Ok-Arm-362 t1_jdyyfya wrote on March 28, 2023 at 5:25 AM

How it actually works for most studies for meds. We get shipped a bunch of identical boxes - identical except some contain placebo, some investigational product. After the potential subject passes the screening process (to ensure they are a good candidate and meet all inclusion criteria), we log into a program that gives us the code number for the box to give the subject. The distribution of numbers is predetermined. No one really knows what is distributed.

FWIW, fraud - if it exists - has nothing to do with the desired outcome. It is the result of the financial motivation to enroll subjects, which can be significant. Most of the unsavory activity is from greedy sites enrolling unqualified or even phony people.

dkppkd OP t1_jdz50p3 wrote on March 28, 2023 at 6:49 AM

This is the answer i was looking for. Is there a type of company or organization in charge of labeling these boxes and keeping the secret or is this just another group within your organization?

Ok-Arm-362 t1_je0hdr6 wrote on March 28, 2023 at 3:09 PM

Glad it helps. Actually, many more layers of separation than you imagine for clinical trials. (And many variations on how randomization is achieved). Most trials have dozens of independent locations that have little to connection with each other. Typically, the pharmaceutical company contracts with a 'clinical research organization' (CRO) to coordinate it all. The CRO usually uses a separate system and/or company to perform randomization. And the whole thing is potentially monitored by yet another separate agency and subject to legal scrutiny and penalties for wrongdoing by the FDA. You can find more deets at clinicaltrials.gov. have fun 👍