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  Carlo Gambacorti: DIAG,ETHI: "Widening gap between clinicians and scientists"  

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To: Multiple recipients of list HUM-MOLGEN <HUM-MOLGEN@NIC.SURFNET.NL>
Subject: DIAG,ETHI: "Widening gap between clinicians and scientists"
From: Carlo Gambacorti <GAMBACORTI@icil64.cilea.it>
Date: Thu, 31 Aug 1995 15:55:32 MET-DST

A note from the DIAGnostics/Clinical Research Editor


This note is intended to stimulate debate and discussion on a
topic that I consider very important for most HUM-MOLGEN

     Rapid and efficient translation of preclinical data into
early clinical studies represents a critical problem in
biomedical research. Modern science is becoming more and more
specialized and focus demanding. In addition, clinical and lab
activity follow quite different and often contradictory rules.
Thus, it could seem natural that different individuals will deal
with preclinical (the "scientist") and with clinical (the
"clinician") research. Such an organization can work for basic
research and for advanced clinical studies (phase III-IV). In the
delicate field of "translational research" (pilot, phase I-II
studies), this separation of duties carries with it a significant
risk: to create two almost independent and mutually impermeable
systems. The field of molecular genetics is quite exposed to this
problem, since more and more techniques (usually developed by
people with little or no clinical experience) are entering the
clinical arena (where few people have consistent lab background).

In the extreme of this context (let's call it the "schizophrenic
theater") the two players have different goals: molecular
modeling (independently from its clinical relevance), papers and
grants on one side, tailoring of existing treatments
(independently from their often marginal value), patients and
money on the other. Paradoxically, the development of new
treatment modalities is not a first priority for anybody. The two
participants in this surrealistic game do not know each other
situation sufficiently well to perceive and understand the other
side problems and perspectives. Reciprocal misunderstandings and
distrust can develop. This results in an inefficient
translational research. I can supply interested readers more than
one such example.

     Having worked both in Europe and in the US I think the
situation is different in the two continents, although a similar
trend is emerging.
     In Europe this represents an endemic problem. The
organization of work tends to ask a 100% clinical commitment to
people in clinical departments (the concept of rotation is mostly
unknown) and to put non clinicians in separate departments with
their own structures, hierarchies and directors. It is usual
that clinical studies list the involved personnel in two separate
columns, one for the clinicians and one for the non-clinically
involved staff.  While these divergent goals can (perhaps) be
more easily reconciled inside the management of a private
company, this is more difficult to be accomplished in entities
like research institutions and universities characterized by a
high degree of complexity and independence of different
departments. There is no defined granting agency or program,
specifically designed to fund clinical research or the clinical
component of a research project, whose cost usually rests over
the respective national health system, with all its pros and
cons. Some past attempts at creating clinical research centers,
on the example of american GCRC, have been found to be
incompatible with the existing structures or were mainly
"political" attempts (Nature, 369,92, 1994, Nature 361, Jan.21,
classified #2 and #5, 1993).     The problem is more evident in
countries (Italy and Germany are to my knowledge the worst
examples) where a more pyramidal organization is present inside
hospitals and universities, and perhaps less in the UK.
     In the US many of the above mentioned problems do not exist,
even if the situation for clinical research is far from optimal
there too (Nature, 371, 468, 1994).  Rotations are usual in
clinical departments, thereby freeing research-protected time.
Clinical training usually include at least some research-oriented
time (in hematology and medical oncology for example). Programs
like the NIH-funded General Clinical Research Center (GCRC) do
exist and assure financial support and extra-mural peer review
for clinical protocols.  Recently, however, a trend toward a more
demarcated separation between lab and clinical activity is
emerging. Most people working as "clinician-scientists", with
whom I recently spoke, find more and more difficult to remain in
this position, without losing competitiveness. There is a diffuse
feeling of inadequacy to compete for grants with PhDs, who do not
have any clinical burden and are often technologically more
experienced, on one side, and to compare with people on clinical
tracks, who have far higher clinical volumes and therefore carry
more clinical revenues to the institution.
     This editor does not mean that everybody inside an
university hospital should become a physician-scientists, but
that a critical number of such professional figures should be
allowed to successfully work in an institution encompassing both
clinical and lab activity, to avoid or limit the above mentioned
      Some publication data can be illuminating: I looked at the
first 3 months of MedLine 1995, and searched for all publications
with CLINICAL/RESEARCH (mostly pilot, phase I-II studies) among
keywords. Among the 208 papers, 2/3 come from North America (42%
of them acknowledging public support), 1/3 from the rest of the
world (31% with public funding). Data concerning publications
from more basic fields (like for example HLA/PEPTIDE), show
publication from North America (US + Canada) accounting for only
42% of total (68% of them with some public funding), the rest of
the world getting the remaining 58% (with 80% acknowledging
public funding).
What these data do tell us ?   In my opinion four things:
1. original clinical research is best played in america (little
doubt about it), where, 2., it also gets a level of public
financial support higher than in the rest of the world (42% vs.
31%); 3. clinical research, however, is in general less likely
to get public funding than basic research, and this, 4. is
particularly evident for non american countries (31% vs. 80%).

      Although there is wide acknowledgment on this issue (J.
Clin. Oncol., 11, 1639-51, 1993, Nature, 371, 468, 1994, American
Association for Cancer Research, Association News, March 29,
1994, pages 1-2, Nature Medicine, 1, 281, 1995), little (Nature,
376, 547, 1995) is being actually done.
     I hope this short piece can result in an healthy debate.

Questions that interested readers could try to answer are:

1.    do you agree in general with this analysis ?
2.    do you think this trend represents an inevitable
      development ?
3.    do you have comments, ideas or proposals ?

  Carlo Gambacorti MD, Editor,
  Human Molecular Genetics network
  Diagnostics/Clinical Research Section

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