Compliance Consultants proposes a new inventive model for clinical trials: Sequential Bounded Clinical
Investigations (SBCI). This model is perfectly suited for the new CDRH strengthening initiatives. It
departs significantly from the classic pharmaceutical model using the old "Bell curve". The Bell curve
requires large groups of patients (4500 patients) to eliminate biological diversity.
The SBCI is a model for new form of simplified, highly specific process to obtain clinical data for non- significant risk medical devices. These are clinical investigations as opposed to a clinical trial. This allows the establishment of a basic FDA claim from which to grow into a final claim. Typically, a clinical demonstration could be as limited as recruiting patients (typically 85 patients) at 3 sites to conduct a small, limited investigation to achieve a limited claim. These clinical investigation can be performed for fee (paid for by patients), provided the fee covers the FDA approved device (per labeling) and the investigation would cover the unapproved part (off-label) of the claim to establish issues of effectiveness.
Off label clinical investigations are paid by the patients will withstand FDA scrutiny. It is like climbing a ladder. We use the approved claim to achieve the next claim. It could require 3-4 clinical investigations to achieve a final claim. And, in this process, all clinical investigations would be paid by patients.
By using Sequential Bounded Clinical Investigations (SBCI) a sponsor can charge a basic cost per patient to diagnose or treat patients under a corporate IRB. This data is used to collect data that will later be used to "climb the ladder". These Sequential bounded clinical investigations also avoid contaminating the mathematical model that would yield metrics to support our statistical results.
The pharmaceutical model is higher risk model for non-significant risk medical devices. It requires many patients 1500-3500 and large budgets or they fail when the FDA wants to see a narrower claim by including larger groups. Only the consultants and contract research organizations (CRO). benefit. The sponsor loses. Our plan (Sequential Bounded Clinical Investigations) gives you, the sponsor a revenue stream to fund many trials and build a solid clinical claim.
This reduces the extended time, risky, error prone cycle where a sponsor must make a significant risk to achieve a significant claim. The sponsor must raise massive amounts of capital and test thousands of patients. Where the clinical investigations fail is usually in unanticipated errors. Our plan (Sequential Bounded Clinical Investigations) eliminates those errors by having the FDA approve each step before going onto the next step.
The sponsor would use the next clinical investigation to achieve a "better claim" at the FDA. In fact, this sequence of controlled clinical investigations. Each clinical investigation would build a step closer to the final claim.
The SBCI is a model for new form of simplified, highly specific process to obtain clinical data for non- significant risk medical devices. These are clinical investigations as opposed to a clinical trial. This allows the establishment of a basic FDA claim from which to grow into a final claim. Typically, a clinical demonstration could be as limited as recruiting patients (typically 85 patients) at 3 sites to conduct a small, limited investigation to achieve a limited claim. These clinical investigation can be performed for fee (paid for by patients), provided the fee covers the FDA approved device (per labeling) and the investigation would cover the unapproved part (off-label) of the claim to establish issues of effectiveness.
Off label clinical investigations are paid by the patients will withstand FDA scrutiny. It is like climbing a ladder. We use the approved claim to achieve the next claim. It could require 3-4 clinical investigations to achieve a final claim. And, in this process, all clinical investigations would be paid by patients.
By using Sequential Bounded Clinical Investigations (SBCI) a sponsor can charge a basic cost per patient to diagnose or treat patients under a corporate IRB. This data is used to collect data that will later be used to "climb the ladder". These Sequential bounded clinical investigations also avoid contaminating the mathematical model that would yield metrics to support our statistical results.
The pharmaceutical model is higher risk model for non-significant risk medical devices. It requires many patients 1500-3500 and large budgets or they fail when the FDA wants to see a narrower claim by including larger groups. Only the consultants and contract research organizations (CRO). benefit. The sponsor loses. Our plan (Sequential Bounded Clinical Investigations) gives you, the sponsor a revenue stream to fund many trials and build a solid clinical claim.
This reduces the extended time, risky, error prone cycle where a sponsor must make a significant risk to achieve a significant claim. The sponsor must raise massive amounts of capital and test thousands of patients. Where the clinical investigations fail is usually in unanticipated errors. Our plan (Sequential Bounded Clinical Investigations) eliminates those errors by having the FDA approve each step before going onto the next step.
The sponsor would use the next clinical investigation to achieve a "better claim" at the FDA. In fact, this sequence of controlled clinical investigations. Each clinical investigation would build a step closer to the final claim.
