Patient-centric trials to give CROs competitive edge, say sponsors

The patient is becoming the lead focus in the future of clinical trials as understanding their experiences and demands will help ensure the right patients are recruited and accelerate lead times, delegates at the PCT conference in Hamburg agreed this week.

“There is a need to get patients on board and let them determine what is needed. They are really educated, and increasingly in charge of their own health data,”​ said Paolo Moreira, Head of External Innovation at EMD Serono during a panel discussion.

“We often assume the physician is the consumer, but it is the patient and we are probably the only industry which doesn’t ask the consumer about their preferences.”​

AstraZeneca’s Vincenzo Garzya agreed, and asked his fellow panellists how much of the patient journey is understood by the industry. “Understand this and we can increase patient recruitment and speed up trials.” ​

Garzya, who is Director of Patient Centricity Excellence for the Big Pharma, added that from a sponsor’s perspective a contract research organisation (CRO) needs to have a flexible approach to a patient centric model. “I see this as a competitive advantage for the CRO.”​

Bayer’s Barbara Voith concurred, saying a shifting focus to the patient “would make a CRO more cutting edge and attractive to multiple sponsors.”​

CRO acknowledgement​

CROs represented on the panel acknowledged the need to embrace this shift and “to stop treating patients like passive raw materials,” ​as Icon’s Chief Medical Officer Brendan Buckley explained.

Through disease awareness and personal health devices such as smartphones “the concept of patients as self-investigators is very important to understand and take on board over the next couple of years.”​

However, he warned industry should not get carried away with idealism as implementing a complete change in trial model would be hard to do due to the “many moving parts”​ in current outsourcing partnerships.

“If we continue with piece-by-piece outsourcing models it will be impossible to do this, and we’ll forever be stuck in the 1970s,”​ he said.

Strategic partnerships the answer?​

“But there is some chance to implement this in full service arrangements,”​ he added, as the CRO would be managing the candidate’s entire clinical lifecycle.

Moreira agreed, saying “patient centricity is a vision and a culture, and the less parties involved in implementing this, the better.” ​EMD (known as Merck outside North America) has an end-to-end strategic partnership with Quintiles​.

Voith also advocated closer, single-partner CRO relationships to drive patient centricity, but acknowledged this was not the driver for the growing number of strategic partnerships in the industry.