Gaea was glad to be back working with intensive care. We took over from a global big 5 CRO, the first double-blind placebo-controlled phase III trial in acute respiratory distress syndrome ( ARDS), a serious condition with a 30-% mortality by day-28 under the best standard of care. With our knowledge of the issues in the acute and emergency care settings, we defined and set up an eligibility confirmation process. This was complex as diagnostic chest X- rays cannot be emailed from most centres. Our two senior intensive care medical monitors teamed up to be on call “24/7” to check every screened patient, to reduce ineligible patients, and talk through the issue with the enrolling site staff. ARDS is a syndrome, so diagnosis is difficult and borderline screened subjects may represent typical patients but are a major issue for protocols in the acute care setting with the critically ill. This was a first time in an intensive care trial.
Gaea worked through the national variations in consent in the seven countries for incapacitated patients.
Gaea set up and managed the IDMC.
We ran the trial, through regulatory and opening 65 sites in the seven countries, enrolling 95 percent of the subjects and assessed three more countries.
For the sponsors’ strategic reasons, the trial was then moved another global big 5 CRO.
It was a stimulating and hard 2,5 years, and we thank the sites’ staff that worked hard on this complex protocol and e-CRF and supported the Gaea team in our delivery.
We look forward to using this rare and significant experience to assist any sponsors with trials in the acute and intensive care settings.