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.
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.
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.
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.
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|