The high stakes of running an oncology clinical trial

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Unlike other therapeutic trials, oncology trials are more sensitive in nature and require specific clinical expertise to properly manage. Many participants are required to have already undergone front and even second lines of therapy and only if these have failed are they eligible for the experimental and toxic drugs often required in oncology trials. Costs are high, enrollment can be challenging and you are often working with medically-fragile patients. However, when managed properly, effective oncology trials can save lives, generate new revenue streams and make breakthrough discoveries in a challenging therapeutic area.

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The high stakes of running an oncology clinical trial

  1. 1. Click to edit Master title style Click to edit Master title styleThe High Stakes of Running a Successful Oncology Trial David Hinds, MBA Global Project Director CLINIPACE WORLDWIDE
  2. 2. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES Technology-Amplified CRO With our technology-amplified delivery model, sponsors have visibility to make critical decisions around enrollment, site management, data collection, investigator payments, milestone tracking and more. Project Management Site Selection and Global Study Feasibility Clinical Monitoring and Site Management Data Management Biostatistics Medical Management/Monitoring Patient Recruitment Regulatory Services Medical Writing Drug/Device Safety Frictionless Services
  3. 3. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES The Stakes are High…
  4. 4. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES …And Getting Higher
  5. 5. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES Industry is Responding… 652 358 345 326 296 223 155 131 100 99 98 97 94 77 72 50 31 2009 trial starts by therapeutic area Cancer Infectious Diseases Miscellaneous Central Nervous System Hormonal Systems Cardiovascular Musculoskeletal Respiratory Gastrointestinal Genitourinary Dermatology Hematological Immune System Pain Eye and Ear HIV Infections Nephrology Source: clinicaltrial.gov
  6. 6. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES … But the Challenges are Great Source: Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 (Washington, DC: PhRMA, March 2008). RegulatoryAnalysisOperationsDesign
  7. 7. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES We already know Source: CenterWatch 2003, 2005 survey of sites in U.S. Getting it right at start-up can make all the difference
  8. 8. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES Eligibility Criteria Begins with therapeutic understanding Seek input from treating clinicians Evaluate trials in process Remain current with literature review Focus on the primary endpoint Not too stringent Not too relaxed Consider the need for prior tissue samples
  9. 9. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES Placebo-Controlled Trials Traditionally best study design for regulatory Conventional approach Less opportunity for analysis bias Seek to enable placebo-control while building rationale for alternate design Evaluate target sites and countries Access to the appropriate patients Effects on timeline on budget Regulatory perspectives on Placebo-Control
  10. 10. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES The Best Team Trial Success Right Patients Right Structure Right Staff Right Relationships Right Sites (location)
  11. 11. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES Engaging Experts Adaptive Trial design experts Regulatory Biostatistics Operations Work with your Agency(s) Get to know your review division Work with FDA to determine efficacy and safety criteria Seek guidance early and often Find the right CRO to meet your needs  Objectives are not clear Outcomes not well-defined or analyzed  Sample size not properly documented  Missing patients without explanation  Un-blinded analytic changes without explanation  SAEs that are dismissed without description as “inter-current illness”  Sloppiness FDA Red Flags
  12. 12. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES Embracing Technology Own, Use and Understand your Data Start-up Screening / Recruitment Treatment Operations Analysis Organize to leverage technology Adjust your trial as needed in real-time Avoid common operations nightmares
  13. 13. Click to edit Master title style Click to edit Master title style www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES Q&A David Hinds, MBA Global Project Director dhinds@clinipace.com

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