It is part of it as it shows why the research should be carried out or the motivation for the research

Thank you Oluwafemi Samson Balogun

Its quite good not to state " Problem statement is the heart of a research " in a flat-out but problem statement is the fundamental part of any research work where some times introduction, gap, problem statement or discussion can be the heart of respective study.

Best

Rahaman, M.S

Problem statement is cardinal in research. It makes the reason for research known. At a glance of problem statement, research's contribution to knowledge and the knowledge gap that research findings will close can be conceived.

Statement of problem is a pointer to the specific area of focus in research. It is major goal drive towards making concrete contribution to knowledge in the research work.

Thank you Nyakno jimmy George, Joseph Isabona and Rahaman for your observations....

Thank you Nyakno jimmy George, Joseph Isabona and Rahaman for your observations....

Hi Mohammad. The problem statement is a vital first step to any research project which sets the direction the research planning, methodology, and overall implementation should go. It identifies the gap which the research hopes to fill in or at least, provide a lead for other researches to follow through. In that regard the problem must be a SMART one— Specific, Measurable,Actionsble, Relevant and Time-bound.

Definitely, the problem statement is the heart of the research. From the PS we go for the objectives. Why it is heart? because we are going to solve the problem. if we do not have the problem, there is no need to research. The problem statement fulfill the theoretical gap, industrial or practical gap and literature gap. So, from the problem we can come out with a solutions. So, conceptually and literally we can say it is the heart of the research.

Thank you Rafael R. Castillo and Alam for such your valuable observations....

In the old days, namely until 2002, the highest documents in European regulatory submission dossiers, namely the "Clinical Expert Report" or the "Nonclinical Expert Report" had to have such section at the beginning, named "Problem statement". With the ICH CTD rules (2002) this was skipped and replaced simply by "Introduction".

Actual clinical trial protocols did almost never have a section named "problem statement".

Having said this, it is certainly self-evident that the authors of any research plan should state the problem the study is related to.

As far as clinical research is meant, I would add that it is very helpful to state a "clinical hypothesis", saying what you expect from Treatment A and Treatment B and with the comparison. However, I very rarely read such statements. Unfortunately, as afterwards it is often difficult to recall why the investigators actually did it in this way and not in that way and maybe why did they do it at all...

In clinical research it is a must that the protocol states crystal clear "objectives", often referred to as "primary objective" and "secondary objectives", some now write "primary and secondary endpoints", but these terms might not be the same.

In controlled clinical trials you, but usually the statistician then formulates an actual hypothesis (to be tested statistically). This hypothesis is certainly bound to the definition of a primary endpoint or, as I prefer, a primary variable, and a specific test procedure.

In preclinical research, these formalisms might not so often be followed. But it would be better to do so.

Otherwise you are more likely to run into the risk that your paper is thrown into the ocean of irreproducible research or even once into the arctic sea of retracted research. Maybe, these formalisms will be at the price of a lowered chance to get a "significant" p-value, and in turn a higher risk for no research article published, at least as far as nonclinicl research is concerned.