March 30, 2022
7
 min read

Why Clinical Research Has Failed

It takes over 10 years and $2.6 billion to bring a drug to market (including failed attempts). It costs $41k per subject in Phase III clinical trials.

It takes over 10 years and $2.6 billion to bring a drug to market (including failed attempts). It costs $41k per subject in Phase III clinical trials.

The high costs lead to:

1. No Data on Unpatentable Molecules

We still know next to nothing about the long-term effects of 99.9% of the 4 pounds of over 7,000 different synthetic or natural compounds. This is because there's only sufficient incentive to research patentable molecules.

2. Lack of Incentive to Discover Every Application of Off-Patent Treatments

Most of the known diseases (approximately 95%) are classified as rare diseases. Currently, a pharmaceutical company must predict particular conditions to treat before running a clinical trial. Suppose a drug is effective for other diseases after the patent expires. In that case, there isn't a financial incentive to get it approved for the different conditions.

3. No Long-Term Outcome Data

It's not financially feasible to collect a participant's data for years or decades. Thus, we don't know if the long-term effects of a drug are worse than the initial benefits.

4. Negative Results Aren't Published

Pharmaceutical companies tend to only report "positive" results. That leads to other companies wasting money repeating research on the same dead ends.

5. Trials Exclude a Vast Majority of The Population

One investigation found that only 14.5% of patients with major depressive disorder fulfilled eligibility requirements for enrollment in an antidepressant trial. Furthermore, most patient sample sizes are very small and sometimes include only 20 people.

6. We Only Know 0.000000002% of What is Left to be Researched

The more research studies we read, the more we realize we don't know. Nearly every study ends with the phrase "more research is needed".

If you multiply the 166 billion molecules with drug-like properties by the 10,000 known diseases, that's 1,162,000,000,000,000 combinations. So far, we've studied 21,000 compounds. That means we only know 0.000000002% of the effects left to be discovered.

BSc Electrical Engineering and Physics, Decade of Root Cause Failure Analysis and Software Engineering Exp.

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