Placebo Response Mitigation

Placebo response is a potentially devastating component of CNS trials, particularly those with subjective patient-reported outcomes and high levels of interaction with clinical staff. In clinical trials using subjective primary endpoints, particularly CNS trials and trials in pediatric populations, high placebo rates contribute substantially to late-stage failure of promising treatments.

The Placebo Control Reminder Script (PCRS) on Pathway

VeraSci offers a scientifically-backed instrument, the Placebo Control Reminder Script (PCRS), through the Pathway eCOA system. The PCRS, developed by the Hassman Research Institute, is a brief script read to participants immediately before administering study assessments. It educates and reminds them about placebo response factors and has been shown to decrease placebo response.

The Placebo Control Reminder Script (PCRS) on Pathway

VeraSci offers a scientifically-backed instrument, the Placebo Control Reminder Script (PCRS), through the Pathway eCOA system. The PCRS, developed by the Hassman Research Institute, is a brief script read to participants immediately before administering study assessments. It educates and reminds them about placebo response factors and has been shown to decrease placebo response.

Common Placebo Response Mitigation Strategies

(And Why They May Not Be Enough)

VeraSci offers a scientifically-backed instrument, the Placebo Control Reminder Script (PCRS), through the Pathway eCOA system. The PCRS, developed by the Hassman Research Institute, is a brief script read to participants immediately before administering study assessments. It educates and reminds them about placebo response factors and has been shown to decrease placebo response.

Placebo Response Training for Raters

As part of our rater training and certification service, VeraSci can provide a didactic training on mitigating placebo response for raters and site staff. Key elements include:

  • What is the placebo effect, and why does it present a risk to this trial?
  • What staff behaviors increase and reduce the placebo effect?
  • What specific language increases and reduces the placebo effect?
  • What types of subjects should be considered as high risk for placebo effect, and thus potentially screen failed?

For trials utilizing the PCRS, raters would also receive training on the delivery of the PCRS.

Placebo Response Training for Raters

As part of our rater training and certification service, VeraSci can provide a didactic training on mitigating placebo response for raters and site staff. Key elements include:

  • What is the placebo effect, and why does it present a risk to this trial?
  • What staff behaviors increase and reduce the placebo effect?
  • What specific language increases and reduces the placebo effect?
  • What types of subjects should be considered as high risk for placebo effect, and thus potentially screen failed?

For trials utilizing the PCRS, raters would also receive training on the delivery of the PCRS.