CLINICAL RESEARCH SCENARIO

Here we represent the current scenario of clinical research activity at Radiology Department of HUVH. Our team is involved in a total of 203 studies, which 135 are clinical trials and 68 are clinical research projects including competitive and non-competitive under collaboration or direct leadership.

Fig 1: Number (n) and percentage (%) of total clinical research activity within the radiology department of HUVH. Research was divided into Clinical Trials (n=135; 67%) and into Clinical Research Projects (n=68; 33%).

Main clinical trial characteristics and topics are:

• Oncology, Hepatology and Pneumology early-phase stages (efficacy, security, dosage)
• Multicentric
• High complexity pathologies 
• Study-specific imaging CT and MR protocols 
• High imaging tracking with centralised reading
• Trial patient enrollment relies on screening imaging results

Main clinical research projects characteristics and topics are:

• New radiological methodologies, biomarkers and clinical guidelines refinement
• Optimization of image processing methods
• Organ segmentation and clinical workflow improvement
• AI-based radiology technology development (syntethic imaging, personalized medicine)
• Big data management and collection, dataset and database development

CLINICAL TRIAL SCENARIO

Non-vascular Interventional Radiology

We observe an increase of 36% in clinical trial activation since CRC implementation. Patients requiring ultrasound-guided interventionisms represents a 47% of all trial patients. Among these, the vast majority of patients, a 94.6% require core-needle biopsy mainly for diagnostic, monitoring disease progression and evaluation of experimental therapies purposes. The remaining 5.4% of patients are related to intratumoral therapy, which involve delivering of experimental drugs (i.e immunocheckpoints inhibitors, oncolytic viruses bacteria and immunomodulators) directly into tumors by US. This type of procedure is increasing on its demands as perfectly shows tumor impact of experimental drugs and its efficacy.

Fig 2: Percentage of trial patients requiring US interventionism among the most demanded procedures in trials: core-needle biopsy and intratumoral delivery of drugs.

CT-guided interventionism represents only a 2% of all trial procedures, showing the limited and specialized use of CT in therapeutic interventions.

Fig 3: Percentage of trial-derived patients at the radiology department of HUVH. Patients were divided into interventionism (US and CT) and diagnostics (US, CT and MR). Most demanded radiologic area is also included in all cases.

Diagnostic Radiology

Diagnostic US is used in 3% of patients comming from clinical trials, mostly requiring multi-organ abdominal US using innovative multiparametric techniques such as elastography and ATI. Diagnostic CT represents a 29% of trial cases, making it the most frequently used diagnostic technique. Multiplanar and high-resolution CT images are crucial for oncology follow-up disease monitoring, for coronary and vascular disorders diagnostic and for interstitial lung disease evaluation, among others. Diagnostic MR-requiring patients accounts for a 19% of total, where most of them come from neuropediatrics, oncology and trauma departments.

CRC ROLES IN A RADIOLOGY DEPARTMENT

During these two years of implementing the clinical research coordinator (CRC) role in radiology, we have identified needs that have been addressed through the figure of the CRC. The CRC’s tasks are primarily associated with two major processes: 1. Study start-up and project initiation, and 2. Study development. The specific functions for each process have been collected and detailed, as explained below and represented in Fig. 4:

Fig 4: Study and project flow tasking representation process in charge of the radiology CRC consist in two main steps: (1) study start-up including proposal wiriting, budget management, ethics committee approval and site qualification, training and initiation, and (2) study development including patient scheduling and imaging test coordination, imaging anonimization and database creation, project management, among other

Start-up Process

• Sponsor communication
• Assist in Site Initiation Visits (SIV)
• Introduction of study-specific imaging protocol into scans
• Phantom test qualification (SQ) with radiographers
• Radiologists’ training in study protocols
• Budget management
• Study protocol design and writing
• Link between radiology staff and ethics committee
• Site Selection visit with medical radiology staff
• Site Initiation Visits with medical staff

Study Development

• Imaging-specific test schedule for trial patients in ultrasound, conventional X-ray, CT, and MR
• Coordinate imaging tests with medical, nursing, and technical staff
• Imaging anonymization, download, and upload process
• US-guided intratumoral therapy coordination: drug handling and data collection
• Patient preparation for radiological tests with nursery and radiographers
• Data entry into eCRF
• Assist in Site Monitoring Visits (SMV)
• Detect and report adverse events (AE/SAE)
• Coordination of technological and innovative radiology clinical projects
• Creation of imaging and clinical-data databases
• Project management and radiologists' assitance on execution 
• Assist in project follow-up meetings
• Budget management