John L. Anderson - Demystifying Research for Medical and Healthcare Students

So, there may be a potential to exploit people who are financially disadvantaged in clinical trials – as in all types of research – and I shall discuss later when considering ethical issues.

Phase I and Phase II clinical trials are the earliest tests of new treatments on human volunteers. The examples shown demonstrate that they are quantitative, hypothetico‐deductive. and experimental.

The difference between these and the majority of experimental approaches we have discussed so far, is that these do not include a control group. They are all tightly controlled and usually conducted under close clinical supervision. They are part of the progression to the next step – Phase III Clinical Trials or Randomised Control Trials.

So, remember, earlier I asked you to consider two questions about Arkenau et al.'s work (2008): (i) What sense do you make of these findings? (ii) What is missing from these trials? In answer to my questions:

1 There is the possibility of their results being due, in a large part, to a placebo effect. There are a lot of negative side effects – including the occasional death.

2 How do we rule out the placebo effect? We use a control group. That is what is missing in the studies they included in their review.

Clinical trials have to be done if we are to develop new medicines. The challenge for us is to make them fair and ethical.

Remember: ‘Research is the art of the possible!’

1 ABPI. (2014). Guidelines for phase 1 clinical trials: 2012 edition. (Updated in 2014 by Arnold & Porter LLP on behalf of the ABPI.)

2 Arkenau H‐T, Olmos D, Ang JE, et al. (2008). Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience. British Journal of Cancer 98, 1029–1033.

3 Attarwala H. (2010). TGN1412: from discovery to disaster. Journal of Young Pharmacists 2(3), 332–336.

4 Cancer Research UK. (2020). Phase 1 trial. Available at https://www.cancerresearchuk.org/about‐cancer/find‐a‐clinical‐trial/what‐clinical‐trials‐are/phases‐of‐clinical‐trials(accessed 6 May 2020).

5 Chen SC, Sinai N, Bedarida G, et al. (2017). Phase 1 healthy volunteer willingness to participate and enrollment preferences. Clinical Trials 14(5), 537–546.

6 Health Research Authority. (2020). Phase 1 clinical trials. Available at https://www.hra.nhs.uk/planning‐and‐improving‐research/policies‐standards‐legislation/phase‐1‐clinical‐trials(accessed 6 May 2020).

7 Kerbrat A, Ferre JC, Fillatre P, et al. (2016). Acute neurologic disorder from an inhibitor of fatty acid amide hydrolase. The New England Journal of Medicine 375, 1717–1725.

8 Matt L and Carl E. (2018). Avoiding exploitation in phase I clinical trials: more than (un)just compensation. The Journal of Law, Medicine & Ethics 46, 52–63.

9 Suntharalingam G, Perry MR, Ward S, et al. (2006). Cytokine storm in a phase 1 trial of the anti‐CD28 monoclonal antibody TGN1412. The New England Journal of Medicine 355(10), 1018–1028.

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