The Role of the Pharmaceutical Industry in Conducting Clinical Trials

(https://www.fda.gov/media/136238/download Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards March 2020 Updated on August 30, 2020, Psotka et al., 2020, https://insights.som.yale.edu/insights/how-is-the-pharmaceutical-industry-responding-to-covid-19 March 31, 2020, Park et al., 2021, https://www.drugwatch.com/featured/clinical-trials-and-hidden-data/ , Chopra et al., 2003, Weigmann et al., 2015, Clinicaltrials.gov/ct2/about-studies/learn#whoconducts, Fain, et al., 2021).

• Pharmaceutical companies help to develop new vaccines and treatments for diseases.
• The companies perform clinical studies, or clinical trials, to determine the safety and efficacy of new treatments and vaccines.
• Pharmaceutical companies sponsor the clinical trial process and distribution to the market for new treatments.
• Clinical trials seek to gather a diverse set of people such that treatments represent the patients they intend to treat.
• Companies work with doctors, healthcare professionals, and pharmaceutical scientists to provide the necessary resources to conduct the trials.
• Companies fund the expenses of conducting the trials and providing patient compensation.
• Pharmaceutical companies must comply with medical ethics and regulations to prioritize patient safety.
• The companies submit their reports to the Food and Drug Administration (FDA) in the United States for approval of the new treatments or vaccines.
• Pharmaceutical companies must submit results to independent regulatory agencies so that the approval of the treatment is dependent on the clinical trial data, not the company’s interest.