Telephone Diary Support Service
When a senior patient pool, vital to the study, failed to embrace the technology the rate of patient recruitment suffered greatly. This case study highlights the implementation of a protocol amendment allowing for an alternative support service for collection of vital data to be recorded on a daily basis, by contacting patients directly over the telephone instead of requiring them to complete an electronic diary. This allowed the recruitment process to grow for patients who would otherwise not be able to participate in the study.
Preventing Unnecessary Unblinding
In an emergency medical situation, the treating physician usually wants to know what study medication the patient is receiving, and many of the calls that ESMS receive start with a request for unblinding. However, equipped with information from the protocol and Investigator’s Brochure, it is often possible for ESMS to prevent unnecessary unblinding while providing the physician with the information they need to treat the patient safely.
Occasionally ESMS receive telephone calls from frustrated and concerned trial patients who are unable to make contact with their Investigator when they might feel unwell. As daunting as this may be for the patient, ESMS can be a supporting voice over the telephone to reassure the patient, engage with them and help to keep them on the trial.
Medical Device Support
Where medical devices are used in clinical trials, direct-to-patient technical support is often required to ensure correct usage of the device and to allow for rapid identification of faults or associated adverse events. Subsequently, having the correct level of support can help to maintain patient retention. Our client, top 10 major pharmaceutical company with a global presence, conducted an oncology study across 50 sites in several different countries. The requirement was to provide a 24/7 technical advice and support service for the device, with the ability to screen and report adverse events.
APIPPRA – Arthritis Prevention In The Pre-Clinical Phase of Rheumatoid Arthritis
ESMS Client and top ten UK university in the world, Kings College London. KCL approached ESMS to support their phase IIb trial to investigate Arthritis prevention in the pre-clinical stage. This case study highlights their need for a solution to provide support to healthcare professionals looking after trial patients in medical emergencies and perform codebreaking as required in order to satisfy following ICH-GCP E6-R2 and MHRA GCP guidelines
Performing an Emergency Unblinding
In an emergency medical situation, the treating physician usually wants to know what study medication the patient is taking, and many of the calls that ESMS receive start with a request for unblinding. While it is often possible to prevent unnecessary unblinding, in some cases it is essential for unblinding to be performed quickly, to ensure safe management of the patient.