PROST Protocol Validation Standards

Section

Section No.

Requirements

Title

1.0

Title: Proposed Validation Protocol for Modeled Product Claims: [ name of product]

Abstract

2.0

Structured summary of protocol objectives, claims to be validated, target population, study design, data source, timelines and reporting date

Context

3.0

A statement of the context of the proposed study to include a systematic review of effectiveness studies and a statement of the contribution this study is expected to make in  evaluating competing interventions in this disease or therapy area

Claims

4.0

A statement of the claims to be quantitatively evaluated:

4.1 Clinical effectiveness (including patient reported outcomes)

4.2 Safety

4.3 Resource utilization

4.4 Direct medical costs

4.5 Cost-effectiveness

4.6 Budget impact

Target Population

5.0

Characteristics of study target population (age, gender, ethnicity, race) to include sub-groups and clinical markers (presence/exclusion of co-morbidities; stage of disease)

Data

6.0

Description of proposed data source(s) and any permissions required to access data/target population (e.g., IRB approvals, EMR approvals, access to administrative claims data) and confidentiality requirements

Study Design: Cost-Effectiveness Claims

7.0

Rationale and description of study design:

7.1 Rationale for choice of study design

7.2 Concurrence with good practice guidelines

7.3 Estimation and reporting of treatment effects

7.4 Timeframe

7.5 Treatment comparators

7.6 Data assembly

7.7 Confidentiality

Study Design: Budget Impact

8.0

Rationale and description of budget impact study design

Progress reporting

9.0

Proposed study timeline and interim progress reporting 

Reporting

10.0

A brief description of proposed final report format, to include

9.1 Title

9.2 Abstract: study objectives and assessment results

9.3 Study design: brief description, including risks of bias and other limitations.

9.4 Claims validation: target population and sub-groups

9.5 Claims review: degree of confirmation of predictive claims and implications for place of product in therapy