Clinical Trials Report

as of 01/01/2012


As of 01/01/2012 118602 clinical trials records were collected and processed. They came from 9068 different sources. 35344 (29.8%) of them are assigned as FDA regulated and 25151 (21.2%) as Section 801 controlled substances. 70929 (60%) trials had treatment purpose. 4927 (4%) of them had reported clinical results.

Overall status of the trails has been assigned and distributed as following:

overall status

# of trials

%

Completed

53109

44.78

Recruiting

33453

28.21

Active, not recruiting

15848

13.36

Not yet recruiting

6208

5.23

Terminated

5421

4.57

Enrolling by invitation

1949

1.64

Withdrawn

1334

1.12

Suspended

733

0.62

Withheld

393

0.33

Available

75

0.06

No longer available

41

0.03

Approved for marketing

24

0.02

Temporarily not available

14

0.01

They were subjected to 9 different intervention types:

intervention type

# of trials

% (of total)

Drug

26565

22.4

Procedure

5183

4.37

Device

5043

4.25

Behavioral

4267

3.6

Other

3830

3.23

Biological

2777

2.34

Dietary Supplement

865

0.73

Radiation

477

0.4

Genetic

215

0.18

For the trials with clinical results:

Completed

4272 (3.6% of all, 86.7% of clinical results)

Terminated

494 (0.4% of all, 10%)

Active, not recruiting

161 (0.1% of all, 3.3%)

Top 20 location countries pointed in the records:

country

# of trials

United States

51096

Canada

4290

Germany

3765

France

3702

United Kingdom

2712

Israel

2193

China

2096

Korea

1984

Denmark

1718

Japan

1692

Italy

1688

Taiwan

1553

Netherlands

1505

Brazil

1409

Spain

1221

Switzerland

1071

Belgium

943

Norway

883

Sweden

832

Australia

803



They can be classified into following classes/categories:


class

# of trials

%

cancer

26545

22.38

mental/nervous

10333

8.71

cardio/blood

8536

7.20

diabetes/obesity

7401

6.24

bones/joints

6292

5.31

immune

5484

4.62

respiration

4996

4.21

infections

4410

3.72



The trials are deposited by different kind of organization, namely:


Educational/Research Institutions deposited

~37275 trials

Companies -

~29968

Government/National Institutions -

~18242

Hospitals/Clinics -

~10784

Centers/Collaborations -

~9561

(*) not all trials were classified by above source kind


Most of all deposited trials for each kind of organization were devoted to cancer research. The second in the number of deposits decease category is already different so for educational/research institutions and companies it is mental/nervous deceases for government/national institutions more trials belong to immune deceases research. At the 3d position for educational/research institutions we have cardio/blood deceases while for companies it is diabetes/obesity.

If we will look only for trials with clinical results it appeared

Educational/Research Institutions deposited

~561 clinical results data

Companies -

~3378

Government/National Institutions -

~108

Hospitals/Clinics -

~273

Centers/Collaborations -

~143

Relative distribution of clinical results data for different decease categories is almost the same as for the trials except infections and immune categories interchanged their positions.

Overall top 10 sources deposited clinical studies:

source

# of trials

National Cancer Institute

6158

National Institutes of Health Clinical Center

3193

GlaxoSmithKline

2289

Pfizer

1844

Novartis

1742

AstraZeneca

1452

National Heart, Lung, and Blood Institute

1425

National Institute of Allergy and Infectious Diseases

1302

M.D. Anderson Cancer Center

1207

Sanofi

1069

Top 10 companies deposited the studies:

source

# of trials

GlaxoSmithKline

2289

Pfizer

1844

Novartis

1742

AstraZeneca

1452

Sanofi

1069

Merck

1003

Eli Lilly and Company

826

Hoffmann-La Roche

731

Bristol-Myers Squibb

678

Bayer AG

615

Top 10 depositors provided clinical results:

source

# of trials with results

GlaxoSmithKline

293

Merck

274

Pfizer

274

Novartis

237

Schering-Plough

185

Eli Lilly and Company

171

Teva Pharmaceuticals

142

Boehringer Ingelheim Pharmaceuticals

107

M.D. Anderson Cancer Center

101

Bristol-Myers Squibb

93

Top 10 depositors with so to say the highest efficiency (ratio of trials with clinical results (c1) to total number of deposits (c2) ) (ratio):


source

c1

c2

ratio

Mutual Pharmaceutical Co.

41

45

0.911

Bayer HealthCare

10

11

0.909

Labopharm Inc.

17

19

0.895

Teva Pharmaceuticals

142

165

0.861

Colgate Palmolive

24

29

0.828

Purdue Pharma LP

27

44

0.614

Ciba Vision

23

42

0.548

Meda Pharmaceuticals

8

15

0.533

Biotronik, Inc.

6

12

0.500

Theravance

7

15

0.467


For depositors with more than 100 trials the numbers/rank will change to:



source

c1

c2

ratio

Teva Pharmaceuticals

142

165

0.861

Shire Pharmaceutical Devel.

37

104

0.356

Schering-Plough

185

574

0.322

Merck

274

1021

0.268

Ferring Pharmaceuticals

26

107

0.243

Allergan

45

186

0.24

Takeda Global R&D Center

52

234

0.22

Daiichi Sankyo Inc.

24

115

0.21

Eli Lilly and Company

171

826

0.21

UCB, Inc.

55

273

0.2



There are more Phase 2 trials than Phase 1 in the deposits.

For different phases the ratio of deposits (ratio) with clinical results (c1) to total number of deposits (c2) :


phase

c1

c2

ratio

Phase 3

1647

17707

0.093

Phase 4

908

12963

0.070

Phase 2

979

22859

0.043

Phase 1

431

13793

0.031

Phase 2/Phase 3

72

2570

0.028

Phase 1/Phase 2

110

4902

0.02



Top 10 depositors with intervention type='Drug':


source

# of trials

National Cancer Institute

909

Novartis

874

GlaxoSmithKline

755

National Institutes of Health Clinical Center

673

Pfizer

612

Sanofi-Aventis

433

AstraZeneca

344

Johnson & Johnson

321

Wyeth

288

NIH AIDS Clinical Trials Information Service

268



Top 10 depositors with intervention type='Procedure':


source

# of trials

National Institutes of Health Clinical Center

101

Department of Veterans Affairs

82

Stanford University

75

M.D. Anderson Cancer Center

68

National Cancer Institute

67

National Taiwan University Hospital

66

University Health Network, Toronto

65

Mayo Clinic

49

University Hospital, Ghent

47

National Center for Complementary and Alternative Medicine

46



Top 10 depositors with intervention type='Device':


source

# of trials

Boston Scientific Corporation

78

St. Jude Medical

67

University of California, Irvine

56

Department of Veterans Affairs

47

National Taiwan University Hospital

41

Stanford University

40

Medtronic Bakken Research Center

40

Medtronic Cardiac Rhythm Disease Mgmt

38

National Institutes of Health Clinical Center

38

Abbott Vascular

37



Number of trials for different kind of depositors devoted to 3 different intervention types:




source kind

# of trials

Drug

Procedure

Device

Educational/Research Institutions

6575

2590

1623

Companies

10054

193

1129

Government/National Institutions

3249

629

229

Hospitals/Clinics

1878

823

532

Centers/Collaborations

1856

461

355

Characteristically that Educational/Research Institutions have more Phase 4 than Phase 3 trials (4809 vs 3011).

Number of trials for different phases filed by 5 depositor kinds

Number of trials started and completed in the last decade.


Summary


Analysis of clinical trials data deposited to ClinicalTrials.gov database showed that results outcome is only about 4% of the deposited studies. Most of the studies devoted to drug research. While all categories of depositing institutions are more focused on drugs, eventually companies pay extremely little attention to novel medical procedures development. Most interest related to cancer research with more than 50% difference from the next investigated decease class (mental & nervous). About a half of all deposited studies were located in USA. While educational/research institutes are main contributors to the trials database, most of clinical results comes from companies. National Cancer Institute appeared to be a number one contributor. GlaxoSmithKline deposited biggest number of clinical trials results, it is also biggest contributor among the companies. In 2011 number of studies completed exceeded number of trials started the only time over the last decade. Overall through the last decade number of trials started increased more than 6 time and number of trials completed increased more than 37 times.