The Advantages of Translational Research Methodology

Applying basic research knowledge to practical applications is a well-known obstacle to?progress?in science. This issue is seen most often in medical science. There is often a lag between emerging scientific findings and their application as treatments to patients who may benefit from them.Translational research is aimed at taking basic science? research to the next level.?It connects new discoveries to application in patients.

Multidisciplinary Collaboration
There are four basic steps to consider in this research tactic.

  • Development of techniques to translate new knowledge generated in a lab environment, or at the bench level, to human testing
  • Refinement of human study results for? clinical use
  • Transference of practices from academic medical centers to use in the care of patients in community practice
  • Continued evaluation of data from the previous steps to provide confirmation of the efficacy and tolerability of new therapies

The goal of translational research is to quicken the transition from the lab to the patients who may benefit from the basic science findings. Thus translational research is a collaborative effort among basic researchers, academic physicians and community health professionals to provide new treatments to appropriate patient populations.

Funding Options
Translational research can potentially expand the funding options for a project.

  • Researchers benefit by working with a center that is able to provide seed funding. They reduce overall project costs by utilizing basic science center personnel for development of new therapies that then can be applied to patients in the community..
  • For universities, setting up a translational research center is a tactical approach to improving funding options. Through the research center, academic organizations develop strategic plans to provide improvements in public health benefitting overall community.
  • Communities benefit by gaining a stake in the study. The community becomes a contributing member of innovative medical research.

Stoking Excitement in a Field of Study
The developing barriers between research and clinical applications tend to dim interest in research projects. Moving towards a translational approach expands these possibilities. The power to take new knowledge from the bench to a clinic setting and then back to the bench for analysis lifts some of the impediments to expanding interest in a project.

Translational Science Research

Physicians in the community are able to see
basic research translated into practical application. A project that was once unapproachable due to time constraints and the complexity of the study boundaries will now draw interest and participation.

Translational research is a bench-to-bedside approach to medical developments. With this two-fold methodology, basic science presents tools to clinicians that have the potential to improve patient care. Clinicians are able to make observations and provide valuable feedback about the progression of disease that will lead to more discoveries. A translational model benefits the community by speeding the application of new research findings to patients and thus drives the clinical research progress at a quicker pace.

The Oncology Consortia of Criterium believes this methodology is the best way to speed results of research to benefit the public – it’s why we say we are “Changing the Way Cancer is Managed”.? Read more about our approach at the Academic GI Cancer Consortium or at the Academic Myeloma Consortia web pages.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 11 Apr 2013 15:07:00 GMT

Quick Takes: the Pharma C-Suite with Mary Stefanzick, Data & Operations Director


mary

 

?The Evolution of the CDL?- The Clinical Data Liaison

The CDL is a role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money.?Criterium has been utilizing the efficiencies of the CDL position since 2001. It is a successful tool we use to streamline our clinical trials.

The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager.? The best of both worlds.?

Within any CRO, a CDL is the link to a successful clinical trial. ?This individual has the ability to influence the three Cs of site management: connect, communicate, and control. This position is key in that he or she conducts real-time data review and facilitates centralized control of data management.?

To really improve the workflow process, the CDL is a clinical and data expert who connects team members ? sites, CRAs, and data managers ? through the use of data collection technologies that are used in a workflow that emphasizes real-time receipt and review. The ultimate benefit of the workflow that is managed through the CDL is to reduce the barriers between monitoring and data management.

Three of the most important reasons to utilize CDL?s in your study:?

REDUCES MONITORING COSTS
The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager. As such, CDL’s are the first to review CRF’s to make sure that the protocol is being followed.?

STREAMLINES DATA PROCESSING
They are responsible for timely review of data safety values, such as SAE’s, AE’s, lab values, and ECG’s that are critical to the safety of the patients; they do this in the context of the overall database. This is especially important, as the field monitor?s perspective is based on the review of individual site visits.


cdl chart for blog

COST SAVINGS
Because CDL’s monitor site data daily, they are able to identify potential problems before they arise thereby reducing the cost of field monitoring per patient by as much as half when compared with traditional monitoring.

Find out more about this efficient and cost-effective method of trial management:

what_cdl

 

 

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 28 Mar 2013 20:33:00 GMT

Quick Takes: the Pharma C-Suite with John Hudak, President Hudak-President

john hudak quote_325We have successfully conducted trials for over 20 years – since 1991.
Criterium?s mission to provide our clients, staff, consultants and sites an extraordinary experience, with integrity.

Our focus, for every client, is simple, and we mean it:? Provide Quality Solutions.? Reduce Costs.? Accelerate Timelines.? It?s the root of our business philosophy.? We respond very quickly to clients from their first contact with us for a bid proposal to every aspect of the projects we win.? Every single person on our staff is aware of these company directives and works towards them.? This is a very real, daily, activity for us, not just words.? When I look ahead at the next twenty years, I am enthusiastic about what lies ahead in this field and committed to establishing better and more efficient ways to support drug development, to cut costs and to improve technology resources directly related to these initiatives.

We offer the broadest range of services in our market niche, because we CAN.? We have staff from all aspects of clinical research experience?? that allows us to do that.? It?s a unique mix of incredibly bright and dedicated people ? I am very fortunate to have them.? As a medium-sized CRO we can be more agile, and have the advantages of moving more quickly than the larger, leviathan CRO?s, starting and completing trials more efficiently, and giving clients a much more personalized, one-on-one experience. Our unique technology-based paradigm allows us to respond to sponsor needs in specific detail and to deploy trials rapidly throughout the world for fast, successful trials.

Our clients are among the top 10 pharma companies to small venture capitalized biotechnology and new formulation companies. They are USA domestic and they are also based in Europe, Israel and Asia. We have worked with generic companies when they need to have bioequivalence studies with clinical endpoints done.? We have a satisfied client list as varied as the therapeutic areas in which we have experience.? Our personalized service experience and ?Get to Know Us!? philosophy has proven to serve our clients well.?

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

John HudakThu, 17 Jan 2013 22:45:00 GMT