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Epidemiological studies are either observational or experimental study designs. Innovative designs have been used by experts and researchers. Researchers test the efficacy of their findings on human volunteers, the sample being touted as potential treatment having passed through preclinical phases (Pearce 2012, p. 394). Hip fractures are common in older people, especially 65 years or above. This is because of the reduction in bone density and mass as one grows older. Women are likely to get hip fractures compared to men, probably because of the decrease in estrogen levels. In this case, to determine the efficacy of this drug, a randomized controlled trial would suffice. Drug X is developed to strengthen bones in order to reduce the incidence of hip fractures (Pearce 2012, p. 395).

First of all, there would need to be a research time consisting of clinicians of relevant expertise(orthopedics), researchers with experience in randomized controlled trials, statisticians and investigators who will be in charge of administering the intervention. Two orthopedics, two statisticians, ten investigators, and two researchers who have relevant experience on the methodology of randomized controlled clinical trials are used (McGarry and Kiel 2000, p. 80).

There’s a need to formulate the research question. What impact does drug X has on the strength of bones among the elderly? The impact is measured in terms of bone density, which is a measure of bone strength. The bone mineral density test is thus used to assess efficacy.

Inclusion and Exclusion Criteria. Inclusion criteria involve age requirements. The human volunteers should be 65 years or older. Exclusion is also based on age and the presence of other underlying conditions that might affect the study, such as advanced osteoporosis or even osteoarthritis (McGarry and Kiel 2000, p. 86).

The next step is randomization. Here the human volunteers are selected randomly into two groups. One group of human volunteers will be given drug X, and the other group will be given a placebo during the study to assess the efficacy of drug X. The number of human volunteers required is eighty people who are divided equally without bias into the two groups. Blinding of the human volunteers is important in making sure that the process is void of bias that may arise from external nature. The research time, however, is not blinded during the study for easy identification of human volunteers (McGarry and Kiel 2000, p. 87).

The next step is determining and delivering the intervention. This step involves thorough training of the investigators to make sure that they are well versed with the requirements of the study and that they are aware of what’s expected of them. The timing of the intervention using drug X is touted to be consistently a few minutes after 9 am on the day of the administration. This is for every day of delivering the intervention. Monitoring visits are clearly and specifically and carefully outlined by the investigators upon approval by the doctors and researchers. This also includes a dose adjustment protocol (McGarry and Kiel 2000, p. 88).

The next step involves selecting a control. The control of this study is composed of about forty healthy human volunteers. They are given a placebo during their participation in this study of determining the efficacy of drug X.

The following step in a randomized controlled clinical trial is the determination of the outcome. This is important in the assessment of the efficacy of drug X. As alluded to earlier, the bone mineral density of the human volunteers is measured and recorded. Other outcomes that are not the core of this study are also noted. In this step, the statisticians do a thorough analysis of data and present them for interpretation by experts (McGarry and Kiel 2000, p. 91).

References

Pearce, N., 2012. Classification of epidemiological study designs. International journal of epidemiology, 41(2), pp.393-397.

McGarry, K.A., and Kiel, D.P., 2000. Postmenopausal osteoporosis: strategies for preventing bone loss, avoiding fracture. Postgraduate medicine, 108(3), pp.79-91.