Trial Outcomes & Findings for A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging (NCT NCT03445559)
NCT ID: NCT03445559
Last Updated: 2025-07-28
Results Overview
Facility-level utilization of bone scan imaging among men with newly diagnosed, low-risk prostate cancer. (Inappropriate Imaging according to NCCN guidelines)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Through study completion, an average of 4 years
Results posted on
2025-07-28
Participant Flow
Dates: March 2018 - March 2021 Type of location: VA Medical Centers Urology providers (physicians, physician assistants, nurse practitioners) from 10 VA medical centers who treat prostate cancer were enrolled in the study. Prostate cancer patient charts were reviewed but were not directly recruited into the study.
There was a minimum 3 month (maximum 30 month) run-in period prior to provider exposure to the intervention. A total of 58 clinical providers were enrolled at 10 VAMC sites. At the 10 VAMC sites, 2,374 patient charts were reviewed, 2,358 met inclusion criteria and were assigned to an arm. 16 patient charts were excluded at baseline due to * Prior diagnosis of prostate cancer * History of other prior malignancy * Low risk \& missing clinical stage or PSA
Participant milestones
| Measure |
Sequence Site 7: 21 Months of Control, Then 15 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 8: 24 Months of Control, Then 12 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 9: 27 Months of Control, Then 9 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 10: 30 Months of Control, Then 6 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 6: 18 Months of Control, Then 18 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 1: 3 Months of Control, Then 33 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 2: 6 Months of Control, Then 30 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 3: 9 Months of Control, Then 27 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 4: 12 Months of Control, Then 24 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
|
Sequence Site 5: 15 Months of Control, Then 21 Months of Intervention
Control: No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
Intervention: Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging. The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data for measure was not entered by 4 providers in survey.
Baseline characteristics by cohort
| Measure |
Control - Bone Scan Imaging Not Indicated
n=690 Participants
Patient charts reviewed prior to intervention initiation in a stepped wedge design where a bone scan was not indicated according to National Comprehensive Cancer Network guidelines.
|
Intervention - Bone Scan Imaging Not Indicated
n=734 Participants
Patient charts reviewed after intervention initiation where a bone scan was not indicated according to National Comprehensive Cancer Network guidelines.
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Clinical Order Check: A Clinical Order Check is an evidence-based, systems-level method to affect significant behavior change. It addresses the intervention functions of education, enablement and incentivization which are effective methods to change behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Academic Detailing: Academic detailing is an individual and facility-level intervention consistently shown to improve provider behavior. This strategy addresses the intervention functions of persuasion, coercion, modeling, and education which are effective methods for affecting behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Audit and Feedback: Audit and feedback is an effective, individual-level intervention for changing healthcare provider behavior. Audit and feedback addresses the intervention functions of education, persuasion and incentivization, all of which are important for addressing beliefs about capabilities and consequences, knowledge, and social influence.
|
Control - Bone Scan Imaging Indicated
n=425 Participants
Patient charts reviewed prior to intervention initiation in a stepped wedge design where a bone scan was indicated according to National Comprehensive Cancer Network guidelines.
|
Intervention - Bone Scan Imaging Indicated
n=453 Participants
Patient charts reviewed after intervention initiation where a bone scan was indicated according to National Comprehensive Cancer Network guidelines.
|
Intervention - Providers
n=58 Participants
Enrolled Urology Providers (urologists, Physician Assistants, Nurse Practitioners) who treat prostate cancer patients at the 10 participating VA Medical Centers.
The following baseline characteristics were not collected from enrolled providers: 1) Reside in Zip Code with High Education, 2) Reside in Zip Code with High Broadband Access, and 3) Marital Status.
|
Total
n=2360 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 12.6 • n=690 Participants
|
66.7 Years
STANDARD_DEVIATION 6.8 • n=734 Participants
|
68.0 Years
STANDARD_DEVIATION 10.3 • n=425 Participants
|
67.2 Years
STANDARD_DEVIATION 10.5 • n=453 Participants
|
49.71 Years
STANDARD_DEVIATION 5.09 • n=58 Participants
|
67.3 Years
STANDARD_DEVIATION 7.7 • n=2360 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=690 Participants • Data for measure was not entered by 4 providers in survey.
|
0 Participants
n=734 Participants • Data for measure was not entered by 4 providers in survey.
|
0 Participants
n=425 Participants • Data for measure was not entered by 4 providers in survey.
|
0 Participants
n=453 Participants • Data for measure was not entered by 4 providers in survey.
|
10 Participants
n=54 Participants • Data for measure was not entered by 4 providers in survey.
|
10 Participants
n=2356 Participants • Data for measure was not entered by 4 providers in survey.
|
|
Sex: Female, Male
Male
|
690 Participants
n=690 Participants • Data for measure was not entered by 4 providers in survey.
|
734 Participants
n=734 Participants • Data for measure was not entered by 4 providers in survey.
|
425 Participants
n=425 Participants • Data for measure was not entered by 4 providers in survey.
|
453 Participants
n=453 Participants • Data for measure was not entered by 4 providers in survey.
|
44 Participants
n=54 Participants • Data for measure was not entered by 4 providers in survey.
|
2346 Participants
n=2356 Participants • Data for measure was not entered by 4 providers in survey.
|
|
Race/Ethnicity, Customized
Non-Black
|
531 Participants
n=690 Participants
|
538 Participants
n=734 Participants
|
329 Participants
n=425 Participants
|
301 Participants
n=453 Participants
|
55 Participants
n=58 Participants
|
1754 Participants
n=2360 Participants
|
|
Race/Ethnicity, Customized
Black
|
116 Participants
n=690 Participants
|
138 Participants
n=734 Participants
|
56 Participants
n=425 Participants
|
84 Participants
n=453 Participants
|
3 Participants
n=58 Participants
|
397 Participants
n=2360 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
43 Participants
n=690 Participants
|
58 Participants
n=734 Participants
|
40 Participants
n=425 Participants
|
68 Participants
n=453 Participants
|
0 Participants
n=58 Participants
|
209 Participants
n=2360 Participants
|
|
Region of Enrollment
United States
|
690 Participants
n=690 Participants
|
734 Participants
n=734 Participants
|
425 Participants
n=425 Participants
|
453 Participants
n=453 Participants
|
58 Participants
n=58 Participants
|
2360 Participants
n=2360 Participants
|
|
Reside in Zip Code with High Education
|
485 Participants
n=690 Participants • Data measure not collected for enrolled providers.
|
524 Participants
n=734 Participants • Data measure not collected for enrolled providers.
|
306 Participants
n=425 Participants • Data measure not collected for enrolled providers.
|
280 Participants
n=453 Participants • Data measure not collected for enrolled providers.
|
—
|
1595 Participants
n=2302 Participants • Data measure not collected for enrolled providers.
|
|
Reside in Zip Code with High Broadband Access
|
616 Participants
n=690 Participants • Data measure not collected for enrolled providers.
|
604 Participants
n=734 Participants • Data measure not collected for enrolled providers.
|
368 Participants
n=425 Participants • Data measure not collected for enrolled providers.
|
350 Participants
n=453 Participants • Data measure not collected for enrolled providers.
|
—
|
1938 Participants
n=2302 Participants • Data measure not collected for enrolled providers.
|
|
Marital Status
Not currently married
|
307 Participants
n=690 Participants • Data measure not collected for enrolled providers.
|
361 Participants
n=734 Participants • Data measure not collected for enrolled providers.
|
215 Participants
n=425 Participants • Data measure not collected for enrolled providers.
|
216 Participants
n=453 Participants • Data measure not collected for enrolled providers.
|
—
|
1099 Participants
n=2302 Participants • Data measure not collected for enrolled providers.
|
|
Marital Status
Married
|
372 Participants
n=690 Participants • Data measure not collected for enrolled providers.
|
345 Participants
n=734 Participants • Data measure not collected for enrolled providers.
|
198 Participants
n=425 Participants • Data measure not collected for enrolled providers.
|
189 Participants
n=453 Participants • Data measure not collected for enrolled providers.
|
—
|
1104 Participants
n=2302 Participants • Data measure not collected for enrolled providers.
|
|
Marital Status
Not reported
|
11 Participants
n=690 Participants • Data measure not collected for enrolled providers.
|
28 Participants
n=734 Participants • Data measure not collected for enrolled providers.
|
12 Participants
n=425 Participants • Data measure not collected for enrolled providers.
|
48 Participants
n=453 Participants • Data measure not collected for enrolled providers.
|
—
|
99 Participants
n=2302 Participants • Data measure not collected for enrolled providers.
|
PRIMARY outcome
Timeframe: Through study completion, an average of 4 yearsFacility-level utilization of bone scan imaging among men with newly diagnosed, low-risk prostate cancer. (Inappropriate Imaging according to NCCN guidelines)
Outcome measures
| Measure |
Control
n=690 Participants
No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
|
Intervention
n=734 Participants
Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging.
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Clinical Order Check: A Clinical Order Check is an evidence-based, systems-level method to affect significant behavior change. It addresses the intervention functions of education, enablement and incentivization which are effective methods to change behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Academic Detailing: Academic detailing is an individual and facility-level intervention consistently shown to improve provider behavior. This strategy addresses the intervention functions of persuasion, coercion, modeling, and education which are effective methods for affecting behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Audit and Feedback: Audit and feedback is an effective, individual-level intervention for changing healthcare provider behavior. Audit and feedback addresses the intervention functions of education, persuasion and incentivization, all of which are important for addressing beliefs about capabilities and consequences, knowledge, and social influence.
|
|---|---|---|
|
Facility-level Inappropriate Prostate Cancer Bone Scan Imaging Rates
|
141 Participants
|
109 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 4 yearsFacility-level utilization of bone scan imaging among men with newly diagnosed, high-risk prostate cancer. (Appropriate Imaging according to NCCN guidelines)
Outcome measures
| Measure |
Control
n=425 Participants
No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
|
Intervention
n=453 Participants
Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging.
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Clinical Order Check: A Clinical Order Check is an evidence-based, systems-level method to affect significant behavior change. It addresses the intervention functions of education, enablement and incentivization which are effective methods to change behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Academic Detailing: Academic detailing is an individual and facility-level intervention consistently shown to improve provider behavior. This strategy addresses the intervention functions of persuasion, coercion, modeling, and education which are effective methods for affecting behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Audit and Feedback: Audit and feedback is an effective, individual-level intervention for changing healthcare provider behavior. Audit and feedback addresses the intervention functions of education, persuasion and incentivization, all of which are important for addressing beliefs about capabilities and consequences, knowledge, and social influence.
|
|---|---|---|
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Facility-level Appropriate Prostate Cancer Bone Scan Imaging Rates
|
396 Participants
|
428 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 4 yearsPopulation: Clinical provider encounters (urologists, nurse practitioners, and physician assistants) that can order imaging for staging of prostate cancer patients. Patients may have seen multiple unique providers during the study period.
Provider-level utilization of nuclear medicine bone scan among men with newly diagnosed, low-risk prostate cancer (Inappropriate Imaging). Imaging is not recommended to stage low-risk prostate cancer men with PSA\<10, Gleason\<7, and clinical stage \<T3.
Outcome measures
| Measure |
Control
n=77 Participants
No intervention. Patient charts reviewed prior to intervention initiation in stepped wedge design.
|
Intervention
n=68 Participants
Patient charts reviewed after intervention initiation for guideline-concordant prostate cancer imaging.
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Clinical Order Check: A Clinical Order Check is an evidence-based, systems-level method to affect significant behavior change. It addresses the intervention functions of education, enablement and incentivization which are effective methods to change behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Academic Detailing: Academic detailing is an individual and facility-level intervention consistently shown to improve provider behavior. This strategy addresses the intervention functions of persuasion, coercion, modeling, and education which are effective methods for affecting behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources.
Audit and Feedback: Audit and feedback is an effective, individual-level intervention for changing healthcare provider behavior. Audit and feedback addresses the intervention functions of education, persuasion and incentivization, all of which are important for addressing beliefs about capabilities and consequences, knowledge, and social influence.
|
|---|---|---|
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Individual-level Inappropriate Prostate Cancer Imaging Rates
|
10.7 percentage of inappropriate bone scans
Interval 8.0 to 19.0
|
8 percentage of inappropriate bone scans
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 4 yearsProvider-level utilization of bone scan or abdominal/pelvic CT or abdominal/pelvic MRI among men with newly diagnosed, high-risk prostate cancer. (Appropriate Imaging)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 4 yearsQualitative outcome assessed through semi-structured, in-depth interviews with participating providers
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Intervention Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Danil V. Makarov
VA New York Harbor Healthcare System
Phone: 212-686-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place