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E{JBLIC~[=S C CtISUL113D ISSUE 1. THE EUND~G OF CLINICAL INVE=IG~CNS IN IRE ~[rED SUMS Ar~erson, G. Iea*~i~ Hospitals in tile USA: Institutions Under Stress? Finarx~ial Anility and ~3nager~nt. 3~2~: 117-127, 1987. Anderson, G.F. and rave, J.R. Finarx:~ng Graduate Medical Education and Bi~ima~ Parch: nose Respons~bili~. Health Polity 7: 3-12, 1987. Sunrey Report, U.S. E~armacelxtim=1 It, 1986-1987, B~tcima1 M~fac~ Association. Antman, K., Sinister, L.E., Etrei, E. Ike Crisis in Clinical Or Prearm. ]bird-Party ~ arxt Investigational Therapy. NE]M 319: 46-48, 1988. Consensus Stint for the Rent Policy Meting, National Over Institute, June 15, 1988. The Contribution of Academic Health Centers to C]inim~.1 heat, The nweal~ hi, Report of the Task Force on Academic Hearth Centers, ur~bli~hed manuscript. r~ger, D. dives: A Senator; H~a1ff, Affairs 7~1~: 39-44, 1988. I=; Peer Refries Ohs. Workload ark Anions of 1~; Sty Sections 1975-1985, Statistics ark Analysis Broth, Division of heard Grants, National Institute of Heals. Guidelines on Diagnostic Testing will Lead to Cost Bevies, Better Patient Arm, Blue Cross and Blue Shield Association, 1987. me Entire Financing of leaching Hospitals, me Realm Few, Report on me Task Force on Academic Heals Cents;, Report III, 1985. Hospital is and Clinical math Project; National Center for Health Service Research; Abstract of sway in progress, 1988. Lange andiron, B., Cudd~h~ck, J.K., Ives, J.E., Carton, M.J. me Impact of =;s on Clinics Research Canters. A Millti-institutional Study. M~im~ Care 26: 510-514, 1988. It of a Stay in a Hospital Fat to lip 22% in 5 years (by Martin Baldwin), The New York Times, W~ay, my 25, p.A20, 1988. 23

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i, S.E. in Patients Be Asks to Pay for E~rimenta1 Treatment? Clinics ~ 32: 393-398, 1984. Mdnnisto, M. EN Payment Changes Raise Quali - , Ovation and Medical J~nt Issues, Journal of ~ ~rmn ~nage~nt 3 (1~: 9-15, 1988. M~rthy, C. M. Is - Five Years rater. NEJM 318: 1683-1686, 1988. Medicare: fist M~di~1 Education Payments to leaching Ho~pit:=ls, P - ort of the Office of Or General, it of Health arm swan Saris, July, 1988. M~dicare~s Prospective Payment System: Strategies for Evaluating rant, Quality, and M~di~1 Technology, Office of Technology Assessment, one, 1985. Miller, J.E. The Private Insurer Response to Advanced Health Care Technology: The Case of Organ Transplants, Health Insurance Association of America, 1988. Morbenson, L.E. Audit Indicate= Half of Current Chemotherapy Uses Lack FD~ Apprcval, Journal of Cancer Program Management 3~1~: 21-25, 1988. Nathan, D.G. Sa ~ i ~ ~ rd. Furring S ~ cialty Trainer for Clinical investigators, NE]M 316: 1020-1022, 1987. National Institutes of H-a1th Clinical Shies Report BY 1985-E Y 1986, Office of M~i~1 Applications of March, NIH, ~r~t of Health am Mean Searing, 1988. NIH Data Book. A Cen~ry of Science for H ~ th. U.S. Department of Hearth and mean Services, NIH Publication No. 88-1261, 1987. NIH ~n~rnal me: Resource Allocation E ~ ess at the NIH. No Easy Answers for Sufficient Third-Party Coverage of Clinical Trials Expenses. News Section, Journal of the National Cancer Instibube 80(10): 714-717, 1988. Pollard, M. R., Persinger, G.S., Perpich, J.G. Technology Innovation in Health Care, Health Affairs 5: 135-147, 1986. Reports of Congressional Commit on Appropriations on NIH Grant Funding Policies Richards, T., Tarrier N., Rogers, W.H., Brook, R.H., Measuring Differences Between Teaching and Nonteaching Hospitals. Medical Care, 2~5) Supplement, 1988. 24

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Score, C.J. and Gavel, J. E~tive Payment: Scare Ret~tive C~ervations. NE]M 318(25): 1681-1683, 1988. Shortage of Enrolled Patients Ales ~r-l~rug basting, Wa~i~t~n Post, July 25, 1988. Tows in Hospital Average Ier~s of Stay, Admix, arm Discharge Rates, 1980-1985, H - pitch Studies E~rmnPesear~Nute, #11, National Racer for Health Services ~ and Heady Care Teleology Asset, IT Publication No. (em) 88-3420, 1988. Wittes, R.E. Paying for Patient ~ in Treatment Mario is Extensible? Rex Treatment Purports 71(2): 107-113, 1987. Wittes, R.E. Cones Statement for the Rei~rs~t Polity Meting, Curse 15, 1988. Yarbro, J.W. and Mortensx:n, L.E. The N~1 for Diagnosis-Related Group 471, JAM 253: 684-685, 1985. ISSUE 2. TANG AND sUPPORr OF To Yaw COMICAL INVESrIG~R THE UNTrED CAPES Beatify, H.N., Babbitt, D., Higgins, E.J., Jolly, P., I'vey, G.S. P~r~h Activities of Faculty In Academic r~ar~ts of Medicine. Armals of eternal Medicine 104: 90-97, 1986. Cox, M.W., Amy, L.A., Levey, G.S., Andersen, R.M. National Stud of Internal Medicine Member: X. Internal Medicine Residency and Fellch~ship Raining: 1985 Update. Annals of Internal Medicine 104(2) 241-245, 1986. Federal Polity for Biomedical and Behavioral Research, AAMC ad hoc (remittee on Federal Research Policy, pp. 13-17, 1986. Gentile, N.O., Jolly, P., Covey, G.S., Dial, T.H. Peseardl Activity of ~ll-Time Faculty ~ Departments of Medicine, Final Report, Asscx:iation of Professor of }medicine and Asscx:iation of American Medical Colleges, 1987. Herman, S.S. and Singer, A.M. Relic Scientists In Clini~1 ~r~tsofM~icalS~ools, ClinicalResear~34: 149-158, 1986. High Cows Pinch Health Pesear~er training, freon H=a11:h Grants and Contracts Weekly, Allqust 15, p.7-8, 1988. 25 .

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The fact of ~ Containment ~asu~ on Clinics Regears and Irk Training in Academic Heals Cents;, E~i~s of the 53rd Meeting of the Acrimony Unit ~ He Direr, National ~i~es of H-alt:h, ~~t of Health arid Human Septic:, June, 1986. Halley, W.N. Are We Abort to Enter He Golden Era of Clinical Ir~vestigation? J. Tech. Clan. Mod. 111: 365-370, 1988. Halley, W.N. Personnel Needs for Clinical Research: Role of the Clinical Investigator. Clin. Research 33: 100-104, 1985. Levey, G.S., Sherman, C.R., Gentile, N.O., Hough, L.J., Dial, T.H., and Jolly, P. Postdoctoral Research Training of Ful1JTime Faculty Academic Departments of Medicine, Annal of Internal Medicine 109: 414-418, 1988. Personnel NO and Training for Biomedical and Behavioral Research, Institute of Medicine, National Academy of Sciences, 1985 Report. Prnceelings of a workshop on the training and professional support of medical reviewers at the Food and Drug Administration, February 4 and 5, 1988, sponsored by the Forum on Drug Development and Regulation, ION, NAS. Workload and Actions of DRG Stay Sections 1975-1985, Division of Research Grants, National Instigates of Health. Wyngaarden, J. B. The Clinical Investigator as an Endangered Species, Bull. N.Y. Acad. Med. 57(6): 415-426, 1981. ISSUE 3. O~NIZAlT~L SECURE OF CONICAL INVEIGH 1 EM Draft Statement on Nursing Research Facilities NONES in Academic and Clinical Research Institutions, American Nurses' Association, 1988. m e Ethics in Patient Referrals Act of 1988, Statement of the Honorable Fortney Pete Stark, (D.~alif.), Chairman, Subcommittee on Health, Committee on Ways and Means, 1988. Fox, I.H. AFCR Position Paper. General Clinical Research Centers: A Program in Jeopardy, Clinical Research 30: 437-440, 1982. Sherman, B. and Genel, M. Ivan Ir~restigation ~ e 1980s: memes four the Scottsdale Inference, Clinical Research 31: 570-571, 1983. Vaitukaitis, J. L. 1987. Changing Reseal Directions of Inters, p 1-6, 26

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Vaitukaitis, J. L. NDI Role in E~r~ Pa Sorting Vaccine D^relc~nt. Role of We General Clinical Sea. Cedars Pi., t~ to the AXIS tram Advisory Remittee, p 1-3, 1988. 4. THE NEED EAR CLINICAL INVE~G~RS TO BE CONCEDED Wllff 1 ISSUES OF Alicia ASSE=MENr AND CX~FE~ ANALYSIS Assessing Medical ]~x~logies, agitate of Medicine, National Academy E0ss, Wa~ir~ton, D.C., 1985. Booth, W. FDA Looks to Speed Up Drug ApprcNa1 Process, Science 241: 1426, 1988 Eulger, R.J Archie Cbahrane Revisited, JAMA 260(9): 1284, 1988. Eddy, D. M. and Billings, J. The Quality of M~di~a~ Evidence: Implications for Quality of care, Hearth Affairs 7~1~: 19-32, 1988. Ellwcod, P. M. Shattuck Lecture: outcomes Management. A Technology of Patient Experience. GERM 318: 1549-1556, 1988. Feinste~n, A.R. An Additional Basic Science for Clinical Medicine: II. The Temptations of R~omizect Trials, Annals of Internal Medicine 99: 544-550, 1983. Hoer Agrees to Bush Palest for gibe of FDA on Or, AIDS is, The Cancer Letter 14~29~: 7, 1988. I~gna, L. Cordless, the Food and ~ A~ni~sExation, and New lag Development Before at After the 1962 K~fauver-Harris its, paper prepare for Committee. NCHSR Funding History, September 7, 1988. National H~1= Polity Formn, Nudity of Vicar Ore: Sea~i~ for Scientific Stats; Results of a workshop with Rev. D.M.. Wig, J.E., Gartland, J.J. and Kt~, K. B. Washington, D. C. , , _ , April 11, 1988, Peto, R., Pike, M.C., Armitage, P., Breslaw, N.E., Cox, D.R., Harvard, S.V., Mantel, N., Peto, J., Smith, P.G. Design and Analysis of Rarxic~mized Clinical Trails R~irir~ Wronged Conservation of Eadh Patient. I. Introduction art Design. ~it. J. Or 34: 585-612, 1976. 27

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Peto, R., Pike, M.C., Armitage, P., E~;law, N.E., Cox, D.R., Harvam S.V., Intel, N., Peto, J., - i=, P.G. ~ Design arm Analysis of Rar~nized Clinical Trails Requiring Prolor~ed C~ation of Each Patient. II. Analysis arm E~les. Etrit. J. ~ 35: 1-39, 1977. Erg, J.E. momentary: farming me Medical ~ision~ki~ Ems, Heal= Affair'; 7~1~: 99-106, 1988. fig, J.E. Dim Testimony before me Senate FiT=xx Wee on Health on July 11, 1988. Yew, F.E., Norris, J.A., Ievi=, J.A., Nightir~e, S.L. Ice Flus Nr Em for me Use of Ir~vestigational is In 1=abrent. JP~ 259: 2267-2270, 1988. 28