Commercial clinical drug development requires formulating the clinical development plan, executing the plan, compiling the regulatory dossier, and regulatory review and approval of the dossier. Streamlining the development plan with fewer but larger studies, executing the plan using a trial management organization (TMO) approach, taking a proactive, standardized approach to compiling the regulatory dossier, and requiring total quality may shorten the total time required to approval.
PoweNRKinnisonMLSteinbergEP. Quality assessment of randomized controlled trials of contrast media. Radiology1989;170(2):377–380.
2.
LiberatiAHimelHNChalmersTC. A quality assessment of randomized control trials of primary treatment of breast cancer. J. Clin. Oncol.1986;4(6):942–951.
3.
NorrbyR. Quality of antibiotic clinical trials. J. Antimicrob. Chemother.1984;14(3):205–208.
4.
HunigRLandmannCRothJ. Quality control of radiotherapy in acute lymphocytic leukemia protocol treatment: Experience with 610 cases. Eur. J. Cancer Clin. Oncol.1983;19(11):1585–1591.
5.
GlickmanASReinsteinLEBrotmanRMcShanD. Quality assurance programs in clinical trials. Cancer Treat. Rep.1980;64(2–3):425–433.
6.
KirschTJ. Auditing of clinical research: Internal and external panel discussion. Drug Inf. J.1988;22(2):225–238.
7.
CocchettoDMJohnsonJRWernerK. Accuracy of data collection in a clinical trial with guidelines for case report auditing. J. Clin. Res. Drug Dev.1987;1:187–196.
8.
OttTJHerczegSACampbellRK. Clinical quality assurance. Drug Inf. J.1986;20(2):195–198.
9.
CooperGR. The importance of quality control in the multiple risk factor intervention trial. Controlled Clin. Trials1986;7(3 Suppl):3–15.
10.
AntczakAATangJChalmersTC. Quality assessment of randomized control trials in dental research. I. Methods. J. Periodont. Res.1986;21(4):305–314.
11.
AntczakAATangJChalmersTC. Quality assessment of randomized control trials in dental research. II. Results: Periodontal research. J. Periodont. Res.1986;21(4):315–321.
12.
Symposium on methodology and quality assurance in cancer clinical trials. Washington DC, Oct 24–26 1984. Cancer Treat. Rep.1985;69(10): 1039–1229.
13.
PeaceKE. Design, monitoring and analysis issues relative to adverse events. Drug Inf. J.1987;21(1):21–28.
14.
deMaarEW. Global core clinical protocol and its rational adaptations. Drug Inf J.1986;20(3):257–261.
15.
An international trial of antihypertensive therapy in elderly patients.Objectives, protocol and organization. European working party on high blood pressure in the elderly (EWPHE). Arch. Int. Pharmacodyn. Ther.1985;275 (2):300–334.
16.
DicksonBDixonWPeaceKEPuttermanKYoungMD. Cimetidine single-dose active duodenal ulcer protocol design. Postgrad Med.1985.
17.
GriggW. Kelsey's Kops: They investigate the investigators. FDA Consum.1981;15:23–25.
18.
HemminkiE. Problems of clinical trials as evidence of therapeutic effectiveness. Soc. Sci. Med.1982;16(6):711–712.
19.
Organization, review, and administration of co-operative studies (Greenberg Report): A report form the heart special project committee to the national advisory heart council, May 1967. Controlled Clin. Trials1988;9(2):137–148.
20.
DunbarJMcKeownMB. Organization and management of recruitment. Circulation1982;66(6.2):IV49–53.
21.
KirschTMHildebrandMBegMFoxMJ. Ancillary data management. Drug Inf. J.1988;22(1):99–101.
22.
SummerfeltAFunderburkFR. Implementation of clinical trials: Simple, but not easy. Drug Inf. J.1987;21(2):159–164.
23.
StewartPE. Comparative clinical trials: Role of a drug company's medical division. Drug Inf. J.1983;17(2):67–72.
24.
ChanYKArchibaldDDPeduzziPN. Management of a multicenter clinical trial. Trends Pharmacol. Sci.1983;4:21–24.
25.
IlberyPLT. Clinical trial structure and design. J. Hosp. Pharm.1981;11:9–17.
26.
KirshTJ. Sponsor education of clinical investigators in the clinical research process. Drug Inf. J.1988;22(2):181–186.
27.
HonohanT. Practical problems in the conduct of non-US studies from which data will be used for registration. Drug Inf. J.1988;22(2):193–197.
28.
KirschTJ. Interrelationships of sponsors, clinical investigators, and institutional review boards. Drug Inf. J.1987;21(2):127–31.
29.
PeaceKE. A two-day workshop on statistical aspects of clinical research. Harrison Conference Center. Lake Bluff, IL; Dec 1983.
30.
WilkeMG. New concept in clinical monitoring. Drug Inf. J.1983;17(2):113–115.
31.
StoweSMHammondGDChardRHornbergerJANonourRCSpostoRWeinerJM. Monitoring clinical research. A. report from the childrens cancer study group. Am. J. Clin. Oncol.1984;7(5):557–566.
32.
FisherLDGillespieMJJonesMMcBrideR. Design of clinical database management systems and associated software to facilitate medical statistical research. Crit. Rev. Med. Inform.1988;1(4):323–331.
33.
van der PuttenEvan der VeldenJWSiersAHamersmaEA. A pilot study on the quality of data management in a cancer clinical trial. Controlled Clin. Trials1987;8(2):96–100.
34.
JovalJJKwarciakLMGraceMGLockwoodBJ. A comprehensive database management system for a variety of clinical trials. Methods Inf. Med.1987;26(1):24–30.
35.
SteinIMSloanCKingCShattuckEDoxtaderD. Computerized management of clinical trials and patient data: Clinical Data Manager. Clin. Res. Pract. Drug Regul. Aff.1987;5(4):203–230.
36.
SaltzmanAM. MIS system for worldwide acquistion of remote clinical information. Drug Inf. J.1987;21(3):335–352.
37.
D'AmbrosioA. Interactive clinical monitoring system. Drug Inf. J.1986;20(3):275–278.
38.
GomeniRLaYNIssakidesNDe RotrouMA. Clinic/3000: New approach for clinical database implementation and management. Drug Inf. J.1986;20(2):237–253.
39.
AverkinGBeaverBM. Quality assurance in clinical data management. Drug Inf. J.1984;18(1):76–79.
40.
SchwartzSGeorgeROwensJEdsonJ. Clinical data base management system. Drug Inf. J.1984;18(1):33–42.
41.
TealTKopkoSJ. Clinical data processing — management perspective. Drug Inf. J.1984;18(1):71–79.
42.
BerndCL. Clinical case report forms design-key to clinical trial success. Drug Inf. J.1984;18(1):3–8.
43.
PeaceKE. Biopharmaceutical statistics for drug development. New York: Marcel Dekker; 1988:01–640.
44.
PeaceKE. Statistical issue in drug research and development. New York: Marcel Dekker; 1989.
45.
LanKKWittesJ. The B-value: A tool for monitoring data. Biometrics1988;44(2):579–585.
46.
GoldmanAI. Issues in designing sequential stopping rules for monitoring side effects in clinical trials. Controlled Clin. Trials1987;8(4):327–337.
47.
DemetsDL. Practical aspects in data monitoring: A brief review. Stat. Med.1987;6(7):753–760.
48.
GreenSJFlemingTRO'FallonJr.. Policies for study monitoring and interim reporting of results. J. Clin. Oncol.1987;5(9):1477–1484.
49.
ZelenM. Early stopping, interim analyses, and monitoring committees: What are the tradeoffs?. J. Clin. Oncol.1987;5(9):1314–1315.
50.
PocockSJHughesMDLeeRJ. Statistical problems in the reporting of clinical trials: Survey of three medical journals. N. Engl. J. Med.1987;317:426–432.
51.
PeaceKESchriverRC. p-value and power computations in multiple look trials. J. Chron. Dis.1987;40(1):23–30.
52.
LeeYJ. Phase II trials in cancer: Present status and analysis methods. Drugs Exp. Clinc. Res.1986;12(1–3):57–61.
53.
PolkREHeplerCD. Controversies in antimicrobial therapy: Critical analysis of clinical trials. Am. J. Hosp. Pharm.1986;43:630–640.
54.
BlandJMJonesDRBennettSCookDGMacFarlaneAJ. Is the clinical trial evidence about new drugs statistically adequate?. Br. J. Clin. Pharmacol.1985;19:155–160.
55.
O'NeillRT. Statistical considerations in geriatric drug testing. Drug. Inf. J.1985;19(4):453–458.
56.
FrancisK. Sample size determination: Power in research. Trends Pharmacol. Sci.1985;6:350–352.
57.
PeaceKEDicksonBDixonWPuttermanKYoungMD. A single nocturnal dose of cimetidine in active duodenal ulcer: Statistical considerations in the design, analysis and interpretation of a clinical trial. Post Grad. Med.1985.
58.
KochGGSollecitoWA. Statistical considerations in the design, analysis, and interpretation of comparative clinical studies. Drug Inf. J.1984;18(20):131–151.
59.
AnelloC. Statistical issues of comparative trials. Drug Inf. J.1983;17(2):55–62.
60.
AnelloCFairweatherWR. Statistical principals in the regulatory process. Pharm. Tech.1981;5:90–97.
61.
JacobsenBSMeiningerJC. Randomized experiments in nursing: The quality of reporting. Nurs. Res.1986;35(6):379–382.
62.
HerbalES. Integrated clinical research support. Drug Inf. J.1984;18(1):89–94.
63.
FletcherRHHorwitzRKInuiTSKaneRWilliamsSV. Clinical research methods: Annotated bibliography. Ann. Intern. Med.1983;99:419–424.
64.
DerSimonianRCharetteLJMcPeekBMostellerF. Reporting on methods in clinical trials. N. Engl. J. Med.1982;306:1332–1337.
65.
Guideline for the format and content of the clinical and statistical sections of an application. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services; May 1988:i–ix, 1–125.
66.
NeherGH. Finding and evaluating CROs. Drug Inf J.1988;22(2):199–201.
67.
ValenzuelaJDicksonBDixonWPeaceKEPuttermanKYoungMD. Efficacy of a single nocturnal dose of cimetidine in active duodenal ulcer. Postgrad Med.1985.
