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Table 1 Telethon management of criticalities in the conduct of multicentre clinical trials

From: Fondazione Telethon and Unione Italiana Lotta alla Distrofia Muscolare, a successful partnership for neuromuscular healthcare research of value for patients

Critical issues (causes and consequences) Actions taken
Extension of trial duration Administrative management of the grant
* Time lag among centres for Ethics Board approval Start of the study only when all centres are ready
* Difficulties in patients’ enrolment Administrative distinction between start-up/follow up (fixed) costs and “per patient” (variable) costs, with funds on variable costs allocated only to performing centres, based on periodic reports on patient enrolment and follow-up
** Expanded recruitment time and length of the study
** Insufficient statistical power; inclusion of additional centres; protocol amendments; lack of funds
Lack of standardisation of operations Management support to Coordinator
* Uneven execution of functional measurements between centres Clinical monitor support and good clinical practice compliance assessment
* Unequal data quality and poor case report form maintenance Request for stronger coordinator management and training on outcome measures and data collection
* Poor awareness of data protection principles Regular periodic meetings with the study steering committee
** Clinical data provided by the centres not comparable Regular periodic reports to Telethon
** Lack of secure centralised systems for data management Centralised IT platform available for patient registries and standard operating procedures for data sharing
Centres’ over-commitment Rules of the grant applications
* Lack of dedicated personnel Limitation in the number of active studies in which an investigator can participate
* Overlap with routine clinical activities Cross-check of the number of staff full time equivalents reported in the applications
** Inadequate number of professionals to ensure patient follow-up on schedule
  1. In the column “Critical issues”: * Indicates “cause”, ** Indicates “consequence”