Posted by: shoji | April 29, 2008

Interpretations of Clinical Trial Results

Philip Boffey, editorial writer of The New York Times, authored a [mostly] thoughtful editorial on medical research and the interpretation of clinical trial results. In this case, he focused on the news reports that a landmark (and controversial) study on lung cancer screening using CT scans was funded by the Liggett Group, a tobacco company.

He does a fine job explaining control groups and the important distinction between early diagnosis vs. lengthened survival– points that are not well understood by the general public or even “experts”. (If you consider all physicians as “experts”.)

My one gripe with his editorial is on his descriptor of academic [medical] research: “pokey pace”.

The best hope for an answer to the screening puzzle lies with a large federal trial of 50,000 current and former smokers that is comparing spiral CT screening with standard chest X-rays to see which saves more lives. The National Cancer Institute needs to do everything possible to expedite the researchers’ analysis of their data. The usual pokey pace of academic research seems inadequate when many thousands of lives could be at stake. [emphasis mine]

Pokey pace implies that medical researchers are performing their duties in a leisurely manner. But there are challenges that could be explained (or at least not dismissed as inherent to medical research). Clinical trials do take work: (i) designing the clinical trial; (ii) creating the back-end systems for running the trial; (iii) enrolling 50,000 patients (who must all meet stringent characteristics such as years of tobacco use); and (iv) analyzing the data.

And one more thing: if the clinical trial of interest is looking at the most important outcome of survival data (e.g., how many years, if any, lung cancer screening would be expected on average to add to a patient’s life), then there is the insurmountable challenge of time.

Take a guess: what is the minimum number of years required to assess a five-year survival?

The pace of research, of any kind, can sometimes be pokey. Unfortunately, expediting the researchers’ analysis for this lung-cancer screening trial is a case of “hurry up and wait”.

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Responses

  1. Great post!

    Yeah it is a shame that trials and studies and papers all seem to take “forever” but that is the way thay they can be done and all of it takes time, especially if good results are wanted.

    I always joke with friends whenever a “new breakthrough”, “new drug” or a “new development” occurs in the field and it won’t take until 10 years later when the development is used commerically. Sad but somewhat true.

    Anyhow, keep up the good work!
    Cheers.


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