When it’s time to rescue a study

Planning and executing a global, interventional medical device study is a complex process. Whether you’re managing the study internally or partnering with a qualified CRO, there are times when studies may not go as planned. If multiple problems arise that negatively impact enrollment, data quality or budget, the study may need to be “rescued.” Once the difficult decision to change course has been made, it’s imperative to take steps to ensure the rescue and its new strategy is effective.

There are many reasons to select a new CRO partner for a clinical trial but the two we see the most often are enrollment which does not meet expectations and lack of operational medical device expertise resulting in effective delivery. Slow enrollment is no surprise; according to the National Institutes of Health, more than 80% of clinical trials in the United States fail to meet patient recruitment timelines. If a new CRO partner is engaged, one with a knowledgeable study start-up team is key to anticipating medical device trial challenges. An advanced feasibility assessment (or reassessment) may also be necessary to accurately identify the right medical experts and assess the patient populations a potential study site can realistically target.

Medical device companies need to be selective when choosing a CRO partner to ensure the operations team will be staffed with professionals experienced in the appropriate therapeutic area and device type for their study. This holds true for all aspects of approval trials as well as post-approval trials. Ask for full CVs of the proposed team members and meet with several key staff prior to them being assigned. They include, but should not be limited to, project manager, clinical trial manager, data manager or safety personnel.  Avoid staff with exclusively pharmaceutical trial backgrounds as they may not fully understand the nuances of running medical device trials. Finally, discuss your expectations around budget, protocol design, data collection, regulatory strategy and communication preferences with potential CROs to determine the best fit for your company and product.

Once a new CRO partner has been selected, open communication is critical to begin building trust between the sponsor, the new team and the sites. Start by taking a full assessment of all current study elements to identify key problems and put firm goals and timelines in place to keep the study moving forward and your management team are tracking to measurable goals and metrics. Don’t forget to include the clinical sites in the transition process. It is important to keep them informed and focused on resolving data backlogs, such as traditional data within the EDC system, applicable imaging or adjudication data.

Read our case study to learn more about our strategy and operational delivery services and how we helped a cardiovascular medical device company transition an active study and get it back on schedule to meet its primary endpoint targets. Case Study: Global Cardiovascular Medical Device Rescue Trial

If you need advice on clinical trial rescue services, contact us.

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