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RESEARCH AND TECHNOLOGY DEVELOPMENT IN SARDINIA
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Scientific role

Two researchers in a sterile environment
The discovery of any new drug is the result of a complex R&D process, which requires substantial investments and involves high uncertainty and risk of failure. On the other hand, successful market launch of a new drug generates huge returns.

Fase 1 selects projects pursued by public or mixed public-private research centres in order to facilitate and support first their patenting process and subsequently their clinical development. The company also delivers to small and large biotech and pharmaceutical companies the services required in the first, essential phase of clinical development of new drugs.

Pharmacological and clinical testing of any new drug involves a series of steps aimed at assessment of drug efficacy and tolerability.

Pre-clinical:
- Pharmacological activity assessment
- Experimental toxicity assessment (short and long term toxicity, carcinogenicity, reproductive toxicology).

Clinical:
- Clinical safety and efficacy testing.

Clinical safety and efficacy tests are performed by administering the drug first to healthy volunteers and then to patients. Clinical testing involves three phases, based on a format standardised at international level:

- In PHASE I the effects of the drug are studied on a small group (20-80) of healthy volunteers. This phase makes it possible to define the tolerable dose range and product safety as regards administration pathways and pharmacokinetic profile. In this phase side effects are also determined. In some serious diseases (e.g. end-stage cancer), the drug can be tested on real patients.

- In PHASE II, the drug’s activity is tested on a restricted number (100-300) of patients suffering from a specific disease. the aim is to confirm efficacy, assess precisely the tolerable and effective dose range, and define possible clinical "end points".

- PHASE III expands considerably both the number of patients (1000-3000) and the clinical criteria assessed. In this phase too, control groups are used, which receive a placebo or an existing treatment. The ultimate aim is to enable correct assessment of the therapeutic efficacy and possible side effects, to ensure effective, safe use of the drug.

- PHASE IV focuses on post-marketing surveillance of a drug once it is available on the market and widely used for treatment.