Solving the operational challenges of oncology clinical trials

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

Solving the operational challenges of oncology clinical trials

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