The Changing Role Of CROs

By Ed Miseta, Chief Editor, Clinical Leader

Sponsors can have wide-ranging relationships with their CROs, from strategic partnering arrangements all the way down to the more simplistic transactional models. Regardless of the model in place, how do sponsors actually view the role of CROs in clinical development? A recent survey by Worldwide Clinical Trials (WCT) attempted to answer that question.

It turns out that most sponsors are growing more comfortable outsourcing their trials to a contract provider. Sixty-two percent of respondents were more likely to engage a CRO partner than just five years ago, demonstrating the increasingly vital role that CROs play in modern drug development. The survey, conducted at DIA 2016, solicited the opinions of nearly 300 drug development executives from pharma and biotech companies who visited the WCT booth during the show. 

Peter Benton, president and COO at WCT, notes DIA presented a unique opportunity to gather input from leaders in the industry, and discover what is important to sponsors. A few areas of interest included potential barriers to drug development, areas where sponsors are looking for CRO innovation, and the key factors considered when selecting a CRO.

Innovation is important in clinical research. Today many sponsors expect their CROs to provide many of the innovative ideas needed to improve and advance trials. That trend came out in the survey. When asked about the impact of innovative approaches from a CRO, 29 percent of respondents noted innovation in overall trial management would have the greatest impact on clinical development. Twenty-six percent said innovation in patient recruitment and retention would have the second biggest impact on their trial efforts. This is not surprising, considering recruitment continues to be a struggle for sponsors. According to a report from the Tufts Center, approximately two-thirds of sites do not meet the enrollment requirements for a trial. This causes many trials to be cancelled or delayed, which drives up the cost of drug development. Trials will also run over budget when sites fail to hit recruitment goals.    

Cost Leads List Of Clinical Trial Barriers

When it comes to barriers to new drug development, the cost of discovery research and clinical development was the factor most cited by respondents. After cost, regulatory guidance and the risk associated with the clinical development process were also cited as primary concerns.

With the rise in outsourcing also comes the necessity of sponsors to select an appropriate CRO partner. This is not an easy task for many companies. Quality is an important factor in every step of the drug development process, especially in the area of clinical trials where an FDA approval or denial is riding on the quality of the data submitted. It should come as no surprise that the top concern of respondents was selecting a CRO that has the capability to deliver high-quality data. This concern was cited by 83 percent of respondents. Quality was closely followed by the ability of the CRO to deliver on time (76 percent) and the ability to deliver within budget (68 percent).

Some sponsors may prefer to bring CRO partners onboard early in the development process, while others might wait until a drug is about to enter a critical Phase 3 trial. Interestingly, the survey found little variation in the timing of when sponsors choose to engage with a CRO. Later-phase studies (Phase 2 and 3) narrowly beat out early-phase investigations.

The survey of 300 drug development leaders and executives was conducted by Worldwide Clinical Trials at their booth during DIA 2016 in Philadelphia, PA, in June 2016. For more information, contact Worldwide Clinical Trials.