A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. These delays are a big deal, since every day that is delayed can cost sponsors up to $8 million in lost sales. If your study is struggling because of recruitment issues, here are some considerations that can be used to rescue your clinical trial.
Reviewing the protocol
The first step to recovering from a poor study recruitment issue is to examine the study design itself. An unrealistic protocol can make recruitment too challenging, if not impossible, without significantly improving the results of the study. One potential solution is to reduce the protocol’s complexity – particularly regarding inclusion/exclusion criteria. Reducing complexity can boost trial enrollment without compromising the strength of your data. For example, a wash-out period can be introduced to recruit subjects who failed to be treatment naïve.
Reassessing your struggling sites
If the protocol is solid, then you may have to either assist or terminate certain struggling sites to minimize delays in recruitment. Often, the best chance to rescue your sites is with proactive involvement – especially in the areas of marketing, staffing, patient education, etc. For example, encouraging and facilitating your investigators to meet local doctors who might have access to the patient populations you need. 63% of investigators “strongly agreed” that positive awareness is vital to enrollment, and this can be done by networking with practitioners near the site to advertise the study. A dedicated staff on site to educate patients on risk mitigation and study benefits can help investigators enroll hesitant patients. Pooling marketing resources between sites close to one another can also boost enrollment by increasing the reach and impact of your media buys.
On the other hand, some sites are simply incorrect for a particular study, and may need to be cut from the study. Continuing to pour resources into under-performing sites is a classic case of the sunk costs fallacy – the belief that once you’ve invested and lost some money, you may as well ride it out until the end. The truth, however, is that the cost and risk to startup a new, higher-performing site is far lower than continuing to throw good money after bad and hoping that a poorly performing site improves significantly. In our extensive study rescue experience, we’ve seen too many studies completely derailed because the CRO refused to cut under-performing assets.
Consulting a rescue CRO
An internal plan may go a long way towards correcting some of the issues causing your trial to falter, but getting it back on track quickly will usually require professional intervention. This is where hiring a study rescue CRO that can complete these tasks in a proficient and cost-effective manner becomes important. An outside rescue expert can bring a fresh set of eyes to a troubled study and help you identify the true root causes of the failure. They can also find more cost-effective and efficient ways to implement some of the strategies you were planning to implement internally, resulting in a net savings.
Rescue CROs also come with additional resources and benefits that may not have been available previously. Strong site networks, relationships with vendors, or specific insight on rescuing your trial from experience all come to mind. These benefits cannot be overstated, and more than offset the cost and trouble of finding and hiring a rescue partner.
If you do decide to hire a CRO, you will need to determine the level of service necessary for the rescue. For example, when the entire protocol is flawed, the incumbent CRO is under performing, and the sites are struggling, hiring a full service and skilled CRO like Biorasi would make sense. However, not all rescues require a full and complete takeover. Rescue CROs can, and often do, work side by side with incumbent CROs – either adding manpower and resources to existing remediation strategies or by pursuing novel approaches to fix recruitment issues. In some cases, the rescue service can be something as unobtrusive and relatively minor as consulting and helping to strategize on the best ways to boost recruitment.
Do not wait too long and hope that recruitment will “magically” improve at month 12 because the ROI of intervention significantly diminishes over time. If you are unsure whether your study needs a rescue, feel free to request a Clinical Trial Rescue Assessment.