Study Funding
This largely is a patient-funded clinical
trial in which costs of testing, drugs, drug administration, and clinical
management, to include treatments for drug side effects, if any, plus
routine patient follow-up and clinical assessment are borne by the patient.
No funding will be accepted from any outside
entity, nor will physicians receive compensation in exchange for referring
patients to the study. This
will ensure that treatments are selected for patients in an individualized
manner and solely on the basis of demonstrated in vitro activity and the
suggestion of the greatest patient benefit.
No treatment will be recommended simply because it happens to serve
the financial or other interests of any pharmaceutical company or research
entity (this occurs often in traditional clinical trials).
If possible, as service to the patient, the Weisenthal Cancer Group
will seek to obtain a recommended drug for free - as a donation from the
manufacturer directly to the patient.
However, there is no guarantee that a specific manufacturer will
agree to do this.
Method of Billing
Participants will be billed for
study-related costs separately by each healthcare entity that provides
services. These costs could
exceed $100,000, depending upon the treatment which is identified as being
the most effective for a specific patient.
Testing and Treatment Design
Fee
The fee which is billed directly to the
patient by Weisenthal Cancer Group is $9,750, payable when initial services
are rendered. This includes
costs for MVV and functional tumor cell profiling testing involving several
different tests. It also
includes individualized design of drug test panels, performed personally by
Dr. Weisenthal, in order to include the widest range of anti-angiogenic
drugs, anti-tyrosine kinase drugs, standard antineoplastic drugs, and where
applicable, biologic response modifying agents, which are appropriate for
each patient. Also included is
individualized treatment design based upon data which are elicited by
testing, including specific agents and administration strategies.
This will also be based upon extensive background research conducted
by Dr. Weisenthal individually for each patient, including mechanisms of
drug activity, potential drug synergies, and cross-resistance and
cross-toxicity properties of drugs under consideration.
Also included are ongoing medical and technical consultation and
coordination of physician services extending throughout the course of the
patient’s treatment, to include communication with surgeons, oncologists
and, where necessary, pharmaceutical companies.
Also included is initial patient consultation.
Insurance
It is expected that Medicare and some
private insurance carriers will reimburse patients for some portions of some
drugs and/or laboratory and medical services received by patients within the
context of the study. However,
patients should anticipate that many costs
for drugs and other services will not be reimbursed by third party payors
and will therefore accrue to the patient.
Administrative Study Costs
Administrative costs of the study to include study monitoring, data collection, analysis, and data management, IRB costs, and other costs not directly related to the patient’s clinical care will not be borne by the patient. Instead these costs will accrue entirely to Weisenthal Cancer Group, which will fund them from its own resources.
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