A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
EvoPAR-PR02
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).
2 other identifiers
interventional
700
27 countries
324
Brief Summary
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Aug 2025
Longer than P75 for phase_3 prostate-cancer
324 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedStudy Start
First participant enrolled
August 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2036
April 21, 2026
April 1, 2026
7.7 years
April 30, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metastasis-free survival (MFS)
MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging \[computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)\], as assessed by blinded independent central review (BICR) or death due to any cause.
Up to approximately 93 months
Secondary Outcomes (14)
Overall Survival (OS)
Up to approximately 11 years
MFS (CT/MRI and bone scan)
Up to approximately 93 months
MFS (PSMA-PET)
Up to approximately 93 months
MFS (standard clinical imaging)
Up to approximately 93 months
Time from randomisation to Progression Free Survival 2 (PFS2)
Up to approximately 93 months
- +9 more secondary outcomes
Study Arms (4)
Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
EXPERIMENTALParticipants will receive saruparib along with ADT.
Cohort A: Placebo + Physician's Choice ADT
PLACEBO COMPARATORParticipants will receive matching placebo to saruparib along with ADT.
Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
EXPERIMENTALParticipants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.
Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
PLACEBO COMPARATORParticipants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT.
Interventions
Standard of care ADT will be administered.
Saruparib will be administered orally.
Matching placebo to saruparib will be administered orally.
Abiraterone will be administered orally in combination with prednisone/prednisolone.
Eligibility Criteria
You may qualify if:
- Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
- Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
- Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
- Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
- Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
- Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
- Minimum life expectancy of 12 months.
- Adequate organ and bone marrow function as described in study protocol.
- All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis.
- All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
- Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.
- Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
You may not qualify if:
- Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Participants with any known predisposition to bleeding \[e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy\].
- Any history of persisting (\> 2 weeks) severe cytopenia due to any cause.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone.
- History of another primary malignancy, with exceptions.
- Persistent toxicities \[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\] caused by previous anticancer therapy.
- Cardiac criteria, including history of arrhythmia and cardiovascular disease.
- Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
- Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
- Active tuberculosis infection.
- Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
- Prior treatment within 14 days with blood product support or growth factor support.
- Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.
- Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
- Participants with a known hypersensitivity to saruparib or any excipients of these products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (329)
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Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85741, United States
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La Jolla, California, 92037, United States
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La Jolla, California, 92093, United States
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Los Angeles, California, 90048, United States
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San Diego, California, 92123, United States
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San Luis Obispo, California, 93401, United States
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Lakewood, Colorado, 80215, United States
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Hialeah, Florida, 33016, United States
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Jacksonville, Florida, 32224, United States
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Tampa, Florida, 33612, United States
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Newnan, Georgia, 30265, United States
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Chicago, Illinois, 60611, United States
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Chicago Ridge, Illinois, 60415, United States
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Greenwood, Indiana, 46143, United States
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Jeffersonville, Indiana, 47130, United States
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Bethesda, Maryland, 20817, United States
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Towson, Maryland, 21204, United States
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Plymouth, Massachusetts, 02360, United States
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Rochester, Minnesota, 55905, United States
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Hackensack, New Jersey, 07601, United States
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Voorhees Township, New Jersey, 08043, United States
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New York, New York, 10065, United States
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Syracuse, New York, 13210, United States
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Columbus, Ohio, 43230, United States
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Springfield, Oregon, 97477, United States
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Hershey, Pennsylvania, 17033, United States
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Lancaster, Pennsylvania, 17601, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Providence, Rhode Island, 02903, United States
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Myrtle Beach, South Carolina, 29572, United States
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Nashville, Tennessee, 37209, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78745, United States
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Houston, Texas, 77074, United States
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San Antonio, Texas, 78229, United States
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Spring, Texas, 77380, United States
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Salt Lake City, Utah, 84112, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24014, United States
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Virginia Beach, Virginia, 23462, United States
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Seattle, Washington, 98109, United States
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CABA, 1426, Argentina
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CABA, C1113AAE, Argentina
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Ciudad de Buenos Aires, 1181, Argentina
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Ciudad de Buenos Aires, 1426, Argentina
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Ciudad de Buenos Aires, C1419AHL, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5008HHW, Argentina
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Cuidad Autónoma de Buenos Aire, C1426ANZ, Argentina
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La Plata, 1900, Argentina
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Pergamino, B2700CPM, Argentina
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Rosario, S2000KZE, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Viedma, R8500ACE, Argentina
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Kingswood, 2747, Australia
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Murdoch, 6150, Australia
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Orange, 2800, Australia
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South Brisbane, 4101, Australia
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St Leonards, 2065, Australia
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Waratah, 2298, Australia
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Woolloongabba, 4102, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Vienna, 1020, Austria
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Vienna, 1090, Austria
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Jette, 1090, Belgium
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Kortrijk, 8500, Belgium
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Libramont-Chevigny, 6800, Belgium
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Roeselare, 8800, Belgium
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Wilrijk, 2610, Belgium
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Cachoeiro de Itapemirim, 29308-014, Brazil
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Curitiba, 80810-050, Brazil
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Curitiba, Brazil
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Jaú, 17210-120, Brazil
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Londrina, 86015-520, Brazil
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Pelotas, 96020-080, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 91350200, Brazil
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Rio de Janeiro, 22.250-905, Brazil
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Rio de Janeiro, 22775-001, Brazil
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Salvador, 41950640, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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Calgary, Alberta, T2V 1P9, Canada
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Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Brampton, Ontario, L6R 3J7, Canada
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London, Ontario, N6A 5A5, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Toronto, M4N 3M5, Canada
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Concepción, 4070196, Chile
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Temuco, 4781156, Chile
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Beijing, 100020, China
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Beijing, 100021, China
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Beijing, 100176, China
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Changchun, 130012, China
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Changsha, 410013, China
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Chongqing, 400016, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510180, China
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Guangzhou, 510280, China
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Hangzhou, 31000, China
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Hangzhou, 310022, China
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Jinan, 250021, China
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Jinhua, 322100, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Ningbo, 315010, China
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Shanghai, 200025, China
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Shanghai, 20032, China
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Shenyang, 110001, China
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Shenyang, 110042, China
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Sichuan, 610041, China
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Suining, 629018, China
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Tianjin, 300201, China
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Wuhan, 430022, China
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Wuhan, 430060, China
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Wuhu, 241000, China
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Xiamen, 361003, China
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Yangzhou, 225001, China
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Zhuhai, 519099, China
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Helsinki, 00290, Finland
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Helsinki, FI-00180, Finland
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Kuopio, 70210, Finland
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Oulu, 90029, Finland
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Tampere, FI-33521, Finland
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Turku, 20520, Finland
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Angers, 49100, France
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Bordeaux, 33000, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Le Mans, 72000, France
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Marseille, 13273, France
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Montpellier, 34070, France
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Montpellier, 34298, France
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Nice, 06100, France
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Nîmes, 30029, France
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Paris, 75020, France
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Paris, 75674, France
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Paris, 75970, France
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Pierre-Bénite, 69310, France
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Rennes, 35000, France
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Saint-Herblain, 44805, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67200, France
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Suresnes, 92151, France
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Tours, 37044, France
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Vandœuvre-lès-Nancy, 54511, France
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Villejuif, 94805, France
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Augsburg, 86156, Germany
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Berlin, 10117, Germany
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Braunschweig, 38126, Germany
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Cologne, 50937, Germany
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Dresden, 1307, Germany
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Duisburg, 47169, Germany
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Düsseldorf, 40226, Germany
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Essen, 45147, Germany
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Giessen, 35392, Germany
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Göttingen, 37075, Germany
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Hamburg, 20246, Germany
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Herne, 44625, Germany
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Kiel, 24105, Germany
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Lübeck, 23538, Germany
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Marburg, 35043, Germany
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Münster, 48149, Germany
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Nuremberg, 90419, Germany
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Nürtingen, 72622, Germany
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Regensburg, 93053, Germany
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Schwerin, 19049, Germany
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Trier, 54292, Germany
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Ulm, 89081, Germany
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Würzburg, 97080, Germany
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Budapest, H-1145, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Zalaegerszeg, 8900, Hungary
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Ansārinagar, 110 029, India
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Babgalore, 560069, India
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Delhi, 110085, India
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Hyderabad, 500019, India
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Kannur, 670103, India
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Kanpur, 208005, India
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Mumbai, 400012, India
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Nagpur, 440001, India
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Varanasi, 221005, India
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Afula, 18101, Israel
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Beersheba, 8410101, Israel
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Haifa, 31096, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 6423906, Israel
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Arezzo, 52100, Italy
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Bari, 70124, Italy
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Bergamo, 24125, Italy
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Bergamo, 24127, Italy
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Chieti, 66100, Italy
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Genoa, 16132, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Palermo, 90127, Italy
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Pisa, 56126, Italy
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Roma, 00144, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Torino, 10126, Italy
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Varese, 21100, Italy
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Verona, 37134, Italy
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Bunkyō City, 113-8431, Japan
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Fukuoka, 812-8582, Japan
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Kamakura-shi, 247-8533, Japan
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Kawagoe-shi, 350-8550, Japan
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Kawasaki-shi, 216-8511, Japan
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Kisarazu-shi, 292-8535, Japan
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Kumamoto, 860-8556, Japan
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Kyoto, 606-8507, Japan
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Maebashi, 371-8511, Japan
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Miyazaki, 889-1692, Japan
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Ōta-ku, 373-8550, Japan
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Sagamihara-shi, 252-0375, Japan
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Shimotsuke-shi, 329-0498, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Batu Caves, 68100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Pulau Pinang, 10450, Malaysia
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Hilversum, 1213 XZ, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Roosendaal, 4708 AE, Netherlands
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Lima, 15036, Peru
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Lima, LIMA 29, Peru
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Lima, Lima 34, Peru
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Trujillo, 13008, Peru
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Gdynia, 81-519, Poland
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Gliwice, 44-101, Poland
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Koszalin, 75-581, Poland
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Krakow, 30-727, Poland
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Piotrkow Trybunalski, 97-300, Poland
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Poznan, 61-731, Poland
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Rzeszów, 35-001, Poland
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Warsaw, 04-073, Poland
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Busan, 49241, South Korea
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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Barcelona, 08041, Spain
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Barcelona, 8035, Spain
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Girona, 17007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Málaga, 29009, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Sabadell, 08208, Spain
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Santander, 39008, Spain
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Valencia, 46009, Spain
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Valencia, 46014, Spain
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Gothenburg, 413 45, Sweden
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Malmo, 205 02, Sweden
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Stockholm, 112 81, Sweden
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Stockholm, 141 86, Sweden
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Umeå, 901 85, Sweden
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Uppsala, 75185, Sweden
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Kaohsiung City, 83301, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 43503, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10055, Taiwan
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Taipei, 110, Taiwan
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Taipei, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 50200, Thailand
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Pathum Thani, 12120, Thailand
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Songkhla, 90110, Thailand
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06520, Turkey (Türkiye)
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Ankara, 06620, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Istanbul, 34010, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Sakarya, 54290, Turkey (Türkiye)
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Şahinbey, 27310, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Greater London, SW3 6JJ, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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London, EC1M6BQ, United Kingdom
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London, NW3 2QG, United Kingdom
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London, WC1N 3BG, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle, NE7 7DN, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Romford, RM7 0AG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 1, 2025
Study Start
August 6, 2025
Primary Completion (Estimated)
March 31, 2033
Study Completion (Estimated)
April 30, 2036
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.