Outsourcing clinical research activities to CROs has become an integral part of the drug development process for pharmaceutical and biotech companies of all types and sizes. Study after study points to a continued growth in CRO usage. Moreover, the financial markets reinforce this message by rewarding CROs with higher P/E multiples than for most established pharmaceutical and biotech companies.
The University of the Sciences in Philadelphia and TTC, llc have been conducting a multi-year study on why some clinical trials finish faster than others. Understanding the role and effectiveness of CRO run studies is a key element of the research. Part of the CRO specific research in this multi-year effort involved a Web-based survey of both sponsor company and CRO professionals to understand the criteria used in the selection of CROs. Other studies have reported the significance of previous work quality as a central criterion in CRO selection. This study accepted that criterion’s importance and examined other potentially major issues.
The results in this article are distinctive in two ways. First, the research made use of factor analysis to understand how the various individual criteria used in CRO selection grouped together. People rarely make important decisions using only one consideration at a time. Rather, they bring in a number of elements. Factor analysis allowed us to determine how the individual elements fit together. Second, we examined the decision criteria of sponsor company participants, comparing them to how CRO company participants believed sponsor companies made their decisions.
Our factor analysis of the various individual criteria used in CRO selection revealed five underlying dimensions, in order of importance: team chemistry; CRO experience; the project execution plan; problem solving processes; and price and other less important criteria. There was widespread agreement between sponsor company and CRO respondents, with two exceptions. Unsurprisingly, CRO respondents believed that the final bid price played a more important role in the decision-making than sponsor company participants indicated was the case. More importantly, sponsors value the quality and detail of the execution plan far more in selecting an outsourcing partner than many people in CROs realize.
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One Comment
Selecting the right CRO is certainly a key decision point for a sponsor
planning a trial of any size and scope. However, other elements in the
research continuum cannot be overlooked, and actively contribute to the
success – and failure – of a trial to meet its designated timeframe.
Identifying the right sites, at the outset, helps to ensure the trial
is “in the right hands.” Even the most seasoned CRA cannot be expected
to shepherd a site successfully through the duration of the trial if
the site’s own processes, approach to recruitment, personnel
experience, and patient engagement is insufficient. Trials ultimately
rise or fall on the skills of the individual sites and their commitment
to excellence. CROs can certainly raise red flags and prevail upon the
sponsor to intervene. But Benjamin Franklin’s saying “an ounce of
prevention is worth a pound of cure” is very relevant in this context.
Kimberly Irvine
EVP Operations
BRANY (Biomedical Research Alliance of New York)