Page 17 - Recommendations-for-biostatisticians-in-managing-and-conducting-medical-research-consultations

previously-published studies that seem to be very similar to the proposed study (in their
research designs and scopes of research area). Say, for example, a research client aims to
determine the effectiveness of a new intervention for reducing weight. However, if the
research client has claimed that an appropriate study design for evaluating the
effectiveness of the new intervention might not be available yet; then he/she can begin by
reviewing all the relevant literature regarding the evaluation of effectiveness of any
interventions for weight reduction.

Although the intervention mentioned in the existing literature is not the same as that in
the proposed research, it is however still beneficial to review the all the relevant literature
with regard to the previous study designs of research that aimed to examine any
interventions for weight reduction. This is because the research client will already have a
reference base on which he/she can draw, and therefore he/she will not have to start
everything from scratch.

Similarly, for observational studies, those previous studies with almost the same study
objectives or hypotheses can often serve as a reference base on which an ideal study design
for a pioneering new type of study can be drawn. In addition, it will also be helpful for a
biostatistician to first get a glimpse of all the relevant information by conducting a
preliminary review of the literature, which can enable him/her to propose an appropriate
study design (and also to tailor a research methodology for addressing all the research
objectives) in the new research proposal.

If, however, there are no similar previously-published studies found in the newly
proposed research area, then both the research client and the biostatistician will find
themselves to be in a more challenging situation. In this case, both of them will share the
same concern of whether (or not) the planned study will actually be feasible. Both will also
be wondering why the other researchers have never explored the same research topic. This
means that both will have to seriously consider one of the following three possibilities. The
first possibility will be the study is truly pioneering a new branch of study which is also
scientifically relevant; the second possibility will be that even though the study is
scientifically relevant, it may not be feasible; and the third possibility will be the study is
not scientifically relevant (regardless of whether it is feasible or not).

In order to decide whether the study is feasible or not, it may be necessary for the
subject matter expert in the relevant medical field to first review the research topic
and also the scope of proposed study. If the subject matter experts have found that
the research topic is truly pioneering a new branch of study and also its proposed
scope of study has scientific merit (and is therefore scientifically relevant), then it
will be challenging for the biostatistician to conduct a biostatistical consultation
(since there is no reference base on which an ideal research design for a pioneering
new type of study can be drawn). Hence, it may become necessary for a
biostatistician to seek for a second opinion from other subject matter experts in the
relevant medical field (for selecting an ideal research design for a pioneering new