Reporting and dissemination

Question 1

What is a statistical analysis report? what does it include?

Answer 1

A document provided by statisticians with the results of the analyses specified in the SAP

need to specify
* any deviations from the SAP
* additional analyses not specified in the SAP

Question 2

when is a clinical study report important?

Answer 2

important document in the drug development and regulatory submission process

especially important for drug marketting applications

regardless of whether the trial is completed or the study is terminated prematurely the slinical trial report should be provided to the regulatory agencies

Question 3

what is a clinical study report

Answer 3

• a detailed description about the trial design, methods,, results and conclusions
• guildlines on this provided by ICH
• many organisations will have there own template

Question 4

what is the EudraCT?

Answer 4

European clincal trials database

Question 5

do sponsors need to post the results of clincal trials in the EudraCT?

Answer 5

Yes, this is now mandaroty

important to provide transparancy of medical products in the EU

Question 6

what are EQUATOR reporting guidlines?

Answer 6

The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that promotes the use of reporting guidelines to improve the accuracy, completeness, and transparency of research publications

different reporting guidlines prodided for different types of studies including:

> CONSORT (Consolidated Standards of Reporting Trials) for randomized controlled trials
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) for observational studies
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) for systematic reviews and meta-analyses
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) for clinical trial protocols

Question 7

CONSORT reporting guidlines

Answer 7

• research on humans, quantitative results, analysis ocmbined with results of previous stieies and a randomised trial

Question 8

CONSORT reporting guidlines

Answer 8

• research on humans, quantitative results, analysis ocmbined with results of previous stieies and a randomised trial

Question 9

Example guidlines for reporting results?

Answer 9

> Sequence generation
8a method used to generate sequence generation
8b Type of randomisation, details of any restriction such as
blocking and block size
Allocation concealment
9. Mechanism used to implement random allocation sequence
Implementation
10. Who generated the random allocation, who enrolled
participants, who assigned participants to interventions
Blinding
11a. If done, who was blinded after assignment to
interventions
11b. If relevant, similarity of interventions

Question 10

for primary and secondary outcomes what should be reported?

Answer 10

effect size along with its precision (CI)

Question 11

for binary outcomes what should be reported?

Answer 11

Both the absolute and relative effect sizes

Question 12

what is a way to minimise publication bias and selective reporting?

Answer 12

Register trials in clinical trial registries

Question 13

how does submitting trials in trial registries combat bias reporting?

Answer 13

> registering a trial on a publis database
requires n to provide detailed desctiption about the design, methodology and outcomes that will be measured
prevents selective rporting - n outline the outcomes they specified before hand, not new ones or just the significant ones

Question 14

strategires minimising bias in reporting

Answer 14

• Trial Registries
• Submission of protocol, statistical analysis plan
  along with manuscript
• Reporting guidelines (e.g. CONSORT)