chufangao/CTO huggingface dataset:
Clinical trial NCT04564417: First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors
Official title: Phase I Dose Escalation and Dose Expansion, International, Multicenter Study of W0180 as Single Agent and in Combination With Pembrolizumab (Anti-PD-1) in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor: Pierre Fabre Medicament (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Enrollment: 33.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-08
Primary completion date: 2023-12-19
Completion date: 2023-12-19
Plan to share individual participant data: NO
Clinical trial NCT04602507: Ivermectin in Adults With Severe COVID-19.
Official title: Ivermectin in Adults With Severe COVID-19. Double-blind Randomized Clinical Trial
Sponsor: CES University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of severe COVID-19 cases in the place of study
Enrollment: 75.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-10
Primary completion date: 2021-12-09
Completion date: 2021-12-09
Plan to share individual participant data: YES
IPD sharing description: For a reasonable scientific purpose, we may share individual patient data (IPD) that underlie results in a publication under direct request to the principal investigator. We reserve our right to share IPD.
IPD time frame: One year
IPD access criteria: Under direct request to principal investigator
Clinical trial NCT04502069: Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen
Official title: Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation
Acronym: Opaganib-RHB
Sponsor: RedHill Biopharma Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: To be replaced with a randomized placebo-controlled study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-08-31
Primary completion date: 2021-02-28
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT03464136: Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
Official title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease
Acronym: SEAVUE
Sponsor: Janssen Scientific Affairs, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 386.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-29
Primary completion date: 2020-12-15
Completion date: 2021-05-21
Clinical trial NCT03858049: Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
Official title: Comparison of Crinone ® Versus Combination Medication for Luteal Phase Support on the Ongoing Pregnancy Rate of Frozen-thawed Cycle in Chinese Population a Randomized, Interventional, Open-label, Phase IV, Single Center, Pilot Study (ACCESS)
Sponsor: Merck KGaA, Darmstadt, Germany (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The trend in LPS treatment tends to increase the dosage of progesterone in FET-HRT, this study was designed 5 years ago.
Enrollment: 172.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-31
Primary completion date: 2021-10-27
Completion date: 2021-10-27
Baseline population: Intention-to-Treat (ITT) population included all participants who received at least one dose of randomized study intervention.
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT04217720: SNS-301 Monotherapy in High Risk MDS and CMML
Official title: An Open-Label, Multi-Center Phase 2 Clinical Trial Evaluating SNS-301 in Patients With ASPH+ High Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
Sponsor: Sensei Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-01
Primary completion date: 2022-01-01
Completion date: 2023-01-01
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.
IPD time frame: Beginning 9 months and ending 36 months following article publication.
IPD access criteria: Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal Proposals should be directed to info@senseibio.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.
Clinical trial NCT03784443: Combined Ranibizumab and Iluvien for Diabetic Macular Oedema
Official title: Combined Anti-VEGF Intravitreal Injections With Sustained Steroid Implantation for the Treatment of Diabetic Macular Oedema
Acronym: CASSIE
Sponsor: Imperial College London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Funder withdrawn funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-01
Primary completion date: 2022-09-01
Completion date: 2023-09-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03338777: Suicide Plus Immune Gene Therapy for Advanced Melanoma
Official title: Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma
Acronym: IGTM-101
Sponsor: Hospital Italiano de Buenos Aires (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Failure to achieve primary objective
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-20
Primary completion date: 2020-02-20
Completion date: 2020-02-20
Plan to share individual participant data: NO
Clinical trial NCT04363203: VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
Official title: VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
Acronym: VA-REACH
Sponsor: San Francisco VA Health Care System (FED)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: concerns related to study drug
Enrollment: 300.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2020-04-30
Primary completion date: 2021-03-31
Completion date: 2021-08-31
Plan to share individual participant data: NO
Clinical trial NCT04051996: GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia
Official title: A Randomized, Parallel-arm, Phase 2 Clinical Trial of the Combination of Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia Who Are Unfit for or Refuse Intensive Chemotherapy (GLAD-AML)
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unable to accrue patients following COVID-19 study pause.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-06
Primary completion date: 2020-06-09
Completion date: 2020-06-09
Baseline population: Only 1 patient was enrolled in the study prior to termination and therefore would be identified through presenting these characteristics.
Plan to share individual participant data: NO
Clinical trial NCT03174184: Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB
Official title: A Phase 2a Study of the Early Bactericidal Activity of Rifampin (RIF) in Combination With Meropenem Plus Amoxicillin/Clavulanate Among Adults With Rifampin-resistant or Rifampin-susceptible Pulmonary Tuberculosis
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 112.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-08-23
Primary completion date: 2022-05-13
Completion date: 2022-05-13
Plan to share individual participant data: NO
Clinical trial NCT04046328: Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
Official title: A Phase IIa, Proof of Concept, Randomized, Double-Blind, Dose-Finding, Cross-Over Study of the Efficacy, Safety and Tolerability of a New Enteric-Coated Cholestyramine Capsule in Adult Short Bowel Syndrome Patients
Sponsor: Pharmascience Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Difficult recruitment
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-15
Primary completion date: 2021-12-22
Completion date: 2021-12-22
Limitations and caveats: Early termination leading to small numbers of subjects analyzed and abbreviated statistical analyses.
Plan to share individual participant data: NO
Clinical trial NCT04864522: Phase I/II Study of SLAMF7 FPBMC/CS-1 FPBMC in Relapsed/Refractory Multiple Myeloma
Official title: Phase I/II Study of Anti-CD3 x Anti-SLAMF7 (Anti-CS-1) Bispecific Antibody Armed Fresh Peripheral Blood Mononuclear Cells (SLAMF7 FPBMC) in Relapsed/Refractory Multiple Myeloma
Acronym: MM FPBMC
Sponsor: University of Virginia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Slow accrual due to a crowded field of effective drugs by the time the study opened
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-08-31
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: NO
Clinical trial NCT03773978: A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)
Acronym: JUVE-BASIS
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 220.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-17
Primary completion date: 2022-01-26
Completion date: 2022-01-26
Baseline population: Baseline analysis Population includes all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04233801: A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Empagliflozin (10 mg and 25 mg) Administered Orally Once Daily in Combination With Insulin With or Without up to Two Oral Anti-diabetic Agents for 24 Weeks in Chinese Type 2 Diabetic Patients With Insufficient Glycemic Control.
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 219.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-04-15
Primary completion date: 2022-03-03
Completion date: 2022-03-10
Baseline population: Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT03617224: Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome
Official title: Phase I Trial of Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Unable to enroll patients that met enrollment criteria.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-24
Primary completion date: 2022-07-24
Completion date: 2024-07-24
Plan to share individual participant data: NO
Clinical trial NCT04189848: Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc
Official title: A Trial to Complare the Injection Site Pain Experience of Semaglutide 0.25 mg and Dulaglutide 0.75 mg Administered sc
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-03
Primary completion date: 2020-01-29
Completion date: 2020-02-27
Baseline population: Full analysis set (FAS) included all randomised subjects who had received at least 1 injection of semaglutide or dulaglutide (included any skin contact with trial product whether the injection was completed or not).
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04070781: Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease
Official title: Phase I Study of Itacitinib in Combination With Tocilizumab for the Treatment of Steroid Refractory Acute Graft Versus Host Disease
Acronym: GVHD
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The primary reason for study closure is slow enrollment.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-20
Primary completion date: 2021-12-13
Completion date: 2021-12-13
Clinical trial NCT02288832: Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by Point-of-care During Pregnancy
Official title: Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by Point-of-care During Pregnancy
Acronym: AuTop
Sponsor: Assistance Publique Hopitaux De Marseille (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 6800.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-03-06
Primary completion date: 2018-07-01
Completion date: 2022-10-21
Clinical trial NCT04094870: A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Official title: Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-30
Primary completion date: 2020-10-30
Completion date: 2020-10-30
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD time frame: 9 to 36 months following publication
IPD access criteria: Investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
Clinical trial NCT03735758: Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib
Official title: Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib - a Randomized, Controlled Trial
Acronym: PazoQoL
Sponsor: GWT-TUD GmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: problems with recruiting
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-02
Primary completion date: 2020-10-06
Completion date: 2020-10-06
Clinical trial NCT02958709: Optimizing Treatment to Improve TBM Outcomes in Children
Official title: Phase I/II Randomized, Open-label Trial to Evaluate the PK, Safety, and Outcomes of Treatment Including High Dose Rifampicin +/- Levofloxacin vs Standard Treatment for Pediatric Tuberculous Meningitis (TBM)
Acronym: TBM-KIDS
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 38.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-02-22
Primary completion date: 2020-11-15
Completion date: 2020-11-15
Plan to share individual participant data: NO
Clinical trial NCT02870920: Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
Official title: A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients With Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies
Sponsor: Canadian Cancer Trials Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-12
Primary completion date: 2018-10-18
Completion date: 2022-06-07
Plan to share individual participant data: NO
Clinical trial NCT04317066: A Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-A33/KEYNOTE-A33)
Official title: A Phase 1 Clinical Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (KEYNOTE-A33)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-26
Primary completion date: 2024-04-11
Completion date: 2024-04-11
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03622658: Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Official title: A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
Acronym: NAMASTE
Sponsor: Izana Bioscience Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-06
Primary completion date: 2020-02-04
Completion date: 2020-02-04
Clinical trial NCT02228382: Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
Official title: A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Enrollment: 163.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-11-07
Primary completion date: 2020-10-13
Completion date: 2020-10-13
Baseline population: Safety analysis set included all participants who received at least 1 dose of bosutinib
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT02799602: Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Official title: A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
Acronym: ARASENS
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1306.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2021-10-25
Completion date: 2023-04-11
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.