National Institute of Diabetes and Digestive and Kidney Diseases MAJOR NEW CLINICAL TRIALS READY TO BEGIN IN FISCAL YEAR 1992 IF FUNDS WERE AVAILABLE (Dollars in thousands) To determine if subcutaneous administration of low-dose PTH will increase bone density in women already receiving estrogen. Treatment(s) of Primary Biliary Cirrhosis To test methotrexate and/or FK 506 as treatments in the early stages of primary biliary cirrhosis. Preventive Therapy for Urolithiasis To compare hydrochlorothiazide, inhibitor supplementation, and diet restriction in prevention of renal stones. Surgical Intervention of Morbid Obesity 187 1,500 To study the indications for, complications and benefits of, and specific procedures associated with surgical intervention in morbid obesity. Comparison of Interventions for the Resolution of Symptomatic Benign Prostatic Hyperplasia (BPH) 833 3,075 6 To compare 5-alpha reductase inhibitors and alpha blockers and to evaluate optimal time for intervention in BPH. Title Therapy of Graves' Ophthalmopathy To evaluate unilateral orbital radiotherapy in Graves' ophthalmopathy. Long-Term Effectiveness and Side Effects of Shock-Wave Lithotripsy on Urolithiasis To evaluate serum and diagnostic parameters of organ function and damage in follow-up of patients who have had shock-wave lithotripsy. Comparison of Surgery Versus Medical Follow-up in Asymptomatic Primary Hyperparathyroidism 1,000 11,230 14 To compare surgery with medical followup in the management of asymptomatic primary hyperparathyroidism. Immunosuppressants in Crohn's Disease 1,450 8,300 8 To evaluate whether patients with Crohn' disease benefit from therapy with cyclosporine and/or methotrexate. Immunotherapy for the Prevention of Insulin-Dependent Diabetes Mellitus (IDDM) To determine whether immunosuppressant drugs can prevent clinical manifestations of IDDM in patients at risk. Treatments of Helicobacter Pylori To evaluate the effectiveness of various antibiotic regimens in eradicating and preventing recurrence of H. pylori. Title End-Stage Renal Disease in the Pediatric To develop protocols for testing in pediatric patients with renal disease. Progressive Renal Disease in Childhood: To test promising therapeutic Nonpharmacologic Treatment and Preven- To develop and test techniques for New Agents for Prevention or Amelioration of Long-Term Diabetic Complications To test the effects of candidate drugs Kidney Disease and Hypertension in Blacks To determine whether progressive, renal disease in Blacks due to hypertension can be slowed by antihypertensive therapy. 875 Title Use of Recombinant Human Erythropoietin Totals $26,277 $159,630 Mr. Early: COST MANAGEMENT Doctor, what impact will the financial management plan have on your institute's ability to mount and fund clinical trials? Dr. Gorden: The plan will have an effect on our clinical trials, since the largest trials are performed through the mechanism of cooperative agreements, in the research project grant mechanism. Many trials have a markedly similar trend in growth from year to year. In the earliest stage of the trial, each participating clinical center must gradually recruit appropriate patients. This may take two years to complete, with a substantial difference in costs from the first to the second year. Later, as the full trial is conducted, the annual cost will be substantially more than at any time during the recruitment phase. Finally, the annual cost drops considerably after completion of the clinical portion, as the data analysis and closure stage of the trial occur. Normally we would anticipate these costs and plan to accommodate them within our budget. However, the financial management plan's cost controls on average grant size growth from year to year mean that the increases needed to accommodate the normal course of a clinical trial will have to be recovered from other research project grants, placing them below the biomedical research deflator price index. Therefore, we will have to make the choice between placing such restraints on research project grants in order to carry out a trial, or extend the time period of the trial, to lower the costs of the experimental stage. CENTERS FUNDING ISSUES Mr. Early: What is the average increase in a center grant under the budget request? Dr. Gorden: The average increase for a center in 1992 will be $21,500. Mr. Early: How was the size of this increase determined? Dr. Gorden: The overall increase for centers was determined after careful consideration of funding in all mechanisms. Our first priority continues to be more adequate support for regular research grants. Small increases are requested for the other mechanisms including centers. Mr. Early: What was the level of downward negotiations in the center program in Fiscal Year 1989 and Fiscal Year 1990? And what is the estimate for Fiscal Year 1991? Dr. Gorden: In 1989, centers were reduced an average of 21 percent, and in 1990, an average of 23 percent. If we had not adjusted the commitments it would have been an average of 30 percent in 1991. Mr. Early: How much would have to be added to your Fiscal Year 1992 request to restore the reductions taken in Fiscal Year 1991? |