Gratuitous photo of our beloved O’s – we couldn’t help ourselves…
It’s that time of the year when we prepare for one of the greatest sporting events ever (in my opinion) - the World Series. After recently speaking with a site, I was inspired to write this blog. The site was frustrated - they had completed over 50 feasibility questionnaires and did not get selected for one single study. Want to set your site up to be an all-star and get you back into the game with more studies? Read on…
Site marketing and online presence
Many sites do not realize how their marketing efforts and online presence are hindering them from getting in the game. A colleague from a CRO once told me “I would never buy a house without knowing the details: bedrooms, bathrooms, square footage - so it’s hard for me to give a site a chance if I can’t get basic information on them.” In terms of your website, it doesn’t have to be flashy, but make sure it outlines all of your capabilities in a clear and precise manner. Just as with a job resume, nobody is going to take more than a few moments to go through your information. When it comes to your marketing materials, make sure they stand out above other sites. If your research interests start with vaccines, osteoarthritis or low back pain, then the rest of your materials are not getting read because EVERY site lists those studies first. When you are marketing to a sponsor or CRO, make sure the materials are targeted to the correct sponsor or CRO. I once had a site approach me during a conference and ask why he never got selected for any of my studies back when I worked for a sponsor. I informed him that while his materials were phenomenal and his site would be a good fit for a vaccine study, the problem was he didn’t take two minutes to look at my company’s website and realize we were an oncology company. It’s all in the details, people!
Sometimes it just best to sit the bench for a study
Not every study is for every site. Your enrollment is your best marketing tool, so taking on too many studies and not hitting your contracted amount of patients will leave a negative impact with sponsors and CROs and on your bottom line. During the feasibility process, take a hard look to make sure that you can execute the trial. If you can not enroll for the study, respectfully decline. If you are declining a study, always give a reason why (when allowable). Many times sites receive feasibility requests for studies that are not within their therapeutic capabilities, but even in this event you have to reply with a decline. Many sponsors and CROs will deem a site unresponsive because they didn’t reply to a feasibility request even though it was not within their expertise. Seems silly, I know - but it happens.
Now this is your tryout for the big leagues. Make sure that you put real thought and effort into your responses to feasibility questionnaires. Make sure your numbers are realistic. Sponsors and CROs have sophisticated tools (pharmacy records, IMS data etc.) to be able to compare your results against your local demographics. A sponsor once told me, “In order for this site to have this many patients with this condition in their database, the doctor would have to be the only doctor within 50 miles treating this condition.” Don’t be afraid to voice your concerns during the feasibility process. Sponsors and CROs are open to hearing about your potential challenges. This will make the sponsor or CRO know that you gave a critical analysis of the study and not just checked boxes. After looking at historical data, only about 5% of sites actually give feedback on a study and the others always say there are no challenges to participating in this program.
Stats are king
We always talk about metrics, but never the proper metrics. Every site I speak with has been the top 5 enroller in their past 5 studies. Reporting of the metrics is key! Sites will say they overenrolled their last migraine trial. That could mean they contracted for 20 and enrolled 21 (+5%) or contracted for 10 and enrolled 20 (+100%). Which of these look more attractive to a sponsor or CRO? Beyond enrollment rates are metrics showing how long it takes you to enroll your contracted amount of patients. If you are a standalone research site and rely on advertising, have metrics on the number of patients the Sponsor or CRO can expect from your requested ad budget.
Making it into the series – or onto a study – is the first step in winning the game! Make that first step GREAT!