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The regulatory authorities of each country and the FDA (Food and Drug Administration) have strict guidelines as to what makes a drug fit for human use and it must be proven safe and effective before it is allowed to be registered.
How patients benefit
Patients that normally will not be able to use new drugs because it is too expensive or not available in certain countries may have the opportunity to use these drugs free of charge. All the laboratory tests and examinations are also done free of charge to the patient.
They are however, protected by strict ethics’ committee evaluation of protocols and do not get paid for participating in trials.
Patients with diseases for which no treatment is currently available, can also benefit from new research and provisional drugs. Some companies allow the trial patients of phase III trials life-long compassionate use of the drug – if it has been proven to be beneficial to them.
Investigators compensated
Pharmaceutical companies compensate investigators for the clinical trial work that they do.
They are invited to investigator meetings where they can be exposed to colleagues from other countries. It can be very interesting and academically stimulating to be involved in the development of a new therapeutic agent.
Bets Breedt, MBChB, B Med Sci, M Fam Med
Manager Investigator Services: Quintiles
References:
1. Code of Federal regulations.
2. International Conference on Harmonisation guidelines.
3. Ken Flieger. Testing drugs in people. FDA Consumer July-August 1994.
4. Joanne Kabak. Clinical Trials: How drugs get from the test tubes to us. Drkoop.com:Family:Features.
5. T.A.M. Kramer. Drug Development. Medscape Psychiatry & Mental Health eJournal, 24 July 2002.
