Supporting Clinical
Trials in Pain

The relative subjectivity of pain makes an accurate assessment of the efficacy of analgesics difficult. Pain trials rely heavily on patient-reported outcomes and often include patient diaries. Although many commonly used scales are relatively straightforward, rescue medications, high placebo response rates, and comorbidities can make discerning a signal difficult. VeraSci’s expertise in selecting clinical outcome assessments combined with our state-of-the-art ePRO and eCOA technology can assist sponsors in overcoming these hurdles.

Pathway, VeraSci’s proprietary ePRO and eCOA solution offers several features that are beneficial to pain trials:

  • ePRO allows patients to record pain levels, events (like migraine), and medications in real-time
  • In addition to smartphones, Pathway is available in tablet format for patient populations that may have difficulty completing assessments on a smaller screen
  • Notifications and alerts that contribute to patient compliance and more complete data
  • Flexible assessment scheduling that can accommodate complex scenarios such as triggering an additional assessment after medication dosing or changes to assessment intervals based on patient input

VeraSci also has extensive experience training clinicians and raters on how to educate patients on properly rating their pain and how to interact with patients in a way that reduces placebo response.

We provide expert solutions in:

Jan Sedway, PhD

Senior Clinical Scientist

Chris Brady, PsyD

VP, Clinical Science

Select Endpoints & Assessments for Analgesia Trials

30-Second Chair Stand Test
40-m Fast-Paced Walk Test
6-Minute Walk Test
BPI—Brief Pain Inventory
COWS—Clinical Opioid Withdrawal Scale
Daily Pain Diaries

FPS-R—Faces Pain Scale-Revised
LANSS—Leeds Assessment of Neuropathic Symptoms and Signs
Likert Scale
MIDAS—Migraine Disability Assessment

MPI—Multidimensional Pain Inventory
MPQ
—McGill Pain Questionnaire

NPSI—Neuropathic Pain Symptom Inventory
NRS—Numerical Rating Scale
PainDETECT
PQAS—Pain Quality Assessment Scale
Timed Up-and-Go Test
VAS—Visual Analog Scale for pain intensity
VRS—Verbal Rating Scale for pain intensity
WOMAC—Western Ontario and McMaster Universities Arthritis Index

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.

Image of 3 iPads with Pathway logo

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.