Running a Clinical Study In-House: What You Need to Know
You've moved past the concept phase and are deep into product development, perhaps in feasibility or pre-clinical stages. You need product-testing samples from healthy volunteers. Here's a thought that might surprise you: those volunteers could be your own employees.
Conducting an in-house study for non-significant risk products to collect samples from healthy staff is an option, but it brings several critical considerations. Here is a guide to navigating the process smoothly.
1. Check Your Company's Policies
Some organizations have strict policies that prohibit employees from enrolling in company-sponsored studies. This should be your first point of investigation.
2. Engage Your Clinical Department
Don't go at it alone. Reach out to your clinical department to formally request and initiate the study. They likely have a process in place as it also needs to follow FDA and other applicable regulations (e.g., ICH guidelines and GCP). Some key information they may ask that will help them design the study and allocate personnel is the following:
Purpose of the study
Objectives
Sample size
Subject population
When do you need the data by
3. Complete a Risk Assessment
It's essential to understand any potential risks for the healthy volunteers. Even if they are healthy, remember a critical regulatory point: the FDA considers employees a vulnerable population in this context. Your clinical team will make the determination and, if needed, confirm with the IRB.
4. Protocol, Consent, and IRB Review
Even for an in-house study collecting data from your own employees, you must write a comprehensive protocol, consent forms, and associated study documents and submit them to an IRB. You cannot enroll anyone until the IRB provides formal approval. Another critical decision: will the same participants be allowed to provide samples multiple times? If so, make sure this provision is clearly written into your protocol and consent form.
5. Appoint a Principal Investigator
You need a Principal Investigator (PI) for the study. The PI serves as the main point of contact for participant questions. This individual can be a doctor hired specifically for the study or already employed by your company, provided they have sufficient knowledge of your study and/or indications.
6. Address Compensation Clearly
If you plan to offer monetary compensation, it must be approved by the IRB. This payment must be considered separate from the participant's regular employment compensation.
7. Maintain Blinding Procedures
To prevent bias in result analysis, you must implement strict procedures to keep participant information and samples blinded from others in the company, including the R&D team and the participants themselves. In many situations, double-blinding the information is the best practice.
8. Maintain Clinical Files
As with any other Sponsor study, your clinical department must maintain a Trial Master File (TMF) that contains all clinical study documents and training materials. This file must be audit-ready at all times.
9. Duration of the study
The duration of your study depends on R&D needs. If R&D requires samples over many months, it's often best practice to keep the study open for a year or longer. You can add this language to your protocol.
Running an in-house clinical study can be an efficient way to support early product development, but it requires the same level of oversight and regulatory discipline as any sponsor-led study. With the correct planning and governance in place, in-house studies can be conducted responsibly and successfully.
