Clinical Development and Trial Operations

Protocol Design and Cost per Patient Benchmarks

Clinical Development and Trial Operations


Minimize trial cost and delvelop more efficient clinical operations.

  • Staff trials appropriately using KPIs like patients per CRA and sites per CRA.
  • Use per-patient cost benchmarks to guide budgeting decisions.
  • Adopt a patient-centric approach to protocol design and patient recruitment/retention.
  • Create realistic trial protocols that balance scientific needs and patient needs.
  • Description
  • Additional information


Clinical cost drivers may include trial location, required medical procedures, manufacturing costs and, in some cases, the need to supply a comparator drug. Developed from quantitative and qualitative research, our study contains benchmarks and best practices to overcome major clinical challenges, including trial cost management and patient recruitment delays.

Clinical Development and Trial Operations: Protocol Design and Cost Per Patient Benchmarks

  • Publication Date: November 2013
  • Pages: 221
  • Chapters: 5
  • Metrics: 500+
  • Charts/Graphics: 147

Data have also been split by therapeutic area:

  • Arthritis
  • Autoimmune
  • Cardio & Thrombosis
  • Cardiovascular Diseases
  • Central Nervous System/Neurology
  • Dermatology
  • Diabetes (Type 1)
  • Diabetes (Type 2)
  • Endocrinology/Metabolic Diseases (non-diabetes)
  • Gastroenterology
  • Hematology
  • Immunology/Vaccines (non-Autoimmune)
  • Infectious Diseases
  • Inflammation (General)
  • Mental Health / Psychology
  • Musculoskeletal
  • Oncology (Phase 1-4)
  • Respiratory
  • Rheumatic Diseases/Rheumatology
  • Urology
  • Virology
  • Women's Health

Key performance indicators such as cost per patient, trial duration, patients per clinical research associate (CRA) and patient recruitment and retention are presented for all development phases. Where possible, the data are split across 25 commonly recognized therapeutic areas.

Report Features

The average delay in a clinical trial’s durations is 25% beyond the expected timeline. The report includes recommendations from experienced drug developers and CROs that have implemented best practices for minimizing clinical trial delays, managing non-performing sites and accelerating site initiation and contracting. Furthermore, the report’s data reveal how much time and money companies should invest to not only plan for trial delays, but also to avoid them completely. Compare per-patient costs for each drug development phase in 25 therapeutic areas.

Reason To Buy

Sponsor companies share the need to recruit experienced trial staff to run clinical studies. Several factors — including development phase and therapeutic area — drive trial staffing decisions. The report provides key recommendations for vendor/CRO management. Benchmark your company’s clinical outsourcing performance using detailed metrics for more than 450 trials across multiple therapeutic areas. Use this report to learn how companies improve investigator and site support through patient-centric protocol development. Create understandable and easily implemented protocols that remove large burdens from the patients.

Target Audience

Directors, VPs, global managers and clinical trial managers can benefit from this reports. Findings will help clinical executives minimize trial costs and create realistici trial protocols that balance scientific needs and patient needs.

Chapter Example

The healthcare industry has seen several major shifts over the past five years. Austerity measures have strained the reimbursement climate in many EU countries and caused government payers to scrutinize each new drug like never before. Healthcare reform in the US has the potential to add coverage for 30 million uninsured Americans. As a result, pharmaceutical companies must work even harder to gain favorable formulary placement with private payers. While there are several regional differences, one thing is universal: regulators and payers want more data. With the stakes raised, the value of that data has never been higher. For a new drug, regulatory approval is no longer the finish line. Clinical development teams must arm their commercial organizations and market access teams with the most useful data, as early as possible.