How IVR and IWR Improve Compliance in Seasonal Allergic Rhinitis Studies
‘Tis the season for studying SAR, or Seasonal Allergic Rhinitis (SAR). Allergic rhinitis is an allergic reaction that occurs when your immune system overreacts to substances that you have inhaled. Seasonal allergic rhinitis is hay fever caused by outdoor allergens such as pollen.
If you haven’t thought about starting your study, the trial window is approaching quickly. In the United States, the trial window starts August 1st and extends through November.
Still need more time to prepare your study? 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.
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.
At IVRCC we set up clinical trials for Seasonal Allergic Rhinitis quickly and effectively by bringing our expertise to SAR studies:
- When designing a seasonal allergic rhinitis trial, one must understand that the patients’ symptomology is the basis for evaluating the agents tested efficacy. 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% (data on file).
- Using IVR or IWR we provide a reporting window in which the subject can enter his or her ratings for effective TNSS (Total Nasal Systems Score). We collect data that is reported closer to the time the patient is experiencing the symptoms.
- Even though patients know they are being monitored closely, 5 -15% 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. Because the data is recorded close to the time of the symptoms, the data is more precise.
- 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.