Patient-Centered Outcomes Research Institute (PCORI ...Attendee phone lines are muted Questions may be submitted via Chat in the lower right hand of ... clinical trials and ... does

PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE

August 2012

Patient-Centered Outcomes Research Institute (PCORI)

Reviewer Live Webinar Training

2

Housekeeping – Presentation Mode

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Chat in the lower right hand of your screen

Please send your questions as they

occur to you. Questions will be answered at the end of the session as time permits

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3

Agenda

1. Introduction and Announcements

2. Background

5. Human Subjects and Conflicts of Interest

6. Reviewer Guidelines

7. Q&A

3. Merit Review Criteria

4. Scoring And Critiques

4

Polling Question

Please respond to the following:

A. Call for reviewers e-mail from PCORI

B. PCORI website

C. College

D. Twitter

E. I already knew about PCORI

How did you find out about and sign up to be a PCORI Reviewer?

5

Our SROs

Parag Aggarwal, Ph.D.

Howard Underwood, MD, MBA, MS Jessica Nadler, Ph.D.

Assessment of Prevention, Diagnosis, and Treatment Options

Lev Nevo, MD Sabina I. Robinson, Ph.D.

Improving Healthcare Systems

Kimberly A. Marschhauser, Ph.D.

Marianne H. Alciati, Ph.D.

Communication and Dissemination Research

Addressing Disparities

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Announcements

Open session to any pertinent announcements

Notification of assignment to Phase I or Phase II in Cycle I – by August 10th Reviewer trainings – August 13th to August 21st Release of applications for review – by August 24th Phase I application reviews due – September 28th Phase II review panels – November 15th (in Washington, D.C.)

Key Dates

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Agenda


2. Background



7. Q&A



8

PCORI Mission and PCOR

PCORI Mission Statement

PCORI helps people make informed

healthcare decisions and improves

healthcare delivery and outcomes by

producing and promoting high integrity,

evidence-based information that comes

from research guided by patients,

caregivers, and the broader health care

community

PCORI is a non-governmental, non-profit organization founded by the Patient Protection and Affordable Healthcare Act of 2010

PCORI aims to fund patient-

centered research that will improve healthcare outcomes for patients, their caregivers, and other stakeholders

Patient-centered outcomes

research (PCOR) helps people and their caregivers communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options

For more information on PCOR, please reference the PCORI Methodology report at: http://pcori.org/assets/MethodologyReport-Comment.pdf

http://pcori.org/assets/MethodologyReport-Comment.pdf



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PFAs

The current funding cycle has four issued PFAs:

Assessment of Prevention, Diagnosis, and Treatment Options

Improving Healthcare

Systems

Communication and Dissemination Research

Addressing Disparities

PCORI Funding Announcements (PFAs) are

Accelerating Patient-Centered Outcomes

Research and Methodological

Research

And coming this fall 2012:

the mechanisms by which PCORI gives out research funding

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Polling Question


A. Yes

B. No

C. Undecided

Would you be interested in serving as a Reviewer for the new PFA this

fall: Accelerating Patient-Centered Outcomes Research and Methodological

Research?

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Why is PCORI unique?

PCORI is unique because: (a) it requires stakeholder engagement

throughout the research project, and (b) it is specifically focused on

patient-centered outcomes

• Projects must include stakeholders as partners with significant involvement at all

appropriate stages of the research project

• Tangible, meaningful outcomes are the ultimate goal of all funded research

Who are Stakeholders?

• Patients and caregivers

• Patient and caregiver organizations

• Clinician and clinician organizations

• Organizational Providers

• Purchasers

• Payers

• Industry

• Researchers

• Policymakers

• Training institutions

• Others who can bring insight

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Stakeholder Engagement

PCORI is seizing the opportunity to engage stakeholders in unprecedented ways

To create more relevant decision-making tools to

assure better patient outcomes

Why Engage Stakeholders?

• Partners in the research project enterprise

• View stakeholders as equal partners in research

review

• Leverage their value, including wisdom and unique

expertise

• Socialize a traditional health research culture to

recognize and value stakeholders as equal

research partners

• Increase the relevance and impact of research by integrating multiple stakeholders

into the process

• Create forums and other venues where patients meet with clinicians, providers,

caregivers, and others to identify shared priorities and goals

• Environments that facilitate cross-fertilization and novel collaborations

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Application and Review Process Summary

Application Merit

Review Approval

• LOI submission via PCORI Online

• Application submission via PCORI Online

• Internal quality control

• Phase I: Scientific/ Technical Review

• Phase II: Impact Review

• PCORI Business Review and Balance Analysis

• Board of Governors Approval

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The Merit Review Process

The process by which applications for research

funding are evaluated

Phase I

• Each application is assigned to a pre-determined set number of reviewers

• Phase I Reviewers have scientific expertise and assess the application for scientific rigor and research approach

• Reviewers assign an initial priority score of 1 to 9 based on PCORI-provided review criteria

• Scores are compiled

• Top scoring applications proceed to phase II

Phase II

In-person panel convenes for impact review

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Merit Review Phase I End-to-End

As a Reviewer, you are responsible for assessing and

appropriately scoring your assigned applications

Obtain Assigned Applications

Score and Generate Critiques

Submission

Key Tasks

Raise issues, risks, and request support as needed

1. Access assigned applications in PCORI Online 2. Ensure there are no conflicts of interest 3. Assign numerical criterion scores (1-9) 4. Assign an overall application score (also 1-9) 5. Draft a written critique that corresponds with and justifies assigned

scores (identifies three specific strengths, three weaknesses, plus a narrative)

6. Submit via PCORI Online 7. Re-submit criterion if SROs request update

All submissions must be high quality and

adhere to the three-bullet

and narrative format

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Reviewer Guidance & Scoring Chart

scoring chart below provides a descriptive guide of how strengths and weaknesses

are considered in a rating:

Impact Score Descriptor Additional Guidance on Strengths/Weaknesses

1 Exceptional Exceptionally strong with essentially no weaknesses

2 Outstanding Extremely strong with negligible weaknesses

3 Excellent Very strong with only some minor weaknesses

4 Very Good Strong but with numerous minor weaknesses

5 Good Strong but with at least one moderate weakness

6 Satisfactory Some strengths but also some moderate weakness

7 Fair Some strengths but with at least one major weakness

8 Marginal A few strengths and a few major weaknesses

9 Poor Very few strengths and numerous major weaknesses

High

Medium

Low

For the application score and individual criterion

scores, the far right column in the

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Agenda


2. Background



7. Q&A



18

Origin of the Review Criteria

The Patient Protection and

Affordable Care Act described

important characteristics of

the type of research PCORI

was created to promote

These characteristics are

reflected in PCORI’s 8

Merit Review Criteria

Applicants must respond to

each of the 8 criteria and

explain how the proposed

research question, study

population, analytic methods,

and dissemination plan align

with the criteria.

The 8 Merit Review Criteria:

1. Impact of the Condition

2. Innovation/Potential for

Improvement

3. Impact on Healthcare

Performance

4. Patient-Centeredness

5. Rigorous Research Methods

6. Inclusiveness of Different

Populations

7. Team and Environment

8. Efficient Use of Resources

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Guidance on types of studies

Responsive Non-responsive

Studies that include patient and stakeholders as partners in the research enterprise

Studies that include patient-centered outcomes

Research that has significant patient and stakeholder involvement in the conception, design, conduct and dissemination of the results

Research involving any disease and condition, including chronic diseases and conditions

Research that includes patients with multiple conditions, and/or rare diseases

Studies which are comparative Systematic reviews, clinical trials and

observational studies addressing comparative questions.

Rigorous methods are critical Rapid potential for implementation and

dissemination once results are available

Creation of a registry without comparative research reporting on patient-centered outcomes

Development, testing, and validation of instruments or tests as stand-alone research projects with no comparative element

Studies including cost-effectiveness analyses Any proposal that is not comparative

We are only looking to fund responsive studies. Examples include -

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Grant Review: PCORI-Unique Elements

The 8 Merit Review Criteria:

1. Impact of the Condition

2. Innovation/Potential for

Improvement

3. Impact on Healthcare

Performance

4. Patient-Centeredness

5. Rigorous Research Methods

6. Inclusiveness of Different

Populations

7. Team and Environment

8. Efficient Use of Resources

2. Research will change practice; Dissemination and implementation

4. Patient centeredness as a criterion is unique and absolutely central to PCORI

7. Patient and other stakeholder engagement is also key

Human Subjects

Data Sharing

Other Distinguishing Attributes

For additional guidance, please refer to the PFAs and application guidelines for information and vignettes

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• Impact of the Condition

• Innovation/ Potential for Improvement

• Impact on Healthcare Performance

• Patient-Centeredness

• Rigorous Research Methods

• Inclusiveness of Different Populations

• Team and Environment

• Efficient Use of Resources

Criterion 1: Impact of the Condition on the Health of Individuals and Populations

Does the application specify the burden of the disease or area

under consideration, with a preference for the U.S. population,

including:

The frequency of the disease/condition,

Expected mortality and burden of suffering from symptoms,

Complications or other consequences of the disease/condition,

The frequency with which the intervention or treatment would apply,

Costs to the US population (healthcare services utilization), and to individual patients (out-of-pocket and intangible costs).

Primary emphasis is on chronic conditions, as well as prevention

and treatment of common acute events that may have long-term

consequences.

Studies that are relevant to patients with two or more conditions

are also of interest. Also of interest are rare diseases.

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Criterion 1: Examples

PCORI Considerations

• Population affected (prevalence and incidence)

• Quality of life (morbidity and mortality)

• Impact on healthcare system (healthcare services use)

High Impact End-Stage Renal Disease

High prevalence with high mortality and high patient

burden

Low Impact

Common Cold in Healthy Adults

High prevalence with low risk of significant

morbidity/mortality

Impact of the Condition on the Health of Individuals and Populations

23

Criterion 2: Innovation and Potential for Improvement

Through Research

How will the research influence current practice and lead to

meaningful improvement in patient health, well-being, or

quality of care?

Does the research involve a novel intervention or employ an

innovative approach in terms of analytics, study population, or

research team that makes it more likely to change practice?

Does preliminary data suggest that the comparison will show

large differences in effectiveness?

Does the research question address a critical gap in current

knowledge? Has it been identified as important by patient,

caregiver, or clinician groups? Have other agencies identified

this topic as a priority?

How quickly could positive findings be disseminated to affect

changes in current practice? How will the research findings

support improved decision-making for patients?










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High Score

Prostate Cancer

Comparison of long-term sequelae of various treatments

for localized prostate cancer

Low Score

Proton Pump Inhibitor (or Statin)

Comparison of outcomes for a newly marketed proton pump

inhibitor (or statin) to previously available agents, when

preliminary data suggests little difference in efficacy or

safety


• Innovation - in ways that are likely to change practice?

• Potential for improvement (will findings improve patient well-being or quality of care?)

Innovation and Potential for Improvement Through Research

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Criterion 3: Impact on Healthcare Performance

What is the impact of the proposed research on the

efficiency of patient care, for individual patients or for

patient populations?

For example, do the findings lead to better outcomes for a

given investment of time, personnel, or other resources? Or

does the research promise potential improvements in

convenience or elimination of wasted resources, while

maintaining or improving patient outcomes?










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High Score

Clinical Decision Support Tool

Potentially large increases in efficiency and patient safety

compared to current practice, while reducing requirements

for follow-up patient visits

Low Score

Automated Appointment Reminder

Applicant question is whether the automated appointment

reminder delivered by phone for a large specialty practice

leads to lower appointment "no-shows" if the recorded voice

is that of the physician instead of the receptionist.


• Addresses all three efficiency factors significantly (time, effort, other resources)

• Extraordinary efficiencies in one area

• Impact of efficiency on patient experience is high

Impact on Healthcare Performance

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Criterion 4: Patient-Centeredness

Is the proposed research focused on questions and outcomes of

specific interest to patients and their caregivers? Patient-

centeredness is a perspective on health that is derived

from and directly relevant to the patient’s experience of

illness and of care.

Does the research address one or more of the key questions

mentioned in PCORI’s definition of patient-centered outcomes

research?

Are the outcomes proposed of importance to patients? Is the

absence of any particularly important outcomes discussed?

Patient engagement in the research team is distinct and

discussed in Criterion 7, Team and Environment.










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High Score

Prostate Cancer Treatment Decision Tool

Patient understands treatment options and how they relate

to his/her preferences for functional outcome, and is

comfortable with his/her final treatment decision based on

the output of the tool

Low Score

Hemoglobin A1C Levels

Levels are difficult to relate to outcomes meaningful to

patients


• Focus on questions and outcomes of specific interest to patients and their caregivers

• Clear link and relevance to patient experiences

Patient-Centeredness

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Criterion 5: Rigorous Research Methods

Does the research use appropriate and rigorous research

methods to generate patient-centered evidence?

Applicants are encouraged to refer to the contents of

the first draft of the PCORI Methodology Report, at

http://www.pcori.org/what-we-do/methodology, in

developing their research plan. Because the draft report

will not have been finalized with the benefit of public

comment before the July 31st, 2012 application

deadline, adherence to the Report’s standards will not

be a required element of applications for this funding

cycle.

How likely is it that the proposed study population,

study design, and available sample size will yield

generalizable information with sufficient precision to be

useful and reliable for patients, their caregivers, and

clinicians?










http://www.pcori.org/what-we-do/methodology





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Dissemination and Implementation Assessment

PCORI is interested in funding studies with a high likelihood that results will be disseminated and incorporated into practice, if study findings warrant. To that end, it is important that key stakeholders are engaged early and throughout the research process, and that potential facilitators and barriers to dissemination and incorporation into practice are assessed and anticipated. The dissemination assessment should include:

Identification of key stakeholders

Description of engagement frequency

Description of engagement type

Governance plan

Resource sharing

Barriers assessment


This plan should be used to assist with scoring Criterion 5, Rigorous Research Methods

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• Appropriate methods used

• Study population size

• Refer to Methodology report

• Yield generalizable information with sufficient precision

High Score

High quality randomized control or observational trial with an

appropriate sample size for comparator groups (e.g. Drug 1 vs.

Drug 2), with access to a large patient population; utilizes

appropriate statistical methods and references standards from

the PCORI Methodology Report

Low Score

Trial with inadequate sample size and no comparison group(s);

without appropriate statistical methods

Rigorous Research Methods

32

Criterion 6: Inclusiveness of Different Populations

Does the research include diverse populations with respect

to age, gender, race, ethnicity, geography, or previously

understudied populations for whom effectiveness

information is particularly needed? Is the study population

representative of the full population of interest?

How does the proposed research enable a more personalized

approach to decision-making based on a patient’s unique

biological, clinical, or socio-demographic characteristics?

Does the study provide sample size calculations that will

describe the power available to evaluate possible differences

in effectiveness in different groups, or the precision available

for estimating effectiveness in a specific previously

understudied population?










33


High Score

Comparative study of a new patient decision support tool versus

usual care (no decision support tool) used in a diverse

population stratified by age, race/ethnicity, and literacy

Low Score

Study of an intervention in a homogenous population that is not

understudied

Poorly defined study population

Inclusiveness of Different Populations


• Diverse and understudied populations

• Study population representative of the target populations

34

Criterion 7: Team and Environment

Are the investigators appropriately trained and experienced

to carry out the planned studies? Is the work proposed

appropriate to the experience level of the principal

investigator?

Does the study team have complementary and integrated

expertise; is their leadership approach, governance, and

organizational structure appropriate for the project?

Are relevant patients and other key stakeholders of the

study information appropriately included on the team?

Do the experiments proposed take advantage of unique

features of the scientific environment or employ useful

collaborative arrangements?

Is there evidence of institutional or other support?










35



• Investigators trained

• Study team expertise

• Plan for leadership and governance

• Robust patient and stakeholder engagement plan

• Institutional or other relevant organizational support

High Score

Integrated research team where researchers and stakeholders,

including patients, are jointly engaged in the design, execution,

and dissemination of the research project

Low Score

Patients or stakeholders only superficially involved, not involved,

or involvement is not adequately described in the application

Investigators are not qualified or supported to perform research

Team and Environment

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Criterion 8: Efficient Use of Research Resources

Does the budget appear to be reasonable in relation to the

potential contribution of the research?

Does the justification address the efficiency with which

PCORI resources would be used? Are there opportunities to

make the study more efficient?

Are there additional benefits to a PCORI investment in this

study through the creation of common data or infrastructure

that could support future research?










37



• Reasonable budget for the research

• Opportunities for improving study efficiency

• Address the efficiency with which resources will be used

High Score

Strong justification of all costs; generates a large data set that

answers specific questions at the conclusion of the study; data

set has potential to be used to answer additional questions in

the future; evidence of non-duplication of current research

Low Score

No justification of cost; large capital expense with little option

for reuse; PI has not considered alternative approaches that

might reduce cost

Efficient Use of Research Resources

38

Agenda


2. Background



7. Q&A



39

Phase 1: Scoring System

Utilizes a 9-point scale

• A score of 1 indicates an exceptionally

strong application

• A score of 9 indicates an application

with serious and substantive

weaknesses

• 5 is considered an average score

Ratings are in whole numbers only (no

decimals)

Scores of 1 and 9 are expected to be

used less frequently than other scores

Reviewer Assignments

• A pre-determined set number of Reviewers

with appropriate scientific and technical

expertise are assigned to each application

• As a Reviewer you will read and assess

your assigned application(s)

• Subsequently, you will prepare a written

critique based upon the selection criteria in

the three-bulleted and narrative format*

• Once a score and critique are

submitted, they can not be edited or

altered

*Flawed critiques will be returned to Reviewers for correction by their SROs

40

PCORI Criterion Scoring Guidance

The eight PCORI Merit Review Criteria serve

as basis for the criterion score • Criterion scores are intended to

convey how each assigned Reviewer

weighed the strengths and

weaknesses of each section

• Equal weights are assigned to all

criterion

• Technical expertise is highly

prioritized in the evaluation of

applications

• The assessment of the reviewer

should be reflected in the

strengths/weaknesses and scores

• Scores without correlated comments

in the written critique will be returned

for revision

1

2

3

4

5

6

7

8

Impact of the Condition

Innovation/Potential for Improvement

Impact on Healthcare Performance

Patient-Centeredness

Rigorous Research Methods

Inclusiveness of Different Populations

Team and Environment

Efficient Use of Resources

41

Reviewer Guidance

Impact is the project’s likelihood to have a sustained, powerful influence on the

research field(s) involved

Additional reviewer scoring guidance -

Minor Weakness: Easily addressable, does not substantially lessen impact

Moderate Weakness: Lessens impact

Major Weakness: Severely limits impact

Moderate Impact 4 through 6

Low Impact 7 through 9

High Impact 1 through 3

42

Application Scoring

Applications also receive a preliminary overall application score from

Reviewers

• Using the same numerical 1 – 9 scoring system

• This score is reflective of the project’s likelihood to have a sustained,

powerful influence on knowledge and change/enhance clinical

practice/implementation/fields involved

• The application score for an application is not intended to be an average of

the criterion scores

43

Score Correspondence

• As a result, a Reviewer may give only moderate scores to some of the review criteria but still

a high overall application score because the one review criterion critically important to said

Reviewer is rated highly

• An application does not need to be strong in all categories to

be judged likely to have a major impact

• E.g., a project that by its nature is not innovative may

be essential to advance a field

• Make sure to utilize the full range of scores 1-9

It is critical that the assigned score corresponds to your written critique

• Your description of the strengths and weaknesses of a specific Merit Review Criterion must

align with the score you assign

• I.e., a score of 4 would have both strengths and weaknesses listed while a score of 1 would

have only minor or no weaknesses

Please write constructive feedback, bearing in mind comments and critiques will be re-

distributed to applicants

Each review criterion should be assessed

based on how important it is to the work

being proposed

44

Score Distributions

• The scoring system is meant to

normalize scores across the board

• Reviewers should use the full range of

the scoring scale and spread their

scores to better distinguish between

applications

• Scores of 1 and 9 should occur far less

frequently than mid-range scores (of 4-

6)

• Thus, it is important that as a Reviewer

you carefully assess every application

for its individual strengths and

weaknesses as well as alignment with

Merit Review Criteria and overall impact

Scores 4-6

1-3 7-9

45

Written Critique

• These critiques provide insight to the Phase II panel for conducting their review, as well as

to applicants looking to improve their application

• Due to the small number of applications assigned to each Reviewer we expect high-quality,

thorough critiques

• Make sure to especially highlight patient and stakeholder-centeredness in applications

• Ensure that you are writing critiques, not a summary

• Critical feedback is essential

• Avoid being subjective in your critiques without substantiation

The written critique with three strengths and three weaknesses listed is very important

46

Written Critique: Strengths and Weaknesses

strengths and three weaknesses in the comments field provided*

*If you cannot identify or adequately speak to 3 strengths and 3 weaknesses, please reach out to your SRO

Example: Strengths

• The budget indicates that a community patient representative will be recruited and will

participate in the focus group discussions

• A patient advocate will contribute curricula and review results and participate in project

discussion on a monthly basis

• The application states that patients will be solicited for input on dissemination of results

Example: Weaknesses

• Patient engagement is not strong overall in this proposal. It is unclear whether they were

involved in the proposal or how they will be involved in the research process

• This work is not likely to make a unique contribution to learning about engagement of

patients and stakeholders

• There is no evidence of how these findings could be integrated into routine clinical care

For each criterion and for the overall application score, you must provide a bulleted list of three

47

Written Critiques: Examples

Weak Critiques Lack of substantive information: • The application states that patients will be

solicited for input.

• This work is not likely to make a unique

contribution.

• Patient engagement is not strong in this

proposal.

Lack of clarity/not concise: • The budget indicates that a community

patient representative will be recruited and

will participate in the focus group

discussions. Additionally, the budget

indicates attendance to a conference with

multiple members of the research team

who will be presenting at the conference.

Consultants are also listed in the budget at

a fixed fee, however, is unclear the role of

the listed consultants as well as the

duration of their role during the research.

Correction Examples Provide substantive information: • The application states that patients will be involved as

stakeholders through X, Y, Z…

• This work is not likely to make a unique contribution

because…

• Patient engagement is not strong in this proposal

because/due to…

Utilize bullets: The budget indicates:

• A community patient representative will be

recruited and will participate in the focus group

discussions

• Multiple research team members will attend and

present at a conference

• Consultants are also listed in the budget at a fixed fee

• However, it is unclear the role of the listed

consultants as well as the duration of their role

during the research

48

Scoring: Written Narrative

This addresses, in four brief parts (can also be bullets):

1. Specific criterion focal point from the application

1. E.g. “I am addressing Merit Review Criterion number 4…in relation to X section

of this application”

2. Your critical assessment

3. Suggestion and/or feedback as a Reviewer

4. A summary

In addition to the strengths and weaknesses bullets, you must provide

a written narrative:

49

Written Critiques: Examples

“This application does not adequately incorporate patients and stakeholders

into the research team. The application states that one representative of

each stakeholder group will be a member of the planning group; and it is

not clear how many of these individuals will be participants or continue

providing input as the research progresses. Further, it is not clear as to how

and whether this research will integrate patients into the clinical

environment. There is little discussion of how the results of this science will

advance clinical practice and improve patient outcomes. The application

could be strengthened by clearly describing the role and participation of the

patients and stakeholders involved and other aspects of the research such

as the communication and dissemination of results.”

Example of a strong, well-written narrative:

50

Agenda


2. Background



7. Q&A



51

Patient members of the research

team are not subject to IRB

Human Subjects

Federal regulations for the protection of human research subjects

(45 CFR 46) require that the evaluation of research applications

• You will determine whether the protections of human subjects is acceptable or not

• If unacceptable, please select ‘No’ in the Human Subjects section of PCORI Online and indicate why in the written critique

• Your assessment of human subjects should factor into your overall assessment and score of the impact of an application, as PCORI will only support research that has adequate human subjects protections and minimal risks

• Particularly if the applicant does not describe a plan to adequately protect human subjects and the proposed research may impose risks to participants

If more information is needed, please refer to the Supplemental Instructions for Preparing the Protection

of Human Subjects Section of the Research Plan in Part II -

www.grants.nih.gov/grants/funding/phs398/phs398.doc

If the proposed research will involve human subjects –

that involve human subjects take into consideration the risk to subjects, adequacy of protection against risk,

potential benefits of the research, and the importance of knowledge to be gained.

• If acceptable, select ‘Yes’ and describe the safeguards in place in the written critique

52

Conflicts of Interest

What is a conflict of interest?

As defined by PCORI’s establishing legislation, a conflict of interest is any “association, including a financial or personal association; that has the potential to bias or have the appearance of biasing an individual’s decisions in matters related to the Institute or the conduct of activities”. Conflicts of interest will be considered and prohibited throughout every step of the review and selection process, including but not limited to: the technical and programmatic reviews, the selection and assignment of scientific and stakeholder reviewers, Board of Governors deliberations, and post-award

negotiations and monitoring.

More information is included in the PCORI Online confidentiality and conflict of interest document that you must agree to in order to access your applications.

53

Conflicts of Interest

Key Personnel 1) I co-authored 3 publications in the last year with one of the co-investigators, but not with the PI. 2) In the early 90’s I co-authored a couple of publications with one of the collaborators for this application, but we have not written any papers together since. Primary Organization 3) I am currently on faculty at Northwestern University and the PI is an associate professor in the same department at Northwestern. Affiliated Organization 4) I serve on the Board for the subcontractor’s organization. 5) I used to work at UC Berkeley and the PI is currently on faculty there. I left the institution recently, but our time at the institution overlapped. PI 6) I served on the PI’s dissertation committee, but it was 10 years ago and we have not been in contact since.

Can I review the application if…?

CONFLICT

NOT CONFLICT

CONFLICT

CONFLICT

NOT CONFLICT

NOT CONFLICT

54

Agenda


2. Background



7. Q&A



55

Reviewer Guidelines and Information

For more information regarding compensation, review assignment timeline, and due dates, please refer to the Community Reviewer Site at: http://www.pcori.org/get-involved/become-scientific-reviewer/

Any inadequate reviews will be returned – please follow scoring guidelines covered in this training closely

Always immediately escalate issues or conflicts of interest to your SRO

Communicate with and answer emails from your SRO in a timely manner

56

Polling Question


A. Live session

B. Pre-recorded

C. Indifferent

Would you prefer a live session, or pre-recorded trainings in the

future?

57

Agenda


2. Background



7. Q&A



58

Q&A

59

Wrap-Up

This concludes today’s session. We hope you found this live webinar helpful

and informative.

Thank you again for your commitment to PCORI.

If any questions remain unanswered at this point, please email them to

[email protected]

Documents

Patient-Centered Outcomes Research Institute (PCORI ...Attendee phone lines are muted Questions may be submitted via Chat in the lower right hand of ... clinical trials and ... does