(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.)
Ensure your ROI and keep inflammation clinical trials on track.
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:
- Protocol simplicity
- Reasonable sample size requirements
- Competitive investigator remuneration paid promptly
- Thought leader engagement and professional meeting presentations
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:
- Have an escalation plan in place for non/under-performing sites that facilitates close-out if warranted
- Recruit more sites than needed and bring them through regulatory approval, holding their activation until needed. Usually failing sites are identified within three months of activation and standby sites can be readily deployed to fill the gap without compromising time or quality
- Be able to draw on a knowledge base that enables site, investigator and geographic selection to meet study needs for patient enrollment
Although, IMID studies present challenges, identifying these challenges beforehand and proactively addressing them can protect your objectives, investments and resources.