Science and Ethics of Drug Trials – Class Clips

The BBC’s Class Clips series does exactly what it says on the tin – the programmes are collections of short clips for use in classroom teaching. New in 2007, Class Clips programmes on a variety of subjects have since been transmitted overnight in the Learning Zone on BBC2 on several occasions and it looks like the website is gearing up to offer them via iPlayer, which will be a bonus in terms of availability (although, at the time of writing, the links are not yet active). The intended audience is advertised as Key Stage 3, but they could certainly be used with older students too.

The Biology section of Class Clips Science 2 is the most directly relevant for bioethics education since it includes two short sections on drug trials; one looks more at the procedures, the second at the ethics. However, if you are teaching at other times about modern medicine then don’t be put off by the physics-only sounding section on the electromagnetic spectrum – each of the clips on waves of different lengths (from gamma rays through to radiowaves) is looked at with explicit reference to their medical applications.

Drug Trial – Data starts at 31:52 and lasts 5:45 minutes. The focus of the clip is a drug trial taking place at Richmond pharmacology. It seems a slightly curious example to choose since the medicine in question is actually already licensed for treatment of osteoporosis and here they were looking at potential cardiac side-effects. The concepts of placebos and double-blind trials are introduced. Each time the trial volunteers come to the clinic (in this case nine time in a 140 day period) they undergo a strict admissions test, including checks to see that they are not pregnant (to avoid harm to an unborn child) and have not been using other drugs, either medicinal or recreational (since these could interfere with the metabolism of the drug being studied and therefore confound the study).

Participants are kept in at the test centre overnight before the trial and various baseline data (e.g. heart rate, blood pressure) is collected – to allow for comparison with results after they have had their medicine. The importance of careful timing is emphasised. Drink is limited to water, and only at regulated times. Likewise, all of the trial volunteers have the same meal. The concept of a “fair test” is introduced but, in my opinion, the accompanying commentary somewhat confuses the issue. The examples given re quantities and timing are good examples of the fair test concept, but an interview with the doctor conducting the trial goes on to talk about the benefits of doing the research and ensuring volunteer safety as aspects of a fair test, but I would argue that these are distinct issues. Students already struggle to distinguish a ‘fair test’ from a ‘control experiment’ and this seems to add ‘experimental design’ into the mix. Careful following of pre-determined protocol is also mentioned. Complete reporting of data, including sharing of adverse outcomes, is also described as an aspect of fair testing. Whilst this is certainly an important dimension to research ethics I believe it is somewhat different to the normal secondary school usage of ‘fair test’. There is no discussion of the different phases in a clinical trial.

Drug Trial – Ethics starts at 37:37 and lasts 4:34 minutes. This clip begins with news coverage of the 2006 TGN1412 trial at Northwick Park (see The drug trial that went wrong). Another spokesman for Richmond Pharmology emphasises that participation in a clinical trial is actually much safer than car travel. The role of both the Medicines and Healthcare-products Regulatory Agenct (MHRA) and of a local ethics committee in authorising any trials is mentioned, with minimisation of risk and informed consent for participation as central goals. The diverse background of Ethics Committee members is stressed.

Discussion moves on to the same cardiac safety trial described in the previous clip – it is no good curing people of brittle bones if you are causing severe and potentially life-threatening heart damage via the medication. A statistic is given that 90% of applications to ethics committees are passed, but often only after some refinement of the wording of patient information leaflets such that volunteers can clearly understand the purpose and risks of the research.

The thorny issue of payment to participants is raised. Volunteers are not supposed to be paid for risk but for expenses and for inconvenience – they are not supposed to see participating as a means to generate significant income (though there is certainly evidence that some do, e.g. see Exploiting a research underclass in Phase 1 clinical trials). Ethics committees are therefore supposed to check that the money offered for ‘inconvenience’ is not overly generous.

The clip closes by emphasising that the safety of medicines is vital and is the motivation for these types of trials.

Possible questions for use with the clips (these could be shared with the class before showing the clip in order for them to pick out the main issues on the way through):

From the first clip:
1. Why are clinical trials carried out?
2. What is a placebo? Why is it used?
3. Name three things that are checked before someone is allowed to take part in a trial, and suggest reason(s) why this is important
4. What is a double-blind study? Why is it the best way to conduct a trial?
5. Name at least three important factors in ensuring that the drug trial is a “fair test”.

From the second clip:
6. Which is more dangerous, driving a car or taking part in a clinical trial?
7. Two separate groups need to give permission for a trial to take place – what are they called?
8. Who can be a member of an ethics committee?
9. Do volunteers get paid for taking a risk in being involved in a trial? Why/why not?
10. Why does the interviewed volunteer Trevor say he took part in the trial?

The BBC has commissioned some Teacher notes for these clips, which include some rather tenuous classroom activites on eating chocolate with your nose pinched to model the placebo effect. The Class Clips series is frequently repeated on BBC Two as part of their overnight Learning Zone broadcasts. Alternatively, members of the BUFVC can order copies citing TRILT code 00616874.

4 Responses to Science and Ethics of Drug Trials – Class Clips

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