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Unnecessary and deceptive words

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Biostatistics vs trialist

About the Site
About Curtis Meinert
About the Center for Clinical Trials (CCT)
Good Practice Policies & Procedures (GPPP)
- Notation and terminology
- Ethics
- Funding
- Public access
- Sample size
- Bias control
- Variance reduction
- Stratification
- Drug labeling and distribution
- Randomization
- Randomization override
- Masking
- Laboratory, reading, and banking
- Substudy, ancillary study, and auxillary study
- Screening and eligibility
- Enrollment
- Forms design
- Data collection
- Data entry
- Data processing
- Training, certification, quality control, and quality assurance
- IRBs
- Consent/assent
- Adverse event reporting
- Startup
- Followup
- Close-out
- Conflict of interest disclosure and redress
- Treatment effects monitoring
- Treatment effects monitoring committee
- Analysis
- Publication and presentation
- Administration
- Organization
- Operations
- Meetings
- Numbered memos
- Study e-mail
- Record retention and storage
- Generic
Tables 101 Memo Series
- Introduction
- Scaffolding
- Football pass-off protocol
- 39 Steps on how to produce good TEM reports
- Table makers oath
- Table masters oath
- Homework Assignment #1: Review of ADAPT performance table
- Table layout
- Review of ADAPT performance table
- Table and document specification worksheet
- On the remake of the ADAPT table
- Homework Assignment #2: Header construction
- Document masters oath
- Table breaks
- Glossary of terms and definitions
- Cross checking
- Treatment comparisons
- Layout and format recommendations
- Tab setting, tabbing, and indentation
- Table headers
- Master documents
- Reports and manuscripts as master documents
- Targeting and referencing
- Homework Assignment #3: Targeting and referencing
- Standard template settings
- Data cutoffs and freezes
- Indexing
- Homework Assignment #4: Indexing
- Mechanics of production
- Revisions, divisions, transfers, and assimilations
- On creating templates
- Homework Assignment #5: Make a table template
- Wrap-up and final exam
- Final exam key
Presentation and Publication Policy Memo Series
- Memo Series
- Paper Writing 101
  - No nos for draft manuscripts
- Articles
  - Beyond CONSORT: Need for Improved Reporting Standards
Stratification, Subgrouping, and Quotafication Memo Series
- Memo Series
- Gender Bias Articles
  - Gender Representation in Trials
  - Estimation of Gender Bias
Treatment Effects Monitoring
- Clinical Trials and Treatment Effects Monitoring
- Treatment effects monitoring
- Treatment effects monitoring committee
- Objectivity vs Competency in Randomized Trials
- History of treatment effects monitoring
- Selection of committee members: Competency vs Objectivity
- Interaction interfaces
- DSMB: They told me I need a DSMB - What do I do now?
- Data monitoring committees: Things I hate
- DSMBS
- More on DSMBS
Teaching Materials
- Epi 617 slide set
- Organization slide set
- The language of randomized clinical trials
- Reasons to be wary stopping rules
- Nüremberg Code
- Declaration of Helsinki (1964-2008)
- Belmont Report
- Randomized Trials vs Epidemiology?
- The myths of clinical trials
- Design & Conduct of Clinical Trials References and Readings
- On reading the literature of clinical trials
- The hijacking of clinical trials
- The art & science of paper writing in clinical trials
Assessments for Trialists
- General Knowledge Assessment
- Mother Test
- SAT for trialists
- Scholastic Assessment for Trialists (SAT): Answers
IRBs
- IRBs and Randomized Clinical Trials
- When to terminate IRB approvals in trials?
- IRB questions concerning analysis and data sharing
- More about IRB questions concerning analysis and data sharing
- Comments on proposed NIH policy on use of a single IRB for multi-site research
- IRBs, coordinating centers, and multicenter trials
Word Essays
- Introduction
- Usage practices, cautions, and recommendations
- Baseline
- Guinea pig
- Bias
- Placebo
- Random
- Randomization
- Treatment
- Subject
- Pi
- Open
- On study/off study
- Withdrawal
- Treatment failure
- Time window
- Lost to followup
- Missed contact/missed visit
- Troublesome terms and phrases
- CLM's troublesome words
- Fancy terms for old concepts
- On the definition of protocol
- On the definition of clinical trials
- Nil versus negative
- Subject, patient, or participant?
- Arm versus group
- Platform trials
- On the meaning of OK, good, and not too bad
- Platform, basket, and umbrella trials
- Words to avoid
- Unnecessary and deceptive words
Guidelines, Rules, Suggestions and Reminders
- Specimen banking
- On posting study protocols and consent forms to study websites
- Guidelines on maintaining study protocols in trials
- On the morphing of trials to followup studies
- On whether coordinating centers should have names of persons studied
- Page numbering, footers, and tables of contents
- E-mail and trials
- Keeping track of study data in multicenter trials
- In search of the Yellow Brick Road for for coordinating centers
- Coordinating Center takeovers
- My Yellow Brick Road for blackouts/shielding/ firewalls & access to study results
- When is fraud fraud?
- The story of the duplicate LSOCA patient
- Multiple enrollments in trials
- When to terminate IRB approvals in trials?
- On the magic of transforming human subject research data
- Multicenter trials: Consents and coordinating centers
- My rules as a trialist
- On masked data monitoring committees
- Toward a better system of registration?
- Dating
- Page numbering
- On the difference between design variables and outcomes in trials
- On investigator meetings and site visiting in trials
- Things we should know about trials
- Robert’s Rules of Order and clinical trials
- A DSMB manifesto
- On reasons why DSMBs should not be masked
- Data and safety monitoring boards: The downside
- Counting 101
- Counting 102
- Slide rules
- Archiving
- You cannot study those who do not consent!
- Patient, subject, or participant in trials?
Musings & Rants
- Stapling protocol
- Systematic reviews and meta-analyses
- Specimen banking
- A trialist's view of enrollment overrides
- The first design question: Should the trial be multicenter
- An NLM-indexed website for nil and negative results?
- My don'ts as a trialist
- So you want to run a trial, do you?
- A follow-on to So you want to run a trial, do you?
- Nathan R. Jessup as a trialist
- The perception of trialists
- Transparency
- When is a meeting a meeting?
- On why pigs is pigs, data is data
- Lessons from the ADAPT
- Why does it take so long to do trials?
- Superlatives
- I'm an ordinary trialist
- On the meaning of transparency
- Going green?
- Things learned from a half century of trials
- NIH trials as pieces of the NIH pie
- One-sided print
- Endpoint versus outcome?
- You doesn’t hasta use endpoint!
- Draining the swamp?
- Terms I hate
- Joe DiMaggio?
- More Joe DiMaggio?
- The farmer from Sleepy Eye?
- A rose by any other name?
- Unmask and Sleepy Eye
- Contrived names for trials
- The opaque trialist
- Words you should never use when characterizing your trial
- Addendum to "Words you should never use when characterizing your trial"
- Gender composition of trials: Myth versus reality
- Follow-on to my 26 October memo on gender composition of trials
- I'm mad as hell
- Bias is good
- The phases of a trial
- The rule of twos
- My life as a trialist
- On how to succeed in trials without really trying
- My story
- On the meaning of negative in regard to results from trials
- Negative versus nil in regard to results from trials
- Impact of the 1993 NIH Revitalization Act on trials
- My wishes for 2019
- I give up
- I have been wondering
- Truisms from a trialist
- Plagiarism
- trialsmeinertsway.com
- On the time it takes to do trials
- Hand shakes
- The trend in trials
- Reality check
- What drives the clinical trials enterprise?
- Mentoring help
- On what I learned form 60 years of trials
- Getting Schneider
- NIH trials by institute
- We shall overcome
- More on counting
- On why not to publish protocols until trials are done
- More on why not to publish protocols until trials are done
- The best of times, the worst of times
- Turn the TV off
- I have been wondering
- A new name for an old design strategy
- Where have you gone Joe DiMaggio?
- The standard trial
- Noncompletion rates of trials
- The Moderna phase 3 COVID vaccine trial
- More on COVID-19 vaccine trials
- Relative truth
- Posted results
- Why can't editors remember what they learned in grade school?
- Subgroup analysis
- Stepping in it
- Trials 2020
- Keeping track of time in a pandemic
- Times change
- Clinical trials versus meta-analyses
- The Depression Diet
- My new cell phone
- Things I miss
- No longer a dinosaur!
- Q & D analysis of the COVID pandemic impact on trials
- Trials and common sense
- Self-laudatory language
- Apology
- Counting protocols
- How many does it take to write a clinical trials paper?
- Impact of COVID pandemic on trials
- Things learned doing trials
- On bullshit
- Favorite sayings
- Pandemics and trials
- Pop quiz
- Pop quiz answers
- Down homisms
- Bullshit questions
- The impact of the SARS-COVID pandemic on trials
- Relative risks
- What's time to a hog?
- Farm sociology
- Should directors of Coordinating Centers be on DSMBs?
- Gang emails
- Counting pea aphids at Cal Pac
- More counting at Cal Pac
- The rise of the telephone
- Things I miss
- Alumni verification
- Life in a barrel
- Run over
- High Hopes
- Simple things
- School picnics
Opinions
- Registration of meta-analyses and systematic reviews of trials?
- The ICMJE registration requirement for trials
- Looks at pooled interim results
- NIH-funded phase 4 trials
- A disconnect
- Advances in trials
- How we measure distance
- e-mail etiquette and good practice procedures
- Things I hate
- The "standard" trial
- Relative numbers
- COVID vaccine trials
- Real world evidence
- Data and Safety Monitoring Boards (DSMBs)
- What every epidemiology and biostatistics graduate should know about clinical trials
- The life expectancy of a trial
- Turns
- Intention to treat analysis
- Association versus cause
- Start and end dates for trialists
- Clinical trials essentials
- More on essentials to clinical trials
- COVID-19 and trials
- Twenty plus years
- Odds of finishing a trial
- On the risks of researching on human beings
- What we die from versus who we study
- Biostatistics vs trialist
Historical Archive
- Coordinating Center Models Project (CCMP)
- The Trials and Tribulations of the UGDP
- UGDP memorabilia
- FDA Current Drug Information
- The Coronary Drug Project Revisited
- The trials and tribulations of the University Group Diabetes Program: lessons and reflections
- 1 Coronary Drug Project (CDP): Looking Back 50 Years
- 2 The Coronary Drug Project (CDP): Organization and Selected Design Issues
- 3 Contributions of CDP to Methods for Monitoring RCTs
- 4 Post-randomization subgroups: Lessons from the CDP
- 5 Looking Back 50 Years: Contributions of CDP to the Role and Function of CCs
- The trials and tribulations of the University Group Diabetes Program: lessons and reflections.
- National Emphysema Treatment Trial (NETT) Curiculum Vitae
- Tribute: Jerry Stamler (27 October 1919 - 26 January 2022)
Publication
- On publish first, present later
- The posting of results on ClinicalTrials.gov
- Posting results versus publication
- Publication of trials
- Trouble in River City
- On fixing the trouble in River City
- The trialist's oath
- How many people does it take to write a paper?
- Publication types and authorship modes in trials
- Authorship forms in 2016 publications
- Umbrella and trial names
- Publication records: Case studies
- What's the rush?
- So you have results to publish, do you?
- PubMed Central (PMC)
- 2020 NEJM publications
- Masthead listings in trials
2020 NEJM publications
- Clinical trials publications
Data Collection & Sharing
- What General Motors teaches us about data collection
- Data collection mistakes
- Individual patient data sharing
- Data sharing
- Options for data sharing
- Ethics of data sharing
- Sanity and data sharing
- The Fellow Who Did: Fable About Data Sharing
- Estimating costs for public use data deposits
- Estimates of local costs of data sharing
- Worksheet for estimating cost of data deposits
- NIH applications and data sharing
- On re-identification of de-identified data
- Show me your data
Protocol
- Standardize Protocol Items: Recommendations for Interventional Trials (SPIRIT)
  - Response from Dr. An-Wen Chan
  - Protocols
Registration of Clinical Trials
- Clinical trial publication types
- Clinical trials and the NIH
- NIH vs industry trials
- Clinical trials by phase
- Registration of trials
- Are NIH-funded trials fewer but bigger?
- Clinical trials indexes
- Wish list for ClinicalTrials.gov
- My ClinicalTrials.gov wish list
- Industry versus NIH trials
- NIH trials registered on ClinicalTrials.gov
- Trials by NIH agencies
- Editors: ICMJE help please
- Industry versus NIH trials: Mix of trials
- Industry versus NIH drug trials: Sample sizes and times to completion
- Industry versus NIH drug trials: Registration, tabular results, and publictions
- A modest proposal
- A plea to journal editors
- Miss rates for editors and indexers in regard to registration numbers for trials
- Registration uptake
- Fix the trials registration system!
- Please help Dear Lord
- Beating a dead horse
- Registration dates versus start dates on CT.gov
- Clinical trial versus interventional study?
- What's on your list?
Recreational Writing
- Vignettes in life sojourns
- Pernelda Violet Applebee
- Dickie Harris
- Stories & Essays from Klinkapunk
- Sleepy Eye
- Three new ones and one good one!
- Dudley & Dudley
- Push the button Dud

Last Updated: 05 Jun 2023