In August, Industry Standard Research (ISR) released the 2020 edition of its CRO Quality Benchmarking Report – Phase II/III Service Providers: A Look at Small and Emerging Biopharma. Clinical outsourcing needs vary by company. ISR understands that, and for this report took a deeper dive into the landscape of small and emerging biopharma companies. The research should help those companies make better informed CRO selection decisions.
The findings will also help CROs optimize operational and marketing strategies to better accommodate that segment of the market. The data in the report come directly from small and emerging biopharma customers, and detail CRO awareness, familiarity, reported use, and preference.
I spoke to Rebecca McAvoy, VP of market research at ISR, for some insights into the report and its findings.
Ed Miseta: The report notes just 12 percent of respondents at small and emerging biotech companies use preferred provider agreements (PPAs) for outsourcing Phase II/III clinical programs. That figure is 83 percent for large companies and 47 percent for mid-size sponsors. Are PPAs more essential in larger companies than they are in small and emerging companies, and could smaller firms benefit from their use?
Rebecca McAvoy: The large organizations create PPAs to streamline the selection process by narrowing the number of choices, pre-vetting these providers, and reaching agreements on pricing and other contractual terms. The downside of PPAs is that it can be challenging for outsourcers to work with an off-list provider if their situation calls for it. Outsourcers wanting to work with a non-preferred provider must provide rationale for why they want to use this provider and receive approval before proceeding.
Smaller sponsors often do not have PPAs in place. They are not dealing with the volume of trials that their larger counterparts have. Small sponsors may spend more time on their provider search and negotiations for an individual project but going through the process to vet and negotiate terms with providers to create a preferred list may not be worth the effort for the small volume. Plus, the absence of preferred providers gives small sponsors the flexibility to work with the provider they deem best for each trial.
Miseta: Are the lack of PPAs in small and emerging companies an opportunity for CROs to do business with them?
McAvoy: CROs could aim to win preferred provider status at small and emerging companies but they may first have to convince the small sponsors why a PPA would be beneficial for their company. Additionally, and especially for the larger CROs, becoming a preferred provider at a small/emerging company might not be worth the time and effort if that sponsor only has one or two trials they will be running. So any CRO wanting to go down this route should look at the time that would go into the discussions and negotiations needed to become a preferred provider compared to the benefit of being in a better position to win that company’s trials to determine whether the effort is worth it.
Miseta: Without PPAs, companies must rely on other criteria to select their CRO partners. Survey respondents indicated therapeutic expertise was the most important criteria when selecting a provider (garnering 60 percent of top 5 votes). What other attributes were important to small companies?
McAvoy: When examining the attributes respondents deemed the ‘most important’ when selecting a provider for Phase II/III services, interestingly, the top six attributes are the same among small and emerging pharma companies and larger sponsors. These attributes are Therapeutic expertise, Prior positive experience with service provider, Experience with similar study types, Operational excellence, Project manager quality, and Expectations for data quality. Hard to argue with any of those, right?
However, there is a difference in magnitude that is revealed when we look at respondents from small/emerging companies compared to those from larger companies. While only 13 percent of respondents from larger sponsors chose Therapeutic expertise as the most important attribute, 24 percent of respondents (nearly double) from small and emerging companies selected this as their top attribute. Smaller companies may not have the depth of therapeutic experience that larger companies have and, therefore, must rely more on the therapeutic knowledge of their outside vendors. Additionally, small and emerging companies are frequently working in more niche therapeutic areas, so finding CROs with relevant experience is greatly valued.
Miseta: Your report also looked at CRO attributes that were gaining in importance. Patient recruitment strategy came out on top. Why does recruitment continue to be an issue?
McAvoy: Patient recruitment is a key piece in clinical trials – if patient recruitment drags on for months or years past the timeline, the entire study is delayed. For some therapeutic areas, especially for the rare disease indications with growing interest, it is not easy to find patients. Rare disease patients are often hard to diagnose and may not live close to clinical sites, further complicating the process. In more common disease trials, there are also many barriers to participation – competing trials, long and confusing patient consent forms, and burdensome clinical trial protocols, just to name a few.
CROs with proven track records of successful patient recruitment in similar indications will certainly look like good options for sponsors searching for providers. It will also be interesting to see how the growth of virtual trials will affect patient recruitment. Removing the burden of traveling to the site for study visits could help boost clinical trial participation.
Miseta: For sponsors that do not have a PPA, many (35 percent) turn to consultants for guidance when selecting an outsourcing partner. For the 65 percent who are not using PPAs or consultants, do you have any insights into how they are making their outsourcing decision?
McAvoy: We have asked questions around this in a lot of different research. Outsourcers tend to reach out to peers in the industry to learn about provider experiences. Word-of-mouth can be very powerful. If a CRO does a great job, chances are that the people involved with that project will share their feedback with others. Same goes for negative experiences with CROs. ISR’s CRO Quality Benchmarking research gathers this experiential feedback from outsourcers to offer both performance scores and qualitative explanations of satisfaction with recently used providers. We create these reports so outsourcing decision-makers have the right data at their fingertips to make an informed CRO selection.
Miseta: When respondents were asked about provider preference, the top vote getters were IQVIA, Covance, and Parexel. Did anything in your survey indicate that small and emerging biotech companies prefer large CROs, or are those just the most well-known CROs?
McAvoy: The strong brand presence of the large CROs make them appealing and more likely to be top-of-mind. However, we do see more mid-size and small CROs higher in the list among respondents from small/emerging sponsor companies than we did when respondents from all sponsors sizes were included in the analysis. Among respondents from small sponsors, CTI Clinical Trial & Consulting, Novotech, Rho, and Worldwide Clinical Trials are selected more often as the provider of choice than the remaining large CROs.
Miseta: Smaller sponsor companies reported greater use of providers such as Rho, Synteract, Worldwide Clinical Trials, and Novotech. Still, they selected much larger CROs as the provider they preferred to work with, even though they believe the larger providers to be more expensive. Any thoughts on why the larger companies tend to be preferred?
McAvoy: Study size is an important factor in provider choice. In another study we did on trends in the Phase II/III market, we collected data around these dynamics. Though the majority of respondents believed that small, specialized CROs had superior therapeutic expertise over large CROs and that they prefer the customer service from smaller CROs, over 90 percent of respondents say the size of the study influences which CROs they consider for the work. Even if outsourcers prefer the therapeutic area experience or customer service at a small CRO, they may believe the larger studies can only be handled by the large CROs.
Miseta: Between 50 percent and 60 percent of respondents noted they are likely to engage and recommend CROs they are using or have used in the past. Still, that means 40 percent to 50 percent will likely not recommend or re-engage with those CROs. Any thoughts on what the biggest driver of that dissatisfaction is?
McAvoy: Participants share reasoning for their satisfaction ratings with providers they have used recently. Reasons for low satisfaction scores are often related to specific projects that have gone poorly – unexpected timeline delays, high degree of staff turnover on the project, unable to fulfill promises regarding capabilities or patient recruitment, poor project management, poor communication, or high perceived cost for the work that was performed.
The CRO Quality Benchmarking – Phase II/III Service Providers: A Look at Small and Emerging Biopharma report is produced by Industry Standard Research. To download the report, or to view a preview of it, please click here.