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New Jersey |
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| CRO seeks participants for Clinical Research trials |
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120805102
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Historically, clinical research has been the domain of those physicians with backgrounds steeped in research. Although many doctors were eager to participate in drug company-sponsored studies and have their patients exposed to new treatment options still years away from becoming available on the market, it was a Catch-22: without the experience and practice infrastructure, they and their patients were largely excluded.
Now, Exodon, a New Jersey-based contract research organization (CRO), has created an industry-changing paradigm that allows select physicians in wide-ranging disciplines to participate in clinical research for the first time. Exodon, historically a traditional Phase II neuroscience CRO, is now conducting all phases of clinical trial studies in areas that also include chronic and acute pain disorders, oncology-related illnesses, metabolic
conditions, infectious diseases and ob-gyn problems, as well as other studies.
"For years, clinical research has struggled with a solution to find qualified patients for trials in a cost effective and time efficient manner," said Gerald Tramontano, Ph. D., Director of Clinical Research at Exodon. "This is a reality borne out by the fact that only about 10% of all physicians participate in clinical research and 5,000 to 7,000 patients are often needed to bring a new drug to market."
The Process
Exodon pairs physicians without clinical research training with more seasoned principal investigators, and begins the process of getting them credentialed and started using its new Validate SystemT approach that allows them to quickly start and complete a clinical research trial. The Validate System uses a proprietary method for de-identifying the doctor's medical records, which protects patient confidentiality, and educates the doctor and the staff on how to pre-consent their patients before adding them to Exodon's worldwide clinical research data repository. Participating doctors then have the study delivered to them once they have the patients to satisfy the study's needs.
"The clinical research industry has traditionally following an arcane approach that puts the 'cart before the horse,' leaving patient recruitment, a critical element of the clinical trial's process, for the end," said Dr.Tramontano. "Only after the CRO receives the protocol from the sponsor, does it go to those medical practices it conducts research with, forcing it to scramble to identify those patients who meet the inclusion/exclusion
criteria for the particular study."
This can take a long time, said Dr. Tramontano, and become disappointing both to patients because they may be removed from studies where they don't meet the criteria, and to the CRO and sponsor because of delays and the resultant loss of money. By working with doctors on a day-to-day basis, and utilizing its Validate System - which also works in practices using paper records - Exodon hopes to eliminate these bottlenecks and dropouts, delivering new treatment options to doctors and patients that otherwise would not be available.
The Challenge
"Studies show that the biggest reasons Americans, as well as other patients from around the globe, do not historically participate in clinical trials is because they don't know about them," said Louis Dorio, Vice President of Business Development for Exodon. "The main reason they are unaware is because their doctor is not participating in clinical trials research. By expanding clinical trials outside of traditional medical school and clinical research setting, we have been able to increase the awareness of the
benefits of clinical trials to both doctors and their patients." With the need for patients so great, most studies are delayed. This costs study sponsors hundreds of millions of dollars per study, which ultimately increases the cost of medicine for the consumer. It is estimated that within the neuroscience field alone there are 500 new chemical entities being tested, and that these drugs need to be tested on seven million patients before the FDA can approve them. Compare this to the fact that only one million patients participated in clinical trials across all disciplines in the last year.
To bring into its network of investigators doctors without track records in clinical research, Exodon had to convince sponsors that these sites were "trial ready." To accomplish this, Exodon uses its' Validate System model to validate that the site has pre-consented patients meeting the study's inclusion and exclusion criteria and, so, will not fail the study's screening visit. The CRO also provides necessary site support service to ensure the site is knowledgeable and capable to handle every facet of a clinical trial from negotiating a study's budget to closing out the study.
Study Benefits
Physician reimbursement for clinical research can be lucrative. An Alzheimer's patient, for example, may result in a payment to the participating physician of $12,000, or $1,000 per monthly visit over the course of a year. This can increase to as much as $100,000 for a neurosurgical patient with rare tumors.
"This type of approach is long overdue in the industry and is transforming the process of clinical research," said Dr. Tramontano. "It gives many qualified physicians a chance to step up to the plate for the first time and offers their patients more treatment options, while at the same time expediting the clinical research process."
For more information, call Exodon at 800.581.9022.
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