HUM-MOLGEN archive: DIAG,ETHI: "Widening gap between clinicians and scientists"

A note from the DIAGnostics/Clinical Research Editor ************************************************************** WIDENING GAP BETWEEN "CLINICIANS" AND "SCIENTISTS" ************************************************************** This note is intended to stimulate debate and discussion on a topic that I consider very important for most HUM-MOLGEN subscribers. 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 some 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 difficulties. 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 HUM-MOLGEN@NIC.SURFNET.NL