[The feasibility of randomised controlled trials]

Torkki M, Fredriksson M
Record ID 32000000901
English, Finnish
Original Title: Satunnaistetun hoitotutkimuksen toteutettavuus
Authors' objectives:

Carrying out randomised clinical trials is subject to problems which may bring about difficulties in enrolling the desired number of patients and may cause the trials to drag on. In the worst case, the whole trial may be interrupted. No systematically collected data regarding the risks involved in implementing randomised clinical trials has been published. The aim of this report was to find out how research projects have been realised in practice, what kind of risks are involved and whether the process phases prone to difficulties are the same in different trials.

Authors' results and conclusions: None of the trials faced significant problems in the practical implementation of the interventions. The patients participated in follow-ups and control appointments better than expected. Collecting and processing the research data were also accomplished without problems. The most critical problems in carrying out the trials were related to recruitment: how to find eligible patients. The recruitment rate reached its peak typically within the first six months after the enrolment of patients in the project had started. After reaching its peak, the rate remained at the same level or was reduced. Patients' unwillingness to participate in trials was not the reason for recruitment problems in any of the trials.
Authors' recommendations: A significant difference between the trials was observed in the practical implementation of the study protocol. Three common characteristics of problematical trials were identified: the difference of interventions; the extra burden inflicted through the trial to the surrounding health care system; and the extent of the recruitment area. One should try to estimate the difficulty level of any research project while planning the project. If the interventions differ significantly, extra care should be taken to ensure that the rest of the research protocol is as simple and straightforward as possible.
Authors' methods: Overview
Details
Project Status: Completed
Year Published: 2000
URL for published report: http://urn.fi/URN:NBN:fi-fe201210159435
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Finland
MeSH Terms
  • Patient Selection
  • Randomized Controlled Trials as Topic
  • Research Design
Contact
Organisation Name: Finnish Coordinating Center for Health Technology Assessment
Contact Address: Finnish Office for Health Care Technology Assessment (Finohta)
Contact Name: .
Contact Email: fincchta@ppshp.fi
Copyright: Finnish Office for Health Care Technology Assessment
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.