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Clinical trials, between science and financial and academic interests

On May 22, the Lancet published a peer-reviewed article based on an analysis of 96,000 Covid patient files, which concluded that hydroxychloroquine was ineffective. A few days later, researchers published a letter questioning the methodology and data used by the Surgisphere company to develop this conclusion, and on June 4, the Lancet withdrew the article from publication. This was the beginning of what some people call "Lancetgate", or the "Surgisphere Scandal".

Beyond the frenzy of scientific publications triggered by the Covid-19 outbreak (47,000 in three months!), this event highlighted the questionable reliability of clinical trials. In September 2009, the scientific journal PloS Medicine argued that most trials of new drugs, including those supposedly authored by academic physicians, are subject to frequent manipulation. The title of their editorial clearly indicates scorn: Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Biggerand the piece specifically outlines the influence and power of drug manufacturers in the clinical research process. Yet the poor quality studies published by French hospital doctors on hydroxychloroquine, even with no link to pharmaceutical companies, show that the problem goes far beyond that of trials financed by 'Big Pharma'.

Pierre Chirac, pharmacist and editor of the journal Prescrire, will present his analysis of the pharmaceutical industry's influence strategies and the special interests of university hospital researchers, their consequences on the reliability of drug information and the means now required to rectify a harmful situation.

Summary : 

•    Part 1 -  Introduction: what credit should be given to clinical trials?
•    Part 2 - History and contemporary context of clinical trials     
•    Part 3 - Examples in the private and public sector: Sofosbuvir, Hydroxychloroquine 
•    Part 4 - Publication of protocols, confirmation bias, "publish or perish", access to data
•    Part 5 - Examples: Paroxetine, Surgisphere 
•    Part 6 - Efforts and movements to prevent scientific fraud 

Questions and conclusion : 

•    Question 1 - Make the study protocol visible to reviewers
•    Question 2 - Big Data in clinical trials  
•    Question 3 - Covid-19 vaccine protocols.  Richard Smith and the Solidarity trial  
•    Question 4 - Of the hundreds of Covid-19 vaccines, which ones to choose to test?  
•    Question 5 - Products approved in phase two of clinical trials. Informed consent. DNDi study in Sudan
•    Question 6 - Compassionate use protocols and pharmacovigilance
•    Question 7 - Clinical studies conducted by DNDi
•    Question 8 - The role of public authorities. Financing. Representativeness of the cohorts
•    Question 9 - The databases. The sponsors 
•    Question 10 - Strengthening the obligation of transparency  
•    Conclusion 

To cite this content :
Pierre Chirac, Clinical trials, between science and financial and academic interests, 8 October 2020, URL : https://www.msf-crash.org/en/conferences-debates/clinical-trials-between-science-and-financial-and-academic-interests

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