Lessons of healthcare evolution and development

 “A successful clinical trial is one that reaches the correct conclusion, not one that produces a positive result” (Williams and Carter in Pocock S., 1983, p. 22). Years and centuries of numerous scientific mistakes, as well as breakthroughs, have contributed to the creation of the contemporary codes and regulations. Some failures were as important as many successful experiments, with the crucial sequences that improved the procedures and set the new standards of care and treatments. Let us review several examples of such success vs. failure historical instances that are illustrative in this regard.

 

Most of the retrospectively reviewed examples of medical approaches to treatments and interventions turned out to be advantageous and, after all, outlined the main principles of clinical research as they are known and followed today. It is difficult to choose one example that would highlight all principles to itself due to objective historical incompleteness of the approaches to research. However, to summarize the development of clinical trials before 1950, we can see that in the view of Pocock, S. (1983, p. 14-18), the following research experiments discovered the need for and importance of the basic principles that characterize the clinical research nowadays:

 

Louis (1835, importance of careful counting the numbers of healed vs. not in the light of medical history, natural untreated disease course groups and follow-up of both), Sutton (1865, dispelling doubtful therapies), Lister (need for statistically significant comparisons), as well as by those of early 20th century – Ferguson et al. (introducing of blinding), Evans and Gaisford, Abraham et al, (importance of active controls) and Medical Research Council (1948, duly implemented randomization to a treatment vs. controls).

 

Besides the described above, there were several negative examples that contributed positively to the non-scientific, but though essential concept of ethics in clinical research – viz. the informed consent process. The one conducted by Hansen G., when he was sued at law for performing his experiments with live leprosy bacilli in humans without informing them about the nature of the experiment and not obtaining their informed consent (Hansen G. in Gallin, J.I., 2007,  p. 9).

 

Unfortunately, “… health care has been learning … lesson slowly and painfully” (Kennedy I. In Goodyear M., 2006). If even Semmelweis, I.P. had to struggle from 1847 through 1861 for “recognition of the importance of hand washing” (Gallin J.I., 2007, p.8), what else can be said in the situations when in 21st century “Primum non nocere” principle is often neglected. It seems that we still have many lessons to be learned not to lay down a human life at stake.

 

  1. Gallin, J.I. (2007) ‘A historical perspective on clinical research’. In: Gallin, J.I. & Ognibene, F.P. Principles and practice of clinical research. 2nd ed. Amsterdam: Elsevier, pp.1−12.
  2. Goodyear M. (2006) Learning from the TGN1412 trial. BMJ, Mar 2006; 332; 677-678; [Online].
  3. Pocock, S.J. (1983) ‘The historical development of clinical trials’. In: Pocock, S.J. Clinical trials: a practical approach. Chichester: John Wiley & Sons, pp.14−18.

Recent News

Upcoming Clinical Trials