The registration of clinical investigations and their results in public databases is one of the key requirements of the new version of the ISO14155, and a widespread requirement in international and federal regulations, such as the FDA and the MDR.
In today’s video I will briefly answer the following question:
“Why is the registration of clinical investigations in a public database so important?”
Registration is important:
- For manufacturers, because it enables them to bring fast innovations to patients in need.
- For patients, because the results obtained from clinical investigations may affect their treatment options.
- For clinicians and the research community, because it can demonstrate that ethical obligations towards participants and the research community have been fulfilled, and that publication and outcome reporting biases are absent.
- For research funds, because it can promote a more efficient allocation of their funding.
- And finally, registration is important for Institutional Review Boards (IRBs) and Ethics Committees (ECs), because it helps them determine the suitability of the clinical investigation.
With the upcoming CTIS portal (drug studies) and EUDAMED portal (medical device studies), the spread of publicly accessible results obtained from clinical investigations will be enhanced.