I qualified my statement that I was not familiar with these clinical trials so I don’t know why you think this is some sort of gotcha. I’m not advocating for the current mechanisms we used to fund science and develop new drugs. The entire process socializes the risks and privatizes the profits.

Clinical trials assess the safety and tolerability of a drug in the patient population when dosed correctly. I don’t know off the top of my head what follow-up studies are required for the approval of an analgesic. From my understanding OxyContin is safe when used as intended. The marketing campaign to get doctors to over-prescribe it is a completely different process which would not even begin until after the drug is approved (has passed clinical trials). To expand on this a little there are plenty of drugs with addictive potential that are legal to use (I.e dextromethorphan and Xanax). Just because there are negative side effects like to a drug (like addiction) does not mean it’s development process was flawed. All drugs have side effects.

I don’t know much about the clinical trials run in OxyContin, but why do you think that the trials were flawed?

I see the issue here. Reproducing RCTs in psychology = good idea. Reproducing RCTs in medicine = more often than not unethical (because you could design a better trial based on the previous one).

The paper is trying to provide support for a standard of enabling RWE to support RCT data in the FDA process which is a good thing. You don’t usually run RCTs in heterogeneous populations. You want a heterogeneous sampling of the population you are trying to treat, but depending on where you are on the world that changes ie There are ethnic and geographic differences in CYP enzymes that will change your study (if you are from a specific. Geographic/ethnic group you get 100 mg/kg if you are from group B you get 150 mg/kg). Clinical trials are designed around a specific question. Does my study meet my primary and secondary endpoints. If yes, then it supports approval for your drug. If no, then it discourages approval based on that study. Maybe you will need to do a different RCT. This is a different premise then, for example, research done in metal organic frameworks, providing support for a new battery material. This study contains the methods the authors used to create a new material, the experiment they did to test the energy storage capacity, and the result they obtained. This is the type of research it would be beneficial to reproduce.

Yes. No one is discounting that. Science should be inherently reproducible. The point I’m trying to make is that bringing up clinical trials in the same context and the general reproducibility crisis in science is comparing apples to oranges. You don’t publish the results of a clinical trial so someone can try to reproduce the trial. You share the results so that the next trial done on the same patient population can be designed to yield an even better outcome and as part of the drug/device approval process. If you run a new clinical trial on the exact same drug but you change the recruitment sites to attempt to change the characteristics of the patient population you recruit you are no longer reproducing a study. You are running a new study.

This paper does not discuss duplicating clinical trials. It would most likely be unethical to try to reproduce a clinical trial based on the adverse effects you uncover. If the first study is unclear you design a new trial but you don’t try to replicate it…

Yes but clinical trials are studies run on humans and the goal is not to reproduce the results. The goal is to power the study well enough to show that you meet your endpoints. I completely agree that there is a replication crisis in reproducing research in the literature but talking about this in the same breath as clinical trials displays a fundamental lack of understanding about the drug approval process.

You don’t replicate clinical trials…