ArticleBMC public health2011
The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries.
Article in BMC public health, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Who should be included in first-in-human trials? A systematic review of reasons.Journal of translational medicine · 2025Pooled it
- Emerging Ethical Challenges in Manufacturing of Cell-Based Medicines.Advances in experimental medicine and biology · 2025Review
- Phase 1 Clinical Trials: Challenges and Opportunities in Latin America.Journal of immunotherapy and precision oncology · 2024Article
- Globalisation of industry-sponsored clinical trials for breast, lung and colon cancer research: trends, threats and opportunities.BMJ oncology · 2023Article
- A systematic scorecard-based approach to site assessment in preparation for Lassa fever vaccine clinical trials in affected countries.Pilot and feasibility studies · 2020Article
- Article
- International Clinical Trials in Latin American and Caribbean Countries: Research and Development to Meet Local Health Needs.Frontiers in pharmacology · 2017Article
- Trial watch: global migration of clinical trials.Nature reviews. Drug discovery · 2014Article
- Latest research and treatment of advanced-stage epithelial ovarian cancer.Nature reviews. Clinical oncology · 2013Review
- An exploratory study to develop a practical ethical framework for reproductive health research.Iranian journal of reproductive medicine · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries. DISCUSSION: There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials. SUMMARY: While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.
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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.