According to the textbook, all of the following statements regarding the use of a reimbursement dossier in the US are true except:

a. Its development should be initiated after a regulatory submission has been made and the company is awaiting a decision from the FDA

b. It includes information about the product, key clinical studies and results, economic evaluation of data, modeling reports, and an overall assessment of product value and cost

c. It is typically distributed to payers just after final labeling becomes available from the FDA

d. It anticipates and addresses the information requirements of payers’ technology assessment organizations

I need a report that should include a background on the need of blood pressure machines ; description of lead concept of blood pressure machines , IP position for blood pressure machines ; and the preliminary thinking about regulatory and reimbursement strategy for blood pressure machines . (Note that the information you provide about regulatory and reimbursement can be directional. We don't expect you to have everything figured out yet just help us understand what you've learned to date). You should integrate data from validation interviews performed to date. Total length 8 pages or less, including all figures and references

All of the following statements about off-label device use are true except:

a. Physicians may use a device however they see fit, provided this use is in the best interests of the patient and is broadly within the standard of care

b. Companies sometimes generate significant revenues from the off-label use of their device

c. Start-ups should routinely evaluate strategies focused on off-label use as a mechanism for more quickly becoming cash-flow positive

d. Consultation with an experience regulatory experts is always advisable when evaluating issues related to off-label use of a company’s device

Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power.

A.

B.

C.

D.

E.

F.

G.

Characteristics or indications that subjects must have in order to participate in the clinical trial

A.

DSMB

-

A.

B.

C.

D.

E.

F.

G.

The probability of detecting a meaningful difference, or effect, if one were to occur

B.

CRO

-

A.

B.

C.

D.

E.

F.

G.

Prospectively identified and quantifiable parameters that a study is designed to meet

C.

Inclusion criteria

-

A.

B.

C.

D.

E.

F.

G.

An independent organization that provides management services for clinical trials

D.

CEC

-

A.

B.

C.

D.

E.

F.

G.

An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study

E.

Endpoints

-

A.

B.

C.

D.

E.

F.

G.

An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor

F.

Power

-

A.

B.

C.

D.

E.

F.

G.

An independent body that analyzes data or images from a clinical trial to make specialized quantitative measurements required by the trial protocol

G.

Core laboratory