Monitoring and safety assessment in Phase I to III clinical trials.

Safety issues play an important role for registration of new vaccines due to growing awareness of regulators and growing safety concerns of the general public, whether they are justified or not. Safety of a vaccine implies much more than merely monitoring and reporting adverse events, but relies on a holistic view including control of manufacturing, surveillance of possible long term effects, epidemiological data, the vaccination schedule and signals from post marketing surveillance. Vaccine safety has scientific and organisational implications. To achieve a balanced risk-to-benefit evaluation the input of a central safety department is recommended from planning of a clinical development to post-marketing phase. The concept of data evaluation and data assessment should be medically driven in close cooperation with the biometricians. An integrated safety plan with standardized procedures improves the likelihood of detecting a realistic AE-profile, prior to marketing a vaccine. The unique opportunity of a controlled clinical trial should be taken advantage of by optimizing both the organisation and the scientific methods. Further development of methodology of safety monitoring and assessment should be given the same importance as proving efficacy and complying with the regulatory requirements.