Case Studies

The primary challenges the clinical research unit faced were:

• Ensuring MHRA, ethical and trust approvals were in place as quickly as possible to ensure there were no delays in recruitment.
• Recruiting a large cohort of participants for the study in a tight timeframe.
• Participants had to be educated on how to dose themselves correctly whilst at home with a first in human drug.
• Close monitoring between the study team and the trial participants had to be maintained to ensure safety whilst individuals were dosing outside of the clinical research unit.

MHRA and ethical requests for approvals were followed up regularly to ensure the study was able to start recruiting as soon as possible. The clinical research unit worked closely with their strategic partner ‘Covance’ to enable smooth communication between both sites and to eliminate delays in the study starting. Once both MHRA and ethics approval was received (on a Friday) the CRU team was quickly and efficiently able to update the Royal Liverpool Research and Development team of this and gain approval for the study to run the following Monday. Due to building up a database of patients utilising Consent4Consent prior to the study starting, we were then able to screen our first participant on the Tuesday (the day after R&D approval).

Participants were recruited from the dermatology clinics running across RLBUHT and through individuals directly contacting the research unit after seeing adverts and posters. Once confirmed as eligible each participant was provided with training on how to correctly apply the dose of the drug to their skin, and then assessed as competent by the clinical team prior to discharge. Safety reporting was emphasised and discussed prior to home dosing and participants were encouraged to contact the CRU in and out of hours with any issues or queries they may have. Participants had regular scheduled contact with the research staff to ensure they were happy to continue, and numerous assessments were carried out to ensure safety was maintained and that trial data was collected correctly.

The clinical research team were able to complete recruitment for the study 4 weeks ahead of the study schedule, and now have a cohort of dermatology patients who could be contacted regarding involvement in future studies.

The first two phases of the study have now been completed and all safety and trial data have been analysed.

The CRU and research staff received incredibly positive feedback from the trial participants, most of whom have signed up to the C4C database so that they can get involved in more research in the future.

The primary challenges of this study were:

• Recruiting a large cohort of healthy volunteers into a study with tight inclusion/exclusion criteria and a long follow up of 13 months
• The participants had to have 3 vaccinations, inoculation with S. pneumonia serotype 6, 4 nasal washes and 3 sets of PBMCs
• There was very little flexibility in the 11 outpatient visits dates and times therefore the participants had to commit to these right from the beginning

Participants were recruited primarily from the local Universities through information received at fresher’s fairs or directly contacting the research unit after seeing adverts and posters. Once they had received the patient information sheet and were interested in the study, they would be invited to the unit for a PowerPoint presentation containing study information presented by a member of the study team. If they were interested they could review study dates for each available cohort before committing. This additional pre-screen information session was added to ensure participants knew exactly what their commitment would be to ensure they understood the full facts before committing to a screening appointment.

Over 150 participants were screened with the required number being randomised a month ahead of schedule.

Only one participant was lost to follow up, but there were sufficient numbers of participants to complete all the defined time points for vaccination, inoculation and sampling.

All of the participants who completed the defined timepoints have now completed the study.

The research unit coordinated the research study effectively with all outcomes met and no participants have been lost to follow up ensuring high quality patient safety and complete datasets. The participants on the trial enjoyed their research experience with many interested in taking part in future research studies.