THE RELATIONSHIP BETWEEN SCIENTIFIC RESEARCH, CLINICAL TRIALS AND FDA DRUG APPROVAL

Author(s)

Burgon J*1, Hamerslag L2 1Costello Medical Consulting Ltd, Cambridge, United Kingdom, 2Costello Medical Consulting Ltd., Cambridge, United Kingdom

OBJECTIVES: An important aim of medical research is often to identify potential novel therapeutic targets for disease treatment. Here we investigated whether the amount of scientific research (measured as papers published) in a given disease area correlated with the number of clinical trials, and whether an increased amount of research in a disease area resulted in a higher number of FDA approved drugs. METHODS: FDA drugs approved between 2000-2013 were identified using the online database ‘CenterWatch’, and the number of papers and clinical trials for each disease area was established by running comprehensive searches on PubMed from 1975-2013, and ClinicalTrials.gov from 1999-2013, respectively. The total numbers of approved drugs, published papers and clinical trials were compared for each of 17 disease areas and, to analyse the correlations between these factors, simple regression analyses were performed. RESULTS: Analysis for correlation between the number of papers published and the number of clinical trials per disease area revealed a strong correlation between these two variables (R square: 0.69, p<0.001); thus, increasing numbers of published papers were associated with increasing numbers of clinical trials. Further analyses were carried out to investigate the relationship between the number of papers published, or clinical trials, and the number of drugs approved by the FDA. Interestingly, these analyses revealed that both clinical trials (R square: 0.05, p=0.41) and published papers (R square: 0.09, p=0.25) correlated poorly with the number of FDA approved drugs per disease area. CONCLUSIONS: These data suggest that the amount of research significantly correlates with the number of clinical trials in a given disease area. However, neither research nor clinical trials correlated with the number of drugs approved by the FDA. This may suggest that some disease areas could face a bottle neck at the drug approval stage, perhaps through difficulties in demonstrating efficacy.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP152

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Health Care Research

Disease

Multiple Diseases

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