CTEP's Head of Operations Tomas O'Mahoney presented at the 2015 annual ACDM (Association of Clinical Data Management) Conference on the topic of non-interventional studies.
Tomas presented his topic "Making BIG DATA smaller... Non intervention (NI) studies - 7 simple rules to better data management and 4+1 for improved pharmacovigilance in NI studies" at the industry-leading conference.
A brief introduction to Tomas' talk:
'Non-interventional studies (NIS) are an essential part of the clinical development program. The term non-interventional studies include post-marketing surveillance studies (PMS), as well as disease or drug registries, observational studies and post authorization safety studies (PASS) that can be imposed by competent authorities. Eighteen percent of the clinical studies registered on clinicaltrial.gov site are observational studies.
Similar project tasks are performed in clinical trials and NI studies (e.g. protocol writing, EC applications, eCRF creation and data management) and often the thinking amongst pharmaceutical companies and CROs is that therefore we can follow the same processes and standard operating procedures. In this environment and with the number of NIS on the rise, there is a need to seek efficiencies in the processes and procedures. But is the application of procedures developed for earlier phase studies adding inefficiencies? At the European CRO Federation (EUCROF), we know, from shared experience, that running NI studies along the same processes can lead to inefficiencies and cost for both the clinical investigator teams and our staff. In this article we are going to highlight how following inappropriate processes can have a negative impact on the study progress. We will also provide some guidance as to how this situation could be avoided.
- Late phase studies do not benefit from early phase methods
- Large scale studies demand a different approach
- There is under reporting of serious ADRs in late phase studies, can this situation be improved.'