The Effect of the Opioid Epidemic on Clinical Research

  • Describe the main problem an addicted person brings to CR
  • Compare the Usual AE profile of an addicted person with others following the protocol
  • Demonstrate the need to know if a Protocol volunteer is addicted to opioids  or being treated for addiction
  • Evaluate the potential interactions between a volunteer on an opioid or a treatment of the addiction
  • Explain why it is essential to know well the full volunteer of patients history

Study sponsors of Drug or device research involving human subjects. Also benefiting would be: Investigators, Safety Nurses, Clinical operations staff, CRA and CRCs, Recruiting staff, QA / QC auditors and staff, sponsor monitors, & Clinical Research Data managers.

Target Groups and Companies

  • All Pharmaceutical and Biotech companies
  • All Contract Research Organizations
  • All serious Clinical Research Sites
  • All University Research groups

Charles H. Pierce, MD, PhD, FCP, CPI, is a 25+ year veteran in the Clinical Research arena now specializing in bringing the message (webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He specializes in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

The US and may other countries are in the midst of a large epidemic of addiction to opioids and all of the problems to society that this uncovers. One area not talked about is the effect on Clinical Research, whose main purpose is to assue the safety of the agents they are testing. Those taking addicting substances do not readily admit this fact and in CR, we do not usually test routinely for the usual suspects.

The Opioid epidemic, we are now in, affects all levels of society including those with other diseases or conditions that may be the subject of an investigation. The addicted individual is, by history, not open as to her/his condition and even once on treatment with Buprenorphine or other agents, want to put their opioid addiction in the past. The problem is the potential interactions between the test agent and whatever the patient is recently taking (opioid or treatment). It is a case of “what you do not know is potentially dangerous”. In Clinical research we typically do not test for the aray of agents tested in an Addiction Treatment Center. I know as I work in a Treatment Center.

  • $195.00