NHLBI Review of Clinical Trials

1
NHLBI Review of Clinical Trials

• Valerie Prenger, PhD, MHS
• Chief, Review Branch
• National Heart, Lung, and Blood Institute

2
Where are the trials reviewed?

• Single Site Clinical Trials (R01)
• Most are reviewed by Center for Scientific Review
  (CSR)
• Reviewed in appropriate study section according
  to standard referral guidelines
• Multi-site Clinical Trials (R01)
• Require a staff visit with NHLBI staff
• Program Division representative (DHVD, DLD, DBDR,
  DECA)
• Review representative
• Reviewed by NHLBIs Clinical Trials Review
  Committee (CLTR)

3
Grant review by CLTR

• Standing Committee made up of experts in clinical
  trials of Heart, Lung, and Blood diseases (i.e.,
  clinicians, biostatisticians)
• 1-2 Ad-hoc reviewers brought in for each clinical
  trial reviewed
• Standing members of CLTR read all applications
• Standard review criteria and scoring system used
• Human Subjects issues scrutinized carefully
• Applications are percentiled against other R01s
  received for that round (i.e., no set aside money)

4
Standing membership of CLTR

• 16 members total
• 1 chair (currently a pulmonologist)
• 6 cardiovascular clinicians
• 2 pulmonary clinicians
• 2 hematologists
• 4 biostatisticians
• 1 behavioral medicine/epidemiologist

5
Types of studies reviewed by CLTR

• multi-site clinical trials
• ancillary studies to previously funded multi-site
  trials
• supplements to previously funded multi-site
  trials
• multi-site cohort studies requiring extraordinary
  coordination (across sites) of a clinical
  endpoint

6
Characteristics of CLTR review

• workload approximately 12 studies per round
• multiple applications per study
• 2 day in-person meeting
• multidisciplinary review
• each study receives 1 score
• if multiple applications were submitted, the
  whole group of applications sinks or swims
  together with the same score
• 1 integrated summary statement per study budget
  comments are organized by application at the end
  of the summary statement

7
Typical study reviewed by CLTR

• enrollment of 2,000 patients
• 6-9 sites (have had as many as 150 sites)
• separate Data Coordinating Center application
• reviewed together with Clinical Center(s)
• routine conflicts of members handled using
  standard NIH policy

8
Review of applications by standing members

• reviewed by a SEP in NHLBI
• organized and conducted by different SRA
• current CLTR members are not allowed to
  participate in SEP
• attempt made to recruit past CLTR members that
  did not serve with member being reviewed
• telephone review
• percentiled against all R01s received in that
  round
• anecdotally, no advantage or disadvantage to
  being reviewed in a SEP when compared to CLTR
  review