(This is part 2 of a 3-part series on Inflammatory Disorders Studies. View part 1 here.View the complete series in our Inflammation eBook.)
The good news: The surge in the number and size of industry-sponsored trials in inflammation presents opportunity. The not-so-good news: The surge also presents challenge. Clinical trials for Immune-Mediated Inflammatory Disorders (IMIDs) present certain pressures for even the most committed investigators and sites: IMID trials frequently have longer than usual duration and enrollment can be highly competitive. Additionally, patients whose disease is well-managed by the new treatments available may not be motivated to try something different.
To have investigators who are able to deliver approvable data enrolled on a timely basis, action should be taken to attract and retain investigators through a variety of measures. These include:
To ensure a timely, effective IMID clinical trial, at the most basic level, sites must perform and meet targets. Non-performing and under-performing sites will generate unnecessary delays and waste resources for all concerned stakeholders.
With your CRO, you can take the following steps:
Although, IMID studies present challenges, identifying these challenges beforehand and proactively addressing them can protect your objectives, investments and resources.