CONTROLLING THE KNOWN VARIABLES
Strategies for solving the operational challenges of oncology clinical trials
EXECUTIVE BR...
The Promise of Personalized Medicine
• Reduce drug failure
• Reduce time/cost
• Enhance patient participation
• Increase n...
At the 2011 ASCO Meeting we got a glimpse of
what the future holds for patients and drug
developers.
A deeper understandin...
Glimpse Into The Future
Vemurafenib – A BRAF Inhibitor (ASCO 2011)
Targeted: A mutated form of a gene called BRAF
found in...
Where Are We Today?
Over 9,000 oncology drugs under evaluation
~16 targets
actively
studied
Source: TCSDD
Where Are We Today?
Impact of Personalized Medicine on Clinical
Trials
• 94% of companies investing in personalized
medicine
• 50% of compound...
As an industry, we continue to focus
on the traditional barriers to oncology
clinical research here in North
America…
Traditional barriers to oncology clinical research
Applied Clinical Trials Live Webcast June 14, 2011
New issues as a result of personalized medicine
1. Regulatory oversight (implications for R&D)
2. Reimbursement (testing &...
Most important issue is the impact
Personalized Medicine will have on
your clinical operations.
The goal is to find new wa...
• Impact on Clinical Operations
 Cost
 Site/PI selection
 Administrative burden
A Challenge Often Overlooked
• Average cost of R&D is now $2.3 Billion USD
R&D Spending On The Rise
Low Approval Rate in Oncology
The declining number of North
American investigators means that
your ability to find the right sites that
are motivated to...
Declining Number of Investigators
Source: FDA’s Bioresearch Monitoring Information System File
Increased Administrative Burden
Source: TCSDD
Source: Getz et al. Assessing the Impact of Protocol Design Change on Clinical Trial Performance. American Journal of
Ther...
Personalized medicine adds to the
recruitment problem.
Need for smaller patient populations
means you need to screen more
...
POSSIBLE SOLUTIONS
CONTROLLING THE KNOWN VARIABLES
Challenges
• Cost
• Site/PI Selection
• Administrative Burden
Solutions
 Strategic Relationships
 Identifying Right Site...
• FDA & EMA have created programs to tackle
questions surrounding biomarkers & defining
endpoints
Collaboration with Regul...
• Networks to address “unmet clinical trial
needs”
• Match investigators with trials of interest
Reducing Costs by Enrichi...
Applied Clinical Trials Live Webcast June 14, 2011
Keys To Success
Scimega Research maintains an ongoing
dialogue with a network of oncology
investigators to identify their study needs.
Thi...
SCIMEGA RESEARCH – REVERSE FEASIBILITYTM
A new approach to site selection & patient recruitment
Investigative Network Information Gathered
• Experience
• Interest
• Facilities
• Recruitment openings over
next 6 months
...
The Value of Privileged Relationships
Benefits To You
+ Accelerated communication with the right investigators
+ Protocol synopsis, recruitment target and timel...
CONCLUSION
Are you controlling your known variables ?
SPEAK TO US TODAY ABOUT YOUR SITUATION
Contact Roberto Lara at (450)...
About Scimega Research
Scimega Research was founded as a specialty Oncology CRO in 1997 to meet the demand for
superior cl...
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Solving the operational challenges of oncology clinical trials

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This executive briefing explores new strategies for solving your oncology clinical operations challenges. It also features valuable insights into how you can enrich your site selection, speed up your start-up times and maximize patient recruitment opportunities here in North America.

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  • Creative thinking on how to silence the background noise inherent to clinical development, so as an industry we can keep the focus on mastering personalized medicine for a better tomorrow.
  • Drug failure = better understanding from the onset of who is likely to benefit and experience acceptable side effects .
    Based on greater precision, we are likely to see the size of trials decrease while the number increases.
    The use of bio-markers and companion diagnostics to support acceptable surrogate endpoints will reduce time and cost.
    Being armed with the genetic and epigenetic information of a patient means a more efficient deployment of patients to clinical trials and will likely mean increased interest in participation on behalf of patients. The NCIC recently published data indicating that only 1% of adult cancer patients is participating in trials down from a the previous statistic of 2-6%.
    With the support of regulatory agencies such as the FDA, drug developers will be poised to see a greater number of approvals. Albeit for rarer indications and representing smaller markets, this is likely to be a welcome change for companies fighting for a small share of a large market.
    Review argument for reimbursement

  • At the 2011 ASCO Meeting, we were presented with a glimpse of what the future holds for patients and drug developers, as a deeper understanding of the pathways governing cancer begin to show significant results in deadly diseases that previously had limited options.
  • Today there are over 9,000 oncology drugs and biologics under evaluation that are about to enter or are already in the clinical setting.
    Among the thousands of compounds currently under development, however, there are only about 16 targets actively being studied with two thirds of those projects focused on only a handful of targets and target families.
  • Today there are over 9,000 oncology drugs and biologics under evaluation that are about to enter or are already in the clinical setting.
    Among the thousands of compounds currently under development, however, there are only about 16 targets actively being studied with two thirds of those projects focused on only a handful of targets and target families.
  • As an industry we continue to focus on the traditional barriers to oncology clinical research here in North America:
    Complex trial designs
    Poor patient access
    Intense competition
    Data homogeneity.
  • However, it is also important we consider new issues that will crop up as a result of a shift towards personalized medicine:
    The need for a strong intellectual property system to stimulate investment in innovation
    The need for competent regulatory bodies to engage in discussion and debate with industry about the implications for drug development and regulatory review
    Reimbursement and how the industry should deal with the increased requirements for testing and costly treatment
    Patient safety & protection to rebuild public confidence
  • And most importantly, the impact that personalized medicine will have on your clinical operations.
    The goal is to find new ways of reducing costs by finding the “right sites” more quickly, so as to lessen the administrative burden that micro-population trials will bear on a system that is already in need of repair.

    Large volume of smaller scale trials
    Same set-up time large or small
    Collection/manipulation of samples
    Patient education-personal information

    Set-up includes the following administrative tasks: protocol review, investigator brochure, informed consent, IRB submission, CTA agreement, CRF review, EDC specifics, investigator meeting, kick-off meeting. Many sites already overburdened.

    Have you given enough thought to the impact this will have at the site level?

  • The declining number of North American investigators means the importance of finding the right sites that are motivated to work on your trials is more critical than ever.
  • The average number of investigators per active IND has steadily increased since 1997. Meanwhile, the number of patients per NDA has dropped significantly.
  • Personalized medicine exacerbates the recruitment problem. Imagine a trial that targets two kinases, one of which is mutated in 25% of patients, and the other of which is mutated in 8%. You’d have to screen about 50 patients to find one eligible for the trial.
    We are already noticing a rise in the number of compounds seeking Phase II registration trials
    The need for smaller patient populations may convince drug developers to mitigate IP risks by staying in North America.
  • In this transitional period things may get worse before they get better.
  • Rather than soliciting sites only when there is a sponsor request, Scimega leverages their privileged site relationships by engaging in ongoing dialogue with our network of oncology investigators to identify their study needs.
    This allows us to match studies to sites that are motivated to recruit patients and get trials up and running as soon as possible.
  • The performance stats in Figure 7 show how, through a collaborative approach, Scimega has been able to keep North American Clinical Operations extremely competitive. Simply by identifying the right sites we are able to exceed the recruitment potential of any region.

    9 months to approval but these data are skewed by many years of service we provided with a traditional approach.

    CSP = clinical study package
    Number sites/Number of patients?
  • Accelerated communication with the right investigators to uncover preliminary matches
    Protocol synopsis, recruitment target and timelines as well as a budget then completes the process.
    With this important pre-requisite information, sponsors receive an immediate, accurate assessment.
    Knowing each investigative site’s strengths and particular challenges puts you in the driver’s seat.
    Having access to pre-approved CDA templates and contract “deal breaker” clauses for rapid approval also shaves off critical time by assuring sponsors meet the institution’s standards first time around.
  • The foundation is being laid for a healthcare system in which data will flow freely among all stakeholders, enabling researchers, clinicians, and patients to interact in new and more productive ways.

    Innovative efforts and initiatives provide a tremendous amount of hope for the future, but as a sponsor you need to ensure you maximize the variables you can control by turning obstacles into opportunities for competitive advantage.

    Personalized medicine is complex. Take your mind off what can be controlled and focus where you will get the best return.
  • The foundation is being laid for a healthcare system in which data will flow freely among all stakeholders, enabling researchers, clinicians, and patients to interact in new and more productive ways.

    Innovative efforts and initiatives provide a tremendous amount of hope for the future, but as a sponsor you need to ensure you maximize the variables you can control by turning obstacles into opportunities for competitive advantage.

    Personalized medicine is complex. Take your mind off what can be controlled and focus where you will get the best return.
  • Solving the operational challenges of oncology clinical trials

    1. 1. CONTROLLING THE KNOWN VARIABLES Strategies for solving the operational challenges of oncology clinical trials EXECUTIVE BRIEF
    2. 2. The Promise of Personalized Medicine • Reduce drug failure • Reduce time/cost • Enhance patient participation • Increase number of approvals • Reimbursement of effective drugs Tufts CSDD
    3. 3. At the 2011 ASCO Meeting we got a glimpse of what the future holds for patients and drug developers. A deeper understanding of the pathways governing cancer are showing significant results in deadly diseases that previously had limited options…
    4. 4. Glimpse Into The Future Vemurafenib – A BRAF Inhibitor (ASCO 2011) Targeted: A mutated form of a gene called BRAF found in more than half of patients with advanced melanoma Tailored: 63% less likely to die over a six-month period compared to those taking chemotherapy
    5. 5. Where Are We Today? Over 9,000 oncology drugs under evaluation ~16 targets actively studied Source: TCSDD
    6. 6. Where Are We Today?
    7. 7. Impact of Personalized Medicine on Clinical Trials • 94% of companies investing in personalized medicine • 50% of compounds in development qualify as personalized • 75%* increase in funding for targeted therapies Tufts CSDD *Over the last 5 years
    8. 8. As an industry, we continue to focus on the traditional barriers to oncology clinical research here in North America…
    9. 9. Traditional barriers to oncology clinical research Applied Clinical Trials Live Webcast June 14, 2011
    10. 10. New issues as a result of personalized medicine 1. Regulatory oversight (implications for R&D) 2. Reimbursement (testing & costly treatment) 3. Privacy, confidentiality and patient rights
    11. 11. Most important issue is the impact Personalized Medicine will have on your clinical operations. The goal is to find new ways of reducing costs by finding the “Right Sites” more quickly.
    12. 12. • Impact on Clinical Operations  Cost  Site/PI selection  Administrative burden A Challenge Often Overlooked
    13. 13. • Average cost of R&D is now $2.3 Billion USD R&D Spending On The Rise
    14. 14. Low Approval Rate in Oncology
    15. 15. The declining number of North American investigators means that your ability to find the right sites that are motivated to work on your trials is more critical than ever.
    16. 16. Declining Number of Investigators Source: FDA’s Bioresearch Monitoring Information System File
    17. 17. Increased Administrative Burden Source: TCSDD
    18. 18. Source: Getz et al. Assessing the Impact of Protocol Design Change on Clinical Trial Performance. American Journal of Therapeutics. 2008 15(5); 450 - 457 Increased Workloads
    19. 19. Personalized medicine adds to the recruitment problem. Need for smaller patient populations means you need to screen more patients to find enough that are eligible for your trial.
    20. 20. POSSIBLE SOLUTIONS CONTROLLING THE KNOWN VARIABLES
    21. 21. Challenges • Cost • Site/PI Selection • Administrative Burden Solutions  Strategic Relationships  Identifying Right Sites  Optimizing Output Keys to Success
    22. 22. • FDA & EMA have created programs to tackle questions surrounding biomarkers & defining endpoints Collaboration with Regulatory Agencies
    23. 23. • Networks to address “unmet clinical trial needs” • Match investigators with trials of interest Reducing Costs by Enriching Site Selection
    24. 24. Applied Clinical Trials Live Webcast June 14, 2011 Keys To Success
    25. 25. Scimega Research maintains an ongoing dialogue with a network of oncology investigators to identify their study needs. This allows us to match studies to sites that are motivated to recruit patients and get trials up and running.
    26. 26. SCIMEGA RESEARCH – REVERSE FEASIBILITYTM A new approach to site selection & patient recruitment
    27. 27. Investigative Network Information Gathered • Experience • Interest • Facilities • Recruitment openings over next 6 months • IRB requirements/schedule • SOC – availability and reimbursement • Catchment area
    28. 28. The Value of Privileged Relationships
    29. 29. Benefits To You + Accelerated communication with the right investigators + Protocol synopsis, recruitment target and timelines & budget + Access to pre-approved CDA templates = Immediate, accurate assessment
    30. 30. CONCLUSION Are you controlling your known variables ? SPEAK TO US TODAY ABOUT YOUR SITUATION Contact Roberto Lara at (450) 629-2200 ext. 226 or rlara@scimega.com
    31. 31. About Scimega Research Scimega Research was founded as a specialty Oncology CRO in 1997 to meet the demand for superior clinical trial management services in the complex field of oncology clinical research. The company’s depth of oncology expertise and ability to offer full North American coverage brings tremendous value to its clients. But it’s our privileged relationships with North American investigative sites that allow us to fulfill our mission of accelerating strategic drug development decisions. To learn more visit us at www.scimega.com LinkedIn Group: Optimizing Oncology Clinical Research
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