Requirements and complexity: interprofessional cooperation within a prospective multicenter clinical trial using [⁶⁸Ga]Ga-PSMA-11 - The German Cancer Consortium (DKTK) experience

Aim/Introduction:

Prospective clinical trials are initiated within the field of nuclear medicine to translate the most promising radioligands into clinical routine [1]. A close cooperation and communication between experts from different fields is necessary for the efficiency and efficacy of the clinical trial which can then have a positive impact on the timely start of recruitment and subsequent patient inclusions [2].
Materials and Methods:
Given the exemplary phase 1/2 multi-center clinical trial ,,Ga-68-PSMA-11 in high-risk Prostate Cancer“ (NCT03362359) [3], we demonstrate how professions from clinical research, drug manufacturing and administration can be involved in the planning, preparation and realisation of prospective clinical trials in nuclear medicine. Organisational measures are derived to support the interprofessional cooperation within diagnostic prospective multicenter clinical trials.
Results:
Besides nuclear medicine physicians, urologists and pathologists, other professions like technicians and technologists (nuclear medicine, biology, chemistry), study nurses, radiochemists/-pharmacists and nursing staff are involved in the clinical setting. In addition, radiation safety officers, quality manager, clinical monitors, lawyers, data protection officers, project managers and study coordinators are embedded in the setting of in total eleven study sites in Germany, Austria and Switzerland.
Conclusion:
Interprofessional cooperation is of great importance for high-quality work in health care and re-search in general, as well as the accomplishment of prospective clinical trials in nuclear medicine in particular. Readiness to put oneself in the position of other professions, cooperation under no professional constraints, adequate time for mutual exchange, the ability and skills for interprofessional project management and an integral view on the required expertise by strengthening overall communication skills are required in particular on senior management level.
References:
1. Zippel C, Ronski SC, Bohnet-Joschko S, Giesel FL, Kopka K. Current Status of PSMA-Radiotracers for Prostate Cancer: Data Analysis of Prospective Trials Listed on ClinicalTrials.gov. Pharmaceuticals (Basel, Switzerland). 2020;13.doi:10.3390/ph13010012.
2. Reeves S, Pelone F, Harrison R, Goldman J, Zwarenstein M. Interprofessional collaboration to improve professional practice and healthcare outcomes. The Cochrane database of systematic reviews. 2017;6:Cd000072. doi:10.1002/14651858.CD000072.pub3.
3. Neels O, Zippel C, Giesel F, Kopka K. Initiation Of A Prospective Clinical Multicentre Trial With Local Production Of A Short-Lived PSMA-PET-Radiopharmaceutical In The D-A-CH-Region: Chances And Experiences. Annual Congress of the European Association of Nuclear Medicine October 12 - 16, 2019. 2019;46:S732. doi:10.1007/s00259-019-04486-2.