In May 2008 the US Food and Drug Administration (FDA) launched the Sentinel Initiative to create a national, integrated, electronic system for monitoring the safety of drugs.
Speaking to Outsourcing-Pharma Kathleen Kushner, PRA’sscientific affairs director, late phase services explained that the initiative would help companies tailor studies to answer the unanswered questions.
This is already a focus of PRA’s study design. Drawing on “lessons learned” from its experience in postmarketing PRA tailors each study to the geography, drug and patient pool to ensure the required information is gained.
Mark Nelson Tyrrell, PRA’s director, risk management, who spoke at the World Drug Safety Congress last week, expanded on this point. Tyrrel explained that geography is a big issue in study design, with the US and Europe having differences that impact on the process.
In the US there can be direct interaction between the sponsor and the patient but Europe forbids it. Consequently PRA has a different approach in Europe, assigning components to the prescriber and dispenser. Furthermore, the drug's risk-benefit ratio is taken into account when designing the study.
Tyrrell covered some of these points at the Third Annual World Drug Safety Congress in London last week where he spoke about risk management from an operational stand point.
Evolution of postmarketing
Kushner explained how over the past decade there have been significant regulatory and technological changes that have impacted on postmarketing activities.
There has definitely been an increase in the number of Phase IV studies conducted over this period, according to Kushner, because of the postmarketing requirements that came into place in the US.
In addition there have been technological advances, with the shift beyond paper and into electronic systems reducing the burden of conducting postmarketing studies.
Kushner is talking about technological advances at the12th Bio/Pharmaceutical and Medical Device Registries and Post-Approval Studies Congress in Princeton, New Jersey, US. The conference runs from September 22 to 24.