ArticleTherapeutic innovation & regulatory science2026
Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
3 citing papers in PubMed.
- Predictive Safety in the Era of Artificial Intelligence: Promises, Limits, and the Case for an Enterprise Lifecycle Evidence Ecosystem.Drug safety · 2026Review
- The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion.Trials · 2026Article
- Authentic content as an effective mechanism for embedding patient voices in health innovation: a hypothesis and conceptual framework.Frontiers in health services · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Although past research has quantified the proportion and types of procedures that support clinical trial endpoints, little is known about the volume and nature of data collected by these procedures and their impact on participant and site burden. In response, Tufts CSDD and 15 TransCelerate Biopharma sponsor companies convened to update benchmarks and gather new insights into opportunities to optimize clinical trial data collection. In all, 105 multi-therapeutic protocols with a primary completion date after 2018 were analyzed. Data volume by study and by participant were analyzed and procedures were categorized into core, standard and non-core based on the endpoints they supported. Study results show that total data volume continues to grow with 5.9 million datapoints now collected on average per phase III protocol, up 11% annually since 2020. Non-core procedures comprise 17.8% of total phase II and 16.2% of total phase III procedures per protocol, a downward trend from the proportion of non-core procedures observed in 2020. Nearly half (46%) of phase II and 35% of phase III non-core procedures gather data for exploratory and future use purposes. On average, 6.6% and 12.6% of procedures supporting core and standard endpoints from phase II and phase III protocols are deemed non-essential (i.e., procedures determined by the clinical team or protocol authors as being performed in excess of the number of times required to demonstrate a clinical outcome), and their associated data represents 8.2% to 17.1% of the total datapoints collected. Combined, nearly one-third of all procedures and datapoints collected per protocol is classified as non-core or are non-essential procedures supporting core standard/required endpoints with more than half of this data associated with clinical and patient-reported questionnaires. As much as 30% of participant and site burden is associated with non-core procedures or are non-essential procedures supporting core, standard/required endpoints. The implications of these results and potential strategies to simplify protocol designs and lower site and participant burden, including reduction in the volume of data collected by non-core and non-essential procedures, are discussed.
Indexed as
Identifiers
What OpenQuestion holds
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.