STAT 2 Lecture 2: The Salk Vaccine field trial

Questions?

Review

Statistics gives you a way of thinking about the world Teaches you to draw conclusions and make decisions based on data and evidence Similarly, you can collect data and evidence to test other people's conclusions

Why do experiments?

Have a hypothesis you wish to test Take measurements for two (or more) samples E plain the difference between the two groups

Parts of experiments

!esign the e periment "ollect the data #nalyse the data !raw conclusions

Today

#ll about the Salk $accine field trial %hat does this teach us about e perimental design&

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The history of polio

History

()*+, -(.* deaths in the /0S0, including (12- children

Sabin vs Salk

Salk's vaccine

"omprised of three strains of killed virus 3rotected the immunised, but immunised could still transmit to unimmunised Small scale tests promising, but larger test needed

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The studies

Setting p a st dy

3olio is uncommon 4eed a lot of people to test it on Test to be carried out in selected school districts

St dy concerns

"an't 5ust vaccinate everyone 3olio incidence varies from year to year 6ight 5ust be a low incidence year

St dy concerns

4ot everyone gives consent 'n general, higher7income families more likely to give consent This may bias the study

The !"#P st dy

$accinate all children in grade + whose parents give consent 8eave grades ( and - unvaccinated "ompare incidence of polio in grade + to other grades

The randomised st dy

9f the children whose parents give consent, randomly allocate half to a treatment group and the other half to a control group Treatment group gets the vaccine "ontrol group gets a placebo

$o ble blinding

4either children nor parents know if child has received vaccine or control !octors also don't know

Res lts
NFIP Sample size Rate Grade 2 vaccine 225000 25 Grade 2 no consent 125000 44 Grade 1 and 3 no vaccine 725000 54 Randomised experiment Sample size Rate Treatment 200000 28 Control 200000 71 No consent 350000 46

Res lts
NFIP Sample size Rate Grade 2 vaccine 225000 25 Grade 2 no consent 125000 44 Grade 1 and 3 no vaccine 725000 54 Randomised experiment Sample size Rate Treatment 200000 28 Control 200000 71 No consent 350000 46

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Controlling experiments

Treatments and controls

Treatment group, receives treatment in :uestion "ontrol group, made as similar as possible to the treatment group E;"E3T they don't get the treatment

%ood controls& randomisation

'f you performed random allocation many times, the <average treatment group= would be identical to the <average control group= Even though you only do it once, it's still pretty close if the samples are large

What if yo can't randomise?

Sometimes it's impractical, unethical or impossible to randomise Some suggest historical controls > comparing to results in the past > but this can go horribly wrong E ample, any study of life e pectancy

%ood controls& placebos

'f treatment is a pill, placebo is sugar pill 'f treatment is an in5ection, placebo is a saline in5ection Sometimes it's better to compare to the current established treatment

%ood controls& blinding

'f you know you received the treatment and not the placebo, you may change your behaviour, hence blinding 'f the researcher knows you're in a certain category, he or she may treat you differently, hence double blinding

When controls go wrong

The portacaval shunt

'inds of st dies

/ncontrolled studies /nrandomised controlled studies ?andomised controlled studies

Portacaval sh nt st dy res lts

4o controls, +. out of -+ studies show marked enthusiasm /nrandomised controls, (@ out of (* show marked enthusiasm ?andomised controls, @ out of . show marked enthusiasm

'$

Is there a difference?

#s there a difference?

8ook at treatment rate minus control rate 8arge difference, treatment works "lose to Aero, treatment doesn't work

#s there a difference?

4eed more advanced techni:ues to e amine borderline cases 'f groups are of e:ual siAe, can think in terms of coin tosses This can be misleading to the statistically ine perienced %e'll return to this in #ugust0

The Salk vaccine: the aftermath

The Salk vaccine& the aftermath

Salk vaccine mass7produced in the /0S0 Sabin's vaccine distributed in ?ussia %orld population is now nearly polio7free

Recap

Recap

%ant to avoid confounding %ant to avoid bias %ant to compare two groups that are identical e cept for the treatment being studied

Recap

"ontemporaneous controls ?andomisation !ouble blinding

!ext time&

's smoking bad for your health&