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Leading Non-Interventional Post- Authorisation Safety Studies to Success



The term non-interventional study (NIS) includes observational studies or registries that are initiated by the sponsor. One subset of NIS, which is frequently required by regulatory authorities, is a non-interentional post-authorisation safety study (NI-PASS). NI-PASS comes with its own specific set of challenges, which sites – and sponsors – sometimes tend to underestimate. All parties should be aware that the safety element increases the demands for data quality, completeness, and keeping records up to date. False expectations can reduce motivation on the part of study teams, potentially endangering the success of the whole NI-PASS.

NIS vs Clinical Trials: The Site Perspective

By definition, an NIS is constrained by the limits of standard medical practice. The whole patient care setting must be in accordance with the label, and broadly reflect real-world conditions. Sites involved in an NIS, therefore, do not have to address issues, such as randomisation or study medication logistics. Similarly, the observational plan of an NIS must not ask for extra patient visits or assessments that would not be part of routine treatment. The main effort involved in an NIS is the informed consent briefing at the start and completing the electronic case report form (eCRF) after each consultation. For the sites involved, an NIS generally means significantly less work than a clinical trial.

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About the Authors

Lars Behrend, PhD, is currently Chief Operating Officer at SSS International Clinical Research. He studied Biology in Hamburg, and after receiving his PhD in Molecular Oncology in 2001, Lars worked another four years in the oncology field at the Interdisciplinary Center for Clinical Research in Ulm, Germany. He has published various articles in peer-reviewed journals. After leaving university, Lars started two venture capital-financed companies and a consulting firm in the life science and clean technology field. In 2017, he joined the management board of SSS. Lars' main focus is in strategic positioning and commercialisation of products and services.
 

lars.behrend@cro-sss.com
 


Michael Sigmund, DVM, is Chief Executive Officer of SSS International Clinical Research, which provides CRO services to the pharma and biotech industries. Michael has more than 30 years of experience in the field of clinical research. After studying Veterinary Medicine, he conducted research in the field of virology and received his DVM in 1988 from the University of Munich, Germany. He then joined the pharmaceutical industry and held several positions within biotech and CROs. Michael has ample experience in setting up and running clinical trials. His main interest lies in streamlining information concerning clinical trials to allow easy and effective access to relevant status information for all parties involved. Michael helped significantly to develop SSS’s professional web-based CTMS called accSIS.

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