Irritable bowel syndrome (IBS) is the most common functional gastrointestinal (GI) disorder with worldwide prevalence rates ranging generally in the area of 10–15%. People with IBS typically have following symptoms: abdominal pain, bloating, and diarrhea or constipation (or both).
Only a small number of people with IBS have severe signs and symptoms. Some people can control their symptoms by managing diet, lifestyle and stress. More-severe symptoms can be treated with medication and counseling.
For this clinical trial, Pivotal Patient Journey was contacted to recruit IBS patients with predominantly diarrhea.
The sponsor contacted Pivotal Patient Journey to boost recruitment in 4 countries:
In a timeframe of 4 weeks, Pivotal Patient Journey designed a multichannel recruitment strategy, prepared all recruitment materials (advertisements, study website, telephone script…) and delivered the final documents for Ethics Committee submission to the Sponsor for all countries.
After online and phone prequalification, Pivotal Patient Journey referred 110 eligble candidates to the study sites.
Pivotal Patient Journey prepared a multichannel patient recruitment strategy with two-step prequalification which was submitted to the Ethics Committees in all participating countries.
For Belgium the EC approval of UZ Leuven was received within 8 days after EC submission.
Subsequently also approval from the ECs in Germany, Italy and Spain was secured.
The recruitment strategy involves:
The recruitment campaign was launched mid September 2019 for a 4-month period.