In today’s clinical research industry, sponsors are under increased pressure to cut waste and tighten their budgets. This has made the site selection process highly competitive, especially given the market’s rapid trend toward globalization. Luckily, there are steps you can take that can help increase your odds of selection, while simultaneously making your site a more efficient conductor of clinical trials. This article will discuss four tips to help your site stand out in the selection process.
Tip #1: Be honest about past challenges.
In the current climate of our industry, sites need to make an extra effort to stand out to sponsors and earn their trust. Although it may seem appealing to leave your site’s blemishes out of communications with sponsors, honesty really is the best policy. If your site has dealt with situations that might be viewed unfavorably during the selection process, be candid about them—even if that seems counterintuitive. Trying to hide these situations, or simply neglecting to share them with the sponsor, can be disastrous for your chances of being selected. While it is true that sponsors are generally in search of sites with a clean record, even having a 483 is not an automatic deal-breaker providing that you are open about it from the start. Below, we will discuss possibilities for handling some specific situations during the site selection process:
If you have a 483
If you have a Form 483, be upfront about it. Include your response to the FDA when submitting a 483, along with any supplemental documentation (e.g. corrective and preventative action plans, independent auditor evaluations, etc.). Explain what happened and share the steps your site has taken to rectify the situation to ensure compliance. While there are times when a sponsor will immediately rule out a site with a 483, most sponsors are understanding and are willing to evaluate a site that can prove they took these findings seriously. Present evidence of a well-implemented plan that ensures total compliance with good clinical practice and FDA regulations. This can show sponsors your interest in and commitment to conducting good clinical research.
If you missed enrollment goals
You should always keep enrollment metrics of your studies, and be sure to create a document detailing this information. Be honest about your enrollment rates, even if you didn’t do as well as you had expected. Don’t cherry-pick—if your list shows you met or exceeded enrollment goals on every single study, it will be obvious that the list may not be 100% complete.
When including missed enrollment goals, explain why those goals were not met. Was it a difficult protocol? A rescue situation? Offer this information before the sponsor has an opportunity to come to their own conclusions.
Submit your enrollment metrics document along with your feasibility questionnaire, CVs and site information sheet. One thing to note: these documents, along with your PI and coordinator’s CVs should not be used in lieu of filling out the questions about enrollment and experience on the feasibility questionnaire. Do not make the sponsor dig for the information they need.
Tip #2: Carefully consider rescue studies.
It is sensible to be cautious if you receive an offer for a study that has already begun enrolling. Although it is possible that the study has just started and the sponsor is still working on the selection phase while the initial sites begin enrolling, it is also possible that the study may have been active for a while and needs “rescue” or “add-on” sites. This should raise a red-flag: there are likely important reasons more sites are being added at this phase. For instance, is the protocol very difficult? Does the inclusion/exclusion criteria make it impossible to find eligible patients?
Don’t be afraid to ask questions of the sponsor. For what reason are they are adding more sites? How long has the study been open? When will the enrollment period end? Sometimes these studies are almost finished, so by the time you are IRB approved, contracted and initiated, you may find out the enrollment is closing in a week. Even if the sponsor tells you enrollment will end in six months, the study could easily finish well ahead of schedule if the new sites start seeing improvements in enrollment and performance.
This being said, participating in a rescue study is not something you always have to avoid. If your site serves the patient population the initial sites were lacking, this study might be a great match, and you might come out looking like a hero in the sponsor’s eyes. Still, rescue studies are often a steep up-front investment without any guarantee that you will be able to randomize enough patients to make it worthwhile.
Tip #3: Know when to say “no.”
In our experience, some of the best performing sites are those that turn down most of the opportunities they receive. While this might seem surprising, knowing when to walk away from a study is an underrated skill for sites. Taking on competing studies or trials you know your team might not do well on will mean that your time and resources will be tied up in damage control, and you will be unable to consider better opportunities that may come your way.
When a sponsor presents an opportunity, don’t be afraid to ask questions and request more information to determine whether the study will be a good fit for your site. Sponsors tend to have their own rules regarding how and when they will offer more information on their studies, and they typically require an initial questionnaire in order to issue a confidential disclosure agreement (CDA). Keeping this in mind, understand that asking for more details may not always yield results, but it is certainly worth the attempt. Learning more about a study can save you from wasting time and effort on opportunities that turn out to be poor matches for your site.
If you find that a study is likely to be a bad fit, don’t be afraid that the sponsor will overlook your site for future studies if you say “no” to one. If they have contacted you for one study, odds are they will probably come back to you the next time they need sites to run a trial. Regardless, it is much better to run the risk of not being on a sponsor’s list than to perform poorly on a study you accepted just to stay on their radar. If you do turn down a study, let the sponsor know as soon as your decision has been made. While declining one study will not keep you from being considered in the future, turning one down after the sponsor has made a significant investment in your site can definitely leave a bad impression—especially if you decline for a reason that should have been obvious from the outset.
Tip #4: Get creative in your approach to clinical research.
Now more than ever, it is important to be creative in your approach to clinical research; you should constantly be on the lookout for ways to grow. Consider hiring a fulltime patient recruiter and/or marketing coordinator, or even establish a close relationship with a patient recruitment agency to ensure enrollment in the studies you take on. Not only are these personnel positions helpful additions to your team, sponsors will see these as assets when evaluating your site.
If you are focused on a narrow area of research and you are seeing fewer opportunities, aim to diversify your research site. Forge new relationships with investigators in other specialties or recruit and mentor a physician who has not been involved in research to become a new investigator for your site. Consider supporting further training or certification for your investigators, coordinators and other staff. While we have yet to see a sponsor require a Certified Principal Investigator (CPI) or Certified Clinical Research Coordinator (CCRC), sponsors do take note. These certifications are a fantastic selling point to show the sponsor your dedication to conducting high-quality, high-integrity research.
The clinical research industry is constantly growing and changing. To stand out in the site selection process, be honest in your representation of your site, take time to ask questions and carefully consider study opportunities, and don’t be afraid to get creative in your approach to conducting research. A commitment to good communication and a realistic understanding of your site’s strengths, capabilities, and needs can go a long way toward helping your site stand out.