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End of Summer Rant: CDER Must Have Clinical Trial Reform

By John Russell 

September 27, 2011 | The Russell Transcript | It’s not always easy to know what to make of FDA initiatives, particularly at the time they are announced. Some are modest and administrative in nature (Fast Track, 2009) and some constitute a grand vision (Critical Path Initiative (CPI), 2004). Last month, FDA’s Center for Drug Evaluation and Research (CDER) issued another call to action in the form a report, Identifying CDER’s Science and Research Needs Report, prepared the CDER Science Prioritization and Review Committee (SPaRC).  

What should we make of it besides good intent? Published in the Federal Register and available online, the report outlines seven areas of need. FDA is soliciting public input before prioritizing efforts and it is also seeking to stimulate public-private partnership.  

“We look forward to hearing from and working with our stakeholders,” said CDER Director Janet Woodcock in the July 25th press release.  

OK, here’s my input. 

The lucky seven—well at least six of them—are important issues: 

1) better use of post-market data (important) 

2) risk management strategies (important) 

3) scientific approaches to regulatory communications (not so much) 

4) product quality and performance (important) 

5) predictive models (very important, but I am biased) 

6) design, analysis, and monitoring of clinical trials (most important), and 

7) individualization of patient treatment (very important). 

Interestingly, the latest initiative notes “while computational infrastructure needs and data standards were critical for a number of these topic areas, efforts were already underway in CDER to address this important issue; therefore these needs are not included in this document.” Good to hear work is ongoing.  

FDA says the new document complements the broader Advancing Regulatory Science for Public Health document released in October 2010, which among other things is intended to incorporate CPI into a “broad framework for advancing regulatory science.” So many documents; so little time.  

Punch List 

I guess this is all well and good. The laundry list of bullets to be attacked under each of the seven categories in the latest document includes mostly worthy topics and some are even critical. But given current budget constraints as well as other confidence-straining issues, it’s time to dump diffuse grand schemes. What they generally do is make it too easy to find something that went right and trumpet it, too easy to downplay less successful pieces of the initiative, and too easy to rejoice over incremental progress (which isn’t bad but shouldn’t require slathering praise). 

Instead, CDER should focus on reforming the clinical trial paradigm. The current approach is broken: one market researcher reports per-patient costs have risen 70% across all development phases since 2008, a terrifying number if even close to accurate. The low number of drug approvals speaks for itself.  

It’s time for trial reform, which is sort of category #6 of the latest document (“Improve Clinical Trial Design, Analysis and Conduct.”) It shouldn’t be #6. It should be the title of the document. It should be CDER’s overarching theme, at least for the time being.  

Clinical trials take too long, cost too much, and often don’t incorporate the latest science. Changing the clinical trial paradigm will involve tackling many of the topics brought up in CDER’s new initiative, but there is great value in painting a clear bulls-eye on clinical trial reform and explicitly aligning virtually all CDER effort to hit that target. Measuring success will also be clearer. (Did we put a man on the moon or not?)  

FDA has many jobs, not just overseeing drug approval, and drug development is complicated, no doubt. The tools required to do the job are complex, no doubt. CDER, especially, must understand and appropriately use old and new science, no doubt. But too many reports and objectives won’t get the job done. Currently clinical trials constitute the single biggest bottleneck in the drug discovery & development, no doubt.  

Frequently, when everything is important, nothing is important. It’s time to make clinical trial reform the most important thing on FDA’s drug-related agenda. That doesn’t mean ignoring other important stuff—it just means saving the artillery for the main target.  

This article also appeared in the 2011 September-October issue of Bio-IT World magazine. 


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