21,000 Women Initiated Onto An IUD
This is our largest non-interventional study to date, 20,979 patients recruited and followed up over 5 years with a loss to follow up over the duration of the study of <5%.
Challenge: Observational studies involve observing patients within routine clinical practices. This project was a prospective cohort study conducted to a strict protocol and which was granted ethical committee approval. Our client was required to conduct a phase 4 non-interventional study with 20,000 female patients recently fitted with a contraceptive coil (IUD/IUS) to complete a 5 year protocol.
Process: This study involved patients completing a baseline questionnaire within 14 days of the coil being fitted, then both patient and physician being followed up 1 year later then the patient followed up over a further 4 years later. In total we recruited 365 active individual GPs, gynaecologists, Contraception and Sexual Health (CASH) clinics and sexual health centres from across the UK to participate in the study.
Outcome: We recruited a total of 20,979 patients into the project and manged to achieve a loss to follow up over the duration of the study of <5%.
Feedback: Our client was very involved throughout the project, monitoring our performance and auditing us on a regular basis. The feedback we received was we were far outperforming their partners in other EU markets in terms of the numbers of patients recruited and we passed all GCP audits successfully. Our client was so pleased with our performance that they have placed several other non-interventional studies with us too.
To download the case study please click on the link : 21,000 Women Initiated Onto An IUD