solving the operational challenges of oncology clinical trials
DESCRIPTION
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.TRANSCRIPT
CONTROLLING THE KNOWN VARIABLESStrategies for solving the operational challenges of oncology clinical trials
EXECUTIVE BRIEF
The Promise of Personalized Medicine
• Reduce drug failure
• Reduce time/cost
• Enhance patient participation
• Increase number of approvals
• Reimbursement of effective drugs
Tufts CSDD
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…
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
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 compounds in development qualify as personalized
• 75%* increase in funding for targeted therapies
Tufts CSDD
*Over the last 5 years
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 & costly treatment)
3. Privacy, confidentiality and patient rights
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.
• 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 work on your trials is more critical than ever.
Declining Number of Investigators
Source: FDA’s Bioresearch Monitoring Information System File (BMIS)
Increased Administrative Burden
Source: TCSDD
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
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.
POSSIBLE SOLUTIONS
CONTROLLING THE KNOWN VARIABLES
Challenges
• Cost
• Site/PI Selection
• Administrative Burden
Solutions
Strategic Relationships
Identifying Right Sites
Optimizing Output
Keys to Success
• FDA & EMA have created programs to
tackle questions surrounding biomarkers
& defining endpoints
Collaboration with Regulatory Agencies
• Networks to address “unmet clinical trial
needs”
• Match investigators with trials of interest
Reducing Costs by Enriching Site Selection
Personalized Medicine
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.
This allows us to match studies to sites that are motivated to recruit patients and get trials up and running.
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
• IRB requirements/schedule
• SOC – availability and reimbursement
• Catchment area
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 [email protected]
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