IVR Clinical Concepts develops both telephone and web-based diaries to collect subjective Total Nasal Symptom Score (TNSS) data directly from patients. IVRCC’s IVR and IWR solutions can often save clients from prematurely closing studies by adding enough patients to achieve the necessary statistical analysis.
"We have pioneered the use of IVR/IWR in the collection of patients’ TNS scores in seasonal allergic rhinitis (SAR) studies with approvals based on ePRO. We use the compliance information to manage a successful study by ensuring accurate diary reporting,” explains Nancy Hudak, Business Development Manager for IVR Clinical Concepts
Because IVRCC tracks patient compliance in real time, they can also save clients money by closing studies early when compliance rates are better than predicted. When asked what expert advice she would give to those setting up SAR studies, Hudak says, “Be aware that using IVR and IWR technology for patient diaries will expose the actual patient diary compliance rates, necessitating enrolling more patients to complete the compliant group of patients.”
If you haven’t thought about starting a SAR 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. “Enroll enough sites and patients to insure adequate numbers of completed patients for your statistical needs,” advises Hudak. “Have a contingency plan if you run out of ‘season’. We often use South Africa as back up for the USA autumn season and the USA Spring season as back up for South Africa”, she adds.
IVRCC establishes clinical trials for SAR quickly and effectively by bringing their expertise to SAR studies. While in the past paper diaries have been acceptable for recording data, 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%.
Looking for some expert insight on SAR and setting up a clinical trial? Give IVRCC a call to discuss quick and cost-effective options. Call: 800-486-1779. Visit us online at www.ivrcc.com or email us at firstname.lastname@example.org.
About IVR Clinical Concepts
IVR Clinical Concepts is an Interactive Voice and Web Response applications company dedicated to providing real-time data and reports for real-time results in clinical research for pharmaceuticals, biotechnology, and medical device companies.