"I do not know what I may appear to the world; but to myself I seem to
have been only like a boy playing on the sea-shore, and diverting myself
in now and then finding a smoother pebble or a prettier shell than
ordinary, whilst the great ocean of truth lay all undiscovered before
me. " - Isaac Newton
Through its partnerships, the ISM will be positioned to effectively leverage
the need for improved collaboration in clinical trials between private
industry, public institutions, and government agencies. This network is
intended to speed the introduction of new medical treatments by breaking
down political, organizational, and commercial obstacles that can be
associated with their development. Additionally, the collaborative clinical
research model will be an essential component of the regional economic
landscape, benefiting several groups within the community including clinical
research sites and patients.
Sites
In general, new therapeutics and diagnostics have resulted in improved
health status of the U.S. and the world. Clinical research provides a
mechanism for sites to provide these advances to patients earlier, through
the clinical trial and for quicker adoption of the product once it receives
FDA approval, since the site already has experience with it.
Secondly, clinical research stimulates the organization to translate
clinical questions into protocols that can improve clinical care. Based on
anecdotal evidence from both academic medical centers and community
hospitals, internally-develop research protocols have provided opportunities
for trainees, resulted in cost savings, and increased the national
reputation of the organization through presentations of the results.
In addition to innovation, there are other more direct benefits of
conducting clinical research. For example, sites can generate additional
revenue with the increased flow of patients into their organization.
Specifically, patients who are enrolled onto clinical trials often have a
number of procedures and tests performed outside of the clinical research
protocol, which are reimbursable. Additionally, the clinical research
infrastructure can attract additional area physicians into the hospital, who
in turn, bring in additional patients who would have otherwise not come into
the hospital.
Patients
For many patients, clinical trial participation allows for access to
innovative treatments. For life-threatening conditions such as cancer,
advanced heart disease, HIV and others, there is a significant unmet medical
need for effective treatments. For these types of conditions, experimental
treatments may offer the best opportunities for successful care.
Additionally, and as discussed above, patients with access to medical sites
who have conducted clinical trials for FDA approved therapeutics and
diagnostics may have earlier access to such treatments.
Sponsors
As part of the product approval process mandated by the FDA and other
regulatory agencies worldwide, clinical trials must be performed to
establish safety and efficacy. Sponsor organizations must find qualified
physician investigators to participate in these clinical trials and to
enroll patients into the various clinical protocols. The need for qualified
and experienced clinical investigators is a recognized need for the sponsor
industry, with the numbers of experienced investigators declining over the
past 10 years, despite the significant increase in the amount of clinical
research being performed.
Sponsor organizations face significant time and budget pressures to complete
clinical trials quickly and with limited funds. Because of these pressures,
sponsors benefit when large numbers of qualified and experienced
investigators are available to participate in their clinical trials.
Physician investigators who can consistently enroll high numbers of
qualified patients are a precious resource to these sponsor companies.