Wednesday 22 January 2020

Cut your cloth

The Institute offers a number of post-graduate courses, mostly through our Night School. If I leave work at 17:00 the concourse is eerily empty; except that the cleaners are doing the floor and emptying the bins. There is little appetite for working a minute over 9-5 M-F, so there can be a bit of a log jam getting through the door to the car park at 17:02. But if I am unavoidably delayed at my desk and leave after 6PM then the place is starting to hum again. Evening classes start at 7PM and it looks like people go straight from work to college to meet their pals and have a coffee before class.

Christmas 2019, I was asked if I was interested in supervising a student [or two] in one of the bioscience/business taught MSc courses. For the MSc, they have lectures every Tue and Thu evening for 2-3 hours but they are also requested and required to carry out an independent research project. This 'thesis' is cut to the aptitude, ability and spare-capacity at work of each student. A mentoring gig pays me for 12 hours of contact time to help extract a chunk of original research from each mentee . . . and correct the structure, intelligibility and apostrophes of the finished product.

I want all my students to do the best they can and a little bit more. The poor lonely, cold, young chaps from Southern India who first spoke English as a teenager in High School won't have as much to say as a middle aged Irish line-manager with 20 years experience in the industry. But both those exemplars will rise to the challenge and turn in something at the end of this Summer. This year one of my mentees is biddable, polite "Don't call me, Sir!" and a bit lost. His research proposal is a bit of a boiler-plate Compare the Regulatory Protocols for [insert drug-or-device here] in the EU vs USA. I dragged him off to the library to look at a previous thesis doing a FDA vs EMA comparison. Then I told him he couldn't cover every drug in all its Regulatory aspects if he was going to do, say, 10 hours research and writing every week for the next 26 weeks. He'd have to focus on a chunk of that Universe and diligently try to abstract the data, analyse it in some way, and write up a coherent and interesting report. Jaysus, it has to be interesting - to student and reader - with the whole universe of Pharmacy regulation to choose from, you have no excuse to be bored and boring.

What is a MSc-worthy chunk, Sir? his eyes pleaded. I grabbed his note book [at least he was taking notes, which is not always the case in these interviews] and sketched a diagram [like above R] to indicate three possible solutions to his dilemma.

  1. Scatter-gun [open squares]: these 8 student-hour blocks represent a full quota of 260 stud/hr work. That's a lot of work, yes, but between them they do not answer any question or aspect fully or comprehensively
  2. Take a slice [hatched column]: start off with a really narrow sample from the drug  universe and cover oneclass of drugs for one aspect of regulatory detail. If that takes a week, then expand the number of drugs OR the regs so you finish up with either a solid vertical or solid horizontal bar of research.
    • It's up to the student to gather the data, marshall the evidence [I've not had 100 hours of lectures on Pharm Regs, so haven't a clue where to start]. I can help with forming the hypothesis and the statistical analysis - that's generic. 
  3. Worse case [splat]: make no attempt as comprehensiveness; pick a bit of this and a bit of that; lash it down on paper any which way; do no statistics.
I did have one good idea about data access. If it turns out that data is more easily obtainable from the FDA than EMA it would be prefectly legit to do "Comparing the time taken for regulatory approval by the EMA for antibiotics against Gram+ve vs Gram-ve bacteria". That's a slice that ignores [the boring predictable] EMA vs FDA transAtlantic comparison but nevertheless delivers some data to which a t-test or a ChiSq may be applied.

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