BCSDP epidemiologists have expertise in the use of electronic patient healthcare data sources for studies of drug safety and disease epidemiology for a wide variety of drugs and diseases. BCDSP also performs validation of exposure and outcome data within each data source. Research studies are either investigator-initiated or performed on a contract basis in collaboration with regulatory authorities or the pharmaceutical industry. Below are some examples of prior research conducted at BCDSP.
If you want to see our publications as they happen, follow us on LinkedIn!
Drug Safety Studies
Observational studies of drug safety require specialized methods to avoid major biases, particularly confounding by indication and protopathic bias. BCDSP has longstanding expertise in the design and conduct safety studies for a broad range of drugs, disease areas and outcomes. Some examples of previous drug safety studies conducted at BCDSP are below.
Safety of hormonal contraceptives
Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006 Mar;73(3):223-8. doi: 10.1016/j.contraception.2006.01.001. Epub 2006 Jan 26. PMID: 16472560.
Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ. 2011 Apr 21;342:d2151. doi: 10.1136/bmj.d2151. PMID: 21511805; PMCID: PMC3081040.
Jick SS, Hagberg KW, Hernandez RK, Kaye JA. Postmarketing study of ORTHO EVRA and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism. Contraception. 2010 Jan;81(1):16-21. doi: 10.1016/j.contraception.2009.07.004. PMID: 20004268.
Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ. 2011 Apr 21;342:d2139. doi: 10.1136/bmj.d2139. PMID: 21511804; PMCID: PMC3081041.
Safety of other hormone therapies
Jick SS, Hagberg KW, Kaye JA, Jick H. Postmenopausal estrogen-containing hormone therapy and the risk of breast cancer. Obstet Gynecol. 2009 Jan;113(1):74-80. doi: 10.1097/AOG.0b013e31818fdde4. PMID: 19104362.
McGlynn KA, Hagberg K, Chen J, Braunlin M, Graubard BI, Suneja N, Jick S, Sahasrabuddhe VV. Menopausal hormone therapy use and risk of primary liver cancer in the clinical practice research datalink. Int J Cancer. 2016 May 1;138(9):2146-53. doi: 10.1002/ijc.29960. Epub 2015 Dec 31. PMID: 26662112; PMCID: PMC4764427.
Drugs and risk of cancer
Jick SS, Hagberg KW, Kaye JA, Jick H. Postmenopausal estrogen-containing hormone therapy and the risk of breast cancer. Obstet Gynecol. 2009 Jan;113(1):74-80. doi: 10.1097/AOG.0b013e31818fdde4. PMID: 19104362.
Hagberg KW, McGlynn KA, Sahasrabuddhe VV, Jick S. Anti-diabetic medications and risk of primary liver cancer in persons with type II diabetes. Br J Cancer. 2014 Oct 28;111(9):1710-7. doi: 10.1038/bjc.2014.447. Epub 2014 Aug 5. PMID: 25093492; PMCID: PMC4453721.
McGlynn KA, Hagberg K, Chen J, Graubard BI, London WT, Jick S, Sahasrabuddhe VV. Statin use and risk of primary liver cancer in the Clinical Practice Research Datalink. J Natl Cancer Inst. 2015 Feb 26;107(4):djv009. doi: 10.1093/jnci/djv009. PMID: 25722350; PMCID: PMC4351398.
McGlynn KA, Hagberg K, Chen J, Braunlin M, Graubard BI, Suneja N, Jick S, Sahasrabuddhe VV. Menopausal hormone therapy use and risk of primary liver cancer in the clinical practice research datalink. Int J Cancer. 2016 May 1;138(9):2146-53. doi: 10.1002/ijc.29960. Epub 2015 Dec 31. PMID: 26662112; PMCID: PMC4764427.
Hagberg KW, Sahasrabuddhe VV, McGlynn KA, Jick SS. Does angiotensin-converting enzyme inhibitor and β-blocker use reduce the risk of primary liver cancer? A case-control study using the U.K. Clinical Practice Research Datalink. Pharmacotherapy. 2016 Feb;36(2):187-95. doi: 10.1002/phar.1704. Epub 2016 Feb 5. PMID: 26846893; PMCID: PMC5808860.
Drahos J, Li L, Jick SS, Cook MB. Metabolic syndrome in relation to Barrett’s esophagus and esophageal adenocarcinoma: Results from a large population-based case-control study in the Clinical Practice Research Datalink. Cancer Epidemiol. 2016 Jun;42:9-14. doi: 10.1016/j.canep.2016.02.008. Epub 2016 Mar 9. PMID: 26972225; PMCID: PMC4899201.
Safety of drugs in pregnancy
Hagberg KW, Robijn AL, Jick S. Maternal depression and antidepressant use during pregnancy and the risk of autism spectrum disorder in offspring. Clin Epidemiol. 2018 Nov 1;10:1599-1612. doi: 10.2147/CLEP.S180618. PMID: 30464639; PMCID: PMC6219268.
Vasilakis-Scaramozza C, Aschengrau A, Cabral H, Jick SS. Antidepressant use during early pregnancy and the risk of congenital anomalies. Pharmacotherapy. 2013 Jul;33(7):693-700. doi: 10.1002/phar.1211. Epub 2013 Jun 6. PMID: 23744675.
Vasilakis-Scaramozza C, Aschengrau A, Cabral HJ, Jick SS. Antihypertensive drugs and the risk of congenital anomalies. Pharmacotherapy. 2013 May;33(5):476-82. doi: 10.1002/phar.1212. Epub 2013 Apr 1. PMID: 23553869.
Hak E, Mulder B, Schuiling-Veninga CC, de Vries TW, Jick SS. Use of acid-suppressive drugs in pregnancy and the risk of childhood asthma: bidirectional crossover study using the general practice research database. Drug Saf. 2013 Nov;36(11):1097-104. doi: 10.1007/s40264-013-0093-z. PMID: 24018582; PMCID: PMC3824882.
Safety of new therapies for autoimmune disorders
Vasilakis-Scaramozza C, Persson R, Hagberg KW, Jick S. The risk of treated anxiety and treated depression among patients with psoriasis and psoriatic arthritis treated with apremilast compared to biologics, DMARDs and corticosteroids: a cohort study in the United States MarketScan database. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1755-1763. doi: 10.1111/jdv.16231. Epub 2020 Feb 28. PMID: 31981426.
Hagberg KW, Persson R, Vasilakis-Scaramozza C, Niemcryk S, Peng M, Paris M, Lindholm A, Jick S. Herpes zoster, hepatitis C, and tuberculosis risk with apremilast compared to biologics, DMARDs and corticosteroids to treat psoriasis and psoriatic arthritis. Clin Epidemiol. 2020 Feb 12;12:153-161. doi: 10.2147/CLEP.S239511. PMID: 32104099; PMCID: PMC7024766.
Persson R, Hagberg KW, Qian Y, Vasilakis-Scaramozza C, Jick S. The risk of myocardial infarction, stroke, and revascularization among patients with psoriasis treated with apremilast compared with biologics and disease-modifying antirheumatic drugs: A cohort study in the US MarketScan database. J Am Acad Dermatol. 2020 Jul;83(1):271-274. doi: 10.1016/j.jaad.2020.03.043. Epub 2020 Mar 25. PMID: 32222448.
Safety of other important drugs
Qian Y, Jick S. Proton-pump inhibitor use and myocardial infarction: a nested case-control study in the UK Clinical Practice Research Datalink. 2020 May;31(3):423-431. doi: 10.1097/EDE.0000000000001152. PMID: 31809341.
Persson R, Jick S. Clinical implications of the association between fluoroquinolones and tendon rupture: The magnitude of the effect with and without corticosteroids. Br J Clin Pharmacol. 2019 May;85(5):949-959. doi: 10.1111/bcp.13879. Epub 2019 Mar 18. PMID: 30682225; PMCID: PMC6475686.
Jick SS, Hedderson M, Xu F, Cheng Y, Palkowitsch P, Michel A. Iodinated contrast agents and risk of hypothyroidism in young children in the United States. Invest Radiol. 2019 May;54(5):296-301. doi: 10.1097/RLI.0000000000000541. PMID: 30562272.
Hagberg KW, Divan HA, Persson R, Nickel JC, Jick SS. Risk of erectile dysfunction associated with use of 5-α reductase inhibitors for benign prostatic hyperplasia or alopecia: population based studies using the Clinical Practice Research Datalink. BMJ. 2016 Sep 22;354:i4823. doi: 10.1136/bmj.i4823. PMID: 27659058.
Hagberg KW, Divan HA, Fang SC, Nickel JC, Jick SS. Risk of gynecomastia and breast cancer associated with the use of 5-alpha reductase inhibitors for benign prostatic hyperplasia. Clin Epidemiol. 2017 Feb 10;9:83-91. doi: 10.2147/CLEP.S124674. PMID: 28228662; PMCID: PMC5312705.
Christiansen CF, Ehrenstein V, Heide-Jørgensen U, Skovbo S, Nørrelund H, Sørensen HT, Li L, Jick S. Metformin initiation and renal impairment: a cohort study in Denmark and the UK. BMJ Open. 2015 Sep 2;5(9):e008531. doi: 10.1136/bmjopen-2015-008531. PMID: 26338686; PMCID: PMC4563232.
Li L, Jick S, Gopalakrishnan C, Heide-Jørgensen U, Nørrelund H, Sørensen HT, Christiansen CF, Ehrenstein V. Metformin use and risk of lactic acidosis in people with diabetes with and without renal impairment: a cohort study in Denmark and the UK. Diabet Med. 2017 Apr;34(4):485-489. doi: 10.1111/dme.13203. Epub 2016 Sep 19. PMID: 27504911.
Disease Epidemiology Studies
Descriptive epidemiology can provide important background information on risk factors, disease progression, and comorbidities. These data are important for clinicians and for researchers developing new therapies and when evaluating post-marketing safety data. Some examples of previous disease epidemiology studies conducted at BCDSP are below.
Multiple sclerosis
Persson R, Lee S, Ulcickas Yood M, Wagner Usn Mc CM, Minton N, Niemcryk S, Lindholm A, Evans AM, Jick SS. Infections in patients diagnosed with multiple sclerosis: A multi-database study. Mult Scler Relat Disord. 2020 Jun;41:101982. doi: 10.1016/j.msard.2020.101982. Epub 2020 Feb 4. PMID: 32070858.
Persson R, Lee S, Yood MU, Wagner M, Minton N, Niemcryk S, Lindholm A, Evans A, Jick S. Incident cardiovascular disease in patients diagnosed with multiple sclerosis: A multi-database study. Mult Scler Relat Disord. 2020 Jan;37:101423. doi: 10.1016/j.msard.2019.101423. Epub 2019 Oct 1. PMID: 32172996.
Persson R, Lee S, Yood MU, Wagner MR, Minton N, Niemcryk S, Lindholm A, Evans AM, Jick S. Incident depression in patients diagnosed with multiple sclerosis: a multi-database study. Eur J Neurol. 2020 Aug;27(8):1556-1560. doi: 10.1111/ene.14314. Epub 2020 Jun 8. PMID: 32397001.
Jick SS, Li L, Falcone GJ, Vassilev ZP, Wallander MA. Epidemiology of multiple sclerosis: results from a large observational study in the UK. J Neurol. 2015 Sep;262(9):2033-41. doi: 10.1007/s00415-015-7796-2. Epub 2015 Jun 13. PMID: 26067217; PMCID: PMC4768220.
Jick SS, Li L, Falcone GJ, Vassilev ZP, Wallander MA. Mortality of patients with multiple sclerosis: a cohort study in UK primary care. J Neurol. 2014 Aug;261(8):1508-17. doi: 10.1007/s00415-014-7370-3. Epub 2014 May 18. Erratum in: J Neurol. 2014 Aug;261(8):1518-21. PMID: 24838537; PMCID: PMC4119255.
Rare and understudied diseases
Jick S, Li L, Gastanaga VM, Liede A, Hernandez RK. Prevalence of hypercalcemia of malignancy among pediatric cancer patients in the UK Clinical Practice Research Datalink database. Clin Epidemiol. 2017 Jun 15;9:339-343. doi: 10.2147/CLEP.S137616. PMID: 28670142; PMCID: PMC5479301.
Hagberg KW, Jick S, Du P, Truong Berthoz F, Özen G, Tzivelekis S. Impact of von Willebrand Disease on Women’s Health Outcomes: A Matched Cohort Database Study. J Womens Health (Larchmt). 2022 Sep;31(9):1262-1270. doi: 10.1089/jwh.2022.0082.
Hagberg KW, Jick S, Özen G, Du P. Pharmacologically Treated Anxiety and Depression in People Diagnosed with von Willebrand Disease: Matched Cohort Study. J Blood Med. 2023 Jul 11;14:413-425. doi: 10.2147/JBM.S407993.
Other important conditions
Hagberg KW, Li L, Peng M, Shah K, Paris M, Jick S. Incidence rates of suicidal behaviors and treated depression in patients with and without psoriatic arthritis using the Clinical Practice Research Datalink. Mod Rheumatol. 2016 Sep;26(5):774-9. doi: 10.3109/14397595.2015.1136726. Epub 2016 Feb 16. PMID: 26882216; PMCID: PMC5020333.
Li L, Hagberg KW, Peng M, Shah K, Paris M, Jick S. Rates of cardiovascular disease and major adverse cardiovascular events in patients with psoriatic arthritis compared to patients without psoriatic arthritis. J Clin Rheumatol. 2015 Dec;21(8):405-10. doi: 10.1097/RHU.0000000000000306. PMID: 26406567; PMCID: PMC4654263.
Li L, Jick S, Breitenstein S, Michel A. Prevalence of diabetes and diabetic nephropathy in a large U.S. commercially insured pediatric population, 2002-2013. Diabetes Care. 2016 Feb;39(2):278-84. doi: 10.2337/dc15-1710. Epub 2015 Dec 17. PMID: 26681728.
Validation Studies
Rigorous and interpretable observational research requires validated data sources, exposures and outcomes. BCDSP conducts validation studies at each level of data. In particular, BCDSP’s validation work on CPRD GOLD (then GPRD) is fundamental to the thousands of studies world-wide that have used this data source over the last three decades. More recently, investigators at the BCDSP have completed validation studies of the newer CPRD Aurum database. Some examples of prior validation studies conducted at BCDSP are below.
Early database validation studies
Jick H, Jick SS, Derby LE. Validation of information recorded on general practitioner based computerised data resource in the United Kingdom. BMJ. 1991 Mar 30;302(6779):766-8. doi: 10.1136/bmj.302.6779.766. PMID: 2021768; PMCID: PMC1669537.
Jick SS, Kaye JA, Vasilakis-Scaramozza C, Garcia Rodríguez LA, Ruigómez A, Meier CR, Schlienger RG, Black C, Jick H. Validity of the general practice research database. Pharmacotherapy. 2003 May;23(5):686-9. doi: 10.1592/phco.23.5.686.32205. PMID: 12741446.
Recent database validation studies
Jick S, Vasilakis-Scaramozza C, Persson R, Neasham D, Kafatos G, Hagberg KW. Use of the CPRD Aurum Database: Insights Gained from New Data Quality Assessments. Clin Epidemiol. 2023 Dec 16;15:1219-1222. doi: 10.2147/CLEP.S434832. PMID: 38126004; PMCID: PMC10732313.
Hagberg KW, Vasilakis-Scaramozza C, Persson R, Neasham D, Kafatos G, Jick S. Presence of Breast Cancer Information Recorded in United Kingdom Primary Care Databases: Comparison of CPRD Aurum and CPRD GOLD (Companion Paper 1). Clin Epidemiol. 2023 Dec 16;15:1183-1192. doi: 10.2147/CLEP.S434795. PMID: 38126005; PMCID: PMC10731985.
Hagberg KW, Vasilakis-Scaramozza C, Persson R, Neasham D, Kafatos G, Jick S. Correctness and Completeness of Breast Cancer Diagnoses Recorded in UK CPRD Aurum and CPRD GOLD Databases: Comparison to Hospital Episode Statistics and Cancer Registry (Companion Paper 2). Clin Epidemiol. 2023 Dec 16;15:1193-1206. doi: 10.2147/CLEP.S434829. PMID: 38126002; PMCID: PMC10731987.
Vasilakis-Scaramozza C, Hagberg KW, Persson R, Kafatos G, Maskell J, Neasham D, Jick S. Comparison of Rheumatoid Arthritis Information Recorded in UK CPRD Aurum and CPRD GOLD Databases (Companion Paper 3). Clin Epidemiol. 2023 Dec 16;15:1207-1218. doi: 10.2147/CLEP.S434831. PMID: 38126003; PMCID: PMC10731986.
Outcome and exposure validation
Persson R, Jick S. Incomplete capture of apremilast in Clinical Practice Research Datalink Aurum: An example of exposure misclassification of specialty treatments in United Kingdom general practice databases. Pharmacoepidemiol Drug Saf. 2023 Oct 2. doi: 10.1002/pds.5707. Epub ahead of print. PMID: 37786242.
Hagberg KW, Jick SS. Validation of autism spectrum disorder diagnoses recorded in the Clinical Practice Research Datalink, 1990-2014. Clin Epidemiol. 2017 Sep 15;9:475-482. doi: 10.2147/CLEP.S139107. PMID: 28979165; PMCID: PMC5608225.
Persson R, Lee S, Yood MU, Wagner M, Minton N, Niemcryk S, Lindholm A, Evans A, Jick S. Multi-database study of multiple sclerosis: identification, validation and description of MS patients in two countries. J Neurol. 2019 May;266(5):1095-1106. doi: 10.1007/s00415-019-09238-8. Epub 2019 Feb 18. PMID: 30778708; PMCID: PMC6469671.
Student Studies
BCDSP welcomes collaboration from students and professionals seeking training in pharmacoepidemiological methods. Some examples of student research conducted at BCDSP are below.
Recent PhD studies conducted at BCDSP
Ayodele O, Cabral HJ, McManus D, Jick S. The Risk of Venous Thromboembolism (VTE) in Men with Benign Prostatic Hyperplasia Treated with 5-Alpha Reductase Inhibitors (5ARIs). Clin Epidemiol. 2021 Aug 3;13:661-673. doi: 10.2147/CLEP.S317019. PMID: 34377032; PMCID: PMC8349190.
Crowe HM, Wesselink AK, Hatch EE, Wise LA, Jick SS. Migraine and risk of hypertensive disorders of pregnancy: A population-based cohort study. Cephalalgia. 2023 Apr;43(4):3331024231161746. doi: 10.1177/03331024231161746. PMID: 36935588.
Recent guided student studies conducted at BCDSP
Qian Y, Jick S. Proton-pump inhibitor use and myocardial infarction: a nested case-control study in the UK Clinical Practice Research Datalink. 2020 May;31(3):423-431. doi: 10.1097/EDE.0000000000001152. PMID: 31809341.
Troelsen FS, Jick S. Antibiotic use in childhood and adolescence and risk of inflammatory bowel disease: A case-control study in the UK Clinical Practice Research Datalink. Inflamm Bowel Dis. 2020 Feb 11;26(3):440-447. doi: 10.1093/ibd/izz137. PMID: 31265060.
Baak BN, Jick SS. Non-steroidal anti-inflammatory drugs and risk of myocardial infarction adjusting for use of proton pump-inhibitors in patients with no major risk factors: a nested case-control study in the UK Clinical Practice Research Datalink. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 15;9(1):58-75. doi: 10.1093/ehjcvp/pvac041.