1. INTRODUCTION TO BIOMEDICAL AND CLINICAL RESEARCH
Overviews on how to design an experiment collect data and use an appropriate statistical method for analysis.
Research in clinical pharmacy
Clinical trials.

2. Defination
Research is the system collection, analysis, and interpretation of data to answer a certain question or solve a problem.
Biomedical research refers to health-related research.
Health is a state of complete physical, mental and social wellbeing and not just the absence of disease or infirmity
Health related researches are geared towards promoting and protecting wellbeing so as to attain and sustain an optimal quality of life

3. It also relates to preventing disease at all levels (three levels)
At primary level: That is to prevent the occurrence of disease among the healthy population through health promotion and specific protection
Secondary level: this type of prevention is to institute efforts to make an early and correct diagnosis and to ensure appropriate and prompt treatment
Tertiary level: It involves limitation of disabilities and appropriate rehabilitation of the affected persons

4. Characteristics of Research
It demands a clear statement of the problem and a purpose
It requires a plan so that a researcher is not aimlessly “looking” for something in the hope that a solution would be found.
This plan is the study design, which will be specified in a proposal prior to implementation of the research
It builds on existing data using both positive and negative findings
New data is collected as required and organized in such a way that they answer the original research question.

5. Types of Research
There are two main types of research
Basic research
Applied research

6. Basic research:
It generates knowledge and technologies to deal with
major unresolved problem.
It provides information required for planning health care and monitoring trends among others.

7. Examples:
Identifying the factors that influence a certain behavior.
Determine the cause or risk factors of a disease by comparing the presence/absence of specified factors among people with/without the disease so as to determine any association between the factors and the disease.
Comparing treatment regimens such as 8 months versus 6 month therapy for tuberculosis

8. Applied Research
This identifies priority problems, designs and evaluates policies and programmes that will deliver the greater benefits using optimally the available resources.

9. Stages in research
Developing a project title
Formulating the statement of the problem
Literature review
Formulation of research objectives
Hypothesis
Selecting a research method
Data collection
Data processing and analysis plan
Dissemination

10. Developing a project title
The title should reflect as precisely as possible the specific focus and scope of the project.
Formulating the statement of the problem
There should be a clear statement of the research problem. A statement makes it easier to find information on similar studies, which will contribute to the research design.
Literature review
Relevant literature on the topic should be studied to know what information is already available. This helps us know what others have learnt and reported on the problem. It also prevents the duplication of work already done.

11. Formulation of research objectives (what does the researcher wish to achieve).
In an intervention project, it is the overall impact the project is expected to have on the target population.
Objectives are activity-related statements leading to the achievement of the aims. Good objectives must be SMART. It should be (specific, measurable, achievable, realistic, and time-bound).
Hypothesis
An hypothesis is a prediction of a relationship between one or more factors and the problem under study.

12. Selecting a research method
In selecting a research method a decision should be made for the study to be either quantitative or qualitative or a combination of both.
For quantitative studies: primary data will be collected from (observational studies or experiment)
or from secondary data (pre-existing records). It could also be from both.

13. Selection of subjects
Decisions have to be made on who the study
population should comprise of.
Will the study cover the whole population or a sample?
If it’s a sample population, what is the sample size?
What sampling technique will be used for subject selection?

14. Data collection
Qualitative methods: This includes participant observation e.g. Unstructured interviews, focus group discussions, etc.
Quantitative methods: This includes structured and semi-structured interviews, self-administered questionnaire, telephone interview, others.

15. Data processing and analysis
Decisions should be taken about method of data processing.
Coding instructions should be prepared.
Decisions must also be taken concerning the programme that will be used. (e.g. EPI-INFO, SPSS etc.).

16. Types of Research Methods
1. Epidemiological studies
Epidemiological study designs seem to be the foundation for research in health sciences.
This type of study could be observational or experimental.
It may involve distribution of diseases or health-related characteristics in groups (descriptive surveys) or it could deal with the factors influencing this distribution (analytical surveys, experiments)

17. 2. Observational studies
In observational studies, the researcher collects information on the attributes or measurements of interest, but the experimental method is not used.
That is, there is no active intervention by the investigator. Observational studies can be sub-divided into descriptive or analytical study.

18. 1.DESCRIPTIVE STUDIES
Descriptive studies include case reports and case series reports, cross sectional or longitudinal surveys, surveillance, and screening.
A descriptive epidemiological studies are observational studies which studies the amount (frequency) and distribution (by person place and time) of disease or events within a population.

19. Case-report: A clinical case report is a descriptive epidemiological study, which reports an unusual disease (e.g. mode of presentation) or association. While an aggregate of individual cases is id to constitute case series report).
Cross sectional studies
A descriptive cross-sectional study sets out to describe a situation. E.g. The distribution of an event in a population in relation to age, sex and other specific characteristics.
Longitudinal study
Longitudinal (time-span) surveys provide data about events or changes during a period of time. Example a 5-yearly monitoring of trends of substance use among secondary school students in Bornu, Nigeria,

20. ANALYTICAL EPIDEMIOLOGY
This is an observational study that has control or comparison group(s). This includes case-control and cohort studies. These studies would investigate causal factors. They are stronger than cross-sectional studies in establishing associations.
Case –control
This is an observational study used to test hypothesis on association between suspected etiological factors and occurrence of a disease. It is a retrospective study.
Cohort study
A cohort is a group of individuals who share a common experience within a defined time period. It also tests hypothesis on suspected aetiological factors and disease occurrence. This is a prospective study design, in which the investigator compares the occurrence of disease in the group of individuals exposed to the suspected risk factor with another group of individual who are not exposed. E.g graded smokers.

21. EXPERIMENTAL STUDIES
A controlled project to establish a hypothesis or illustrate a known or unknown law is an experiment.
In experimental studies the investigator wishing to study the effects of exposure to or deprivation of a defined factor would select study units according to stated criteria.
Informed consent is then obtained.
Then subjects (persons, animals, or towns ) would be selected at by randomization. It is called a controlled experiment

22. CLINICAL TRIALS
A clinical trial appraises the worth of a form of care- preventive, curative, educational, etc.
The evaluation of new drugs or of new medical or surgical procedures involves comparison of two series of observation.
One series is obtained with the use of the new drug procedure, the other is a control series that is obtained without its use, though the use of some standard therapeutic agent.

23. Randomization
Subjects would be allocated into groups by randomization.
Randomization means that subjects are allocated to the treatment and control groups by chance.
The assignment follows a predetermined plan that is usually devised with the aid of a table of random numbers

24. Cross-over designs
These are used in paired samples, as a self-pairing technique. With two drugs A and B, it means random assignment to receive the drugs in the order AB or BA.
This is also applicable in field trials such as comparison of validity or reliability of methods of data collection,

25. Stratified randomization
This is intermediate between paired and independent sample designs.
Stratification could be performed by various characteristics (e.g. age, sex, presence/ absence of other conditions) before randomization. Within each stratum randomization into treatment or control group is performed.

26. Matching
Matching of the study and control subjects by certain criteria could also be performed. In this case, the investigator forms matched pairs of subjects, and assign the two members of the pair at random to each of the treatment and control groups.

27. Blinding
Blinding is done to eliminate biases and prejudice of the patient or of both the patient and physician.
Single- blind, double blind, or triple blind trials could be designed.
In the single blind, the subjects do not know which group they have been assigned to – treatment or placebo, or treatment A or treatment B.

28. In the double blind trial, both the subject and the investigator do not know who is in what group.
In the triple blind, the situation is the same as with double blind but in addition, there is a blind data analysis.

29. Retrospective cohort study
In some cohort studies, participants are not followed from current time into the future, but from sometime in the past to a later time.
These are known as retrospective cohort studies, and are almost always based on records; such as hospital records, employment records, and military service records.

30. Was there active intervention
Did investigator assign exposure
Yes No
Observational Study
Experimental Study
  Random allocation
Any control group? No
Yes No
Non-Randomized controlled trial
Yes
Analytical Study
Descriptive Study
Randomized controlled trial
Case report.
Cross Sectional.
Ecological Study.
Direction exposure to outcome outcome to exposure
Cohort Study
Case control study

31. Thank you for Listening