Central Challenges for Clinical Trials
90% of all clinical trials are not completed in time.More than a third of study centers do not recruit any patients by the LPFV date.Approx. 60% of all study centers generally miss their recruitment targets for clinical trials.
A much higher investment in the study process than plannedSignificant increases in the cost of gaining approval for a drug andA large loss of market revenue as a result of this increase
Situation and Background
An unnecessarily complex study design reduces too often the patient clientele from the very beginning.
A lack of acceptance of protocols e.g., for background transparency has a demotivating effect on study centers.Oftentimes study centers are not integrated into the planning of the operative process.The quality of selection in study countries/centers is generally not oriented on real/realistic patient potential.The communication strategy for the study offers no added value for patients and study centers in their competitive environment (competing trials and approved medications).In many cases contracts with study centers are non-binding.The training of centers at the beginning of a study (and also partner CROs) in Initiation Visits or Investigator Meetings is often only focused on aspects of study protocols. Recruitment is seldom thematized.There is generally no segment-specific support of centers through sponsors or CROs (“Site Life Cycle”).
All cost drivers for a clinical trial depend on the quality of the planning phase.Deficits in planning qualities manifest themselves in higher additional investments, which can then only be purely reactive – (“Reparations are always more expensive than prevention,” Investigator from North America).Delayed “Time-to-Market” is an additional negative effect.
Ways to solve the Dilemma
In order to make your clinical trial globally successful, primus consulting group offers a unique service portfolio to support you in:
The planning phaseRoll-OutThe recruitment phaseClosing
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