From Research to Clinical Testing
Research laboratories are well established in their research areas, they have deep experience in these areas because they have been running progressive research studies that answer one question at a time. Researchers also have wide experience in materials they use, their pros and cons, and their limitations.
The interesting part comes when these researchers identify key markers that predict the success of their protocol, or monitor its progress. Often these researchers invent a protocol to solve a problem, with such innovative protocols, many protocol-outcomes (key markers) are new, and for which there are little or no diagnostic assays. But this usually is not an issue to researchers, they would simply device a diagnostic test to test that specific marker, and continue their study.
It all goes well until these researchers decide to translate their invention to the clinic. During translation, all protocol components (material, staff, facility, and diagnostics) need to translate. Most component would translate well with little impact on the protocol, but the diagnostic test may become the bottle-neck if no approved alternatives exist.
What options do researchers have?
It is the responsibility of the translational research team to translate all protocol components, including the diagnostic test if not approved test is available, the translational researchers have two options:
A. The first option is to change the diagnostic method from research method to a validated method. This process goes in to steps:
- Identify higher quality material to substitute the research use only (RUO) material, however, if regulators approve it, RUO may also be used for clinical testing.
- Validate the new method. Translational researchers need to develop a validation protocol, validate the new method, and get it approved by the quality assurance team. The advantage of this option is testing remains in-house with full control over the method conditions and rights. The downside is the time and cost associated with method validation.
B. The second option, and perhaps the easier one, is to outsources the test to a Contract Research Organization (CRO) to run the test. It is still possible the CRO has no approved method for the intended marker, but CROs are generally prepared to develop diagnostic methods that are customized to specific client requirements.
The advantage of this option is there would be no need to develop an in-house method with all related issues. The downside to this approach is translational researchers would need to identify & contract a CRO with whom they develop the method, and send the samples for testing.
To avoid method related development delay, it is best if researchers approach the translational team early in the process, this way they ensure the protocol would translate smoothly; refer to this post for further information about product development timing (link).
Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us.
About the author
Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here