The effectiveness of CROs to manage

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1 May 2013 A CenterWatch Article Reprint Volume 20, Issue 05 INC Research, PPD, inventiv named top CROs Yet most CROs slipping in ability to manage site relationships By Karyn Korieth and Annick Anderson The effectiveness of CROs to manage working relationships with investigative sites has slipped during the past two years, according to a new CenterWatch survey, with the average CRO falling below performance expectations in several critical areas including study monitoring and project support. Top relationship concerns for sites include working with CROs that are responsive to their needs, have well-trained monitors empowered to answer their questions and pay them in a timely fashion. Yet one out of every five sites expressed being unhappy with the quality of their relationships with the average CRO. In fact, investigators indicate the average CRO s ability to deliver in each of the relationship attributes measured in the global 2013 CenterWatch survey has dropped since In the 2013 survey, the largest survey CenterWatch has conducted to measure the quality of working relationships between CROs and sites around the world, five CROs came out on top: INC Research, PPD, Pharmanet/i3 which has been renamed inventiv Health Clinical Covance and Quintiles. Kendle, which merged with INC Research in 2011, and PPD also ranked among the top CROs in the 2011 global site survey. The rankings are based on a combination of two measures: an overall relationship quality rating based on excellent scores from sites, and the frequency with which CROs placed among the top-three rated CROs across 36 CROs perceived to have the best industry reputation Percent of total 45% 39% 35% PPD (n=1,530) relationship attributes measured. In addition, the 2013 survey asked sites to evaluate, for the first time, CROs on their overall reputation in the industry. The large CROs were ranked highest in terms of reputation, with PPD, Covance, Quintiles and INC Research the only companies to rank in the top five in both reputation and direct working relationship quality. Significantly, the survey results suggest several areas in which CROs can improve the effectiveness of their relationships with sites, particularly with investigators from North America, as the industry moves ahead. Relationships are a cornerstone for all of our strategies going forward, said Kevin Renahan, executive director of investigator relations, clinical development services at Covance. It is our ability to adapt within the context of relationships that is going to dictate our success in the marketplace, because you might have the best molecule in the world but if you can t engage the right investigators, who deliver the work the way it needs to be delivered, the molecule has no value. Excellent Good Average Fair Poor 40% 13% 5% 2% 18% Covance (n=1,325) 42% Quintiles (n=1,450) 32% 43% ICON (n=1,165) 30% 40% 14% 18% 22% 2% 6% 5% 5% 1% 2% 2% 3% INC Research (n=653) Unprecedented response rate The CenterWatch 2013 Global Sponsor/ CRO and Investigative Site Relationship Survey, conducted online between November 2012 and January 2013, asked principal investigators, sub-investigators and study coordinators to rate the CROs they had worked with during the past two years on 36 relationship attributes. In addition, sites provided feedback on the importance of these attributes when conducting their clinical trials. The response rate to the survey, which CenterWatch first conducted 16 years ago, suggests that investigators and their staffs want greater input into how both sponsors and CROs manage their relationships and how clinical studies can be run more efficiently. A total of 2,032 global sites completed the 2013 survey, a nearly 70% increase from the number of responses in 2011, with the majority of respondents originating from North America and Europe. The 2013 survey ranks among the most relevant conducted by CenterWatch, since drug sponsors, who rely on their investiga- Copyright CenterWatch. Duplication or sharing of this publication is strictly prohibited.

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To subscribe or for more information: Sales: (617) or sales@centerwatch.com IndustryNews Top rated CROs Average percent of sites giving good CRO or excellent rating across attributes INC Research 80.4% 36 PPD 78.2% % 34 inventiv Health Clinical (formerly Pharmanet/i3) tors for trial success, are transferring site management responsibilities to CROs at a rapid pace. As they have downsized in recent years, sponsors no longer have the manpower to manage site relationships on a day-today basis, yet they expect high levels of efficiency and performance when handing over these activities to their CRO partners. Although CROs overall received lower ratings this year compared to the 2011 survey, CenterWatch analysis of surveys conducted during the past decade finds that as the role of CROs has evolved from providing transactional support for specific projects to becoming strategic partners with sponsors and being increasingly responsible for day-to-day management of clinical studies, CROs have significantly improved in their ability to work with sites. While surveys from a decade ago identified a 10% gap between how investigators rated their working relationships with sponsors compared to CROs, in the 2013 survey, the difference in the overall excellent/good rating received by sponsors and CROs narrowed to 2%. In addition, the overall excellent rating for CROs has more than doubled during the past decade, increasing from 20% in 2003 to 42% this year, as leading CROs have adopted a more strategic view of their site relationships. Leading CROs have developed preferred partnership programs, invested time and resources into training programs, given investigator insight into industry pipelines so they are ready for upcoming studies and asked sites for feedback on how to improve the quality of their relationships. Areas for improvement Total number of attributes rated in the top three Covance 75.4% 8 Quintiles 72.6% 8 PRA 71.2% 6 Parexel 72.5% 3 ICON 72.7% 0 As CROs move to the front line in managing site activities for sponsors, investigators report they could improve the quality and efficiency of their relationships with better study monitoring support. This category received the highest importance rating (61%), yet only 43% of sites believe CROs are excellent in this area, representing an 18% gap. In particular, 77% of respondents rated working with well-trained, professional and prepared CRAs as the most important element for building a strong working relationship with CROs. Investigators want to work with monitors who know the protocol, understand how sites work and can help solve problems when necessary, yet only 46% of sites rated the average CRO as excellent in this area, which represents an 8% drop since The most important site relationship issue is working with well-trained CRAs, said Larry Seidman, D.O., president of Philadelphia Clinical Research, who has served as an investigator in 230 trials in his 17 years of research. Due to such a high CRA turnover rate, we oftentimes have to train them on the conduct of the study. On site initiation visits, we find some CRAs are not well versed on inclusion/exclusion criteria, study protocols 2 The CenterWatch Monthly May 2013

3 and pronunciation of medical terms. CROs could improve by training the CRAs better and ensuring they are fully knowledgeable about the study. In this way, they may assist us instead of the other way around. Investigators also said the average CRO s study monitoring activities fell short in terms of their responsiveness to inquiries and in being organized and prepared; both of these areas had gaps of 14% or more between the sites expectations and CRO performance. In addition, overall excellence ratings fell by at least 6% during the past two years in both of these attributes. I don t know if the project managers are not as skilled as they used to be or whether it s coming from the sponsor putting too much last-minute pressure on the CROs, but things come to us not well-organized, from the regulatory package to the contracts and budget, said Richard Litov, Ph.D., director of Kentucky-based Pedia Research. It ends up taking us more time. Sites also identified monitor turnover rates as a significant problem, with only one-third of investigators rating CROs excellent in this area, a drop from 42% in Investigators from North America, in particular, expressed dissatisfaction with turnover rates, with only 25% rating the average CRO as excellent; this was among the lowest ratings for any attribute surveyed. Staff turnover is high, said Linda Bennett, executive director, Canadian Rheumatology Research Consortium, a network of rheumatologists that conducts industryfunded trials at 39 sites. One site reported 12 different monitors for a single trial in a one-year period. Many companies have decided to work with a couple of CROs, presumably to manage risk and drive performance; this makes it difficult to build longer-term relationships that might lead to more efficient collaborations. Three-fifths of sites rated overall project support as another important area for maintaining high-quality relationships with CROs. However, a 20% gap was evident in one of the most critical attributes in this category: having staff easily accessible for escalation of issues and providing timely resolutions. The CRAs should be professional and knowledgeable because they are our first line of contact. But I think it is more important for the CRA to have a strong support system, said David Scott, president and CEO of Florida-based Palm Beach Research Overall ratings of CRO and sponsor performance by relationship category Percent of sites rating CROs excellent Contracts and budgets Workstyle Site management Innovativeness Protocol/Study design planning Study monitoring support Overall project support Percent rating sponsors excellent Percent rating attribute very important 37% 38% 54% 43% 46% 53% 43% 44% 51% 39% 40%42% 40% 43% 57% 43% 47% 61% 45% 50% 59% Center. It should be easy for CRAs to reach their IT department to resolve issues, easy to reach the medical monitor to answer specific patient and protocol questions and easy to reach other project managers involved with the study to receive guidance on how to answer issues. As a site, we can see when the CRAs are handcuffed by their resources. We can also see when the CRA is able to easily get this information. Some of the largest declines from 2011 were in work style issues, with drops of 7% or more in the average CRO s ability to effectively work with sponsors, maintain open communication with sites and create a collaborative team environment. Investigators say it s often difficult to build relationships with CROs, since the project team members constantly change. They are moving on to some other place, to another CRO or another location within their organization, said Phillip D. Toth, M.D., medical director and president of Midwest Institute for Clinical Research in Indianapolis, Ind. That is the frustrating part. Because you may have solved one problem, but come next study, you have a whole new set of people to deal with. As in previous years, budget negotiation and grant payment process received some of the lowest scores in the survey. In results and interviews, sites expressed frustration that negotiation processes often are slower when a CRO is involved, and that their needs often are not communicated to the sponsor. More than half of sites rated this category as very important, but only 37% of sites rated the contract and budget process as excellent this year. In particular, the percentage of sites ranking CROs excellent for their willingness to modify protocols and budgets fell 9% during the past two years. It takes a lot longer these days to get feedback, because the CRO has only very limited authority to make changes, even in budgets and contracts. It has to go to the sponsor and that causes delays, said Pedia Research s Litov. 3 The CenterWatch Monthly May 2013

4 Survey results also indicated CROs may need to find new ways to reach out to their experienced investigators and sites based in North America. Sites with more than 10 years of experience rated CROs significantly lower than sites with five to 10 years of experience; these more-experienced investigators have witnessed significant changes in the clinical trials landscape and expressed dissatisfaction about having less input into reviewing protocols and no longer having direct relationships with sponsors. Overall excellent ratings from investigators with more than 10 years of experience fell 5% during the past two years. At the same time, sites in North America generally rated CROs lower across attributes versus investigators from other regions; some categories, including keeping open communication and providing ongoing help in running the study, had gaps of at least 18% when comparing ratings from investigators in North America and those from other parts of the world. In addition, CenterWatch this year began measuring a much broader set of attributes that relate to site management, an area that will continue to grow in importance as the industry moves toward risk-based monitoring models that generally require fewer CRA visits to sites. Fewer than half of sites gave CROs excellent ratings in this category, which includes providing patient recruitment planning and assistance and supporting initiatives to build stronger relationships with sites. CenterWatch will track changes in this area in its future surveys. Building stronger relationships As they increasingly take over day-today site management responsibilities, topranked CROs focus on developing long-term relationships with investigators and finding ways to reduce burdens on sites. We focus on how we can streamline that process and make it as simple for the sites and the patients as we can. And if you do that, you are going to get the right behaviors from the sites Average CRO rating across attributes Fair 4% Neutral 13% Good 34% Poor 2% Excellent 47% that are going to lead to better recruitment, better-quality data and a faster cycle time for our sponsors, said Paul Colvin, executive vice president, global clinical development at PPD. It really needs to be a win-win-win solution for all three of the parties involved. PPD, which earned the survey s highest rating (42%) for being an innovator in finding ways to improve its relationships with sites and using technology to make processes more efficient, uses data analytics to help target where sites might have a potential issue. There are always going to be concerns and issues that come up around a trial; however, the more that we can use data analytics to target those areas of concern and put plans in place to specifically drive and improve performance, it s truly going to be a gamechanger for the site and the sponsors, he said. It makes life easier in terms of the amount of re-work that needs to be done, and you can target training areas early on in a study. PPD uses its analytics to improve productivity and quality across all project functions, not just monitoring. Our CRAs are very professional and they are an outstanding group, but it s a team effort to manage the sites. It s effective data management, statistics and our global product development team working in tandem, said Colvin. The CRAs are the tip of the sword they are the face to the site. But behind the scenes, there is a huge team that is working in unison to ensure that all of Fair 4% Neutral 16% Good Poor 2% Excellent 42% those data analytics are done, the CRA has the right information and we can continually be responsive to that site in a way that supports them and makes their life easier so they can focus on patient care. Similarly, INC Research, which received the highest excellent scores in six out of seven working relationship categories, has developed several initiatives to help reduce site workload. INC Research earned some of its highest marks in having professional staff monitors, medical experts and administrative staff and for being organized and prepared in supporting studies. When it launches a study, INC Research has a medical monitor prepare a training package on the indication, along with the particular challenges the study may encounter, to ensure the CRAs, clinical team, project management team and other functional staff working on the project understand the therapy and are alerted to any updates in the field. In addition to ensuring knowledgeable, prepared CRAs to assist the sites, the model also reduces the number of unnecessary queries. We spend a lot of time making sure the planning and design of the database matches the protocol very carefully and cleans the data to specifications, said Alistair Macdonald, chief operating officer at INC Research. It keeps any work that doesn t need to be done any waste down. I think that has a lot to do with site relationships as well. 4 The CenterWatch Monthly May 2013

5 INC Research also reduces the burden on sites through its project management system, called Trusted Process: the project team leaders sit down during a week-long camp to review project specifications and develop plans for project management, clinical monitoring, data management and data cleaning. Since the planning is completed in a week, instead of taking several months, monitors have time to organize regulatory binders and investigator brochures to ensure all necessary content has been included. In addition, INC Research works with its customers to make sure the tests and procedures sites are asked to perform are relevant to the protocol. That helps, because it s less work for the site and it s focused work, said Macdonald. New relationship models Some leading CROs have established new relationship models, such as strategic alliances or preferred partnerships, to cultivate stronger ties with top-performing sites. Quintiles, which received high excellence marks for its site management activities, has been at the forefront in developing strategic CRO-site partnerships. Quintiles has established alliances with 20 large hospitals and healthcare systems and with more than 1,000 sites across 20 countries through its Prime Sites and Partner Sites networks. In 2013, more than one-third of all patients Quintiles recruited for studies came from its Prime and Partner sites. The model allows Quintiles to build long-term relationships with site staff and help them navigate the complex clinical research environment, which has resulted in greater operational efficiencies including faster start-up times and a more predictable delivery of patients and quality. We are trying to build relationships over time and to work more intensively with fewer sites, said Lindy Jones, senior vice president of integrated site services at Quintiles. Our investigators are strategically important to us. We don t see them just as the end to recruit patients. We put a lot of emphasis on valuing deep relationships with them. Covance also has developed strategic relationships with sites in core therapeutic areas including oncology, central nervous system and inflammatory disorders through its Covance Scientific Network. The network, which includes 25 sites around the globe, allows Covance to collaborate with its partners to modify budget and contract negotiations, which can reduce burdensome paperwork for sites and decrease the amount of time it takes to start a study. As part of the process, designated representatives from the CRO, sponsor and site are available to quickly resolve questions that arise in negotiations. Covance received among the highest excellent ratings (40%) for having efficient contract and budget negotiation processes; as a result, the CRO has been able to reduce study start-up for its early-phase oncology trials to 22 weeks, compared to the 29-week industry standard. We have engaged sites to work in a collaborative way with us, said Covance s Renahan. Budgeting and contracting can be very, very cumbersome. This process really does reduce the amount of time it takes for us to get a study started. Looking ahead Average CRO ratings by region 30% 37% 44% As the industry evolves, CROs face pressure to achieve higher levels of performance and efficiency in managing site relationships. Survey results show that CROs have stepped up to this challenge during the past decade, as they have invested resources in developing more strategic, longterm relationships with sites and finding ways to reduce the workload on study staff. Yet results indicate several critical areas for improvement, particularly in study monitoring support and overall project management, and suggest that CROs need to reach out to their more experienced investigators and those from North America as they work to improve collaborations with sites. Karyn Korieth has been covering the clinical trials industry for CenterWatch since Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. Karyn holds a Master s of Science degree from the Columbia University Graduate School of Journalism. She can be reached at karyn. korieth@centerwatch.com. Annick Anderson has been conducting market research since Annick holds a Master s of Business Administration from the Boston University Graduate School of Management. She can be reached at annick.anderson@ centerwatch.com. Excellent Good Neutral Fair Poor 46% 33% 41% 35% 23% 6% 16% 3% 17% 3% 19% 3% 4% 1% 1% 2% North America South America Europe Asia Pacific 5 The CenterWatch Monthly May 2013