Oncology drugs since

Since the first edition of this book developments have continued in this area, particularly in respect of computerised databases as a source of detailed and reliable data for use in the pharmacoeconomic assessment of new drugs. The creation of specialised databases, such as HIV Insight, which contains the detailed clinical records of about 2500 patients who are either HIV seropositive or have the disease AIDS, has been very successful and plans are being made to develop other specialised databases in diabetes, oncology, Alzheimer s, osteoporosis and other similar chronic diseases. 

The centralized procedure has been in place since 1995. The review of the MAA is coordinated by nominees from the Committee for Medicinal Products for Human Use (CHMP) called the rapporteur and co-rapporteur. This procedure leads to a single EU scientific opinion, which is then translated into a pan-EU decision by the European Commission. The centralized procedure is mandatory in some cases (for example, for biotech drugs, and drugs intended for oncology, HIV, diabetes, and neurodegenera-tive disease indications) and it is also gaining popularity for all new NCEs. 

As we have shown, personalized medicine at its fullest takes consideration of individual s hereditary, environmental, and lifestyle variances, and hence is not very far removed from the notion of holistic medicine. In clinical practice, holistic medicine has rapidly become the dominant theme in oncology where the therapeutic index of the drugs is perhaps the narrowest. A further development of such personalized medicine may be medical diagnostic devices in the home. A medical diagnostic device in each home could personalize monitoring, since families differ in their genomics and lifestyles and the risk factors implied by both of hereditary traits and phenotypic variances. 

Our ability to treat patients based on their needs is definitely inadequate since we do not know which therapy will be the most effective for each individual patient. Indeed, predicting drug response is a great challenge in oncology, as commonly used therapeutic agents are ineffective in many patients, and side... 

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