Cytomegalovirus Vaccine Study
Background:
A multinational pharmaceutical company needed to speed up development timelines for a new vaccine study.
Requirement:
Sponsor selected five sites in Australia (two from Paratus). Each site needed to recruit 12 women aged between 16-30 years of age.
Outcome:
- Paratus recruited 45 of the 58 participants across all five sites throughout Australia
- Study recruitment closed on time
- Development of the vaccine was not delayed
“For Australia, we screened 145 participants and randomised 58 participants into the study. Congratulations! This is 97% of our target and achieved 10 weeks earlier than planned! Australia was also the 3rd highest for screenings and randomisations in the final month of screening in August. These figures firmly support our ‘bid’ for participation in the much larger phase III study with feasibilities commencing in the second half of 2020.
As a ‘rescue’ country that also requires a GMO licence with OGTR, joining and late participation in the enrolment period has not been easy. However, I’d like to sincerely thank all involved, including your participants for their interest, participation and sometimes patience for supplies to arrive. Lessons learned will be taken from this study into Phase III.”
- Study lead at Sponsor organisation.
Phase II Flu Vaccine Study
Background:
A UK-based biotech company working with an Australian CRO required fast recruitment for a Phase II flu vaccine study.Requirement:
Sponsor needed 2,200 healthy volunteers during the 2019 flu season.Outcome:
- Paratus recruited 893 participants (more than double the initial target of 400)
- Timelines met for the study
- Paratus Western Sydney clinic was the highest recruiting site
Influenza Detection Diagnostic Testing
Background:
An Australian biotech had developed a new point-of-care diagnostic to detect influenza and needed access to patients with ‘influenza-like illnesses’ within 72 hours of symptom onset.Solution:
Paratus worked closely with partner GP practices to set up referral pathways for eligible and interested patients, as well as setting up inside a GP practice to accommodate the study.Outcome:
- Paratus recruited over 150 patients
- The study was able to proceed with a statistically relevant number of patients
- Development of the diagnostic tool was able to continue
New Migraine Treatment
Background:
A small Australian biotech developing a new migraine treatment had experienced difficulty in achieving successful patient recruitmentRequirement:
Sponsor needed fast recruitment after experiencing previous delays.Outcome:
- Paratus delivered 120% of target in two months
- The company was able to progress research to the next stage of development more rapidly than anticipated
Slow participant recruitment is the number 1 limiting factor for clinical research
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