Phase I Clinical Trials

Optimizing Clinical Pharmacology Programs

Phase I Clinical Trials

$995.00

Use this report to address the major factors behind uncertainty in the management of Phase 1 clinical trials. Navigate key cost-drivers, including number of patients, patient visits, trial duration and specialty trial requirements. Data show total trial costs, per-patient costs and per-patient visit costs across 10 key therapeutic areas, including oncology and central nervous system. Balance in-house and vendor capabilities to increase patient recruitment, and analyze staffing metrics, including sponsor headcounts, for 25 Phase 1 trials across therapeutic areas. Lastly, follow strategic recommendations for vendor selection and management

  • Description
  • Additional information

REPORT HIGHLIGHTS

 

Cost-Drivers of Phase-I Trials: Optimizing Clinical Pharmacology Programs

  • Publication Date: January 2013
  • Pages: 112
  • Chapters: 4
  • Metrics: 500+
  • Charts/Graphics: 70+

Therapeutic area data split:

  • Oncology (12 trials)
  • Cardiology (3)
  • CNS (5)
  • Gastroenterology (3)
  • Women’s Health (2)
  • Diabetes (type 2) (1)
  • Rheumatology (1)
  • Respiratory (1)
  • Infectious Disease (1)
  • Endocrinology (1)
Report Features

Use this report to address the major factors behind uncertainty in Phase I trial management. Its benchmarks and best practices explore Phase I clinical team resources, trial timelines, challenges and vendor management. Phase I is a pivotal step in a compound’s journey toward regulatory approval, as
clinical teams shepherd each new wave of investigational medicines toward largescale trials.

Reason to Buy

Examine benchmarks detailing total trial costs, per-patient costs and per-patient visit costs across 10 key therapeutic areas, including oncology and central nervous system. Set defined milestones and explore phase one clinical trials duration data for each stage of the process, and draw on executives’ strategies for keeping ahead of schedule. Balance in-house and vendor capabilities to increase patient recruitment, and analyze staffing metrics, including sponsor headcounts, for 25 Phase one clinical trials across therapeutic areas. Lastly, follow strategic recommendations for vendor selection and management.

Target Audience

Drug company executives involved in the following areas should consider purchasing this report:
– Vice president of clinical operations
– Clinical development directors/managers
– Clinical operations directors/managers
– Toxicology scientists
– Preclinical research managers

Chapter Example

The pharmaceutical industry is feverishly searching for the next big drug to replace lost revenue from blockbuster medicines’ patent expirations. Drugs with more than $30 billion in annual revenue lost patent protection in the last two years. Patent expirations — and the accompanying lost revenue — place great strain on all areas of the company. Much of that burden falls to clinical development teams charged with ushering investigational medicines to market. Phase 1 is an important step for investigational compounds on the journey to regulatory approval. But Phase 1 trials are not as straightforward as they once were.

The rapid expansion of clinical development into oncology and orphan diseases has altered the otherwise predictable Phase 1 protocol design process. The ability to test for safety and efficacy in actual patients can speed up a product’s overall clinical development, but it also radically alters Phase 1 timetables and cost models. Patient recruitment, typically not an impediment for Phase 1 trials with healthy subjects, becomes an immediate concern for drugs seeking fast-track approval. Trial managers must add investigator sites or amend the protocol if patient enrollment stalls.