Presented at at Sigma Xi's iFoRE - 20231110 9:00am

Key Thought

Research, especially Medical Research, can be done better.  Here's how.

Description

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research gave a frank assessment of the state of America’s medical research in 2019.1

“It’s not working, and it won’t work in the future [...] The goal isn’t just improving knowledge. The goal isn’t FDA approval. The goal is to improve human health.”

Woodcock identified three major causes for the disconnect between discoveries in the laboratory and medicines that reach the clinic.

1. Misalignment of academic incentives: Current research norms discourage collaboration. The Grant review processes, promotion criteria and even the concept of tenure ought to be reconsidered. 
2. Corporate Secrecy: When drugs are primarily developed in response to profit motives, important clinical questions go unanswered when they don’t have obvious commercial gain. Additionally, corporate secrecy prevents collaboration in the private sector. When the science is valuable and “not to be shared,” drug trials are fragmented and costly, hindering the process of creating and commercializing drugs.
3. **Lack of patient access: Other industries focus on making their products cheaper. But that’s not the case with the pharmaceutical industry, where high failure rates and expensive clinical trials have led to drugs far beyond the financial reach of those in need.

And there are other problems with the current process that Dr. Woodcock did not discuss.

1. Stagnant death rates: Cancer research hasn't increased age adjusted cancer death rates since 1930. - Dr. Azra Rasa.2
2. The unserved majority: Only 6.6% of cancer patients currently see benefits from existing drugs and at the current rate of progress, it would take more than 200 years for all existing patients to be helped.3 
3. Unsuccessful clinical trials: Oncologic Clinical Trials are even harder to get right, as evidenced by their 3.4% success rate.4
4. Underreporting of results: Less than half of clinical trials report results even though the Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly.5 Perhaps because "one-quarter of clinical trials might be problematic or even entirely made up" [20230718]

So. What to do? In this session, we heard from Speakers who are addressing these issues head on by approaching research differently.

For the most part, their goal is not to improve research, but rather to improve the way that research improves.

Suggested Speakers (√ indicates “confirmed”)