How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum
| Autor: | Hildegard Sourgens, Katharina Erb-Zohar, Gerd Mikus, Frank Donath, Kerstin Breithaupt-Groegler, Stephanie Plassmann, Jens Rengelshausen, Georg Wensing, Timothy C. Hardman |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Research Subjects
media_common.quotation_subject Pharmacy 030204 cardiovascular system & hematology 03 medical and health sciences Presentation 0302 clinical medicine Investigator’s brochure Surveys and Questionnaires Humans Pharmacology (medical) 030212 general & internal medicine Pharmacology Toxicology and Pharmaceutics (miscellaneous) media_common Original Research Risk assessment Medical education Investigator's brochure business.industry Public Health Environmental and Occupational Health First in human Investigational medicinal product Readability Clinical trial Research Design First-in-human Pamphlets Psychology business |
| Zdroj: | Therapeutic Innovation & Regulatory Science |
| ISSN: | 2168-4804 2168-4790 |
| Popis: | Purpose A discussion forum was hosted by the Association for Applied Human Pharmacology (AGAH e.V.) to critically debate how to interpret and optimise the Investigator’s Brochure (IB) for meaningful risk assessment of early clinical trials. Materials and Methods Four topics were specifically discussed: deficiencies/uncertainties in IBs, guidance for the investigator, reference safety information, and potential risks for human subjects associated with inadequate non-clinical safety assessment in the IB. In each case, 43 participants took part in a real-time online survey with pre-defined questions to capture the audience’s opinion. Results The ‘Summary of Data and Guidance for the Investigator’ was considered as the section of the IB with the highest need for improvement with emphasis on readability, comprehensibility, timeliness of data, and appropriateness for risk assessment. It was suggested that the IB should at least be signed by the sponsor’s scientist responsible for the content on pharmacology and toxicology. It was agreed that sponsors should consider thoroughly whether changes to an IB constitute a substantial amendment, and that the IB should include a section on the change history. Non-clinical pharmacology studies with negative outcomes should be reported in the IB in order to avoid assessment bias. The reference safety information for expectedness assessment of suspected serious adverse reactions should be provided as a stand-alone section of the IB. Conclusion The overall consensus was that an optimised presentation of data will ensure the best possible understanding of a compound’s characteristics and an optimal benefit-risk assessment which will safeguard the participants in clinical trials. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink