[2-Year Collaborative Research Initiative Grant between a Department of a British University, and the Clinical Biostatistics & Epidemiology Section, Clinical Research Centre, Cuba]

Name: Rodolfo J. Stusser

Address: Clinical Research Centre: 34 # 4501 / 45-47, Playa, Havana 11300, Cuba

Home: L # 118 apto. F / 11-13, Vedado, Plaza, Havana 10400, Cuba.

Centre: Telephone: 537-23-0087 Fax: 537-24-3298 Home: Telephone: 537-32-3461 Fax -modem: 537-32-3461 Active from 7 pm to 7 am GMT: -5:00 e-mail: [email protected]

Position: Senior Scientist, Adjunct Professor (Havana University), in the Clinical Biostatistics and Epidemiology Section, and Chairman of the Scientific Advisory Council of the Research Centre.

Source of Salary Funding: Cuban Government (5 600 pesos yearly + 100 USD stimulus yearly)

Name of Institution which would administer the award: Department of a British University.

Current Grant Support: None

2. OUTLINE COSTING OF PROPOSAL

STAFF REQUESTED:

1 British researcher: 2 return airfares to visit Havana and 2 month’s stay.

1 Cuban researcher: 2 return airfares to visit a UK city and 2 month’s stay. Subtotal: 20 000 pounds

EQUIPMENT:

PC laptop & desktop, communication means, audio-visual media, etc. Subtotal: 10 000 pounds

OTHER COSTS:

Internet & communication services, materials, consumables, etc. Subtotal: 10 000 pounds

TOTAL: 40 000 pounds

Proposed start date: May 1, 1999 Duration of support requested: two years

Title: "A Unified Methodological Approach to Medical and Health Research across the Laboratory, Clinic, and Field. Research Education Programmes from the Logic of Clinical Medicine".

Conceptual Objectives.

- To establish the conception of a full interactive methodological and logical approach to do research in experimental medicine, clinical medicine, and public health, rescuing the central role of clinical science and scientists in it

• To set the foundation for the flourishing of the clinical method as a more general scientific method again, not only to continue discovering particularities in the clinical patient, but also to discover generalities from him

Operational Objectives.

- To conceive an incipient horizontal research education programme for the full interactive scientific training of all kinds of medical and health scientists, as a complement to the current vertical and less interactive approach, and test it

- To formulate a more vertical and solid research education programme for the training of clinicians in clinical ortho-investigation and meta-investigation, allowing them to suggest more fruitful clinical (and even non-clinical) research, and test it

Underlying Principles.

-Medical and health research is done everywhere: in the basic and technological laboratory, in the epidemiological and public health field, in the clinical ward or office. Most laboratory and field researchers are trained according to their specific research methods and univocal linear relationships with the clinic: laboratory => clinic, field => clinic.

-Every researcher needs to know in a broader extent all of the methods that are used and could be used in this complex research process at every place and in whatever conditions. They also require knowing more about the logic of research under all the methods to go more deeply into their principles through a more interactive approach.

-The approach proposed implies a non-linear interaction among sciences and scientists in every site, in which clinical research could influence the other two creatively. Thus, an integral scientific research education on the diverse and the unity of research methods, could complement every kind of scientific training; particularly that of clinicians and surgeons, who need the top scientific training that their laboratory and field colleagues benefit from.

-Clinical and surgical scientists, in hospitals and communities, with a clinical-centred approach could have more success in their research, developing all the potentialities of their methods and logic. Nowadays, they generally perform randomised-controlled trials in medical diagnostic, prognostic, therapeutic, and preventive means; random controlled surveys in aetiology and pathogeny, non-random classification, incidence and survival studies.

-This has been due among other reasons, mainly to the auto-restriction of the last 55 years in the use of the clinical "judgement" method, to investigate only the patients' particularities, when the experimental and probabilistic methods assimilated from the laboratory impacted the clinical research. Then, the modern epidemiological method, using controls and randomness became the only scientific clinical research method for the patients' generalities.

-Two leading social forces of the very successful clinical medicine progress have taken place in the last half-century: 1) The development of new basic biomedical models and technological means for patient-care through the industry of pharmaceuticals and medical-devices in the research laboratories; 2) The improvement of clinical and public health's indexes of morbidity, disability, mortality, and survival, as well as of expenditures and efficiency of health care.

-The clinical ortho-investigation of high quality, guided by fundamental forces within the qualitative knowledge of clinical medicine, originated-in-the-patient and leaded by the investigator, has not been encouraged enough in the clinical scientists. Thus, more or less guided by health indexes, the clinical meta-investigation evaluating the outputs of the research laboratory is being considered generally up-to-date as the most rigorous clinical research, because it not only uses its methods, but it is also the logical extension of the laboratory research process to test its results. Nevertheless, without good clinical ortho-investigation to open new clinical research spaces, the scientific skills of the investigators are lost, not only to carry out good meta-investigation, but also to suggest non-clinical investigations in the other sites in the old bi-univocal sense. Moreover, the solving of the bio-psychosocial problems of the whole clinical patient, his family and community, is being greatly delayed.

Materials, Methods and Procedures.

-Some preliminary work on the conception of the approach and training programmes, have been prepared by the applicant from 1993-98 at Havana University, but it is unfinished. This was due to the lack of books and journals in the libraries, as well as of access to the WWW sites of research and education top level centres; and of personal exchanges to learn from first hand the practical experience of foreign experts on the matters of experimental, clinical, and health research methodology and logic, in post-graduate and under-graduate education. The lack of hard currency to do research was a fact.

-The access to bibliography & experience would be accomplished in collaboration with the UK dept., through Libraries, WWW & E-mail in British & Havana Universities. This possibility was detected uring a 14-day visit to UK, last Summer 1998. The four exchanges of 1-month in UK and Cuba would include experts in Basic Sciences, Medicine, Surgery, General Practice, Dental, and Public Health Laboratories. The exchanges would be about basic, clinical & health research methodologies in development, and upcoming challenges for all researchers, and specifically for clinical researchers.

-Papers about the unified approach and the training programs should be published in the Lancet, Statistics in Medicine, etc., as well as implemented and tested in Havana and British Universities.

Relevance to a Medical Scientific Problem.

The conceptual results about the unified approach would help to complement the current policy-making on medical and health research, education, and care, and the training of all kind of scientists, specifically of clinical scientists closing the present gap. They would strengthen the linkage within the medical research team, to do a more successful research.

Relevance and Potential Benefit for the Collaborating Centre and for the Patient.

The collaborating centre would benefit from the operational results, by putting into practice the overall medical and clinical research training. Their successful results will provide new scientific knowledge and means that would surely influence the clinical care of the patients at the end.

Relationship to the Applicant’s Past, Current and Future Professional Activities.

This project is related to 3 years physio-pharmacology laboratory researching at the Scientific Research National Centre, a 3 year health care, a 3 year research at the National Institute for Health, 13 years of clinical research including a Dr. Sc. thesis on unified health-science forecast and policy at the National Oncology and Radiobiology Institute, and a 6 year CAD and Stroke researching at a clinical centre. It would allow complete the applicant’s background to face the future medical research strategies.

Reasons for Choice of the Collaborating Centre.

a) There is one strongest tradition on the matters at the British Universities, from the works of the UK physician John Brown in the 18-century; b) The benefit derived from the collaboration with a Uk dept., a top level centre in basic, clinical and health statistics. c) USA today is doing most of its clinical trials in UK; d) The opportunity to work at a top level centre in research & education methodologies & logic, with good Libraries for further studies and located very near to other great UK Universities.

Basic References of Recent Publications in the Project Field.

There are very few references found about this unified approach to medical and health research. Some about clinical research training problems and suggested solutions are as follows:

-Farrell GC. Career paths for clinical scientists. J Gastroent Hepatol 1996; 11:891-894;

-Editorial. Clinical research: Fencing the jumps. Lancet 1993; 341:23-24;

-Editorial. Clinical research: Disturbing present, uncertain future. Lancet 1991; 337:19-20.

Two of the most abstract underlying principles could be found in:

-McIntyre L. Complexity: A philosopher's reflections. Complexity 1998; 3; 26-32.

Justification of Project Duration.

Two-year is the minimum time to prepare the approach & two programme proposals to the British & Havana Universities and Health Authorities, having tested them before in both places.

Facilities Available to Continue the Work, Apply and Disseminate the New Results.

The post-graduate training programmes would be taught and extended from the Clinical Research Centre at Havana University. First, to the researchers now doing clinical trials & studies on diagnostic, therapeutic & preventive methods, using among others, pharmaceuticals, monoclonal antibodies and other bio-molecules of Genetic Engineering. This would include research centres in Cardiology, Medicine, Surgery, Family Medicine, Oncology, Nuclear Medicine, Public Health and Basic Sciences, etc. Second, the training could be extended to other researchers of Latin America and the Caribbean, in centres at Havana, at those countries, and even at UK, if they could be sponsored in the future.