Client 4SC AG: The Marketing Authorisation Application for resminostat has been accepted by the EMA as sufficient for examination.
“Germany, 1 March 2024 – 4SC AG a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), announced today that that its MAA has been accepted by the EMA as sufficient for examination”.
This was a placebo-controlled trial with cross over, of maintenance treatment for patients with CTCL with at least stable disease. Patients with a long-term responding and relapsing condition are wary of more hospital visits and of placebo and especially when the disease is stable.
So, we worked on two campaigns for 4SC – the first to stimulate enrolment at site that were dormant on screening and to share best practices from high enrollers. The second began once enrolling was moving well, to then try to reduce dropouts without good medical cause.
Services of Gaea Trial Acceleration
A successful clinical study needs to efficiently recruit and retain the study population. But participant enrolment issues are a major reason for trial early terminations. Global data analysis of all terminated trials within ClinTrials Database reported 55% of trials were terminated due to the low accrual rate[1]. Globally, it’s stated than 80% of trials fail to enrol on time, resulting in an extension of study and /or addition of new study sites: more sites or more time means more cost.
Similarly, insufficient retention of the participants to study closeout is also an increasing issue as the remaining number of patients may be too small to meet the Primary Objective statistics.
Gaea Trial Acceleration works to solve patient recruitment issues with the site team at the target sites. The process is smart work based on years of experience. I visit top recruiters to see how they achieve enrolment – “best practice”- and visit with non- or slow enrolling sites to find out why they are not achieving. I solve what I can and take back to the sponsor to solve what I can’t– and follow up. I share relevant best practice with the sites.
I have an in-depth knowledge of clinical operations, from years in clinical operations, initially in recruitment issues, then as FSP while CEO at Gaea CRO.
I understand the medical particularities of many target indications. I am persistent and can achieve acceleration of recruitment quite rapidly. Sooner is better as when sites are dormant a longer time and usually more than one visit is needed to try to get sites engaged.
Would you be open to discussing how we can help patient recruitment?
Pharmaceutical Technology Enrolment Issues are the Top Factor in Clinical Trial Terminations. 2018. Dec 05, [Last accessed on 2019 Dec 05]. Available from: https://wwwpharmaceutical-technologycom/comment/reasons-for-clincial-trial-termination.
