Organization of the Clinical Trial by the Sponsor

  • Colin G. Miller


There is a standard set of start-up, ongoing monitoring, and close-out requirements and procedures for all clinical trials. These generic requirements are discussed in other books and are not the remit of this book. However, because of the nature of this therapeutic area, it is important to consider the particular extras and details that have to be evaluated, and this chapter provides an overview of these items. The sponsor needs to be aware of these items in a timely manner — all too often the novice will overlook an important detail until it becomes a critical issue. This chapter will help ensure these kinds of errors are avoided.


Vertebral Deformity Therapeutic Area Core Laboratory Established Osteoporosis Clinical Study Report 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Guidelines for the Pre-clinical and Clinical Evaluation of Agents used in the Prevention or Treatment of Postmenopausal Osteoporosis. FDA, 1994 (
  2. 2.
    Notes for Guidance on Postmenopausal Osteoporosis in Women. CPMP, 2001 (
  3. 3.
    Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis. Geneva: World Health Organization, 1998.Google Scholar
  4. 4.
    Reginster J, Compston J. GREES recommendations for the registration of new drugs in the prevention and treatment of osteoporosis. Calcif Tissue Int 1997; 60: 488.PubMedCrossRefGoogle Scholar
  5. 5.
    Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland 1964 and revised by the 52nd World Medical Assembly, Edinburgh, 2000. (Available at
  6. 6.
    Miller CG, Barden HS. Entrance criteria for clinical trials with DEXA. J Bone Miner Res 1994; 9 (Supplement 1): S209.Google Scholar
  7. 7.
    Looker AC, Wahner HW, Dunn WL et al. Updated data on proximal femur bone mineral levels of US adults. Osteoporos Int 1998; 8: 468–89.PubMedCrossRefGoogle Scholar
  8. 8.
    Faulkner KG, Roberts LA, McClung MR. Discrepancies in normative data between Lunar and Hologic DXA systems. Osteoporos Int 1996; 6: 432–6.PubMedCrossRefGoogle Scholar
  9. 9.
    Chen Z, Maricic M, Lund P, Tesser J, Gluck O. How the new Hologic hip normal reference values affect the densitometric diagnosis of osteoporosis. Osteoporos Int 1998; 8: 423–7.PubMedCrossRefGoogle Scholar
  10. 10.
    International Conference on Harmonisation: Guidance on Statistical Principles for Clinical Trials. Federal Register 1998;63:49583–98. (Available at
  11. 11.
    International Conference on Harmonization: Structure and Content of Clinical Study Reports. Federal Register 1996;61;37320–43. (Available at

Copyright information

© Springer-Verlag London 2002

Authors and Affiliations

  • Colin G. Miller

There are no affiliations available

Personalised recommendations