Background
Clinical research provides the evidence base on which we make patient care decisions. So, patients and health care providers expect that a research project will be well designed, well conducted and well reported.
Previous research has already indicated that while there are many similarities between populations there are also a lot of differences. Hence studies of the Malaysian population, by Malaysian doctors, for the treatment of Malaysian people are required.
We cannot simply take research done on an American (study) population and extrapolate it to a Malaysian (target) population.
Both observational and interventional studies contribute to our management of patients. Observational studies are the workhorse of clinical medicine interspersed with a smaller contribution by interventional studies. However, most countries stringently regulate interventional studies but forget about caring for the loyal and trusty workhorse- the observational study.
Clinical research
Clinical research is a professional activity as, usually, a study will not be allowed to proceed without one of the main investigators being in possession of a valid Annual Practicing Certificate from the Medical Council. This is because clinical research can result either in immediate harm to patients participating in an interventional study or later harm to patients being treated using the results of flawed observational and/or interventional studies.
Responsible research institutions are expected to put in place a stringent vetting and “quality control” process to ensure a study is of good quality. These include, but are not limited to:
- rigorous peer review of the study protocol
- medical ethics committee approval
- clinical data management
- a pre-publication peer review (review panel is usually composed of a team of statisticians, methodologists and clinical specialists, among others).
This is to ensure that the study answers clinically important questions and meets quality indicators such as internal validity, precision and generalisability. Also, it ensures that sloppy and/or fabricated data does not enter the clinical database. It also ensures that investigators prepare and submit an error-free high quality manuscript with no unsupported claims to the external journal and peer preview process.
Ensuring quality of research
There is a misconception that the external journal editors and peer reviewers somehow “ensure quality”. There is not so. They are, usually, neither in possession of the data nor do they possess the team of peer-reviewers that the research institution has. They, in most cases, read through to see if the claims contained in the manuscript seem plausible. The quality of research is entirely the responsibility of the research institution and its investigators. The buck stops right there.
Unfortunately, clinical research is a human endeavour. So occasionally, in spite of best practices, errors are spotted post-publication. It is expected that once notified, the clinical investigator (the one with the Annual Practicing Certificate) will ask the institution to re-review his/her paper and submit corrections to the journal for an “Erratum in” notice. If there are substantial quality issues with the paper this will need to be a “Retraction in” notice. This is an “admission of guilt”, of sorts. Most clinical investigators and institutions dread this. But they are obliged to make the corrections. The regulatory watch-dogs are watching.
Conclusion
The above rosy picture of clinical research is pretty much restricted to interventional studies.
Observational studies on the other hand suffer from issues such as poor institutional oversight, poor design, small sample sizes and poor generalisability and there seems to be no one who notices.
May I suggest that Ministry of Health ensure that the same stringent standards are applied to research institutions and clinical investigators whether the study in question is observational or interventional. This will ensure the safety and well being of Malaysian patients.
Dr. Manimalar Selvi Naicker, MBBS, M.Path (Anatomical Pathology), GradDipMedStat.
[This article belongs to The Malaysian Medical Gazette. Any republication (online or offline) without written permission from The Malaysian Medical Gazette is prohibited.]