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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 ...

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 designsPoor patient accessIntense competitionData 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 trialsSame set-up time large or smallCollection/manipulation of samplesPatient education-personal informationSet-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 trialsThe 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 packageNumber 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 Solving the operational challenges of oncology clinical trials Presentation Transcript

  • EXECUTIVE BRIEF CONTROLLING THE KNOWN VARIABLESStrategies for solving the operational challenges of oncology clinical trials
  • The Promise of Personalized Medicine • Reduce drug failure • Reduce time/cost • Enhance patient participation • Increase number of approvals • Reimbursement of effective drugsTufts CSDD
  • At the 2011 ASCO Meeting we got a glimpse ofwhat the future holds for patients and drugdevelopers.A deeper understanding of the pathwaysgoverning cancer are showing significant resultsin deadly diseases that previously had limitedoptions…
  • Glimpse Into The FutureVemurafenib – A BRAF Inhibitor (ASCO 2011)Targeted: A mutated form of a gene called BRAFfound in more than half of patients with advancedmelanomaTailored: 63% less likely to die over a six-month periodcompared to those taking chemotherapy
  • Where Are We Today? Over 9,000 oncology drugs under evaluation ~16 targets actively studiedSource: TCSDD
  • Where Are We Today?
  • 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 *Over the last 5 yearsTufts CSDD
  • As an industry, we continue to focuson the traditional barriers to oncologyclinical research here in NorthAmerica…
  • Traditional barriers to oncology clinical researchApplied Clinical Trials Live Webcast June 14, 2011
  • New issues as a result of personalized medicine1. Regulatory oversight (implications for R&D)2. Reimbursement (testing & costly treatment)3. Privacy, confidentiality and patient rights
  • Most important issue is the impactPersonalized Medicine will have onyour clinical operations.The goal is to find new ways ofreducing costs by finding the “RightSites” more quickly.
  • A Challenge Often Overlooked• Impact on Clinical Operations  Cost  Site/PI selection  Administrative burden
  • R&D Spending On The Rise• Average cost of R&D is now $2.3 Billion USD
  • Low Approval Rate in Oncology
  • The declining number of NorthAmerican investigators means thatyour ability to find the right sites thatare motivated to work on your trials ismore critical than ever.
  • Declining Number of InvestigatorsSource: FDA’s Bioresearch Monitoring Information System File
  • Increased Administrative BurdenSource: TCSDD
  • Increased WorkloadsSource: Getz et al. Assessing the Impact of Protocol Design Change on Clinical Trial Performance. American Journal ofTherapeutics. 2008 15(5); 450 - 457
  • Personalized medicine adds to therecruitment problem.Need for smaller patient populationsmeans you need to screen morepatients to find enough that are eligiblefor your trial.
  • POSSIBLE SOLUTIONS CONTROLLING THE KNOWN VARIABLES
  • Keys to Success Challenges Solutions• Cost  Strategic Relationships• Site/PI Selection  Identifying Right Sites• Administrative Burden  Optimizing Output
  • Collaboration with Regulatory Agencies• FDA & EMA have created programs to tackle questions surrounding biomarkers & defining endpoints
  • Reducing Costs by Enriching Site Selection• Networks to address “unmet clinical trial needs”• Match investigators with trials of interest
  • Keys To SuccessApplied Clinical Trials Live Webcast June 14, 2011
  • Scimega Research maintains an ongoingdialogue with a network of oncologyinvestigators to identify their study needs.This allows us to match studies to sites thatare motivated to recruit patients and gettrials up and running.
  • SCIMEGA RESEARCH – REVERSE FEASIBILITYTMA new approach to site selection & patient recruitment
  • Investigative Network Information Gathered• Experience • IRB requirements/schedule• Interest • SOC – availability and reimbursement• Facilities • Catchment area• 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 timelines & budget+ Access to pre-approved CDA templates= Immediate, accurate assessment
  • 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
  • About Scimega ResearchScimega Research was founded as a specialty Oncology CRO in 1997 to meet the demand forsuperior 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 coveragebrings tremendous value to its clients. But it’s our privileged relationships with North Americaninvestigative sites that allow us to fulfill our mission of accelerating strategic drug developmentdecisions.To learn more visit us at www.scimega.com LinkedIn Group: Optimizing Oncology Clinical Research