scholarly journals Lack of clinical trial data transparency and current solutions

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Tabassom Baghai

An ongoing challenge in clinical research is the inaccessibility of clinical trial data, which prevents physicians from making an informed decision with regards to patient care. The U.S. Food and Drug Administration (FDA) as well as the World Health Organization (WHO) recently called for all trial data to be registered and made publically available. However, this issue is still ongoing and there are several measures currently being enforced to rectify these concerns. Potential solutions, such as regulations, campaigns, and possible conse- quences, for increasing transparency in clinical trial data will be discussed. RÉSUMÉ L’inaccessibilité des données provenant d’essais cliniques constitue un défi constant en recherche clinique, puisqu’elle empêche les médecins de prendre des décisions éclairées quant aux soins de leurs patients. Récemment, le Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA) ainsi que l’Organisation mondiale de la Santé (OMS) ont demandé que toutes les données d’essais cliniques soient enregistrées et mises à la disposition du public. Toutefois, ce problème persiste et plusieurs mesures ont été mises en place pour répondre à ces préoccupations. Des solutions possibles dont des réglementations, des campagnes et des sanctions possibles pour améliorer la transparence en ce qui concerne les données d’essais cliniques seront discutées. 

Trials ◽  
2009 ◽  
Vol 10 (1) ◽  
Author(s):  
Lorenzo P Moja ◽  
Ivan Moschetti ◽  
Munira Nurbhai ◽  
Anna Compagnoni ◽  
Alessandro Liberati ◽  
...  

2021 ◽  
Vol 9 (4) ◽  
pp. 857
Author(s):  
Robindra Basu Roy ◽  
Sabrina Bakeera-Kitaka ◽  
Chishala Chabala ◽  
Diana M Gibb ◽  
Julie Huynh ◽  
...  

Children affected by tuberculous meningitis (TBM), as well as their families, have needs that lie at the intersections between the tuberculosis and meningitis clinical, research, and policy spheres. There is therefore a substantial risk that these needs are not fully met by either programme. In this narrative review article, we use the World Health Organization (WHO) “Defeating Meningitis by 2030: global roadmap” as a starting point to consider key goals and activities to specifically defeat TBM in children. We apply the five pillars outlined in the roadmap to describe how this approach can be adapted to serve children affected by TBM. The pillars are (i) prevention; (ii) diagnosis and treatment; (iii) surveillance; (iv) support and care for people affected by meningitis; and (v) advocacy and engagement. We conclude by calling for greater integration between meningitis and TB programmes at WHO and at national levels.


2018 ◽  
Vol 6 ◽  
pp. 205031211879239 ◽  
Author(s):  
Jeff Kirk Svane ◽  
Ingrid Egerod ◽  
Hanne Tønnesen

Objectives: Health promotion is on the global agenda. The risks targeted include smoking, hazardous alcohol consumption, nutrition and insufficient physical activity. Implementation of clinical health promotion, however, remains a major challenge. While several processes, models and frameworks for strategic implementation exist, very few have been tested in randomized designs. Testing a strategic implementation process for clinical health promotion was only recently attempted via a randomized clinical trial on the World Health Organization Health Promotion Hospitals Recognition Process. The randomized clinical trial showed that the process improved central parts of implementation. To complement these findings, this nested qualitative study aimed to explore experiences and perceptions of staff and managers, who had completed the process, and generate hypotheses for improvements. Methods: We interviewed a purposeful sample of 45 key informants from four countries, who worked at clinical departments and had undertaken the World Health Organization Health Promotion Hospitals implementation process. The informants included 14 managers, 14 medical doctors, 13 nurses and 4 other clinical staff. Interview transcripts were analyzed using qualitative content analysis and an inductive approach to coding and categorization supported by QSR NVivo. Results: The informants’ experiences and perceptions centered around four global themes concerning (1) awareness, cultural re-orientation and integration; (2) learnings; (3) normalization and legitimacy and (4) a more evidence-based, structured and systematic approach to clinical health promotion. Informants were positive toward the implementation process, although it was sometimes challenging. The suggested improvements to increase acceptability related to the patient survey, time consumption, translation, tailoring to local circumstances and in-advance training. Conclusions: Managers and staff were positive toward the World Health Organization Health Promotion Hospitals process, which was perceived to bring about positive changes and learnings. The findings also suggest that the implementation process may be improved by minor adjustments to process elements and design. It is our recommendation to use the process in clinical departments to further implementation of clinical health promotion.


2005 ◽  
Vol 35 (2) ◽  
pp. 405-407 ◽  
Author(s):  
Michele Simon ◽  
Jean McMahon

Obesity has reached global epidemic levels, and two-thirds of Americans are now either obese or overweight. But the U.S. government, along with the powerful food industry, is trying to thwart the World Health Organization's efforts, through its proposed Global Strategy on Diet, Physical Activity, and Health, to make even the most commonsense recommendations on diet.


2020 ◽  
Vol 114 (4) ◽  
pp. 765-772

President Trump decided in mid-April of 2020 to suspend U.S. funding for the World Health Organization (WHO) and to have his administration review its performance, contending that it was biased in favor of China and inept in its handling of the COVID-19 pandemic. In a letter to the WHO director-general a month later, Trump informed the director-general that his administration's review confirmed his accusations. He threatened that, unless the WHO implemented significant reforms, the United States would reconsider its membership in the organization. Less than two weeks later, on May 29, 2020, Trump announced his decision to terminate the U.S. relationship with the WHO. On July 6, the administration gave formal notice of U.S. withdrawal to the UN secretary-general, the depositary for the WHO Constitution. Assuming certain legal preconditions are satisfied and the notice of withdrawal is not revoked, the withdrawal will take effect on July 6, 2021.


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