Abstract
Purpose: To collect information on the use of integrated protocols in early clinical medicines development. Materials and methods: The questionnaire was mailed in fall 2014 to members of human pharmacology societies in Europe for anonymous responses via the online tool SurveyMonkey®. Results: 97 respondents reported on 164 integrated protocols overall. In general, integrated protocols comprised 2 or 3 trial elements. One third of integrated protocols involved patients. The most frequent trial elements were single dose, multiple dose, and food effect. Drug-drug interaction, age, gender, and relative/absolute bioavailability were less common elements. Ethnic bridging and mass balance were mentioned in single cases. Out of the entire spectrum of reported trial element combinations, single (ascending) dose plus multiple (ascending) dose was most frequent (90/164 protocols, 55%); 84% of integrated protocols used adaptive elements. 29%, 17%, and 8% of integrated protocols required 1, 2, or 3 substantial amendments, respectively. Based on 118 protocols, competent authority approval was granted to 100, deficiency letters were issued 15 times and approval was refused in 3 cases. Conclusion: The use of integrated protocols is common practice in early medicines development. Most often single ascending dose and multiple ascending dose were the trial elements combined in one integrated protocol. Perceived main advantages were gain in time and reduced costs. Perceived main disadvantage was increased complexity.
Highlights
A series of workshops related to early phase clinical development has been hosted by the scientific society “Association forApplied Human Pharmacology” (AGAH e.V.) in Germany since 2012
Most often single ascending dose and multiple ascending dose were the trial elements combined in one integrated protocol
The following definitions were applied: –– Integrated protocol: clinical trial protocol that combines more than one trial element, such as single ascending dose plus food effect or single ascending dose plus multiple dose –– Adaptive elements: the protocol includes elements of flexibility, e.g. dose, sample size, sampling time-points, measurements, overlap of trial elements
Summary
A series of workshops related to early phase clinical development has been hosted by the scientific society “Association for. Applied Human Pharmacology” (AGAH e.V.) in Germany since 2012. In 2014, members from the pharmaceutical industry, contract research organizations, academia, ethics committees, and the German competent authority evaluated the usability of integrated protocols; see http://www.agah.eu/infothek/ workshops/archiv/agah-diskussionsforumzukunftskonzepte-der-fruehen-klinischenpruefung-1.html. A survey was conducted to collect information on the frequency of use and the design features of integrated protocols across European countries. The number of substantial amendments related to these protocols was inquired as well as the perceived advantages/disadvantages
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