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Can We Trust Published Peer-Reviewed Scientific Data?
(Thursday, September 26, 2024) Peer-reviewed publications are the currency of scientific research, the number of publications being directly correlated to the credibility of the research being discussed. But there also have been reports of rampant manipulation and misrepresentation of data in scientific publications. So, how much can one rely on published literature in support of the clinical potential of new medical products? Each year more than 3 million peer-reviewed articles in science and engineering are published in over 30,000 journals worldwide. About one in four (23%) of these articles originates in China, 16% in the US, and 5% in India. Publications are cited in support of the rationale for medical products, design of studies, safety and effectiveness, mechanism of action, optimum manufacturing methods, and practically all other aspects of a given product. Publications are often highly publicized by the publishers, authors, and other stakeholders as credible independent evidence for the product. However, increased scrutiny by independent groups has identified many cases of fraud, misrepresentation, and manipulation of data, together called “fake data”, in peer-reviewed publications. Traditionally, it is assumed that on average about 2% of the data in publications is fake. However, a recent study argues that the amount of fake data is much higher. The study claims that almost 16%, or one in seven, published articles contain at least some fake data if not all of it. The amount of fake data in publications depends on the affiliations of the authors, the country of origin, the past record of the authors, the nature of the study or the concept, the stringency of the peer review process by the publishing journal, and many other factors. Over the last decade, there have been some high-profile retractions and consequences for the authors but based on the above numbers, that’s not even the tip of the iceberg. In light of that, where do data from peer-reviewed publications stand in the regulated industry? First, publications are usually used only for suggesting a hypothesis. Regulators seldom take the data in the publications at their face value and almost always disagree with the conclusions drawn. So, the risk of published data being used by itself for product approval is improbable. Second, all published data must be supported by raw data. Although there is no specific guidance from the FDA or other regulatory agencies about the scope of the raw data, the closest principles are those described for the real-world data requirements. Raw data must be based on well-designed independently reviewed studies, complete, analyzed based on acceptable standards, and verifiable. Third, single, standalone publications discussing one-off conclusions should always be looked at more stringently. With about 9 million scientists worldwide, working in interconnected fields, it is almost impossible to find an area of research conducted by only one. It is critical to critique the presented concepts and independently verify the raw data behind it. Publications are not ever going away or losing their importance in scientific discussion completely. On the contrary, the concerns about the published data emphasize the importance of such data in the first place in the scientific process. The scientific process is based on the age-old concept of “trust but verify”. It is when we forget that tenet do we get in trouble. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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