Download Instructions for Assignment SDM 2014 File

Assignment Drug Development Statistics & Data Management
The final assignment accounts for 75% of the final grade (25% is accounted for
by the exam).
During the fourth day of the module, the students started working on their
assignment, by developing an idea for a study design, and finding two published
articles related to the topic with the objective of analyzing and criticizing the
study methods. For the written assignment, the students should elaborate on this
work by:
1) Choosing one of the two articles to analyse and criticize the research
design and statistical analysis. There should first be an introduction to the
study, including at least, hypothesis, variables, study design, power
calculations and statistical analysis. Subsequently, the students should
analyze the positive and negative aspects of the choices made by the
researchers in the study, providing a clear explanation for each of the points
made. Whenever a negative point is identified, the student should explain
what would have been a better choice. Finally discuss whether the
conclusions on the paper are well justified given the chosen design, statistical
analysis and results.
The word limit for section 1 is 1,000 words (excluding tables or figures).
2) Developing a research study protocol for a new study: Departing from the
study design developed during the module, students should provide more
details and justification for each of the methodological choices.
Following SPIRIT 1, include:
Title (1)
Introduction:
Background and Rationale (6a) –Very briefObjectives (7)
Trial Design (8)
Methods:
Eligibility Criteria (10)
Interventions (11a)
Outcomes (12)
Sample Size (14)
Blinding (17a)
Statistical Methods (20a,b,c)
Conclusions
An-Wen Chan et al., “SPIRIT 2013 Explanation and Elaboration: Guidance
for
Protocols of Clinical Trials,” Bmj 346 (2013), doi:10.1136/bmj.e7586.
1
The word limit for section 2 is 2,000 words (excluding tables, figures or
references).
Please, abide to the word limit. Violations of the word limit of more than 10%
will be penalized with the number of points equivalent to the percentage of
increase, i.e. if you use 20% more words than specified, 20 points will be
subtracted from your final mark.