Central Challenges for Clinical Trials

  • Ninety percent 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.

This leads to:

  • A much higher investment in the study process than planned
  • Significant increases in the cost of gaining approval for a drug and
  • A 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 in 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 phase
  • Roll-Out
  • The recruitment phase
  • Closing

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