Let’s be honest – the pharma industry readily accepts that low-performing sites harm everyone involved. But as sponsors, CROs, and other stakeholders in the drug development process, are we ready to accept there’s more we can do to help our sites? The cost of low-performers is great, with frustrated sites and investigators dropping out of the industry and sponsors losing money that could be spent towards future research. In the end, we’re left with less money and fewer investigators for our next clinical trial. This issue hurts everyone involved, especially patients, so what can we do to help?
Identify the problems
Typically, low-performing sites are not the result of a single large problem. Instead, they are the product of many issues coalescing at once. Since starting DrugDev, I’ve seen sites underperform due to several combinations of issues, including poor sponsor to site communication and support, unrealistic enrollment timelines, poor site selection, and last minute changes to inclusion/exclusion criteria.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
While it’s not ideal for organizations to have a history of trials with low-performing sites, there is a silver lining. Organizations can take the time to review their past problems, identify root causes, and hold lessons learned sessions. Often a simple policy change or updated project plan can make a big difference in reducing the number of low-performing sites.
Know your history
For sponsors, information is key. Sponsors must get off on the right foot by using historical data to begin their site search. Imagine a coach assembling an all-star basketball team from today’s current pool of NBA players. Most coaches wouldn’t blindly select players they know. Instead, they’d likely research which players work best for their team’s needs. That same mentality should go into site selection. Our company is often brought in during “rescue mode” to help get studies with low enrollment numbers back on-track. What we’ve typically seen is that sponsors have gone with sites they’ve worked with in the past even though they were not a good fit for the study.
Start talking
While historical data helps, it’s only the start. Sponsors must start a frank discussion with each site they identify, looking at their strengths and weaknesses. If sites performed well on one study but poorly on another, then sponsors should discuss what was the difference between the two studies. If a study’s protocol does not match the site’s specialty, then it will become apparent to both parties that they may not be the best fit.
In addition, sites are some of the greatest sources of information regarding patients today because they are on the front lines. Sponsors should speak with sites to understand how they can influence their study. For example, sites are a wonderful resource to review inclusion and exclusion criteria, making crucial revisions before the protocol is finalized, which ultimately helps reduce the number of amendments and bolsters enrollment.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Sites are also a great resource to discover which advertising methods worked well for similar studies. Why were they effective, what channels were used, and what can sponsors do to better target the types of patients they need?
Most importantly, these types of conversations help to understand sites, their challenges, and how organizations can help them to meet their enrollment numbers. They also help foster a mutually beneficial relationship.
Give them the right tools
After understanding sites’ challenges, sponsors must give them the tools necessary to overcome them. While some sites may lack time, others may lack materials or staff. Fortunately, there are a host of tools today that can help with different problems.
Today’s mobile enrollment applications are a great way for sites to quickly ascertain if patients would be a good fit for the study. These applications save time by quickly moving through a series of questions tailored towards sponsors’ inclusion/exclusion criteria, providing sites with an instant decision.
Other solutions, like eConsent, provide a valuable opportunity to educate and retain patients, ensuring they understand the clinical trials process, what is going to be expected of them and have had a chance to address their concerns. Even “simple” tools such as visitation calculators can take the administrative burden off sites by automating the dates and times for each patient’s visit.
Think, then act
Sponsors should look towards implementing these solutions either internally, or through a third party, depending on their organizational makeup. While none of these solutions is a cure-all, they often add up to a whole greater than the sum of their parts. Even better, they empower sites when sponsors pair them with an understanding and site-first culture.
So, if organizations are concerned that they may have a low-performing site, they should take a moment to think how they can help. After all, it’s our entire industry that has the most to gain.
Photo: anotherlover, Getty Images
