Academic versus private sites

In our last post, we talked about the importance of having a dedicated phase I oncology team and support structure at your site. Another element to evaluate is the type of site to use — academic or private?

It’s important to match your sites to fit your protocol and trial goals. However, there are differences between academic and private centers that directly affect the success of your trial.

Academic sites

Let’s look at the academic center first. If the site is a comprehensive cancer center, it likely has a dedicated phase I team. This is great and suggests a level of expertise. There’s a common perception, though, that academic centers have greater credibility than private sites. Whether or not that’s true is anyone’s guess.

There are purists who believe that unless a site is tied into an established academic group—in other words, a non-profit setting—the data does not carry weight. Purists might argue that results presented at ASCO, for example, might be dismissible because the study wasn’t done at a Harvard or an MD Anderson-caliber center. This is an important issue for some sponsors and a non-issue for others.

Private sites

In some parts of our industry, private sites suffer from a perceptual lack of credibility. However, a growing number of private sites have created the dedicated team and infrastructure to efficiently and effectively collect high-quality data for your study. These sites are typically headed up by physicians who have implemented an academic-type structure in a private setting.

One example is Premiere Oncology of California and Arizona. Dr. Lee Rosen and Dr. Michael Gordon created Premiere Oncology by combining rigorous academic-like processes with a more entrepreneurial pace. (Note: Dr. Gordon is one of the medical founders of Medelis, and we often recommend Premiere Oncology to sponsors.)

Other private sites might not have a fully dedicated phase I team but could have a dedicated research nurse or study coordinator instead of a complete team. Still other private sites have a single staff that handle all trials (phases I through III), which can create challenges if the entire team didn’t cut their teeth on phase I trials.

Advantages of private sites

If you’re able to find the right private site, you’ll probably find that they can ramp up faster (typically 6 to 8 weeks) compared with 4 to 6 months for academic sites. The bureaucracy from the many institutional levels at academic sites are the main reason for this lengthy timeframe.  (Note:  We have had great experience and rapid, efficient start-ups at Scottsdale HealthCare’s Virginia G Piper Cancer Center, where the experienced staffs from TGen Clinical Research Centers and the Scottsdale Clinical Research Institute collaborate on over 20 cancer studies.)

The other benefit you’ll find from most private sites is that they’re often less expensive. Academic centers add what they call their indirect, or overhead, rate and it adds anywhere from 25% to 35% to costs.

Balance your needs

The decision regarding what kind of site to use should balance the need for rapid start-up with the need for high quality, accurate data. A high-quality academic center can raise the profile of your trial, but are you able to wait six months for the first stream of data?

If your main concern is getting clinical data as fast as possible because of budget concerns, private sites are probably your best bet. If budget and time aren’t much of an issue and you have a potential blockbuster, academic sites will suffice. Most sponsors we talk to fall into both categories – they want high quality data fast, are focused on driving down clinical trials costs, and desire the top investigators.

For them, we recommend using one of each. Use the private site to get the study launched, enrolling patients in the first 8 weeks to gain quality data at an affordable price. Then enroll the later patients at the academic center to add the credibility (whether it’s real or not) that satisfies the academic world and the investors looking for names like Johns Hopkins, MD Anderson, Vanderbilt etc. for your trial.