ArticlePerspectives in clinical research
Investigator-initiated studies: Challenges and solutions.
Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 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
29 citing papers in PubMed.
- Investigator-Initiated Trials as a Clinical Development Approach for Orphan Drugs Compared with Industry-Sponsored Trials in Japan.Therapeutic innovation & regulatory science · 2026Article
- Stakeholder perception of quality management of investigator-initiated clinical trials.BMC medical ethics · 2025Article
- The laboratory billing process and its applications to molecular microbiology testing: guidance for laboratorians.Journal of clinical microbiology · 2025Review
- Collaborative Funding Model to Improve Quality of Care for Metastatic Breast Cancer in Europe.Current oncology (Toronto, Ont.) · 2025Article
- Article
- Enhancing pragmatic competence in investigator-initiated clinical trials: structure and evaluation of the CONSCIOUS II training programme.BMC medical education · 2025Article
- Development, Review, and Activation of Thoracic Oncology Investigator-Initiated Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- Repurposed Medicines: A Scan of the Non-commercial Clinical Research Landscape.Pharmacology research & perspectives · 2025Article
- The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group.Cancer research and treatment · 2025Article
- A qualitative study on the management system for investigator-initiated studies in healthcare institutions in Beijing, China.Health research policy and systems · 2024Article
- Academic vs. industry-sponsored trials: A global survey on differences, similarities, and future improvements.Journal of global health · 2024Article
- Article
- The landscape of investigator-initiated oncology trials conducted in mainland China during the past decade (2010-2019).Cancer innovation · 2023Review
- Current Scenario of Clinical Cancer Research in Latin America and the Caribbean.Current oncology (Toronto, Ont.) · 2023Review
- The Invisible Hand of Industry.Clinical obstetrics and gynecology · 2022Article
- Panoramic quality assessment tool for investigator initiated trials.Frontiers in public health · 2022Article
- Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion: Study Protocol for a Prospective, Open Label, Single-Center Study With 12 Months of Follow-Up.Frontiers in neurology · 2022Article
- Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes.Therapeutic innovation & regulatory science · 2021Article
- Practices and Attitudes of Swiss Stakeholders Regarding Investigator-Initiated Clinical Trial Funding Acquisition and Cost Management.JAMA network open · 2021Article
- Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research.Trials · 2021Article
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
Investigator-initiated studies (IISs) help by generating data on effectiveness and safety of a drug in the real-world setting and attempt to answer questions that clinicians face in their day-to-day practice. These are studies that are initiated and managed by a nonpharmaceutical company researcher/s who could be an individual investigator, an institution or a group of institutions, and a collaborative study group or a cooperative group. They are largely driven by questions that arise beyond the completion of Phase III studies that have not been studied during Phases I-III of drug development. The benefits of doing IISs are often offset by the myriad challenges posed by an IIS. These include finances, regulatory submissions, continuous oversight, training of study personnel, lack of expertise in statistics, data management, and medical writing Nonetheless, doing an IIS is extremely rewarding for the investigator and has the capacity to contribute to evidence and eventually impact policy. The present article presents both a brief literature review of IISs and a personal narrative of experience gained during the conduct several IISs in the last two decades. Challenges and potential solutions are described.
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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.