The concept of payers utilising clinical and outcomes data is not a new one. However, with escalating pressures on national healthcare budgets in today's economy - and as a result of an ever ageing population - the need to prove real-world efficacy is arguably more apparent than ever.
Merely demonstrating safety and efficacy and getting approval in today’s pharmaceutical landscape is no longer enough to launch a product successfully and ensure return on investment, Goldberg said.
Therefore this year, Goldberg predicted there will be a major trend for using real-world proof of improved outcomes to drive prescribing behaviours. There will also be bigger emphasis on integrating commercial insights into clinical data from an early stage to ensure not only regulatory approval, but also commercial success, he said.
For CROs like Parexel and its sponsors, key study focuses will therefore include interventional and observational trials, managed access programs, real-world evidence studies and pharmacovigilance studies.
Parexel has already seen increased outsourcing in regulatory affairs, market access, and pharmacovigilance in recent years, Goldberg noted.
Other CROs which have shown growing interest in real-world data services in recent months includes Quintiles which formed an alliance with IMS Health for access to such information, this publication reported in October.
In June, PPD also partnered insurance company Anthem in a bid to offer real-world outcomes data outside of the clinical trial spectrum.
Parexel also launched its ACCESS marketing and commercial service offering in November, which includes commercialisation and pharmacovigilance aspects.
As for Parexel's new year resolutions, the company will continue to seek M&A opportunities which are complementary to its existing portfolio, he noted. It also expects to see continued demand in complex global studies.