Don’t assume your clinical trial will survive endless change orders, extended deadlines, cost overruns, and missed objectives. Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
The longer you take to address a faltering clinical trial, the greater the risk your trial progresses from faltering to failure. And the deeper a trial's problems, the more likely you'll have to ask for a substantial budget increase — another difficult conversation. Here are some tips to act quickly for the best ROI.
In research, any time variation is introduced and unaccounted for it can mask the true results of an intervention. The summer season can contribute to variation and can introduce other specific challenges to a clinical trial. Here are solutions that can be implemented during the planning stages of a study as well as creative solutions for rescuing a trial failing for seasonal reasons.
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. If your study is struggling because of recruitment issues, here are some considerations that can be used to rescue your clinical trial.
Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. This article attempts to characterize the scope of the problem facing the drug development industry and makes a case for early, proactive intervention in faltering clinical trials.
Site selection and ensuring that sites are performing up to par are crucial parts of a study. Read how a CRO facilitated communication between participants and sites and personally took measures to follow up with participants who would have been otherwise lost between screening visits.