A pilot or feasibility study is typically a small-scale study that is used to test both the practical running of a trial and the statistical design. One key role of a pilot study is in helping to address issues of uncertainty in the main trial design. For example, one objective might be to gain initial estimates for sample size calculation for the main trial that will allow the latter to be sufficiently powered.
Pilot and Feasibility Studies is an open access, peer-reviewed, online journal that encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. By taking a scientific approach to the conduct of pilot and feasibility studies, and by publishing the findings, a more complete evidence-base is created.
Until the launch of this journal, there was no dedicated place for the publication of pilot and feasibility work. It is well known that these kinds of studies suffer from publication bias; the vast majority of pilot and feasibility studies do not get published, only a small minority do.
Those that are published are found across a wide range of subject-specific journals; journals that researchers from outside the subject area are unlikely to read. This confounds the sharing of new methods knowledge. Having them all in one place facilitates learning and sharing of new knowledge across disciplines, and plays an important role in the advancement of further biomedical research.
Publication also allows other researchers to identify what other pilot and feasibility work is ongoing, facilitating collaboration between those with similar interests who may share a common goal.
The journal publishes research articles that are intended to directly influence future clinical trials, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings.
"Pilot and feasibility studies encompass all aspects of the design process, and whilst this work is crucial to the success of a trial such studies seldom reach publication for a variety of reasons. Having an open access journal dedicated to supporting this type of work is long overdue," added Dr Lancaster.