నైరూప్య

Centralized management of clinical trial feasibility requests: a single center database analysis from 2008 to 2015

Dorothee Arenz, Timo Siepmann and Oliver A Cornely

Title: Centralized management of clinical trial feasibility requests: a single center database analysis from 2008 to 2015.

Background: Evaluation of new investigational therapies requires collaborative approaches, which include industry sponsors, contract research organizations (CROs), academic research groups as well as hospital-based clinical trial units (CTUs). However, interfaces between stakeholders in clinical research are usually not standardized and lack efficiency. Research institutions are currently building up structures for mutual identification of suitable partners in the execution of clinical trials.

Methods and findings: The Clinical Trials Centre Cologne (CTCC) is a core facility of the University Hospital of Cologne (UHC) interacting with patient-near departmental CTUs, which participate in clinical trials. The CTCC set up a workflow for centralized management of clinical study feasibility requests. We collected and analyzed feasibility data from 2008 to 2015 to evaluate the concept. The CTCC received 938 requests from 83 institutions. Duration of processing of requests was a median six days (0-148). CTCC forwarded requests to 30 discipline-specific CTUs within the UHC. A super additive number of 1,022 assessments were performed due to forwarding to multiple potentially interested CTUs. Feasibility assessments resulted in 542 (53.0%) accepted offers, 403 (39.4%) were declined and 77 (7.5%) were not answered. Offers were declined because not enough patients were expected (125, 31.0%), CTUs conducted a competing study (70, 17.4%), study design was not accepted (56, 13.9%), insufficient resources were available (40, 9.9%), trial was not feasible within clinical routine (8, 2.0%), insufficient information about trial was given (2, 0.5%). For 102 (25.3%) declined offers, no reason was given.

Conclusions: Our data indicate that centralized feasibility management might be an effective interface in collaborative clinical research. Application to national or international networks may avoid redundant processes and enable successful trial acquisition and site selection.