Which organizations are running the biggest, most complex portfolios of clinical trials in 2010? To find out, ClinPage analyzed the listings in ClinicalTrials.gov, the U.S. government's database of more than 80,000 research projects. Our exclusive list of the 50 largest ongoing studies is below.

The list is a magnificently global one. Many of the top organizations tend to be European, though there is one big Japanese name: Daiichi Sankyo.

None of this is a surprise. Clinical trials have always been global. The rest of the planet is getting better educated and more scientifically sophisticated with every year—making the case for participation in science ever easier abroad. That's where most of the patients are, folks.

But our table also shows how frequently large pharmaceutical companies now collaborate. In some cases, such projects are testing two competing therapies. That advances scientific knowledge and addresses industry critics, who have been demanding head-to-head research comparisons for years. But it could severely trim the returns for life science investors when big firms are jointly shouldering the risks (and rewards) of developing a single drug.

Our Methodology

On Dec. 30, 2009, we checked the ClinicalTrials.gov listings of interventional Phase III projects that were actively recruiting patients. We excluded projects that did not have a primary finish date; our logic was that those those listings were incomplete. The median number of patients on our list is 10,574. So these are massive studies. Even small projects in our list, with 5,000 patients, are larger than most clinical trials.

For space reasons, we only have room to include two sponsors per project; please check clinicaltrials.gov if you need the full record of the trial.

Some trials will conclude this year. The longest-running study in our list, a study of 66,000 patients run by the Norwegian government, is scheduled to complete in 2026.

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Big Projects, Big Sponsors: A global industry

Oncology Projects

There are curious wrinkles in the therapeutic areas represented in our listing. With declining enthusiasm for heart pills, sponsors are designing larger projects for cancer and central nervous system disorders. There are 35,248 breast cancer patients scheduled for the trials in our list; and 130,998 colon cancer patients. But interest in diabetes is muted, with just 22,600 patients in the trials on our list.

Having said that, there are still plenty of projects in cardiovascular and infectious disease. Indeed, the largest project in our tally, a National Institutes of Health project in Africa for HIV, is seeking 228,000 patients. Glaxo has more than twice as many patients as the next industry sponsor of clinical research, Merck, which was allotted the trials of Schering-Plough, which it recently acquired.

In some cases, the nonprofit sector is stepping up to run huge projects. Organizations like Johns Hopkins University, the London School of Hygiene and Duke University feature prominently in our list.

America, Eclipsed

Some big American pharmaceutical companies are absent from our list. Where's Pfizer? Johnson & Johnson? Abbott Laboratories? Can smaller U.S. projects be explained by the difficulties of patient recruitment? Is it too hard to find research participants in a scientifically illiterate, entertainment-besotted U.S. culture? Or are big U.S. companies just more financially constrained than European rivals?

Alternately, the problems may lie in the U.S. site and investigator community. Have the elite U.S. investigators interested in science had their enthusiasm for research crushed by daunting paperwork burdens and administrative hassles? Low fees?

We realize the big U.S. firms are still sponsoring smaller trials. And we do not think that one mammoth trial, by itself, could determine the fortunes of any global company. But American firms are clearly not placing the most audacious projects, starting the largest trials, working with the most clinically relevant ideas. And that has long term implications for the U.S. economy.

In an industry that has a certain resemblance to Las Vegas, only the largest bets will produce the outsized returns needed by companies that have tens of thousands of employees and are increasingly inclined to buy other firms of similar size. The scale of the industry's research in the U.S. may no longer be well-matched to the heft of the biggest companies doing that research.

Constrained budgets for megaprojects with U.S. sponsors, in turn, will mean fewer future blockbusters. That will translate into lower profits and fewer novel therapies that are well-received by skeptical physicians or government officials who seek significant quantities of good clinical data.

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Top 50 Trials of 2010

Sponsor # of Patients Phase Condition Intervention NCT Number
Bayer 12000 Phase III Moderate Risk of CVD Aspirin, BAYE4465 NCT00501059
Bayer, Johnson & Johnson 8000 Phase III Venous thromboembolism Xarelto, BAY59-7939, Enoxaparin NCT00571649
Bristol-Myers Squibb 6524 Phase III Venous thrombosis, pulmonary embolism Apixaban, Enoxaparin NCT00457002
Bristol-Myers Squibb 18183 Phase III Atrial fibrillation, flutter warfarin, apixaban NCT00412984
Bristol-Myers Squibb, Pfizer 5600 Phase III Atrial fibrillation Apixaban, Acetylsalicylic Acid (ASA) NCT00496769
Bristol-Myers Squibb, Pfizer 10848 Phase III Acute coronary syndrome Apixaban, Placebo NCT00831441
Center for International Blood and Marrow Transplant Research 15000 Phase III Healthy Filgrastim NCT00785525
CDC 23082 Phase III Perinatal mortality, stillbirth, neonatal mortality Folic acid, folic acid plus iron NCT00133744
Centre Hospitalier of Chartres, Baxter Healthcare 6422 Phase III Hyperglycemia, critical illness Device: CGAO-based glucose control NCT01002482
Cincinnati Children's Hospital, Gates Foundation 5600 Phase III Influenza Biological: influenza vaccine NCT01034254
Children's Hospital of Philadelphia, AHRQ 35000 Phase III Otitis media 3-Part Intervention, Other: 4-Part Intervention NCT00581711
Daiichi Sankyo 7500 Phase III Venous thromboembolism, deep vein thrombosis edoxaban tosylate, low molecular weight heparin NCT00986154
Daiichi Sankyo, TIMI Study Group 16500 Phase III Stroke, atrial fibrillation, embolism warfarin tablets, DU-176b tablets NCT00781391
Eastern Cooperative Oncology Group, NCI 11248 Phase III Breast cancer anastrozole, chemotherapy, exemestane NCT00310180
Lilly, Daiichi Sankyo 10300 Phase III Acute coronary syndrome Clopidogrel, Prasugrel, aspirin NCT00699998
European Organization for Research and Treatment of Cancer 6000 Phase III Breast cancer capecitabine, cyclophosphamide, docetaxel NCT00433589
GlaxoSmithKline 91000 Phase III Haemophilus influenzae, pneumococcal disease GSK1024850A, Engerix vaccine, Havrix vaccine NCT00861380
GlaxoSmithKline 7000 Phase III Haemophilus influenzae, pneumococcal disease GSK1024850A, Engerix vaccine, Havrix vaccine NCT00839254
GlaxoSmithKline 15500 Phase III Atherosclerosis, cardiovascular disease Darapladib NCT00799903
GlaxoSmithKline 8000 Phase III Breast cancer Trastuzumab, Lapatinib NCT00490139
GlaxoSmithKline 16000 Phase III Plasmodium falciparum Cell-culture rabies vaccine NCT00866619
GlaxoSmithKline 11500 Phase III Acute coronary syndrome, stherosclerosis Darapladib NCT01000727
Greater Glasgow and Clyde NHS Board 9500 Phase III Colorectal cancer capecitabine, fluorouracil, oxaliplatin NCT00749450
Gruppo Italiano Mammella 10000 Phase III Breast cancer anastrozole, exemestane, letrozole, tamoxifen citrate NCT00541086
Harvard Vanguard Medical Associates, Brigham and Women's 6100 Phase III Chest pain, acute myocardial infarction Electronic risk alerts NCT00674375
Hospital Clinic of Barcelona, Grupo Cooperativo 55498 Phase III Colorectal cancer, colorectal neoplasm Fecal occult blood test, colonoscopy NCT00906997
Johns Hopkins, Gates Foundation 36000 Phase III Infant mortality, preterm birth, low birth weight Iron, folic acid NCT00860470
Johns Hopkins, Projahnmo 28797 Phase III Omphalitis, infection Behavioral: chx once, Behavioral: CHX x 7 days NCT00434408
Johns Hopkins University, Sage Products 10000 Phase II- III Nosocomial infections Chlorhexidine gluconate cloth NCT00549393
Johnson & Johnson Pharmaceutical, Bayer 16000 Phase III Acute coronary syndrome, myocardial infarction, Ischemia Rivaroxaban NCT00809965
London School of Hygiene and Tropical Medicine 12000 Phase III Postpartum haemorrhage Tranexamic acid NCT00872469
London School of Hygiene and Tropical Medicine, Kintampo 18000 Phase III Neonatal mortality Behavioral: Home visits NCT00623337
Merck 8044 Phase II- III Staphylococcus aureus, bacteremia, mediastinitis Biological: V710 NCT00518687
Merck, Duke Clinical Research Institute 14000 Phase III Type 2 diabetes mellitus Sitagliptin phosphate NCT00790205
National Institute of Mental Health (NIMH) 228834 Phase III HIV Behavioral: Community-Based HIV VCT NCT00203749
National Institute of Nursing Research (NINR) 14550 Phase III Advanced cancer, COPD, restrictive lung disease Behavioral: Training program NCT00687349
National Institute of Nursing Research (NINR) 6500 Phase III ICU hospitalization Behavioral: Facilitator-based intervention NCT00720200
Norwegian Department of Health, Sklodowska-Curie Center 66000 Phase III Colorectal cancer Procedure: Colonoscopy NCT00883792
Novartis 8600 Phase III Type 2 diabetes mellitus dardiovascular disease Aliskiren NCT00549757
Novartis 7041 Phase III Chronic heart failure Enalapril, Aliskiren, Enalapril NCT00853658
Novartis 7980 Phase III Heart failure with reduced ejection fraction LCZ696, Enalapril NCT01035255
Novartis, Novartis Vaccines 7700 Phase III Meningitis, meningococcal infection Biological: MenACWY, Biological: concommitants NCT00806195
Population Health Research Institute, Sanofi-Aventis 7000 Phase III Acute coronary syndrome Procedure: Percutaneous coronary intervention NCT01014273
Sanofi-Aventis 9600 Phase III Atrial fibrillation SSR126517E, biotinylated idraparinux, warfarin NCT00580216
Sanofi-Aventis 33000 Phase III Influenza Biological: Trivalent inactivated influenza vaccine NCT00976027
Schering-Plough 7500 Phase III Coronary artery bypass, myocardial infarction Acadesine NCT00872001
Schering-Plough, Duke University 12500 Phase III Atherosclerosis, myocardial ischemia and Infarction SCH 530348 NCT00527943
Schering-Plough, Merck 18000 Phase III Hypercholesterolemia, myocardial Infarction ezetimibe/simvastatin, simvastatin NCT00202878
The George Institute, University of Sydney 7000 Phase III Intensive care Hydroxy-ethyl starch NCT00935168
Utah HealthCare Institute 8000 Phase II- III Preeclampsia, pregnancy induced hypertension labetalol, MgSO4 NCT00293735
The largest actively recruiting, interventional, Phase III trials from ClinicalTrials.gov as of December, 2009. Trials without completion dates were excluded. Some entries have been abbreviated for reasons of legibility. To sort the data, click the green triangles at the top of each column. © ClinPage 2010

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