logging in or signing up Key Strategies in Oncology Clinical Research sbroady Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 418 Category: Science & Tech.. License: All Rights Reserved Like it (1) Dislike it (0) Added: March 06, 2011 This Presentation is Public Favorites: 0 Presentation Description This webinar outlines the most critical issues affecting oncology clinical development in the U.S. biopharmaceutical industry and looks at the impact these trends are having on sponsors, investigators, CROs and patients. You’ll also learn about a breakthrough strategy that is changing the way sponsors conduct their clinical trials. Comments Posting comment... Premium member Presentation Transcript Slide 1: Key Strategies You Must Know to Survive In today ’ s rapidly changing world of oncology clinical research Denise Deakin President, Scimega ResearchSlide 2: What ’ s Going On In Your Business? Difficulty raising capital? Problems staying within budget? Operational Challenges? What are others doing to succeed?Slide 3: Helping You Improve Results Breakthrough strategy Change the way you conduct trials Improved clinical performanceSlide 4: The Big Picture Over $200 billion invested in cancer research since 1971 1 Sharon Begley (2008-09-16). "Rethinking the War on Cancer" . Newsweek . http://www.newsweek.com/id/157548/page/2 .Slide 5: New Cancer Cases Each Year Over 50% survive > 5 years * *American Cancer SocietySlide 6: Oncology Drug Development *Source: PharmaProjectsSlide 7: Cost of Ineffective Medicine Cancer Drugs that have no effect on the patient 1 Jane Theaker, Jennifer Lewis and Marc Egelhofer (November 2010) “ Personalized Healthcare: From Vision To Reality ”Slide 8: Pipeline of Targeted DrugsSlide 9: The Promise of Personalized MedicineSlide 10: Industry Challenges Less investment capital 50% fewer trials since 2008* Double the cost of other therapeutic areas Attrition rates ≈ 4 time higher *Capitalized costs – Paul et al, Nature Rev Drug Discov 2010 * Contract PharmaSlide 11: Clinical Challenges in Oncology More screening procedures More specialized tests i.e. biomarkers More regions & sites needed to access patientsSlide 12: Clinical Challenges in Oncology Greater administrative burden Increased competition for sites Rising start-up costsSlide 13: Clinical Challenges in Oncology Protracted contract & CTA review Longer studies = more patient visits Shortage of CRAs with oncology expertiseSlide 14: Early Phase Clinical Challenges 50% of oncology trials are early phase Need for highly experienced teams & sophisticated equipment Coordination between sponsors & sites is even more criticalSlide 15: Early Phase Clinical Challenges 30% of sites are inactive ($16-20K per site) Need to identify specific patient populations Examine opportunities outside the U.S.Slide 16: Traditional Site Feasibility Process Incomplete study & budget info Not getting specific enrollment projections Not allowing time for proper assessment Requesting Free feasibility assessments Not leveraging investigator database Not explaining site selection criteriaSlide 17: The Patient Recruitment Challenge Less than 50% of trials meet enrollment targets $40,000 for each day a site is open *Applied Clinical Trials, July 1, 2008 “ Is Investigative Site Feasibility Feasible? ”Slide 18: How well is your process working?Slide 19: Continuum of Conversations What represents a greater sense of urgency than unmet needs ? Action Quicker Approvals Quicker FPI Needs More PatientsSlide 20: Reverse Feasibility ™ Program No Sponsor or Investigator FeesSlide 21: www.scimega.com 21 4. Anon (2000). Misconceptions and Low Awareness Slow Recruitment for Cancer Clinical Trials. Harris Interactive. 18 October 2000. 5. Anon (2000). Clinton Orders Medicare Coverage of Clinical Trials. American Cancer Society News Center. 10-24% cancer patient participation rate vs. 3-5% in U.S. 4,5 Canada ’ s Commitment To Patient RecruitmentSlide 22: www.scimega.com 22 1. http://clinicaltrials.gov/ct2/results/map 2. Thiers (2007). Trends in the globalization of clinical trials. Nature Reviews Drug Discovery November 2007 2 nd most Oncology studies in the world 1 3rd most number of studies in the world1 Canada ’ s Commitment To ResearchSlide 23: Investigative Site Information Pertinent experience Capacity Equipment Catchment area Genotyping capabilities IRB requirements/schedule Start-up fees SOC – availability and reimbursement Recruitment openings over next 6 monthsSlide 24: Accelerated Communication With the right investigatorsSlide 25: In-Depth Feasibility Questionnaires Synopsis / Protocol Recruitment number & timelines BudgetSlide 26: Recent Pre-Qualification VisitsSlide 27: Site – Historical Performance DataSlide 28: Free Replacement of Non-Active SitesSlide 29: Legal RequirementsSlide 30: Early Indicators of Accrual Success The time it takes to open a trial and the likelihood of having zero accruals are related* *Cheng S, Dietrich M, Finnigan S, et al Cancer Clin Res (in press)Slide 31: Budget Accuracy Greater accuracy of cost per patient (GIA & CRO)Slide 32: Regional Regulatory Expertise Clinical Trial ApplicationSlide 33: How can you be one of the success stories ? Partner with niche service providers & sites Rethink the traditional site feasibility process Embrace change & turn obstacles into opportunitiesSlide 34: Success Story Challenge: Concern about recruiting enough U.S. pts. Rare solid tumor dose-ranging Phase I/II study Situation: Trial ongoing for 14 months in U.S. Need to mitigate potential recruitment riskSlide 35: Success Story Site 1: Major teaching institution Study start-up: 2.5 months ( protocol receipt to 1st patient in ) IRB: 2 months FPI: 9 days post initiation visit Pt. enrollment: target = 3pts/12 months actual = 3 pts/5 monthsSlide 36: Success Story Site 2: Major teaching institution Study start-up: 3.5 months ( protocol receipt to 1st patient in ) IRB: 3 months FPI: 27 days post initiation visit Pt. enrollment: target = 3 pts/12 months actual = 3 pts/4 monthsSlide 37: Value of The Reverse Feasibility ™ Program “ It worked great for us. We ’ re happy to have found a couple fantastic sites that have been very helpful in meeting our aggressive enrollment timelines. ” - Director of Clinical OperationsSlide 38: Reverse Feasibility ™ ProgramSlide 39: Make Better Strategic Decisions Faster For a list of current study placement needs Contact: Roberto Lara Tel: (450) 629-2200 ext. 26 Email: rlara@scimega.com www.scimega.com You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Key Strategies in Oncology Clinical Research sbroady Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 418 Category: Science & Tech.. License: All Rights Reserved Like it (1) Dislike it (0) Added: March 06, 2011 This Presentation is Public Favorites: 0 Presentation Description This webinar outlines the most critical issues affecting oncology clinical development in the U.S. biopharmaceutical industry and looks at the impact these trends are having on sponsors, investigators, CROs and patients. You’ll also learn about a breakthrough strategy that is changing the way sponsors conduct their clinical trials. Comments Posting comment... Premium member Presentation Transcript Slide 1: Key Strategies You Must Know to Survive In today ’ s rapidly changing world of oncology clinical research Denise Deakin President, Scimega ResearchSlide 2: What ’ s Going On In Your Business? Difficulty raising capital? Problems staying within budget? Operational Challenges? What are others doing to succeed?Slide 3: Helping You Improve Results Breakthrough strategy Change the way you conduct trials Improved clinical performanceSlide 4: The Big Picture Over $200 billion invested in cancer research since 1971 1 Sharon Begley (2008-09-16). "Rethinking the War on Cancer" . Newsweek . http://www.newsweek.com/id/157548/page/2 .Slide 5: New Cancer Cases Each Year Over 50% survive > 5 years * *American Cancer SocietySlide 6: Oncology Drug Development *Source: PharmaProjectsSlide 7: Cost of Ineffective Medicine Cancer Drugs that have no effect on the patient 1 Jane Theaker, Jennifer Lewis and Marc Egelhofer (November 2010) “ Personalized Healthcare: From Vision To Reality ”Slide 8: Pipeline of Targeted DrugsSlide 9: The Promise of Personalized MedicineSlide 10: Industry Challenges Less investment capital 50% fewer trials since 2008* Double the cost of other therapeutic areas Attrition rates ≈ 4 time higher *Capitalized costs – Paul et al, Nature Rev Drug Discov 2010 * Contract PharmaSlide 11: Clinical Challenges in Oncology More screening procedures More specialized tests i.e. biomarkers More regions & sites needed to access patientsSlide 12: Clinical Challenges in Oncology Greater administrative burden Increased competition for sites Rising start-up costsSlide 13: Clinical Challenges in Oncology Protracted contract & CTA review Longer studies = more patient visits Shortage of CRAs with oncology expertiseSlide 14: Early Phase Clinical Challenges 50% of oncology trials are early phase Need for highly experienced teams & sophisticated equipment Coordination between sponsors & sites is even more criticalSlide 15: Early Phase Clinical Challenges 30% of sites are inactive ($16-20K per site) Need to identify specific patient populations Examine opportunities outside the U.S.Slide 16: Traditional Site Feasibility Process Incomplete study & budget info Not getting specific enrollment projections Not allowing time for proper assessment Requesting Free feasibility assessments Not leveraging investigator database Not explaining site selection criteriaSlide 17: The Patient Recruitment Challenge Less than 50% of trials meet enrollment targets $40,000 for each day a site is open *Applied Clinical Trials, July 1, 2008 “ Is Investigative Site Feasibility Feasible? ”Slide 18: How well is your process working?Slide 19: Continuum of Conversations What represents a greater sense of urgency than unmet needs ? Action Quicker Approvals Quicker FPI Needs More PatientsSlide 20: Reverse Feasibility ™ Program No Sponsor or Investigator FeesSlide 21: www.scimega.com 21 4. Anon (2000). Misconceptions and Low Awareness Slow Recruitment for Cancer Clinical Trials. Harris Interactive. 18 October 2000. 5. Anon (2000). Clinton Orders Medicare Coverage of Clinical Trials. American Cancer Society News Center. 10-24% cancer patient participation rate vs. 3-5% in U.S. 4,5 Canada ’ s Commitment To Patient RecruitmentSlide 22: www.scimega.com 22 1. http://clinicaltrials.gov/ct2/results/map 2. Thiers (2007). Trends in the globalization of clinical trials. Nature Reviews Drug Discovery November 2007 2 nd most Oncology studies in the world 1 3rd most number of studies in the world1 Canada ’ s Commitment To ResearchSlide 23: Investigative Site Information Pertinent experience Capacity Equipment Catchment area Genotyping capabilities IRB requirements/schedule Start-up fees SOC – availability and reimbursement Recruitment openings over next 6 monthsSlide 24: Accelerated Communication With the right investigatorsSlide 25: In-Depth Feasibility Questionnaires Synopsis / Protocol Recruitment number & timelines BudgetSlide 26: Recent Pre-Qualification VisitsSlide 27: Site – Historical Performance DataSlide 28: Free Replacement of Non-Active SitesSlide 29: Legal RequirementsSlide 30: Early Indicators of Accrual Success The time it takes to open a trial and the likelihood of having zero accruals are related* *Cheng S, Dietrich M, Finnigan S, et al Cancer Clin Res (in press)Slide 31: Budget Accuracy Greater accuracy of cost per patient (GIA & CRO)Slide 32: Regional Regulatory Expertise Clinical Trial ApplicationSlide 33: How can you be one of the success stories ? Partner with niche service providers & sites Rethink the traditional site feasibility process Embrace change & turn obstacles into opportunitiesSlide 34: Success Story Challenge: Concern about recruiting enough U.S. pts. Rare solid tumor dose-ranging Phase I/II study Situation: Trial ongoing for 14 months in U.S. Need to mitigate potential recruitment riskSlide 35: Success Story Site 1: Major teaching institution Study start-up: 2.5 months ( protocol receipt to 1st patient in ) IRB: 2 months FPI: 9 days post initiation visit Pt. enrollment: target = 3pts/12 months actual = 3 pts/5 monthsSlide 36: Success Story Site 2: Major teaching institution Study start-up: 3.5 months ( protocol receipt to 1st patient in ) IRB: 3 months FPI: 27 days post initiation visit Pt. enrollment: target = 3 pts/12 months actual = 3 pts/4 monthsSlide 37: Value of The Reverse Feasibility ™ Program “ It worked great for us. We ’ re happy to have found a couple fantastic sites that have been very helpful in meeting our aggressive enrollment timelines. ” - Director of Clinical OperationsSlide 38: Reverse Feasibility ™ ProgramSlide 39: Make Better Strategic Decisions Faster For a list of current study placement needs Contact: Roberto Lara Tel: (450) 629-2200 ext. 26 Email: rlara@scimega.com www.scimega.com