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In this Q&A, Matt Smith, Vice President Research Site Development, Slope discusses the competition pharma companies and trial sponsors face when trying to become a sponsor of choice and build trust with sites and patients.
Matt Smith — Vice President Research Site Development at Slope, a provider of a clinical trial execution platform focusing on clinical inventory and sample management — discusses the competition companies and sponsors face when trying to become a sponsor of choice, challenges new technologies like artificial intelligence present, how to foster collaboritive relationships, and much more in this Q&A.
ACT : What kind of competition do pharmaceutical companies and trial sponsors face when trying to become a sponsor of choice? Is there more competition for those who are conducting research for oncology trials, rare diseases, and other high-demand areas?
Smith: Pharmaceutical companies face fierce competition when vying to become the sponsor of choice for research sites. Every sponsor wants to have the first pick of the best sites and access to site KOLs. With numerous established sponsors and a steady influx of new companies, the market is saturated with potential sponsors for research sites to collaborate with. Additionally, most studies are conducted by the same small percentage of sites, intensifying the competition for these top sites. Sponsors that specialize in specific therapeutic areas create niche competition for research sites focused on partnering with sponsors with expertise in particular fields.
Another significant aspect of the competition is the emphasis on reputation and credibility. A sponsor's history of developing groundbreaking medications and getting them to market can make a difference in a research site's decision-making process. Sponsors that have experienced controversies or issues with previous studies, especially in the site's target indication, may see reluctance from potential research partners, thinking about what’s best for their patients. Competition can also increase for sponsors on trials in certain indications with a smaller patient population, or one where there are several competing trials looking to reach the same patients, and with existing treatment options.
The good news is that, while there is competition for sites, it’s fairly easy to stand out to sites, earn their trust, and receive your figurative gold star as a sponsor of choice. Even better is that this process is largely free. Sites simply want to be valued for their work, not be seen as a commodity, [be] paid fairly and on time, and know that their voices are heard. If you’re willing to listen, be open, and have these relationships directly, you can quickly set yourself apart from others and be seen as a preferred sponsor.
ACT: What are the most common obstacles faced by trial sites? What challenges do new technologies, like AI, present in trial execution?
Smith: New technology is largely seen as an opportunity to improve our industry. However, we must not only focus on the outcome, but also how the tech is being implemented and used in the trial, who is responsible for the work, and the data that’s necessary for those amazing outcomes we’re all promised.
AI technology holds significant potential, but it's crucial to bear in mind that we are still in the early stages where additional oversight is a necessity. When we’re looking at the promises of any technology, we need to ask a critical question: Who are the people that will be responsible for its success? It is likely that the sites responsible for entering the data or integrating it with existing platforms and processes will take on this role. That’s why it’s important that sponsors support sites with the adoption and integration of new technology to ensure its success.
The importance of technology support also extends to new tools adopted by patients. For example, we often see technology that allows a patient to journal and report their status, which could help to improve trial data and provide insight into the patient’s trial experience.
What’s typically not discussed, though, is the tech support necessary for those patients who may struggle with using the technology. When the tech isn’t working for the patient, it usually requires the site staff to act as IT support. I’ve heard accounts from several sites of technology issues relating to patient apps that required the site coordinators to spend hours on the phone with tech support to get it working for their patients. All of this time is not billable by the site, and may even turn off patients from participating in clinical research.
ACT: What kind of strategies should/do sponsors and companies use to foster collaborative relationships?
Smith: It’s fairly simple, actually, especially as sites are eager to collaborate with sponsors and to work on trials that help their patients. First and foremost, find a few advisory sites within your target therapeutic area. This work can’t be outsourced. Sponsors really need to foster and maintain these direct relationships. Sites are more than willing to help provide feedback, which ultimately benefits patients and the industry, and helps to achieve quicker outcomes with less cost and risk.
Furthermore, provide these two to three advisory sites with the draft protocol, and any specific questions or concerns. Set up a review call to discuss their thoughts and questions; it can’t be an email. To really understand their thoughts, you need to have a call or meeting with each site.
Usually, the sponsors that maintain these relationships with sites have been able to work with these sites on past trials, or have met them at industry events and formed a relationship through common goals. The thing that most of these sponsors have in common is that they manage or are heavily involved in the site selection process, which includes pre- and post-feasibility work, where they’re engaged and asking for feedback from the sites.
ACT: How much does the patient burden impact a site's decision in choosing a sponsor? What can companies do to put patient support at the top of the list?
Smith: One of the areas that sites and sponsors agree on is that the patient experience is a vital consideration of any trial. What’s interesting, though, is that while there is a lot of attention given to the patient experience, as an industry, we seem to forget that the site is primarily responsible for that patient experience.
In competitive indications, and especially those with a decent functioning treatment option, the patient burden can weigh heavily on a site’s decision to work on a trial or not. I recall a promising trial for an indication where the current treatment was effective, while the new trial drug was looking like it would far exceed the status quo. While PIs were excited about the drug candidate, they were turning it down in high numbers. Talking with the PIs directly revealed that their issue was with the protocol design that required the patients to wash out and stop using the current treatment for a few months before starting the trial. While the PIs were excited about the initial data of the trial drug, they couldn’t justify having patients go off treatment.
ACT: Trust is a big theme we’ve been hearing about lately. How can sponsors ensure that sites, and their patients, will be able to rely on them?
Smith: If you want to be a sponsor of choice, simply talk to the sites, see what they need, and how you can help, and pay them what you have committed so they can pay their staff and treat patients. Sites realize you can’t change everything, but your willingness to listen and talk it through will mean everything, especially if you’re able to help streamline a few things going forward. To earn trust, you have to give trust. Having an open dialog where you can listen and talk freely is the easiest way to do that.
ACT: How else can sponsors enhance their trial outcomes and establish themselves as preferred partners?
Smith: Talk to the sites. Don’t be afraid of the hard questions or the awkward answers; you don’t have to fix everything overnight. Utilize the feedback and if you’re not able to make a suggested adjustment, let the sites providing the input know why you didn’t. Also, realize that it’s a process, and engaging sites for feedback is most valuable when done over the course of the trial.
Solicit site engagement during all phases of the trial. This starts with study design, pre-study analysis for enrollment, and soliciting site feedback proactively. During the trial, engage sites to get a live view into patient enrollment status. What trends are they seeing? What issues are leading to screening fails or patients declining to participate? Finally, after the study is complete, talk to a few sites to get a well-rounded perspective. Speaking with sites that had high potential during startup but ended up falling short will likely yield your most valuable feedback.