Purpose: The purpose of this FOEM demonstration project is to promote Osteopathic emergency medicine clinical research by forming a multi-residency network that will enhance our ability to access pharmaceutical company (Pharma) grant funding for Phase III and post-market clinical studies directly from the pharmaceutical industry leaders or indirectly through companies (Contract Research Organizations or CRO’s) that work with pharmaceutical companies to conduct studies for them. During the last 10 years, ACOEP has seen a dramatic transformation in the development of a resident research culture with widespread interest and productivity through adoption of a mandatory research requirement for residency graduation and demonstration of competency. A competitive spirit among residencies has developed that drives quality research and productivity in the form of the resident annual paper competition, oral presentations, posters, and abstracts presented at the ACOEP Scientific Assembly and Spring Seminar. It is the vision of FOEM that the American College of Osteopathic Emergency Physicians (ACOEP) can, through its residency training programs, achieve the next level of excellence by establishing a growing research presence on a national level. This can be accomplished in two ways. First, by providing opportunities for multi-center studies developed by our resident/core faculty research teams in a single institution and disseminated to one or more residencies for more rapid acquisition of quality data. Secondly, providing a venue for Pharma and CRO’s to conduct multi-center trials within our research network hospital systems. During a time when our healthcare system faces a shrinking financial base, a more cost effective, austere approach to clinical research has developed within the pharmaceutical and medical device industry. With less research funding available, The FOEM Research Network can be a very attractive cost effective tool for pharmaceutical companies and contract research organizations (CRO’s) to use for the following reasons:
Our 52 residency programs provide geographically heterogeneous patient populations avoiding regional bias;
Pharmaceutical, medical device companies and CRO’s who utilize the network rather than with multiple small institutions would experience significant cost reduction for expenses incurred by contracting directly with individual residencies.
Procedure and Process: Residencies would share in the grant revenue based on the number of patients they successfully entered into the study protocols and calculated by a percentage of the total grant. For instance, a CRO might pay $3000 per patient to the network for each subject properly entered in the study and protocol objectives achieved... The network would then pay the participating residency $3000 minus an administrative fee to cover expenses for maintenance of the research network and a contribution to FOEM to expand individual research grants under the current model. There would be some monetary support given to residencies for participation in the network derived from grant seed money when part of the research source’s contract. It is anticipated that research grant revenue would be used for residency educational enhancements and faculty development.
In addition to pharmaceutical company grant procurement, the network concept could potentially stimulate larger NIH grants through its ability to study large numbers of patients. It is consistent with the Graduate Medical Education (GME) approach to overall improvement of “Community Health” rather than the traditional clinic model approach to treating single patients. The “Community Health Integrity Model” is ideal for Emergency Medicine research that involves screening for disease incidence, frequency, and severity. The Hospital Emergency Department (ED) has evolved into the safety net under EMTALA for the insured and uninsured population, and does it cost effectively. The ED also acts like an epidemiologic window to the community because it triages and treats large numbers of patients in a captive setting, and can perform disease incidence screening that potentially could have a long-term effect on overall community health, disease prevention, and health promotion. The NIH is interested in giving grants for translational research involving large population-based studies. In addition, community based integrated education for medical postgraduate trainees as a curriculum model enhancement, could be satisfied by doing community research screening projects sanctioned and funded by the government agencies such as CDC, NIH, and AHRQ.
The creation of the FOEM Research Network would involve the establishment of:
A. Close working relationship between research directors and PD’s from each residency program.
B. A computerized patient profile databank segregated by discharge diagnosis compiled from each separate residency’s treatment totals.
C. A participating institution database with detailed demographics and demonstration of research pedigree where it already exists
D. Designated pharmaceutical company liaison representatives assigned from groups of interested research directors to contact and or visit targeted companies to promote the network and solicit studies on behalf of the network. The regional liaison representatives would be chosen on their experience and success in acquiring grants in the past for their own residency and proximity geo-graphically to areas of high pharmaceutical company density, for instance, Northern New Jersey, Wilmington, Delaware, and the Research Triangle in North Carolina, etc.
The concept of a FOEM Research Network, allows small residencies with less capital resources to benefit in several ways by their participation. This would be able to participate in clinical studies that could not have acquired if they solicited them as a single residency applicant. Their residents would benefit by a structured research program that is enhanced by residents participating in national protocols. Please be assured that the Research Network will not negatively impact residency programs with established research grant pipelines but will only serve to enhance their revenue with additional research opportunities.
Based on the success of the Research Network, a portion of the revenue generated will be donated to the grant funds of the Foundation for Osteopathic Emergency Medicine.
The following organizational diagram identifies the network’s primary division of labor and responsibility.
FOEM Research Network Structure
FOEM Research Project Residency Research Pharmaceutical Company
Coordinator (A) Directors (B) Liaison (D) from Regions
Medical-Legal and Contract
Execution (F) Fund Collection & Disbursement Director (E)
A. Assures studies at individual institutions are being approved by individual institutions IRBs, works Through Residency Research Directors, compiles statistics on national patient aggregate yearly totals, insures individual residency research profile documentation.
B. Gets IRB approval at individual institutions; insures study is done in timely fashion with resident involvement.
C. Designee of FOEM, reviews official protocols for quality of study.
D. Visits or contacts pharmaceutical companies, promotes network and procures quality grants.
E. Assures grant money is collected from companies at completion of studies. Disburses grant monies to individual residencies based on patient involvement.
F. Medical/Legal evaluation, legal review of contract, indemnification letter, etc.
Pharmaceutical companies and CRO’s spend a lot of time searching for prospective sites for their phase 3 and phase 4 clinical trials nationwide usually relying ultimately on a small cadre of client institutions based on successful execution of previous studies and protocols as well as respected investigators. Repetitive use of the same study institutions runs the risk of introducing selection bias into the data.
When FOEM approaches pharmaceutical or medical device companies to make financial commitments to the foundation to fund research by residents and young investigators or to fund faculty development within the profession, a value added benefit can now be offered free of charge. Each funding entity will have unlimited access to demographics and site description databases of members of the FOEM Research Network involving more than 45 hospitals with emergency medicine residency programs. This cost effective approach to study site selection will be a valuable asset to Pharma and CRO’s interested in single site or multicenter trials. Mining site selection data can be a cumbersome and costly exercise that delays the start of a study, and prevents potentially valuable treatment regimens from reaching patients in a timely manner. The effect on market timing of the introduction of a new drug or device could also determine the successful return on investment and future funding of new research.