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\begin{document}

\title{``A Process-Based Approach to Conflicts of Interest''}



\author[1]{David Birnkrant}%
\author[1]{Jane Black}%
\author[1]{John  Carter}%
\affil[1]{Case Western Reserve University School of Medicine}%


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  \date{May 24, 2024}


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\begin{abstract}
The current system for disclosing financial conflicts of interest (COIs)
can be traced back to the ``Uniform requirements for manuscripts
submitted to medical journals,'' published in 1997. Meanwhile, new
molecular and genetic therapies are transforming clinical medicine and
these therapies have radically altered the financial landscape of drug
development. The average price of new drugs has risen sharply, and in
niche areas like rare diseases, the cost of new therapies can be
stratospheric. Now, even rare or ``orphan'' diseases are funded by
private investment. With high profitability, there is a new
\emph{pathway} for drug development involving unprecedented ties between
industry and academia. The potential for COIs has greatly expanded and
decisions that were once science-driven have become profit-driven. As a
result, the risk that marginally effective, ineffective and even
hazardous treatments will make their way to patients has greatly
increased. In this editorial, we propose a system built on
\emph{process-based} COIs. This new system would trace the developmental
journey of a drug from the lab to patients. All financial ties that
institutions and individuals have to the drug would be disclosed at each
developmental step. The goal would be to create a healthy skepticism and
debate over the studies behind new drugs, restoring a scientific focus
to the assessment of drug efficacy. When society's limited resources are
used to pay for drugs whose excessive cost primarily benefits investors
and corporations, it derails scientific objectivity, harms patients, and
threatens the financial stability of our health care systems.%
\end{abstract}%



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\textbf{Hosted file}

\verb`Birnkrant et al. Process Based COIs Pediatr Pulmonol Oct 31 2022.docx`  available at \url{https://authorea.com/users/349092/articles/593244--a-process-based-approach-to-conflicts-of-interest}

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