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

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