ArticleTherapeutic innovation & regulatory science2021
Drivers of Start-Up Delays in Global Randomized Clinical Trials.
Article in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.
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
29 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions.BMJ open · 2024Pooled it
- Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.Contemporary clinical trials · 2023Trial
- Patient engagement in protocol development for rare disease clinical trials: a framework.Research involvement and engagement · 2026Article
- Why MASLD Trials Underselect the MENA Region Sites and What Sponsors and Regulators Must Change.Therapeutic innovation & regulatory science · 2026Article
- Causal inference and digital twins: a roadmap for the future of clinical trials.NPJ digital medicine · 2026Review
- TrialR: critical enablers and the need for reusable Rare Disease Clinical Trial infrastructure in Western Australia.Orphanet journal of rare diseases · 2026Article
- A python's embrace? Insurance and the global clinical trial.Health research policy and systems · 2026Article
- Clinical research in private hospitals: a perspective.Journal of translational medicine · 2026Review
- Evaluating the impact of delayed study startup on accrual in cancer studies.Contemporary clinical trials communications · 2025Article
- Wellbeing for staff in UKCRC-registered Clinical Trials Units: Development of the Flourishing As Clinical Trial Staff (FACTS) guidance: a mixed-methods study.Contemporary clinical trials communications · 2025Article
- Mitigating the impact of study-start delays in clinical trials for rare disorders: insights and lessons from a PKAN trial.Orphanet journal of rare diseases · 2025Article
- Landscape of Post-Marketing Requirements Under the Pediatric Research Equity Act for Antibiotics from 2009-2024.Antibiotics (Basel, Switzerland) · 2025Article
- Protocol-in-a-Day Workshop: Expediting IRB Approval for Junior and Senior Faculty.Journal of cancer education : the official journal of the American Association for Cancer Education · 2025Article
- Work smart, not hard: analysis of delays faced by clinical trials investigating spinal fusion using Protocol AI.Frontiers in surgery · 2025Article
- Accelerating start-up cycles in investigator-initiated multicenter clinical trials.Journal of clinical and translational science · 2025Article
- Flourishing and job satisfaction in employees working in UK clinical trial units: a national cross-sectional survey.BMC health services research · 2024Article
- Defining methods to improve eSource site start-up practices.Contemporary clinical trials communications · 2024Article
- Commentary: The North West London Clinical Trials Alliance: efficiency and innovation in clinical trial delivery.Trials · 2024Article
- What Is Ailing Oncology Clinical Trials? Can We Fix Them?Current oncology (Toronto, Ont.) · 2024Review
- Improving eSource Site Start-Up Practices.Research square · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGlobal, randomized clinical trials are extremely complex. Trial start-up is a critical phase and has many opportunities for delay which adversely impact the study timelines and budget. Understanding factors that contribute to delay may help clinical trial managers and other stakeholders to work more efficiently, hastening patient access to potential new therapies.
methodsWe reviewed the available literature related to start-up of global, Phase III clinical trials and then created a fishbone diagram detailing drivers contributing to start-up delays. The issues identified were used to craft a checklist to assist clinical trial managers in more efficient trial start-up.
resultsWe identified key drivers for start-up delays in the following categories: regulatory, contracts and budgets, insurance, clinical supplies, site identification and selection, site activation, and inefficient processes/pitfalls.
conclusionInitiating global randomized clinical trials is a complex endeavor, and reasons for delay are well documented in the literature. By using a checklist, clinical trial managers may mitigate some delays and get clinical studies initiated as soon as possible.
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.