What do you know about clinical trials?

Before they can be used on and by humans, medicines, treatments, medical devices, etc., they must pass extensive tests. After all, how do you know if a substance really is effective in combating a certain disease and has no more side effects than benefits, or if a certain technology is more advantageous and offers more accurate diagnostics, for example?

You may have even heard the term "clinical trial" many times, especially when we see news about laboratories involved in scandals or being overrun by militants. But what do you know about them? Are all medicines and technologies really tested so thoroughly? And who are the individuals participating in the trials?

The folks at io9 spoke to Molly Maloof, a physician and health technology consultant, who explained some clinical trial issues that not everyone knows about. Check out:

Beneficiaries

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It is not always those who participate in the trials who will benefit from the treatments. It is quite common that, especially in the early stages, the groups tested are more limited, as this way it is possible to better control the variables involved and thus simplify the process. After all, if a participant experiences a problem during the tests, it is necessary to know if it is due to the substance administered or not.

Therefore, according to Maloof, women often do not participate in trials because of the hormonal variations they experience that could interfere with the drug being tested, as well as people with pre-existing illnesses. Not to mention that studies are often conducted in other countries - not those of origin from the drug laboratory - which means that the ethnic group tested is also limited.

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While there is nothing wrong with that, limiting the group of participants - for the best results - may mean that a drug for ladies with high blood pressure problems has been tested on healthy, physically active 25-year-olds. with very different lifestyles and conditions than those of the group for which the medicine will be used.

Thus, although studies are valid even when conducted in this way, by reducing the variables to help understand the functioning of new drugs, the results may not be as expected when the drug is used by a larger - and more varied - sample. individuals.

Outsourcing

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While a few years ago the scientists were conducting the trials, they are involved in the development of a particular drug. Today, those who are taking on this work are specialized laboratories. The problem is that often, when the substance tested does not have the expected result for the purpose for which it was developed, these companies make adjustments to see if it can be used for another purpose.

So imagine that a particular substance is being tested for use as a potent pain reliever. However, during the trials it is clear that this element is not as efficient as previously thought. In this case, studies may stop at this point or continue to assess whether the drug may be used in less severe cases of pain or to treat specific cases.

According to Maloof, thanks to this “adaptation”, certain clinical trials are becoming a kind of guided survey of what drugs can do. A positive aspect of this approach is that it can slow the progress of non-working substance testing - thus saving time and money - and allowing researchers to focus on specific uses of new drugs.

Ethical conflict

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Currently, between 80 and 90% of clinical trials are privately funded, which means that ethical missteps can occur in the process. After all, however correct and principled a manufacturer may be, the goal is ultimately to make a profit. And the sooner a drug hits the market, the better.

According to Molly Maloof, the problem with this is that in the rush to launch a new product on the market, not all the risks associated with new drugs are always known to healthcare professionals, however effective they may be. Maloof cited the example of oxycodone hydrochloride, a very effective substance in the treatment of chronic pain, but which can be very additive.

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This is because, unlike other pain medications, there is no limit dose for oxycodone hydrochloride, ie the greater the amount used, the greater the relief. Another feature of this substance is its mechanism of action, which works by releasing the active ingredient over time. However, if this drug is not administered correctly, it becomes extremely addictive.

What happened in the case of oxycodone hydrochloride was a huge increase in abuse by both patients and recreational drug users. However, it was not, however, a bad faith problem of the manufacturer - after all, the drug is effective, albeit addictive - but the lack of training of medical personnel to deal with this specific situation, recognizing the signs of addiction before prescribing the medicine.