Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Completed
• CT.gov ID: NCT04134429
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 13.5

Study Details

Study Description

Brief Summary

In this pilot study the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients wearing the device on seven consecutive days for at least 18h/day, what will be measured by monitored heart rate. Study duration for each participant is 14 days.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer; Febrile Neutropenia; Chemotherapy-induced Neutropenia; Oncology	Device: Everion

Detailed Description

No study has proved feasibility of continuous monitoring of health data with a small wearable device such as the device Everion® in pediatric patients. It is not known if children tolerate the device and if data quality sustains with smaller arm circumferences or when worn on the upper leg. Neither is it known if parents and/or patients can and are willing to handle the device in ambulant setting. Therefore, this pilot study assesses the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study
• Actual Study Start Date: Nov 29, 2019
• Actual Primary Completion Date: Jan 13, 2020
• Actual Study Completion Date: Jan 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Everion® The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.	Device: Everion; The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Outcome Measures

Primary Outcome Measures

1. Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD) [14 days]

   The primary outcome is defined as at least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

Secondary Outcome Measures

1. Continous Monitoring of Oxygen Saturation With the WD [14 days]

   At least acceptable (≥50) quality score (worst quality 0, best quality 100) of oxygen saturation during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

2. Continous Monitoring of Respiration Rate With the WD [14 days]

   At least acceptable(≥50) quality score (worst quality 0, best quality 100) of respiration rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

3. Continous Monitoring of Core Temperature With the WD [14 days]

   At least acceptable(≥50) quality score (worst quality 0, best quality 100) of core temperature during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

4. Continous Monitoring of Heart Rate Variability With the WD [14 days]

   At least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate variability during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

5. Continous Monitoring of Perfusion Index With the WD [14 days]

   At least acceptable (≥50) quality score (worst quality 0, best quality 100) of perfusion index during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

6. Cumulative Time of Monitoring Heart Rate With the WD [14 days]

   Cumulative length of time with monitored heart rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

7. Cumulative Time of Monitoring Oxygen Saturation With the WD [14 days]

   Cumulative length of time with monitored oxygen saturation with at least acceptable quality score (≥50 worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

8. Cumulative Time of Monitoring Respiration Rate With the WD [14 days]

   Cumulative length of time with monitored respiration rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

9. Cumulative Time of Monitoring Core Temperature With the WD [14 days]

   Cumulative length of time with monitored core temperature with at least acceptable quality score (≥50, worst quality 0, best quality 100)) per study day (continuous outcomes, measured daily).

10. Cumulative Time of Monitoring Heart Rate Variability With the WD [14 days]

    Cumulative length of time with monitored heart rate variability with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

11. Cumulative Time of Monitoring Perfusion Index With the WD [14 days]

    Cumulative length of time with monitored perfusion index with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

12. Device Acceptance Assessed With Questionnaires [14 days]

    Proportion of patients and parents indicating that continuous monitoring with the wearable device (WD) is acceptable per day and per entire study duration and reasons not to wear the device.

13. Number and Description of Side Effects [14 days]

    Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.

14. Effort for Investigators Assessed by Number of Contacts [14 days]

    Effort (cumulative number of contacts) for the Investigators.

15. Effort for Investigators Assessed by Duration of Contacts [14 days]

    Effort (cumulative duration of contacts) for the Investigators.

16. Comparison [14 days]

    Difference between discrete measurements performed for clinical routine cares of heart rate and the mean of continuously measured heart rate within +/-10min at times of the discrete measurement.

17. Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection [14 days]

    Exploration of potential changes in or specific patterns of all collected signals and their quality scores in combination (heart rate, oxygen saturation, respiration rate, core temperature, skin temperature, heart rate variability, perfusion index, health score (0-100, higher score means better health), galvanic skin response) , within 48 hours before and after clinical diagnosis of fever (ear temperature of ≥39.0°C, or ≥38.5°C if fever is declared for clinical reasons) with or without neutropenia and microbiologically or clinically defined infections, if applicable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chemotherapy treatment because of any malignancy, expected to last ≥1 months at time of recruitment for myelosuppressive therapy or at least one cycle of myeloablative therapy.

• Age 1 month to <18 years at time of recruitment

• Written informed consent from patients and/or parents

Exclusion Criteria:

• Local skin diseases prohibiting wearing of the device.

• Denied written informed consent from patients and/or parent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inselspital	Bern		Switzerland	3010

Sponsors and Collaborators

• University Hospital Inselspital, Berne

Investigators

• Principal Investigator: Eva Brack, MD-PhD, Pediatric Hematology/Oncology, Inselspital, Bern University Hospital
• Study Chair: Christa Koenig, MD, Pediatric Hematology/Oncology, Inselspital, Bern University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 29, 2019

More Information

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT04134429
• Other Study ID Numbers: Bern 2019 WD Pilot
• First Posted: Oct 22, 2019
• Last Update Posted: Jul 8, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Inselspital, Berne: wearable device; Everion®; Fever and Neutropenia; Pediatric Oncology
• Additional relevant MeSH terms: Neoplasms; Neutropenia; Febrile Neutropenia

Study Results

Participant Flow

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Period Title: Overall Study
STARTED	20
COMPLETED	19
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Overall Participants	20
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	6
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Switzerland	20 100%
Type of malignancy (Count of Participants)
Acute lymphoblastic leukemia	12 60%
Other hematologic malignancies	2 10%
Central nervous system tumor	3 15%
Solid tumor	3 15%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)
Description	The primary outcome is defined as at least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Count of Participants [Participants]	6 30%

2. Secondary Outcome

Title	Continous Monitoring of Oxygen Saturation With the WD
Description	At least acceptable (≥50) quality score (worst quality 0, best quality 100) of oxygen saturation during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Count of Participants [Participants]	0 0%

3. Secondary Outcome

Title	Continous Monitoring of Respiration Rate With the WD
Description	At least acceptable(≥50) quality score (worst quality 0, best quality 100) of respiration rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Count of Participants [Participants]	4 20%

4. Secondary Outcome

Title	Continous Monitoring of Core Temperature With the WD
Description	At least acceptable(≥50) quality score (worst quality 0, best quality 100) of core temperature during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Count of Participants [Participants]	6 30%

5. Secondary Outcome

Title	Continous Monitoring of Heart Rate Variability With the WD
Description	At least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate variability during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Count of Participants [Participants]	1 5%

6. Secondary Outcome

Title	Continous Monitoring of Perfusion Index With the WD
Description	At least acceptable (≥50) quality score (worst quality 0, best quality 100) of perfusion index during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Count of Participants [Participants]	6 30%

7. Secondary Outcome

Title	Cumulative Time of Monitoring Heart Rate With the WD
Description	Cumulative length of time with monitored heart rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Measure hours	6576
Count of Units [hours]	3992

8. Secondary Outcome

Title	Cumulative Time of Monitoring Oxygen Saturation With the WD
Description	Cumulative length of time with monitored oxygen saturation with at least acceptable quality score (≥50 worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Measure hours	6576
Count of Units [hours]	1103

9. Secondary Outcome

Title	Cumulative Time of Monitoring Respiration Rate With the WD
Description	Cumulative length of time with monitored respiration rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Measure hours	6576
Count of Units [hours]	4058

10. Secondary Outcome

Title	Cumulative Time of Monitoring Core Temperature With the WD
Description	Cumulative length of time with monitored core temperature with at least acceptable quality score (≥50, worst quality 0, best quality 100)) per study day (continuous outcomes, measured daily).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Measure hours	6576
Count of Units [hours]	4037

11. Secondary Outcome

Title	Cumulative Time of Monitoring Heart Rate Variability With the WD
Description	Cumulative length of time with monitored heart rate variability with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Measure hours	6576
Count of Units [hours]	3142

12. Secondary Outcome

Title	Cumulative Time of Monitoring Perfusion Index With the WD
Description	Cumulative length of time with monitored perfusion index with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Measure hours	6576
Count of Units [hours]	3992

13. Secondary Outcome

Title	Device Acceptance Assessed With Questionnaires
Description	Proportion of patients and parents indicating that continuous monitoring with the wearable device (WD) is acceptable per day and per entire study duration and reasons not to wear the device.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Count of Participants [Participants]	18 90%

14. Secondary Outcome

Title	Number and Description of Side Effects
Description	Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Superficial skin lesion	1 5%
irritated skin	4 20%
itching	3 15%
sweating	7 35%

15. Secondary Outcome

Title	Effort for Investigators Assessed by Number of Contacts
Description	Effort (cumulative number of contacts) for the Investigators.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Number [Total number of contacts]	52

16. Secondary Outcome

Title	Effort for Investigators Assessed by Duration of Contacts
Description	Effort (cumulative duration of contacts) for the Investigators.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Number [minutes]	390

17. Secondary Outcome

Title	Comparison
Description	Difference between discrete measurements performed for clinical routine cares of heart rate and the mean of continuously measured heart rate within +/-10min at times of the discrete measurement.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

The analysis of differences between discrete measurements and continuously recorded aggregates of vital signs, as defined in the protocol, was found to yield massively distorted results because rapidly changing discretely measured vital signs were compared to aggregated means covering up to 20 min. We deliberately refrain from displaying these nonmeaningful results here.

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	0

18. Secondary Outcome

Title	Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection
Description	Exploration of potential changes in or specific patterns of all collected signals and their quality scores in combination (heart rate, oxygen saturation, respiration rate, core temperature, skin temperature, heart rate variability, perfusion index, health score (0-100, higher score means better health), galvanic skin response) , within 48 hours before and after clinical diagnosis of fever (ear temperature of ≥39.0°C, or ≥38.5°C if fever is declared for clinical reasons) with or without neutropenia and microbiologically or clinically defined infections, if applicable.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

The 4 episodes occured in 3 of these 20 patients. The other 17 patients had no episode with fever or infection.

Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
Measure Participants	20
Episodes with fever	3
Episodes with Infection	1

Adverse Events

Time Frame	17 days
Arm/Group Title	Everion®
Arm/Group Description	The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
All Cause Mortality
	Everion®
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Everion®
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Everion®
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Skin and subcutaneous tissue disorders
Superficial skin lesion	1/20 (5%)	20

Limitations/Caveats

(i) The WDs were studied for only 14 days and compliance might be different during long-term use. (ii) The small number of patients precluded an analysis of patient factors (iii) The planned comparison of discrete measurements versus continuously was not feasible because the exact second-wise time point of discrete measurements was not available.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.