FDA Approves Migraine Drug: ePRO Used in Clinical Trials
The New York Times reported that the FDA recently announced its approval of the first drug designed to prevent migraines. According to the article, one in seven people worldwide experience migraines, among them 37 million Americans — as many as 20 percent of women, and 10 percent of men. The new medicines are intended for the estimated 2.8 million Americans who have a migraine many times each month.
IVRCC has been involved in numerous migraine studies and clinical trials where we’ve collected daily PRN Pain diaries. For migraine and headache studies, the PRN diaries are pro re nata, a Latin phrase used in medicine meaning “as needed.” Subjects would call or log in to our IVR/IWR systems when a headache event occurred. In some studies, we provided daily reminders which alerted subjects to sign in to report “no pain events” or to report a “painless” day. These tools ensure continued positive engagement and retention for maximum subject compliance to their ePRO reporting. The extent of the administration of the diaries is determined by the patients’ needs and the clients’ preferences for their study.
In the various migraine studies we’ve been involved in, we’ve deployed questionnaires including Wong-Baker, Likert and VAS scales, for easily-accessible reporting of headaches and enabled the use of phones, PC’s and smartphones. In addition, we’ve programmed automated outgoing notifications designed to maintain subject engagement with their study diaries. We have also deployed these types of diaries for other indications, including bleed events in hemophilia studies.
According to the article, people taking the new drugs during clinical trials reported no more side effects than those taking a placebo. This is important because patients that have tried various other treatments often find the side effects to be worse than the migraines. While the new drugs do not prevent all migraine attacks, they can make attacks less severe and can reduce their frequency by 50 percent or more.
To read the full May 17, 2018 New York Times article “New Drug Offers Hope to Millions With Severe Migraines.” go to https://nyti.ms/2GuY9MO
About IVR Clinical Concepts Inc. (IVRCC)
IVR Clinical Concepts is a specialty company devoted to developing and implementing cost effective, secure Interactive Voice and Interactive Web Response applications (IVR/IWR) that interface seamlessly with other technologies and provide data collection and reporting tools that enhance comprehensive management of clinical studies.
Users, sites and subjects, can enter data using IVR or IWR in the same application, per their needs or preferences. All data entered is then stored within secure IVRCC databases for virtually immediate real-time data reporting and results for pharmaceuticals, biotechnology and medical device trials.
Data collected by our systems can also integrate directly with other eClinical applications for seamless transfer of once-only entered data between two or more electronic systems. IWR applications can be designed to work on Microsoft Windows, Apple and Android devices according to the needs of the study. Applications by voice or web are available in most regional languages, as needed.
Clients who choose IVR Clinical Concepts for their IVR/IWR solutions are rewarded with flexible data input in globally available applications that put key decision-making information at their fingertips.