The Devil's Drug Development Dictionaries

The definitions here are all original and were coined by me at the Elixir Laboratories of Panacea Pharmaceuticals. They seem to have spread rather like a virus and now often appear unattributed elsewhere. If you do quote them I would appreciate your giving, me, Guernsey McPearson, the credit.

Oscar Wilde. How I wish I had said that

James McNeil Whistler. You will, Oscar you will.

Guernsey McPearson's Drug Development Dictionary Part I.

Global Development - A development which takes place in Europe, USA and Japan - except Japan.

Head of Drug Development - A temporary Pope. One who is infallible for two years and leaves by the means by which his arrival was announced - a cloud of white smoke.

Global Compromise - Implementing the American system.

Clinical Trial - An experiment which any damn fool can design and frequently does.

Sequential Analysis - A means of stopping a trial before it becomes useful.

Marketing Forecast - Twice what you dare not even hope the product might earn multiplied by three.

Marketing Graph - A pictorial representation which uses three dimensions, four colours and five cartoons to show one fact which probably isn't true.

Rapid Development - A bold, imaginative and creative plan. Any drug development programme which has just begun.

Slow Development - An unfolding rapid development.

IT Support - 1) Wheelchairs for the blind. 2) The daily renewed promise of help tomorrow.

Consultant - Stress the first syllable.

Good Clinical Practice - A typographical error. For 'li' read 'y'.

Statistics - A subject which most statisticians find difficult but in which nearly all physicians are expert.

Data-base - A rubbish dump built like a library.

Team Alignment - A process whereby sharks teach gulls to behave like lemmings.

Statistical Significance.- The opposite of Australia: everyone wants to go there but no one is sure how.

Medical Statistician - One who won't accept that Columbus discovered America because he said he was looking for India in the trial Plan.

Generic Companies - The Amerigo Vespuccis of drug development: they profit by what others discover.

Equivalence Trials - Proving that apples are pears by comparing the weight.

Marketing Man - An expert at selling drugs, sometimes, and himself always.

Regulatory Affairs - The Eskimos of drug development. They have 180 ways of saying perhaps.

Pharmacoeconomics Departments - Experts at hiring experts.

Clinical Relevant Difference - That which will produce 80% power given the supposed standard deviation and the number of patients the medical advisor is prepared to recruit.

Trend Towards Significance - An ever present help in times of trouble.

Matrix Management - Two dimensional confusion.

Management Consultant - 1) Executioners disguised as judges. 2) Those who, having failed in drug development themselves, advise others how to do like-wise.

Global Strategy - A plan which is universally valid except locally.

Regulatory Dossier - A document which takes a forest of trees to obscure the wood.

Restructuring - Reverting to the previous organisation.

Me-too - Sixth drug in its class.

Innovation - Fifth drug in its class

Wonder cure - A treatment with no financial future. To be avoided like the plague.

Intravenous - A formulation which marketing consider unusable unless they work for the Mafia.

ASCII - Esperanto for computers.

Patient Listings - So called because they take an age to produce.

CANDA - A submission which is printed out by the FDA rather than by the sponsor.

Software - 'That liquefaction of her clothes ' (Some mistake surely, Ed.)

Open Study - a means of using prejudice and regression to prove effectiveness.

Validated - Has been tried once before.

Reliable - Consistently producing the wrong answer.

Power Calculation - A guess masquerading as mathematics.

Sums of Squares - Statistical calculations. (Think about it.)

Bayesian - One who, vaguely expecting a horse and catching a glimpse of a donkey, strongly concludes he has seen a mule.

Quality of Life - The means by which it is hoped to rescue boring drugs from the rubbish dump of history.

Standard Operating Procedure - A vitally important document whose rate of obsolence exceeds its rate of implementation.

Statisticians - Twice as boring as accountants and half as rich.

Homeopathic Medicine - That which is to pharmacology what the emperor's new clothes were to men's outfitting.

Pharmacokinetics - One of the magic arts of divination whereby needles are stuck into living dummies in an attempt to predict future profits.

Executive Search Consultants - People who make money by throwing names at vacancies.

Guernsey McPearson's Drug Development Dictionary Part II.

Analysis plan. The drug development equivalent of marriage vows.

Type III sums of squares 1) That which is to statistics what the Senate is to Congress*. 2) A powerful means of ignoring information whilst appearing to use it.
Delaware gets the same votes as California

International Conference on Harmoni(z)(s)ation. 1) A body which brings together physicians from all over the developed world and statisticians from the USA to decide how statistics will be handled in Europe and Japan. 2) A powerful irritant for European statisticians and one which makes them ICH.

Pharmacoeconomics. 1) The application of sound economic and business principles to drug development as a means of increasing the profitability of external consultants. 2) A mysterious discipline with whose help reimbursers expect to be able to contain costs at the same time that sponsors expect to boost prices.

Pharmaeconomist. 1) A sort of solar-panel, second hand car and double-glazing salesman rolled into one. 2) One who pedals pipe-dreams to those who pedal drugs.3) One who asks not only if the cure for dysentry was effective but also after the price of toilet paper.

FDA. A body which fulfills that function in drug-development which the bogeyman fulfills in child-development. It provides the argument of last resort as in.Q "Well why should we use these stupid type III sums of squares?" A. "Because if you don't the FDA will get you."

Downsizing. 1) An activity which reduces current costs at the expense of future profits. 2) A cost-cutting exercise which applies across the board but not to the Board.

Survival analysis. Downsizing proportional to the hazard.

Integrated report. Tables and fables.

Basic Drug Information. Labels and fables.

Pharmaceutical development. People who take years and millions of pounds to achieve what others manage in a matter of seconds with a miror, a razor blade and a rolled up five-pound note. (It is hoped that this line is self-explanatory and doesn't get up your nose.)

Non-linear random effects. The process by which salaries appear to be determined in the pharmaceutical industry.

The bootstrap. Examining a chicken's entrails whilst having the efrontery to call it statistics.

The brastrap. A resampling plan for bimodal distributions. See software. (Some mistake, surely, Ed.)

The jockstrap. See hardware.

The jacknife. (Let's cut these resampling "jokes" now. Ed.) .

Gibbs-sampling. How Bayesians came to love frequencies after all.

Management consultant. 1) One who offers succour to suckers. 2) One whose motto is "suck up, suck blood, succeed". 3) One who flatters the CEO's ego but flattens his profits.

Blood pressure. 1) If you can reduce it in patients your profits will rise but if your profits fall yours will increase. 2) A force which determines that a cushy job will be found for the chairman of the board's daughter.

Theoretical statistician. A second class mathematician who imagines that he is a first class statistician.

Applied statistician. A second class statistician who imagines that he is a first class scientist.

Medical statistician. A second class scientist without any imagination.

Marketing forecast. False profits predicted by false prophets.

Contract statisticians. The dentists of pharmaceutical statistics. They fill in on all the boring jobs.

Vision. That which the chairman hopes that the workforce will be stupid enough to share, which the workforce hopes the chairman isn't stupid enough to believe and which the public will think is just plain stupid.

Adverse reaction. Suffered by many when reading Guernsey McPearson.

Luck. See blockbuster.

Decision Analysis. Something you would be well advised to apply before deciding to use decision analysts.

Binary outcome. "Get this product registered or else".

Portfolio management. A method of repeatedly assessing products in development until the CEO's pet project comes out with the highest ranking.

PC 1) A handy tool which assists the statistician in his work. 2) An attitude which dictates that women and other demographic groups shall be "adequately represented" in clinical trials. See Nonsensical Incoherent Hysteria.

Blockbuster. Any product which treats common, mild and incurable disease in the developed world.

Drug Development Physician. One who having failed in treating patients individually has moved on to misunderstanding them wholesale.

Merger. A rape described as a marriage.

Pipeline. 1) For "line" read "dream". 2) For "pipe" read "bottom". 3) The sum of the products you are developing and those you would like to convince the financial analysts you are developing. 4) A pile of postdated cheques. 5) Piglets in a poke but will you bring home the bacon?

Outlier. The chairman's salary.


Guernsey McPearson's Drug Development Dictionary Part III.

Bioequivalence. A type of study originally conceived to reduce the costs of drug development but now primarily used to boost the fees of consultant statisticians.

Placebo run-in. A period in which dummies give dummies in the hope that patients are as stupid as they are.

Bandit design. So called because once you've run one you wish you'd banned it.

Minimisation. 1) A 'platinum standard' for treatment allocation favoured by platinum blondes. 2) A sort of arithmetic in which apples and pears are added together to make turkeys.

World wide web. The litmus paper of social relationships. If your boyfriend finds this interesting you need a lover with more bandwidth.

Volume of distribution. At last: a topic that marketing and pharmacokinetics can talk about together!

Clearance. Redundancies amongst the pharmacokineticists following a merger.

Cmax. What your girlfriend missed while you were pursuing areas under the curve.

Tmax. A concept with sexual dimorphism: invariably shorter in the male than in the female.

Telephone randomisation. It's good to hawk.

Mobile phone. 1) Nerd label. 2) 'The future is bright but the present is horrid,' due to that noisy idiot next to you shouting "it's me I'm on a train" to 40 people who know that already and wish it wasn't true and one other who couldn't care less.

Genotyping. A mysterious science by which marketing expects to increase profits whilst reducing the scope for drugs.

Pharmacodynamics. Who are they kidding?

Bonus. A means of rewarding marketing staff for that serendipity which outweighs incompetence.

Management consultants. Advisors whose expertise has been recognised by managers who have failed to recognise useful drugs.

Pharmacoeconomists. 1) Just like bossom: neither one thing nor the other. 2) Crack at no trades, disaster at one.

Statistician. Someone who thinks that the rest of the world gives a damn whether he bores as a Bayesian or a frequentist.

Epidemiologist. One who thinks that an odds-ratio is an approximation to the relative risk as opposed to a statistician who knows the opposite.

Sequential analysis. A means of stopping a trial early when ethical considerations dictate this is imperative and so that the next trial can start.

Dummy loading. The process by which the new CEO gains total control of the company.

Biotech company. A company that finds patients too difficult a market but pharmaceutical sponsors a soft touch.

Laptops. 1. So called because they are executive toys for lapdogs. 2. A means of allowing those who want to join the eight mile high club to do so playing solitaire.

Alpha spending function. The marketing department.

ACE inhibitor. The statistics department.

Beta blocker. The regulatory department.

CRO. Pronounce 'crow'.... or vulture.

Millennium bug. Impending nemesis for those who did not get their digits out.

Millenium BUGS. 1) What it seems we shall all be using for statistical calculations in the next century. 2) The topless darts of statistics. Who cares if it hits the target; look at all that talent.

EMEA. The latest Brussels' sprout. Goes well with turkey.

NICE. 1) A fine town on the Mediterranean, once Italian now French: very nice. 2) A sixties pop-group, rather short lived: quite nice. 3) National Institute for Clinical Excellence: a means of reducing the price of drugs and raising the price of pharmacoeconomists: not at all nice.

Genetic engineering. The son also rises... if daddy is the CEO.

Nicotine patch. A dangerous addictive treatment, dependence upon which can be completely eliminated by smoking.

Individual bioequivalence. A means of developing treatments for head-lice: beloved of nitpickers.

Homeopathic medicine. A treatment that is so safe you could pour it into your car radiator.

Homeopathic practitioner. One who should be paid a homeopathic salary.

Merger. A means of allowing companies that have failed separately to do so together.

Canyoning holiday. What to buy your boss for Christmas.

Trial simulation. An attractive option for those who don't understand the difference between dice and data.

Simulation software. The gypsy's tea-leaves.

Learning curve. An example of the sort of pathetic vocabulary favoured by those who never got very high on theirs.

Streamlined development. Rushing roulette.

CEOs. The generals of drug development: General Custers, that is.

Medical writers. 1) Hacks who think they can present subtle statistical concepts that they don't understand so that others can. 2) Those who think they can write stuff without the right stuff.

Treatment Emergent Signs and Symptoms (TESS). A concept favoured by those who believe that gravity has no effect on the moon because it still circles the same way it did when they first noticed it.

Meta-analyst. One who thinks that if manure is piled high enough it will smell like roses.

Medical ethicist. 1). The one you would all eat first in an Andes air-crash. 2) One who has exquisite moral sensibility and exact scruples about everything... except earning money for old rope.

Independent Data-Monitoring Committee. A jury with all the self-importance of judges.

Stochastic curtailment. The answer to all our prayers...eventually the wheel of fortune turns and flings the monkey at the top out of the circus.

'Surfing the net'. A glamorous and inaccurate term that geeks have invented for their favourite pastime. Should be called 'golfing the links' on the grounds that it is slow, boring, circular and practised by f**ts.


Guernsey McPearson's Drug Development Dictionary Part IV.

(As statistical tradition requires, these are in random and not alphabetical order.)

NICE. 1. Ration roulette. 2. A sort of five-a-side venue for the game played in the grown up version at the MCA. 3. A means of allowing pharmaco-economists to pretend they understand clinical trials.


Closed test procedure. 1. A magical mystery tour through the sample space. 2 A frequentist freak-show. 3 That which is to statistics what the moiré pattern is to graphics: busy, distracting and conveying no information. 4. A vitally important topic with no known useful application.


Pharmacogenomics. 1.A cutting-edge science that will start delivering miracle cures the year after next§ . 2. A subject with great promise. 3. Ready payment for those who prefer cheques to cash.


Computer aided trial design. 1. A virtual approach to drug development that will virtually develop some. 2. A modern miracle by which you can take five-loaves and two fishes and multiply them to get baskets full of half-baked red-herrings.


Bioinformatics. A science devoted to finding wonderful patterns in data-bases.


Peer review. A rigorous approach to screening papers that ensures that only those which cite the referees' get published.


Numbers Needed to Treat. The only way that physicians can understand probabilities - odds being a difficult, abstract and advanced concept only comprehensible to statisticians, bookies, punters and Sun-readers.


Herbal remedy. One which is natural and therefore safe. See tobacco.


Relevant difference. Used in power calculations: clinical in theory but cynical in practice.


Gender. The politically correct term for "sex" favoured by those who use the slang term for sexual intercourse.


Physician. 1. A scientist with 100 gigabytes of hard-disk and a one kilohertz processor. 2. One who never got beyond the fuzzy to the logic.


Statistician. 1. One devoted to generating statements that are probably true and definitely useless. 2. One who wears a condom for telephone sex. 3. One who thinks that loving your data is more exciting than dating your lover. 4. One who can't run experiments himself, prefers to tell others how they should, steals the data and expects to be thanked for it. 5.One who thinks that the way to be efficient is to measure as little as possible in a trial that costs millions to run.


Data-mining. 1. That awfully clever science that helps you sell beer with your disposable nappies. 2. A synergistic fusion of enormous data-bases and bad statistics.


Decision analysis. A very complex topic capable of finding logical solutions to elementary problems. (For the other sort of solution to elementary problems the pharmaceutical industry employs CEOs.)


Merger. A means of rewarding short-term at the expense of long-term investors.


Mobile phone. A means of allowing those who have no brain to cook it.


Bootstrap. An interesting topic for those who have mistaken simulation for stimulation. See MCMC.


Pharmaco-economist. Half drug developer and half economist, making half a scientist.


Power. That which statisticians are always calculating but never have.


Minimum effective dose. A fundamental concept in drug development whose meaning changes with the sample size.


Maximum tolerated dose. The highest dose you could bribe the medical students to take and not complain.


Academic researcher. One who, apart from being motivated by tenure, fame, money and professional ambition acts always from the purest of motives and whose work can therefore always be trusted, which is just as well since nobody ever checks it.


First author. 1. The most important opinion-leader Marketing could find. 2. A physician who is prepared to stick his or her name to the mess that the medical writer has made of the statistician's report. 3. One who receives top billing and presents a large bill.


Mega-trial. A means of giving some office-based pundit all the credit for a treatment that was discovered by scientists he has never met working in the laboratories of an industry he despises.


Meta-analysts. Bottom feeders.


Analysis plan. 1. In the pharmaceutical industry. A lengthy document written well before the trial is approved. 2. In academic research. A rare and brief note completed after the trial is finished and the data have been inspected.

Marketing department. 1. Clever, brilliant, amusing, innovative and witty - and that's just what they say about themselves. 2. The most hands-on professionals in drug-development: they have the greatest personal knowledge of supply and use.


Type I Error. Consulting the statistician.


Guernsey McPearson’s Drug Development Dictionary part V


Neuraminidase inhibitors. Vital weapons in the fight against bird-flu that lack the efficacy to be reimbursable. See hypocrisy, inconsistency, idiocy and NICE.


Pharmacogenomics. 1. An exciting new science that is vitally important to the future well-being of that section of humanity known as molecular geneticists. 2. A discipline that is regularly finding infallible cures for scientific unemployment. See South Sea Company and Bubble.


Biometrics. 1. The cutting-edge science of human identification, the proponents of which cannot even identify a name for it that hasn’t already been assigned to mean something else. 2. A word that used to have something to do with eyeballing data but now is being applied to eyeball data.


In vitro development. First glass science.


Simulation. A means of proving the validity of statistical methods favoured by those who don’t understand proof.


Pharmaco-economists. Second class economists who have decided to make a career as third class scientists.


Phase IV study. A cynical trial.


Minimisation. A method of producing marginal balance of marginal value promoted by those with a marginal understanding of design.


Micro-arrays. A means of building bigger haystacks as part of the search for rarer needles.


Meta-analysts. 1 Those who think that boring stuff can be made interesting by having more of it. 2. People who are so worried about missing trials that they count some of them twice. See Archie Association


Bioinformaticians. Computer scientists who think that they have discovered important new methods of data-analysis because they are doing logistic regression, discriminant analysis and cluster analysis badly but with new names.


Chief Executive’s Salary A recession-proof return that is uncorrelated with the share price.


Mixed model. For ‘model’ read ‘muddle’.


Uninformative prior. A statistical concept that exists only in the imagination of uninformed Bayesians.


Proteomics. Named after Proteus, the Greek god who could take on any shape at all but would tell your future for you if only you could catch him, which you couldn’t. See Leprechaun, Gold, Rainbow.


Dichotomy. A means by which moronic regulators increase the size of clinical trials. See responder analysis.


Euphemism. A word that has been used to replace another word with distasteful connotations. Eventually the euphemism will acquire the connotation and the process has to start again. See human resources, personnel.


Gender. A word correctly used by grammarians to describe a sub-classification of nouns and which is incorrectly used by just about everybody else.


Gene-Expression. Trouser press (Some mistake surely. Ed)


Standard Error of the Mean. Just what it says on the tin. To the extent that they think it means anything those who calculate it are committing a standard error. A common mistake made by dividing the standard deviation by the square root of n, which is appropriate when the observations are independently sampled from some population of interest, which in clinical research they never are.


Thinking outside the box. The sort of phrase favoured by those who ought to be put in one. See marketing department.


Recruitment agencies. Companies that are experts in helping you find suitable statisticians to employ and which are manned by persons who understand nothing about statistics, have no idea what statisticians do, are ignorant of the sort of qualifications statisticians have but know how to use a telephone.


Marketing department. The crème de la crème. See scum.


NICE A word that meant ‘stupid, foolish and senseless’ in the 13th century, meant ‘pleasant’ from the 18th to 20th centuries, but which in the 21st century is reverting to its earlier usage.


Publication bias. A form of snobbery practiced by journals who won’t accept a first class industry analysis unless it has been replicated by a second class academic one.




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