Trial activation faster under new organization model according to research

Clinical trial activation times can be dramatically reduced if staff have clear responsibilities and are provided with program-specific start-up training according to new research.

The research – published in the journal Trials - is based on an analysis of the impact of reorganization activation training – or “countermeasures “ - on 298 clinical studies carried out at the research and innovation department (DAIRI) of the public hospital of Alessandria in Italy.

Under the reorganization trial staff were tasked with specific responsibilities. For example, staff at the clinical trial center (CTC) was responsible for conducting an assessment of the trial for scientific and economic aspects as well as checking the completeness of the trial dossier provided by the sponsor.

CTC staff were also tasked with sending trial documentation to the secretariat of the Ethic Committee (ECS), which was responsible for including it in the first useful meeting of the Ethic Committee (EC) and producing the minutes of approval. The administrative coordination (AC) team was responsible for negotiating the agreement when required and preparing the authorization act for the conduct of the trial.

And the impact of this demarcation of responsibilities was dramatic.

According to the study average study activation times fell from an average of 218 days to just 56 days at the end of the period under analysis.

“Among the countermeasures taken that led to the reduced timelines was the identification and training of a group of data managers who check the completeness and assess the suitability of documents before the EC meeting, maintaining contact with the sponsor, principal investigator, clinical research organization (CRO), and ECS. This reduced the number of documentation integration requests from the EC, making the ethics approval phase faster,” the authors write.

However, the most effective countermeasure – in terms of its impact on trial start-up times – was to move from a linear process to a parallel approval process.

“According to the current process, the negotiation of the agreement begins in parallel with the evaluation conducted by the CTC, so that once the trial can be forwarded to the EC, the text of the agreement has already been finalized between the AO AL and the promoter.

“In addition, in order to simplify the agreement negotiation phase, the institution decided to adopt the draft agreement issued by the national authority in charge of drug studies (AIFA) and propose its use to sponsors and CROs” the authors say.

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