Clinical Trial

. 2025 Jul 25:225:115584.

doi: 10.1016/j.ejca.2025.115584. Epub 2025 Jun 17.

Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial

Jonathan A Ledermann¹, Amit M Oza², Domenica Lorusso³, Carol Aghajanian⁴, Ana Oaknin⁵, Andrew Dean⁶, Nicoletta Colombo⁷, Johanne I Weberpals⁸, Andrew R Clamp⁹, Giovanni Scambia¹⁰, Alexandra Leary¹¹, Robert W Holloway¹², Margarita Amenedo Gancedo¹³, Peter C Fong¹⁴, Jeffrey C Goh¹⁵, David M O'Malley¹⁶, Deborah K Armstrong¹⁷, Susana Banerjee¹⁸, Jesús García-Donas¹⁹, Elizabeth M Swisher²⁰, Coriolan Lebreton²¹, Gottfried E Konecny²², Iain A McNeish²³, Clare L Scott²⁴, Lara Maloney²⁵, Sandra Goble²⁵, Kevin K Lin²⁵, Robert L Coleman²⁶

Affiliations

¹ UCL Cancer Institute, University College London and UCL Hospitals, London, UK. Electronic address: j.ledermann@ucl.ac.uk.
² Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
³ MITO and Gynecologic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
⁴ Memorial Sloan Kettering Cancer Center, New York, NY, USA.
⁵ Medical Oncology Service, Vall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
⁶ St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.
⁷ Gynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy.
⁸ Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁹ The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.
¹⁰ Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore and Scientific Directorate, Rome, Italy.
¹¹ Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Villejuif, France.
¹² AdventHealth Cancer Institute, Orlando, FL, USA.
¹³ Oncology Center of Galicia, La Coruña, Spain.
¹⁴ Auckland City Hospital and the University of Auckland, Grafton, Auckland, New Zealand.
¹⁵ Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Queensland University of Technology, Brisbane, Queensland, Australia.
¹⁶ The Ohio State University, James Cancer Center Hospital, Columbus, OH, USA.
¹⁷ Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
¹⁸ The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK.
¹⁹ Centro Integral Oncológico Clara Campal, Madrid, Spain.
²⁰ University of Washington, Seattle, WA, USA.
²¹ Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Paris, France.
²² University of California, Los Angeles, Los Angeles, CA, USA.
²³ Imperial College London, London, UK.
²⁴ Royal Melbourne Hospital, Parkville, and Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
²⁵ Clovis Oncology, Inc., Boulder, CO, USA.
²⁶ The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

PMID: 40580808
PMCID: PMC12687737
DOI: 10.1016/j.ejca.2025.115584

Clinical Trial

Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial

Jonathan A Ledermann et al. Eur J Cancer. 2025.

. 2025 Jul 25:225:115584.

doi: 10.1016/j.ejca.2025.115584. Epub 2025 Jun 17.

Authors

Affiliations

¹ UCL Cancer Institute, University College London and UCL Hospitals, London, UK. Electronic address: j.ledermann@ucl.ac.uk.
² Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
³ MITO and Gynecologic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
⁴ Memorial Sloan Kettering Cancer Center, New York, NY, USA.
⁵ Medical Oncology Service, Vall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
⁶ St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.
⁷ Gynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy.
⁸ Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁹ The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.
¹⁰ Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore and Scientific Directorate, Rome, Italy.
¹¹ Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Villejuif, France.
¹² AdventHealth Cancer Institute, Orlando, FL, USA.
¹³ Oncology Center of Galicia, La Coruña, Spain.
¹⁴ Auckland City Hospital and the University of Auckland, Grafton, Auckland, New Zealand.
¹⁵ Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Queensland University of Technology, Brisbane, Queensland, Australia.
¹⁶ The Ohio State University, James Cancer Center Hospital, Columbus, OH, USA.
¹⁷ Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
¹⁸ The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK.
¹⁹ Centro Integral Oncológico Clara Campal, Madrid, Spain.
²⁰ University of Washington, Seattle, WA, USA.
²¹ Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Paris, France.
²² University of California, Los Angeles, Los Angeles, CA, USA.
²³ Imperial College London, London, UK.
²⁴ Royal Melbourne Hospital, Parkville, and Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
²⁵ Clovis Oncology, Inc., Boulder, CO, USA.
²⁶ The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

PMID: 40580808
PMCID: PMC12687737
DOI: 10.1016/j.ejca.2025.115584

Abstract

Background: In ARIEL3, rucaparib maintenance significantly improved progression-free survival (PFS; primary endpoint) and long-term follow-up (LTFU) outcomes (including PFS2: time to disease progression on subsequent therapy or death) versus placebo in patients with recurrent, platinum-sensitive ovarian cancer. Here we report the final analysis of overall survival (OS; key secondary endpoint), LTFU outcomes, and safety.

Methods: OS and updated LTFU efficacy outcomes were analyzed (data cutoff date: April 4, 2022) across three nested populations (BRCA-mutated, homologous recombination deficient [HRD], and intention to treat [ITT]).

Results: Patients were randomized 2:1 to rucaparib (600 mg BID; n = 375) or placebo (n = 189). Median follow-up was 77.0 months. 168 patients in the placebo arm received subsequent treatment; of these, 77 (46 %) received a poly(ADP-ribose) polymerase inhibitor-containing treatment. Median OS from randomization post chemotherapy for rucaparib vs placebo was 45.9 vs 47.8 months (HR 0.83, 95 % CI 0.58-1.19) for the BRCA-mutated population; no OS benefit was found with rucaparib in the HRD and ITT populations. Median PFS2 for rucaparib vs placebo was 26.1 vs 18.4 months (HR 0.67, 95 % CI 0.48-0.94) for the BRCA-mutated population. Rucaparib numerically improved PFS2 and other LTFU outcomes versus placebo in the HRD and ITT populations. Safety was consistent with prior reports; myelodysplastic syndrome and/or acute myeloid leukemia occurred in 4 % and 3 % of patients in the rucaparib and placebo arms, respectively.

Conclusions: OS was similar between treatment arms. PFS benefit with rucaparib was maintained through the subsequent therapy line. These data support rucaparib as maintenance treatment for recurrent ovarian carcinoma.

Keywords: BRCA; Homologous recombination deficient; Long-term follow-up; Overall survival; PFS2; Poly(ADP-ribose) polymerase inhibitor; Progression-free interval; Recurrent ovarian cancer.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JAL has received lecture fees from Clovis Oncology, AstraZeneca, GSK/Tesaro, Merck Sharp & Dohme, and Neopharm; has served on advisory boards for Clovis Oncology, Artios Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Ellipses Pharma, GSK/Tesaro, Immagene, Merck Sharp & Dohme, Nuvation Bio, Pfizer, Regeneron, and VBL Therapeutics, and IDMC for Mersana Therapeutics and Sutro Biopharma; and has received research grants from AstraZeneca and Merck Sharp & Dohme. AMO reports grants to his institution from AstraZeneca; has served on steering committees for Clovis Oncology, AstraZeneca, and Tesaro (uncompensated); has served in an advisory role for AstraZeneca and GSK (uncompensated); has acted as a principal investigator on investigator-initiated trials with agents from Clovis Oncology, AstraZeneca, and GSK; and has received consulting fees from MorphoSys. DL reports institutional research funding from Clovis Oncology, AstraZeneca, Corcept Therapeutics, GSK, Genmab, ImmunoGen, Merck Sharp & Dohme, Novartis, PharmaMar, Roche, and Seagen; reports consulting fees from Clovis Oncology, AstraZeneca, GSK, Merck Sharp & Dohme, Novartis, and PharmaMar; reports payment or honoraria for lectures from Clovis Oncology, AstraZeneca, GSK, Merck Sharp & Dohme, and Seagen; reports support for attending meetings and/or travel from AstraZeneca, PharmaMar, and Roche; reports participation on a data safety monitoring board or advisory board for Clovis Oncology, Agenus, AstraZeneca, GSK, Merck Sharp & Dohme, Novartis, and Roche; serves on the board of directors for Gynecologic Cancer Intergroup; and serves as chair of Gynaecological Cancer Academy for ENGOT. CA has served on a steering committee for AbbVie and Genentech; has served as a principal investigator for studies by Clovis Oncology, AbbVie, AstraZeneca, and Genentech; has served on advisory boards for AbbVie, AstraZeneca/Merck, Blueprint Medicine, Eisai/Merck, Mersana Therapeutics, Repare Therapeutics, and Roche/Genentech; and serves on the board of directors (unpaid) for GOG Foundation and NRG Oncology. AO reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Clovis Oncology, AstraZeneca Farmaceutica Spain, AstraZeneca, Corcept Therapeutics, Deciphera Pharmaceutical, Eisai Europe Limited, EMD Serono, F. Hoffmann-La Roche, GSK, Got-It Knowledge Consulting, ImmunoGen, KL Logistics, Medison Pharma, Merck Sharp & Dohme de España, Mersana Therapeutics, Novocure GmbH, PharmaMar, prIME Oncology, Roche Farma, Shattuck Labs, Sutro Biopharma, Tesaro Bio GmbH, Tesaro Bio Spain, and Tesaro; and reports support for attending meetings and/or travel from AstraZeneca, Roche, and PharmaMar. AD has served in a consulting or advisory role for Precision Oncology Australia, Shire, and Specialised Therapeutics Australia; and sits on the scientific advisory board for A2A Pharmaceuticals. NC reports institutional research funding from Clovis Oncology; reports serving in a consulting or advisory role for Clovis Oncology, AstraZeneca, BIOCAD, Eisai, GSK, ImmunoGen, Merck Sharp & Dohme, Mersana Therapeutics, Novartis, Nuvation Bio, OncXerna Therapeutics, Pfizer, PharmaMar, Roche, and Tesaro; reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Clovis Oncology, AstraZeneca, GSK, Merck Sharp & Dohme, and Novartis; and reports support for attending meetings and/or travel from AstraZeneca. JIW has received research support from AstraZeneca. ARC reports consulting fees for advisory boards for AstraZeneca and GSK; reports payment or honoraria for speakers bureaus for Clovis Oncology and GSK; reports support for attending meetings and/or travel from MSD; and reports institutional research funding from Clovis Oncology, AstraZeneca, Merck, Advenchen, Eisai, Verastem Oncology, and Novartis. GS reports royalties or licences from Merck Sharp & Dohme Italia; reports consulting fees from Tesaro Bio Italy and Johnson & Johnson; and reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Clovis Oncology Italy. AL has served on advisory boards for Clovis Oncology, Ability Pharma, AstraZeneca, BIOCAD, GamaMabs Pharma, Genmab/Seattle Genetics, GSK, Gritstone, Merck Serono, Merck Sharp & Dohme, and Tesaro; has served on steering committee for Merck Sharp & Dohme; reports institutional support for clinical trials or academic research from Clovis Oncology, Ability Pharma, Agenus, AstraZeneca, Incyte, Inivata, Iovance Biotherapeutics, Merck Sharp & Dohme, Pfizer, Roche, Sanofi, and Tesaro; and reports boarding and travel expenses for congress activities from Clovis Oncology, AstraZeneca, and Roche. RWH reports consulting fees from Clovis Oncology, AstraZeneca, and GSK; and reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Clovis Oncology, AstraZeneca, and GSK. MAG has served on speakers bureaus for Clovis Oncology, AstraZeneca, GSK, Merck Sharp & Dohme, and PharmaMar; and reports support for attending meetings and/or travel from GSK. PCF reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Merck Sharp & Dohme; and reports support for attending meetings and/or travel from Merck Sharp & Dohme and Pfizer. JCG reports consulting fees from AstraZeneca, Bristol Myers Squibb, Eisai, and Merck Sharp & Dohme; reports payment or honoraria for lectures, presentations, speakers bureaus, or educational events from AstraZeneca, Bayer, Bristol Myers Squibb, GSK, Ipsen, and Merck Sharp & Dohme Australia; reports support for attending meetings and/or travel from Bayer; reports participation on a data safety monitoring board or advisory board for Bristol Myers Squibb and Eisai; and stock or stock options for ICON Cancer Care, Australia. DMO reports personal fees from consulting and/or advisory board participation from Clovis Oncology, AbbVie, Adaptimmune, Agenus, Arquer Diagnostics, Arcus Biosciences, AstraZeneca, Atossa Therapeutics, Boston Biomedical, Cardiff Oncology, Celcuity, Corcept Therapeutics, Duality Bio, Eisai, Elevar Therapeutics, Exelixis, Genentech, Genelux, GSK, GOG Foundation, F. Hoffmann-La Roche, ImmunoGen, Imvax, InterVenn Biosciences, InxMed, Iovance Biotherapeutics, Janssen, Jazz Pharmaceuticals, Laekna, Leap Therapeutics, Luzsana Biotechnology, Merck & Co, Merck Sharp & Dohme Corp., Mersana Therapeutics, Myriad, Novartis, Novocure, OncoC4, Onconova, Therapeutics Regeneron Pharmaceuticals, RepIimune, R-Pharm, Roche Diagnostics, Seattle Genetics (SeaGen), Sorrento Therapeutics, Sutro Biopharma, Tarveda Therapeutics, Toray, Trillium Therapeutics, Umoja Biopharma, Verastem Oncology, VBL Therapeutics, Vincerx Pharma, Xencor, and Zentalis; reports research funding (all funding to institution) from Clovis Oncology, AbbVie, Advaxis, Agenus, Alkermes, Aravive, Arcus, Biosciences, AstraZeneca, BeiGene USA, Boston Biomedical, Bristol Myers Squibb, Deciphera Pharma, Eisai, EMD Serono, Exelixis, Genentech, Genmab, GSK, GOG Foundation, F. Hoffmann-La Roche, ImmunoGen, Incyte Corporation, Iovance Biotherapeutics, Karyopharm, Leap Therapeutics, Ludwig Cancer Research, Merck & Co, Merck Sharp & Dohme, Mersana Therapeutics, NCI, Novartis, Novocure, NRG Oncology, OncoC4, OncoQuest, Pfizer, Precision Therapeutics, Prelude Therapeutics, Regeneron Pharmaceuticals, RTOG, Rubius Therapeutics, Seattle Genetics (SeaGen), Sutro Biopharma, SWOG, Tesaro, and Verastem Oncology; and has given a presentation on ovarian cancer at the National Comprehensive Cancer Network. DKA has served as a scientific advisor for Morphotek; and has received research funding from Clovis Oncology, Advaxis, AstraZeneca, Pfizer, Syndax, and Tesaro. SB has served on advisory boards and received honoraria from Clovis Oncology, AstraZeneca, Epsilogen, GSK, ImmunoGen, Merck Sharpe & Dohme, Mersana Therapeutics, Myriad, Novartis, OncXerna Therapeutics, Seagen, Shattuck Labs, Regeneron, and Verastem Oncology; has received honoraria from AstraZeneca, GSK, ImmunoGen, Merck Sharpe & Dohme, Mersana Therapeutics, Pfizer, Roche, Takeda, Novocure, and, Verastem Oncology; has received support for travel or accommodation from GSK, AstraZeneca, and Verastem Oncology; and has received institutional funding for academic grants from AstraZeneca and GSK. JG-D has received research funding from AstraZeneca, Pierre Fabre, and Pfizer; has received personal fees from Clovis Oncology, Astellas Pharma, Pierre Fabre, and Pfizer; and has received nonfinancial support from Astellas Pharma, Pierre Fabre, and Pfizer. EMS reports institutional research funding from Clovis Oncology, GSK, PlexxiKon and DSMB participation (Novartis). CL reports honoraria for consulting or advisory board participation from GSK, Abbvie, EISAI and AstraZeneca; and personal honoraria for speaker engagements from GSK, Clovis Oncology, Eisai, AstraZeneca and MSD. GEK has received honoraria from Clovis Oncology, AstraZeneca, Foundation Medicine, and GSK; and has received research funding to institution from Lilly and Merck. IAM has served on advisory boards for and received honoraria from Clovis Oncology, AstraZeneca, Epsila Bio, GSK/Tesaro, Roche, OncoC4, Scancell, and Theolytics; and has received institutional research funding from AstraZeneca. CLS has served in a consulting or advisory role for AstraZeneca, Clovis Oncology, Roche, and Eisai Australia; has received support for travel or accommodation from AstraZeneca, Clovis Oncology, and Roche; has received drugs for research from Eisai Australia; and her institution received in kind research support for parallel laboratory work using rucaparib. LM, SG, and KKL were employees of Clovis Oncology; and may own stock or have stock options in that company. RLC reports grants or contracts from Clovis Oncology, AstraZeneca, Gateway Foundation, Genelux, Genmab, Janssen, Merck, and Roche/Genentech; and reports consulting fees from Clovis Oncology, Agenus, Alkermes, AstraZeneca, Deciphera, Genelux, Genmab, GSK, ImmunoGen, Janssen, OncoQuest, OncXerna Therapeutics, Onxeo, Regeneron, and Roche/Genentech. All support from Clovis Oncology and pharma& reported here were received outside of the submitted work or conduct of the study.

Figures

**Fig. 1.**
Patient disposition (ITT population). Abbreviations: ITT, intention to treat; PARP, poly(ADP-ribose) polymerase; VEGF, vascular endothelial growth factor. *Among patients with disease that progressed and who started subsequent therapy. ^†Excludes regimens containing a PARP inhibitor. ^‡Includes use as maintenance or treatment. ^§Includes bevacizumab monotherapy or other VEGF inhibitor, immunotherapy, hormonal therapy, investigational treatment (unspecified), radiation, and hyperthermic intraperitoneal chemotherapy.

**Fig. 2.**
Kaplan–Meier curves for OS in nested populations. Abbreviations: *BRCA*, *BRCA1* or *BRCA2*; CI, confidence interval; HR, hazard ratio; HRD, homologous recombination deficient; ITT, intention to treat; LOH, loss of heterozygosity; OS, overall survival. *Includes *BRCA*-mutated carcinoma and *BRCA* wild-type/LOH-high groups.

**Fig. 3.**
Timeline of long-term follow-up efficacy outcomes. Abbreviations: CFI, chemotherapy free interval; PD, progressive disease; PFS, progression-free survival; PFS2, time to disease progression on subsequent therapy or death; R, randomization; TFST, time to start of first subsequent therapy; TSST, time to start of second subsequent therapy.

**Fig. 4.**
Kaplan–Meier curves for PFS2 in nested populations. Abbreviations: BRCA, BRCA1 or BRCA2; CI, confidence interval; HR, hazard ratio; HRD, homologous recombination deficient; ITT, intention to treat; LOH, loss of heterozygosity; PFS2, time to disease progression on subsequent therapy or death. *Includes BRCA-mutated carcinoma and BRCA wild-type/LOH-high carcinoma groups.

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References

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1. Ledermann JA, Oza AM, Lorusso D, et al. Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial. Lancet Oncol 2020;21:710–22. - PMC - PubMed
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Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial

Affiliations

Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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Grants and funding

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Medical

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