Clinical Development and Trial Operations


Clinical cost drivers may include trial location, required medical procedures, manufacturing costs and, in some cases, the need to supply a comparator drug.  This report presents trial costs — both overall trial costs and per-patient trial costs — for 22 different therapeutic areas, including cardiovascular, central nervous system, diabetes, and early- and late-stage oncology. Data in this benchmarking study were compiled from primary sources, including surveys and interviews with clinical vice presidents, directors and trial managers.

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Report Details

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

Top Reasons to Buy This Clinical Development And Trial Operations Report

Reduce and Avoid Costly Trial Delays: 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.

Benchmark Clinical Development Costs: Clinical trial costs rise in tandem with healthcare costs, but other market forces also have a profound impact on clinical development investment.  Early-stage trials have shown a dramatic rise in per-patient costs as clinical teams look to collect more data earlier in the drug development process.  Overall trial costs are also rising.  Compare per-patient costs for each drug development phase in 25 therapeutic areas.

Balance In-house Resources with Outsourced Expertise: 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.

Adopt Patient Centric Strategies: The industry’s trend toward patient-centric models has impacted clinical development.  Drug manufacturers now design clinical protocols that center on patients, providing exceptional care and lessening the burden of participating in research.  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.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource.

Excerpt from Clinical Development and Trial Operations

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. Meeting this responsibility means building rigorous safety, efficacy and even health economic endpoints into early-stage trial protocols. This preparation is not something that comes naturally to every clinical team. Scientists are not taught to consider value propositions in their university textbooks. And adding months to a trial protocol to better capture health outcomes data may seem unnecessary and inconsequential to the advancement of science.