FIRE – An academic initiative by Ferozesons
Prof.Adeel Ajwad Butt discusses essential components
of a research study, attributes of a good paper
ISLAMABAD: One of the industry sponsored sessions during the recently held International Medical Conference of Pakistan Society of Internal Medicine (PSIM) by Ferozesons was on “Navigating the Research Landscape Methodology for Healthcare Professionals”. Prof. Adeel Ajwad Butt from United States was the facilitator. The project is named as FIRE- Ferozesons Initiative for Research Excellence. In collaboration with Lahore University of Management Sciences, they plan to organize some training courses on research. Ferozesons is reported to have provided some Endowment Funds for this project.
Prof. Adeel But in his presentation first described the essential components of a research project and referred to Research Plan details, discussed different types of studies and how to execute them. He also referred to attributes of a good paper. During this session, he stated, there will be focus on clinical research. He advised for thorough literature search, talking to the mentors, colleagues, potential collaborators. One should always think about your patient, look at current and recent work by visiting PubMed and other sources. All studies particularly clinical trials, he emphasized must be registered and ClinicalTrials.Gov is one such registry. There are many other registries as well and one can get the trial registered on any one of them. One can get lot of ideas by attending society meetings, looking at abstract books, there are numerous funding sites available.
He emphasized the importance of thinking about the relevance of the project and then think about the availability of the resources time, logistics and potential collaborators. Getting templates or copies of reviewed projects will help and guide you. He then described the Six Steps approach. The first one is ask a clinically relevant question. Do thorough literature search, Develop specific aim, Structural analysis, Think of regulatory reporting requirements i.e. Ethics Committee/Institutional Review Boards approval of the research project. One can look at prevention of diseases, accuracy of diagnosis, incidence, risk factors, prognosis, treatment efficacy, effective impact on outcome, cause of disease, prevention, screening and cost benefit, cost effectiveness.
The six Ds for outcome he said includes Death, Disease, Discomfort, and Disability which are important components of research. One has to look at the personnel, budget and research plan, resources, environment. One also has to think of human subject’s protection, supplementary material and bibliography. One should remember that the reviewers of the research projects may not be subject experts. Any research must address novel aspects. What different it is going to make. Early data is very helpful as it generates questions. There are various ingredients of successful hypothesis. In Pakistan, the clinical trial site may have to be inspected by Drug Regulatory Authority of Pakistan (DRAP) before you start conducting research. Pilot studies can be full studies and it can be published. One must focus on achievable aims which can be performed.
Containing Prof Adeel Butt remarked that one should identify alternate approaches. How the data will be collected? Think of logistics. Team must have enough expertize and time. Statistical analysis has to be undertaken. For determining sample size for the study there are various formulas and they are also freely available on the net. Limitations and Risks should be considered. Larger the sample size, more accurate findings of the study will be. Clinical relevance and statistical significance are two different things. In case the sample size is too small, true effect may not be found. Think of expected drop outs from the study which could be from 10-15%. Sample size will depend on the study design. He also emphasized the importance of developing local Guidelines for the management of various diseases.
Prof. Zaman Sheikh who was chairing the session in his concluding remarks said that now research is essential for healthcare professionals and faculty members in particular. The clinicians are too busy but they must take out some time for research and we need to promote research culture in the country.
Participating in the discussion Prof. Javed Akram said that unfortunately there is no biotechnology plant in Pakistan with the result that many of our patents cannot be used for commercial production. Our research is of no benefit to the society until and unless we produce these drugs locally which are cost effective. Clinical Research Organizations now do provide lot of help and assistance for research but it involves funding. Research has to be a passion and only then one will enjoy it, he remarked.
