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Clinical Trials Strategy

STRATEGY FOR CLINICAL TRIALS IN OUR CENTER: OUR STRATEGY

New industry research indicates that conducting a clinical trial in the United States costs nearly twice as much as the same trial in other countries. Global competition for research funding has increased the pressure to successfully manage resources and processes to start trials in a timely fashion, meet participation targets, and limit financial risk to the organization.Best Practices in Research Program Planning plays a crucial role in the economics of clinical trials. Because the clinical trial type and funding source affect the finances of a clinical research program, trial selection should meet the program’s larger strategic and financial goals. To appropriately manage a program’s trial portfolio, senior management considers the components of planning and implementation that include:

Data-Driven Selection of Trials

Understanding which types of trials have the highest probability of patient enrollment is the first step in appropriately managing research costs. Low-accruing research programs have higher per patient costs and a lesser chance of breaking even. Estimating patient accrual to a particular trial is critical and is based on the following criteria:

• Congruity with patient population/needs.
» Analysis of the program’s patient volumes and
community incidence rates.
» Historical accrual rates for the cancer type.

• Ability to accrue.
» Physician interest or ownership of the trial.
» Selection criteria that are reasonable and easy to screen for.

• Availability of resources (e.g., pharmacy staff, administrative staff, principal investigator [PI] time) in relation to the complexity of the protocol.

Once a financial model is developed, it can be used to determine the feasibility of new opportunities, and the management team can monitor the progress of the clinical trials program against the plan.
IMPLEMENTATION: Reducing Administrative Time Inefficient trial operations result in significant financial risk, programs can mitigate this risk by closely monitoring operations through the following mechanisms:

• Set Deadlines for Reviews—Standardizing processes and limiting the number of negotiating loops between parties greatly decreases administrative setup time.
• Use Administrative Staff Effectively—Standardizing training and utilizing central resources reduces administrative labor costs.
• Increase Transparency of Trial Approval and Setup —
The Feedback Loop.

It is imperative to establish a plan with specific goals and build a process that supports the monitoring of targets for program improvement throughout the term of the business plan. The feedback loop will address questions such as:

• How well did the practice PI recruit to the trial?
• Is there an interested patient base?
• Were staffing and budget benchmarks met?
• Did the program receive all funding related to patient accruals?

The answers are used to refine financial projections and performance metrics for future business planning.

The best practices described can reduce costs, increase patient accrual, and ultimately enhance revenue for clinical trials. Achieving financial administration best practices centers on obtaining the highest-quality data for sound decision making, understanding and acting upon it, and then communicating the financial realities of clinical trial choices to physicians and leadership. Good business planning means that an organization can budget to support underfunded studies when deemed strategically important, such as increasing patient access to new treatments that are of clinical value. Deliberate and efficient allocation of available resources ensures that physicians and organizations can continue to fund the research that provides the most benefit to patients and the research community.

ADVANTAGES OF STRATEGIC PLANNING

Strategic Planning, is the tool for change. A key tool for our facility as under –

    • Help to align the resources of the organization to the areas of most beneficial impact.
    • Creates a common understanding of the goals of the organization.
    • Gives clarity about what we want to achieve and how to go about achieving it in order to determine a plan of action for day-to-day operations.
Issues & Challenges
    • Team Science
    • Transparency of funding
    • Compliance with regulations
    • Justification of programs
    • Changes in healthcare
    • Intolerance of legal risk