Municipal support of biomedical research.

Difficulties in funding promising young researchers at the outset of their careers have led to efforts to find new kinds of sources of support. In the past four years the municipal administration in New York City has funded a program to help support new junior research faculty in the city's research-intensive institutions. Under the aegis of the New York Academy of Medicine a program has been designed that provides support for research proposals that are peer-reviewed and competitively awarded. As measured by the quality of the submitted proposals, progress toward realizing the scientific goals of each, and additional research funding received, the program has been a success, and should be considered for replication by other municipalities.     

A classification for biomedical research reports

Biomedical research uses a wide range of designs applied to problems in laboratory, clinical, and population settings. Whatever the nature of the study, a few key features--such as the admission rule, the method of allocating subjects to treatments, and the use of controls--largely determine the strength of scientific inferences. We used these and other features to classify the 332 Original Articles published in the New England Journal of Medicine during 1978-1979. This classification directs attention to critical aspects of study design and performance and can help in the choice of suitable research approaches and protocols. It emphasizes the critical role of the investigators' intent in performing and analyzing a study, and it alerts readers to important aspects of interpretation. We recommend that authors always report enough detail about their work for readers to apply this or a similar classification. Omission of such detail may limit the interpretation of a research study because a study that cannot be classified has probably been incompletely reported.     

Restoring and preserving trust in biomedical research.

Recent media depictions of the dangers of biomedical research have fueled public and regulatory scrutiny of academic research institutions. The authors argue that if these institutions are to preserve the trust that the public has historically bestowed upon them, they must go beyond mere compliance with regulatory mandates. Several steps are suggested that institutions can take to strengthen and supplement ongoing compliance efforts, steps the authors believe will bolster the public's confidence in the integrity of academic research institutions. These steps grow out of the authors' analysis of three key components of institutional trustworthiness: (1) shared goals between research institutions and the communities they serve, (2) robust institutional oversight of research activities, and (3) training programs that build professional character. The authors' recommendations include the use of research advisory councils to assure the public that research goals reflect community interests, more collaborative relationships between institutional review boards and members of investigative teams, and educational programs that emphasize the importance of professional integrity in biomedical research. These efforts will help preserve public confidence that an institution's research priorities are appropriate and that the research it conducts is ethical. Preserving this public trust is central to the long-term success of biomedical research and the institutions in which such research takes place.     

Aptamers: multifunctional molecules for biomedical research

Aptamers are single-stranded oligonucleotides that fold into well-defined three-dimensional shapes, allowing them to bind their targets with high affinity and specificity. They can be generated through an in vitro process called “Systemic Evolution of Ligands by Exponential Enrichment” and applied for specific detection, inhibition, and characterization of various targets like small organic and inorganic molecules, proteins, and whole cells. Aptamers have also been called chemical antibodies because of their synthetic origin and their similar modes of action to antibodies. They exhibit significant advantages over antibodies in terms of their small size, synthetic accessibility, and ability to be chemically modified and thus endowed with new properties. The first generation of aptamer drug “Macugen” was available for public use within 25 years of the discovery of aptamers. With others in the pipeline for clinical trials, this emerging field of medical biotechnology is raising significant interest. However, aptamers pose different problems for their development than for antibodies that need to be addressed to achieve practical applications. It is likely that current developments in aptamer engineering will be the basis for the evolution of improved future bioanalytical and biomedical applications. The present review discusses the development of aptamers for therapeutics, drug delivery, target validation and imaging, and reviews some of the challenges to fully realizing the promise of aptamers in biomedical applications.     

A last call for self-regulation of biomedical research

The indecisive response of the academic community to well-publicized cases of research fraud or serious misconduct has been characterized as a failure of self-regulation. The Institute of Medicine (IOM) Report on the Responsible Conduct of Research suggests measures for improving the research environment, by a combination of more explicit definition of standards of acceptable research practices, appointment of individuals to promote research standards and to respond to charges or complaints, improvement of supervision of research trainee, teaching of research ethics as well as technical skills, and reduction of the pressure to publish. The National Institutes of Health was asked to ensure that research institutions take such actions by requiring assurances as a condition of research funding. This essay discusses the recommendations and implications of the IOM report.     

Transgenic pigs as models for translational biomedical research

The translation of novel discoveries from basic research to clinical application is a long, often inefficient, and thus costly process. Accordingly, the process of drug development requires optimization both for economic and for ethical reasons, in order to provide patients with appropriate treatments in a reasonable time frame. Consequently, “Translational Medicine” became a top priority in national and international roadmaps of human health research. Appropriate animal models for the evaluation of efficacy and safety of new drugs or therapeutic concepts are critical for the success of translational research. In this context rodent models are most widely used. At present, transgenic pigs are increasingly being established as large animal models for selected human diseases. The first pig whole genome sequence and many other genomic resources will be available in the near future. Importantly, efficient and precise techniques for the genetic modification of pigs have been established, facilitating the generation of tailored disease models. This article provides an overview of the current techniques for genetic modification of pigs and the transgenic pig models established for neurodegenerative diseases, cardiovascular diseases, cystic fibrosis, and diabetes mellitus.     

Outer space medicine and relevant ongoing biomedical research.

An update of outer space medicine is given emphasizing main areas such as cardiopulmonary responses, vestibular functions, physiology, weightlessness, ecosystems, and radiation. A prospective view is also presented on the medical problems resulting from various hazards of outer space and planetary missions. Although an outgrowth of aviation and environmental medicine, this relatively new, special branch of medicine is currently undergoing an unprecedented rise as a vital modern specialty. The aims of the United States, Russia, and the nations of Europe in space research are shown to be in accord in learning how to live and work in space when confronted with the unique factors of zero gravity, cosmic radiation, and magnetic variations.     

Philosophic basis of biomedical research: I. Scientific hypotheses

Hypotheses are central in scientific research. This has been so in all the major scientific works of our time. However, the dangers of projecting the desires of hypothesizing individual into his observations and inferences should be avoided and one should consider a hypothesis as a tentative proposition having varifiable consequences. Our present biomedical literature needs more emphasis on well conceived hypotheses. Many of these when subjected to experimentation would be proved wrong, as many have been in the past. But even these would stimulate experimental testing and eventually add to our understanding.