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Wayne Macfadden
Wayne Macfadden, MD, studied Psychiatry at the University of
Pennsylvania School of Medicine. A former Fellow in the American
College of Psychiatrists, Wayne Macfadden was an attending
psychiatrist at Princeton Healthcare Medical Center in New Jersey
between 2010 and 2011. He was also responsible for conducting
industry sponsored clinical trials.
The vast majority of clinical trials support federal regulatory
approval of a vaccine, drug, or device or track its efficacy and
safety after approval. For example, according to a former FDA
commissioner about 70 percent of all clinical trials in the US in
2018 were industry sponsored.
In industry-sponsored research, an organization contracts a
researcher, often a faculty member, to conduct all aspects of a
clinical trial. That may be an intervention, observation, or
biomedical condition. For most sponsored clinical trials, the
organization designs the study and owns the study protocol. The
trials sponsor often collaborates with contract research
organizations (CROs) that play the role of company
representatives.
Before sharing proprietary information or protocol, most sponsors
want to have a signed confidentiality agreement (CDA). When the
clinical trial results are officially published in peer-reviewed
journals, they provide a scientific basis for medical treatment
decisions and enable insurance companies and governments to
develop policies and study compensation plans.

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Wayne Macfadden: Industry Sponsored Clinical Trials

  • 2. Wayne Macfadden, MD, studied Psychiatry at the University of Pennsylvania School of Medicine. A former Fellow in the American College of Psychiatrists, Wayne Macfadden was an attending psychiatrist at Princeton Healthcare Medical Center in New Jersey between 2010 and 2011. He was also responsible for conducting industry sponsored clinical trials.
  • 3. The vast majority of clinical trials support federal regulatory approval of a vaccine, drug, or device or track its efficacy and safety after approval. For example, according to a former FDA commissioner about 70 percent of all clinical trials in the US in 2018 were industry sponsored.
  • 4. In industry-sponsored research, an organization contracts a researcher, often a faculty member, to conduct all aspects of a clinical trial. That may be an intervention, observation, or biomedical condition. For most sponsored clinical trials, the organization designs the study and owns the study protocol. The trials sponsor often collaborates with contract research organizations (CROs) that play the role of company representatives.
  • 5. Before sharing proprietary information or protocol, most sponsors want to have a signed confidentiality agreement (CDA). When the clinical trial results are officially published in peer-reviewed journals, they provide a scientific basis for medical treatment decisions and enable insurance companies and governments to develop policies and study compensation plans.