| Task |
Is it done? | With what results?
|
| A. | Preclinical animal toxicology
| Always done | Results secret
|
| B. | Preclinical human toxicology, including adverse effect monitoring during clinical trials
| Always done | Results often secret
|
| C. | Gather and analyse spontaneous reports of suspected ADRs
| Done | Crude summaries accessible details usually secret
|
| D. | Assess causality: is a particular kind of adverse event caused by the drug? Can it be distinguished from similar events not caused by it, and if so, how?
| Done, but often by people not medically trained nor experienced
| Some results, published with delay |
| E. | Describe the characteristics and natural history of the effect
| Rarely done | It seems to be no-one's responsibility
|
| F. | Investigate and discover the pharmacological/ biological mechanisms involved
| Rarely discussed; rarely done? | Regulators not equipped companies not interested?
|
| G. | Investigate the epidemiology of the effect: frequency, seriousness, risk factors
| Sometimes done | Selectively published in summary with delay
|
| H. | Work out possible ways of preventing or attenuating the effect, and testing them
| Rarely done properly | Mostly attempted by desk/ armchair work
|
| I. | Develop treatments for people who have suffered damage
| Rarely done systematically | No-one's official job
|
| J. | Review the balance of benefits and harmful effects of the drug in different clinical situations
| Done by regulators | Process and methods secret, results published
|
| K. | Communicate the knowledge gained to health professionals and the public
| Poorly done | Not considered a priority by regulators; distortion by marketing efforts
|
| L. | Revise the official Summary of Product Characteristics, leaflet for patients and licensing status
| Done by regulators | Usually not linked to the underlying data, nor properly explained
|
| M. | Check that the new knowledge is used in practice
| Not done | Seems to be no-one's job
|
