ArticleInternational journal of clinical pharmacology and therapeutics2018
Use of integrated clinical trial protocols - A survey in early medicines development .
Article in International journal of clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Designing integrated early-phase protocols to reduce substantial modifications, including considerations for patient cohorts - a multi-stakeholder consensus view for a practical approach in Germany.Frontiers in pharmacology · 2025Article
- First-in-Human, Healthy Volunteers Integrated Protocol of ETC-206, an Oral Mnk 1/2 Kinase Inhibitor Oncology Drug.Clinical and translational science · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo collect information on the use of integrated protocols in early clinical medicines development. MATERIALS AND
methodsThe questionnaire was mailed in fall 2014 to members of human pharmacology societies in Europe for anonymous responses via the online tool SurveyMonkey
results97 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.
conclusionThe 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. .
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.