Lesson I Learned About Clinical Research

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“I don’t trust people who have never failed at something.”

That’s what my friend said yesterday, and I agree! With that, I’d like to share another lesson learned from my repertoire of how I became a clinical research expert…

The study initially recruited 10 sites, with 2 expected to be leading sites due to their larger patient pool and faster enrollment capabilities. However, after a few months, the leading sites significantly underperformed.

I couldn’t figure out how could this happen there. I conducted a root-cause analysis and discovered that the sites were in a predominantly Spanish-speaking area, and the informed consent forms were only available in English. This language barrier hindered patient comfort, despite some site coordinators being bilingual.

Ramifications:
  • Had to hire a translation service to produce new ICFs in Spanish
  • Lost a few months of the study timeline, missed out on great patients
  • Unexpected increase to budget
  • Had to amend the protocol, obtain additional IRB approval (which incurred more time and money)
Lessons Learned:

Selecting investigators and sites demands thorough diligence and strategic planning. Always factor in external considerations when assessing study sites.

The foundation of any study is its patients. Construct your clinical study with a patient-centric approach, or there won’t be a study.

Successful clinical research is relational and not transactional.

I wouldn’t have known this had I not experienced it.