Regulatory agencies in the US and Europe are putting more pressure on pharma to generate postmarketing data and, given the finite resources and economic pressures at companies, much of this work is being outsourced to contract research organisations (CRO).
Consequently the market for outsourced postmarketing studies now exceeds $1bn, according to Dipti Amin, senior vice president (SVP) of drug safety and medical affairs at Quintiles.
To improve its offering in this area Quintiles has teamed up with Cerner, a supplier of healthcare workflows and electronic health record (EHR) technology, to create “an integrated solution”for areas including patient registries, post-approval and late phase trials and observational studies.
Quintiles claims to conduct more clinical research than anyone else and this gives it the experience and expertise to conduct efficient, cost-effective postmarketing studies.
Drawing on this experience Quintiles designs postmarketing studies tailored to the geographic region and drug being investigated but Amin added that the overall safety focus remains the same, as does the need to identify high risk patients and minimise the risk of side effects.
The US Food and Drug Administration (FDA) is in the process of establishing the Sentinel Initiative to provide a national, integrated, electronic system for monitoring the safety of drugs.
Amin explained that she personally, and Quintiles as an organisation, support the programme and endorse anything that helps improve patient safety, adding that the Sentinel Initiative goes some way to bettering the situation.
The system will access information from disparate databases to enhance the agency’s ability to monitor adverse events. Amin added that she believes the system could lead to an increase in postmarketing requirements.