News from the world of clinical research - proinnovera, CRO for dermatology, oncology and clinical research

Recruitment for Phase 3 Rescue Study closed 4 Months prior Milestone

In November 2016, proinnovera was awarded with the acquisition and conduct of a phase III rescue study in bacterial infected eczema by a mid-sized German pharmaceutical company focused on the development of medicinal products for dermatology. Upon takeover, proinnovera significantly increased the recruitment rate which was well below plan at that time. 104% of the projected patients were randomized four months faster than planned and the recruitment rate increased fourfold.

Facts and Results

TopicProjectionDeliverables
Enrollment Period10 months, aiming for September 2017 for LPFV according to the current enrollment speed at takeoverEnrollment closed 4 months ahead only after 6 months in May 2017
Enrollment Rate11,5 patients per month according to enrollment rate at takeover43 patients per month
Randomized Patients400416
Number of sites1115 including 4 proinnovera sites

Measures

The key to the successful takeover and the earlier closure of enrollment is proinnovera’s well-established site network and the strategic selection of eligible sites based on the following criteria:

  • All four additionally selected sites have already participated in previous or current dermatology studies managed by proinnovera. Thereby our study team could accelerate the negotiation process without the need to focus on legal language but only on study specific aspects.
  • In addition, our Clinical Monitors could tie in with prior collaboration, providing the benefit of a quick site initiation and effective site training as well as a clearly structured ongoing site communication.
  • These four sites are well known for prior excellent recruitment results exemplifying their capability to enroll eligible patients with infected eczema.