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 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

• 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”).

Conclusion

• 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

• The planning phase
• Roll-Out
• The recruitment phase
• Closing