in both voice hearing and inner speech.

Association des anciens élèves de l'École polonaise : procès verbal

1865/08/09 (A1).

Association des anciens élèves de l'École polonaise : procès verbal

1874/10/04 (A10).

Association des anciens élèves de l'École polonaise : procès verbal

1877/08/05 (A13,N5).

Association des anciens élèves de l'École polonaise : procès verbal

1868/04/05 (A4).

Association des anciens élèves de l'École polonaise : procès verbal

1868/08/09 (A4).

Association des anciens élèves de l'École polonaise : procès verbal

1875/02/07 (A11).

Association des anciens élèves de l'École polonaise : procès verbal

1873/02/02 (A9).

Procès verbal (Association des anciens élèves de l'École polonaise)

Etat de collection : A. 1 (1865/08/09)-a. 33 (1897/02/07)

Association des anciens élèves de l'École polonaise : procès verbal

1867/04/21 (A3).

Association des anciens élèves de l'École polonaise : procès verbal

1867/08/04 (A3).

Association des anciens élèves de l'École polonaise : procès verbal

1874/02/01 (A10).

Association des anciens élèves de l'École polonaise : procès verbal

1866/08/08 (A2).

Association des anciens élèves de l'École polonaise : procès verbal

1870/02/06 (A6).