HAUPPAUGE, N.Y., April 15, 2019 /PRNewswire/ -- Almost half of all clinical trials are conducted in countries outside the United States. The globalization of clinical trials requires stronger knowledge and increased efficiencies in the planning and execution stages. Leader of patient recruitment companies, Clinical Trial Media, shares 3 common mishaps for global clinical trials.
Our first common mishap is study feasibility and planning. It's important to realistically evaluate a protocol for the availability of patients. Make sure you're asking yourself - does this target population exist? And if so, take a deep dive into disease prevalence and incidence amongst that population. Utilize local representatives and data sources to recruit and filter enrollment objections, as well as determine a threat of any competing studies. When it comes to timeline planning, you'll want to build in buffers for any unexpected delays. Before implementing the protocol, it should be vetted globally including an internal, external, and local representative and full investigator review.
Another common mishap is regulatory submissions. To mitigate this, you'll want to develop a strategic regulatory plan that includes milestones, steps to achieve them and deadlines they should be achieved at. If needed, stagger submissions to ensure all countries are activated as quickly as possible and enrollment can begin. In addition to your plan, create a checklist and examples of any required documentation. It's important to have a full understanding of country-specific data and the acceptance policies, as any misses or changes can result in major delays. As a safety net, you should apply for more patients and sites then are actually needed.
Patient recruitment can also prove to be a common hurdle that many trials find troublesome. It's critical to develop expertise in your recruitment landscape. Every country is unique and you should develop a proactive recruitment plan that encompasses all geographical locations your study is accepting. Research different ways that patients first hear about clinical trials, examples of successful recruitment plans/sites and identify any common mistakes that you can take steps toward avoiding. Additionally, consider involving local expertise and relevant networks to provide feedback and insight on your recruitment plan to increase overall effectiveness.
As more and more studies move to a global scale, it's important to be wary of common mishaps that occur. Be mindful of these pitfalls and develop plans to mitigate these risks and put your clinical trial in the best possible position to succeed.
About CTM: CTM Clinical Research Patient Recruitment Company is a global patient recruitment and retention firm that provides customized product and service offerings to maximize your study's enrollment potential. With our flexible solutions, superior customer service and vast clinical trial experience around the world, Clinical Trial Media is your global enrollment connection.
SOURCE Clinical Trial Media