Secondary endpoint
In clinical studies, the secondary (secondary) goal of the study is referred to as the secondary endpoint ( Latin secundus = "the second") .
In the study, the extent of these specified criteria in the treated group is compared with the extent of the criteria in a control group. The secondary endpoints, like all other endpoints, must be determined before starting the study.
O'Neill defines the secondary endpoint as:
"additional clinical characterization of a treatment, which, however, on its own does not constitute evidence of a clinically significant treatment effect."
" Additional clinical characterization of a treatment but could not, by itself, be convincing of a clinically significant treatment effect. ”
The results of the primary and secondary endpoints are generally closely related. In most cases, the results of the secondary endpoints are directly related to the primary endpoints.
If the primary endpoint of a study does not show clear statistical significance , the secondary endpoints cannot be validly analyzed.
The secondary endpoints are intended to be supportive of the primary endpoints, especially if the primary endpoints are subjective (soft). Multiple secondary endpoints produce more trustworthy results.
Examples of secondary endpoints
The secondary endpoints chosen for a study are strongly dependent on the study objective and the disease being treated. In contrast to the primary endpoints, soft, that is, non-measurable, criteria are often specified for the secondary endpoints. Examples of typical secondary endpoints from studies are pain and patient quality of life . The safety endpoints “tolerability” and “safety of therapy” are also often defined as secondary endpoints.
Tertiary endpoints
Tertiary endpoints are also more rarely defined in studies . This is the case, for example, if one expects further positive "side effects" from the drug administered. For example, in the ASCOT study in high blood pressure patients, the “new manifestation of diabetes” was set as the tertiary endpoint.
See also
literature
- R. Temple: Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials. In: Am Heart J . 139/2000, pp. 133-135.
- KD Weiss, JP Siegel: Issues in Endpoint Selection. In: Clinical Drug Trials and Tribulations. Marcel Dekker, New York 2002.
- PM Palevsky: Selection of endpoints for clinical trials of acute renal failure in critically ill patients. In: Current Opinion in Critical Care. 8/2002, pp. 515-518.
Individual evidence
- ^ M. Conaway: Endpoints in clinical studies. May 12, 2006.
- ^ A b R. T. O'Neill: Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance. In: Control Clin Trials . 18/1997, pp. 550-556, doi : 10.1016 / S0197-2456 (97) 00075-5 .
- ^ WW Bryan: Regulatory Issues in SMA Clinical Trials. ( Page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. (PDF) In: SMA Summit on Drug Development. September 29, 2007.
- ↑ Jackson SY Wu, Andrea Bezjak, Edward Chow, Paul. Kirkbride: Primary Treatment Endpoint following Palliative Radiotherapy for Painful Bone Metastases: Need for a Consensus Definition? In: Clinical Oncology . tape 14 , no. 1 . Elsevier, February 2002, p. 70-77 , doi : 10.1053 / clon.2001.0012 (English).
- ↑ The ASCOT-BPLA Study Results: A Big Step Forward in Cardiovascular Event Prophylaxis in Hypertensive Patients. ( Page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. on: presseportal.ch , September 4, 2005.
