Better Compliance produces Better Data: What to Keep in Mind When Planning a SAR Study

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Better Compliance produces Better Data: How to Improve Your Seasonal Allergic Rhinitis Study (SAR)




What is Seasonal Allergic Rhinitis (SAR)?

•Allergic reaction that occurs when your immune system overreacts to substances that you have inhaled

•Hay fever caused by outdoor allergens such as pollen




• In the United States, the trial window starts August 1st and extends through November.

• One top study location for SAR is South Africa. Frequently described as the ragweed capital of the world, there are always substantial allergens from ragweed there to be able to evaluate efficacy of treatments.

What to Keep in Mind When Planning a SAR Study




Why Choose IVRCC to Study Allergic Rhinitis?

• IVRCC has developed both telephone and web based diaries to collect subjective Total Nasal Symptom Score (TNSS) data directly from patients.

• We have saved clients from prematurely closing studies by adding enough patients to achieve the necessary statistical analysis.

• Because we track patient compliance in real time, we have helped clients save money by closing studies early when compliance rates were better than predicted.




We set up clinical trials for SAR quickly and effectively by bringing our expertise to SAR studies:

• While in the past paper diaries have been acceptable, a monitoring device added to the paper diary without the patients’ knowledge showed that only 11% of the patients were compliant with the reporting process.

• When the patient is aware that they are being monitored by an IVR or IWR system, the compliance rises to 85 – 95%

• Using IVR or IWR we provide a reporting window in which the subject can enter his or her ratings for effective TNSS.

• We collect data that is reported closer to the time the patient is experiencing the symptoms.




• 5 -15% of patients will fail to meet the compliance criteria for inclusion of their data in the efficacy analysis. We keep this in mind when the study is designed so that the number of patients who start treatment is estimated to account for this non-compliance rate.

• All contacts to the IVRS or IWRS are time-stamped to provide accountability.

• IVRCC staff work with the site staff to alert team members when patients are not completing their diaries as required.

• It’s quick - the entire survey can take just a couple of minutes during a small window of time to ensure accurate data is taken from the subject.

• Using IVR or IWR we provide a reporting window in which the subject can enter his or her ratings for effective TNSS

We set up clinical trials for SAR quickly and effectively by bringing our expertise to SAR studies:




What to Know about Studying SAR:

• A two week diary provides enough data to determine efficacy.

• Reminders make it easy for the subject to remember to fill out the diary and comply with the reporting schedule.

• The FDA is looking for evidence of timeliness in clinical trials because it means better compliance and better data.



Looking for some expert insight on SAR and setting up a clinical trial? Give us a call to discuss quick and cost-effective options.

We offer quick and accurate responses to RFPs. We are happy to discuss options and alternative ways to optimize efficiencies and to achieve quality results using our interactive technologies.

Get in touch| visit: IVRCC.com | email: [email protected] | call: 800-486-1779



Health & Medicine

Better Compliance produces Better Data: What to Keep in Mind When Planning a SAR Study