Overall Goal, And Ethics Of Clinical Trials

Question 1

Overall goals of stats in clinical research (5)

Answer 1

1. Establishing an objective study framework
2. Placing data and theory on an equal scientific footing. Combining using formal methods.
3. Designing data production through experimentation
4. Quantifying the influence of chance
5. Estimating systemic and random effects

Question 2

When is a confirmatory trial appropriate?

Answer 2

When results from another trial are surprising or contradict biological theory.

Question 3

Most expensive and time consuming type of trial?

Answer 3

Prevention trials

Question 4

provide four examples of important medical advances that have been made without the formal methods of controlled clinical trials.

Answer 4

Vitamins, insulin, some antibiotics, and some vaccines.

Question 5

Piantadosi provides five requirements for valid data generated in a non-experimental comparative design trial. What are they?

Answer 5

1 the treatment of interest must occur naturally.
2 the study subjects have to provide valid observations for the biological question
3 the natural history of the disease with standard therapy and in the absence of therapy must be known.
4. the effect of the treatment must be large enough to overshadow random error and bias.
5 evidence of efficacy must be consistent with biological knowledge.

Question 6

In the modern role of scientific investigator a physician has a commitment to two things. What are they?

Answer 6

1. Her patient

2. Promote the acquisition of scientific knowledge

Question 7

What’s the difference between clinical research and clinical practice?

Answer 7

Predictability of the outcome

Question 8

Randomization is justified under what circumstances?

Answer 8

When there is relative collective ignorance about the best treatment. Ie equipoise

Question 9

The use of placebos is unethical when?

Answer 9

When the disease is life-threatening and an effective therapy is available.

Question 10

Alternative to placebo

Answer 10

To use the standard accepted therapy as an active control treatment.

Or

the new therapy can be given in combination with standard therapy

Question 11

ASA and Royal statical society 7 guidelines for conduct for statisticians

Answer 11

1. Maintain professional competence and keep abreast of developments
2. Have constant regard for human rights
3. Present findings and interpretations honestly and objectively.
4. Avoid untrue deceptive or undocumented
5. disclose financial or other interests that may affect or appear to affect professional statements.
6. Seek to advance public knowledge and understanding.
7. Encourage and support fellow members in their professional development.

Question 12

Statisticians should follow 6 guidelines in terms of data collection.

Answer 12

1. Collect only the data needed for the purposes of the inquiry.
2. Inform each participant about the nature and sponsorship of the project and intended uses of the data.
3. Establish the intentions and ability of the sponsor to protect confidentiality.
4. Inform participants of the strengths and limitations of confidentiality protections.
5. Process the data collected according to the intentions and remove participant identifying information.
6. Ensure that confidentiality is maintained when data are transferred to other persons or organizations.