Is marketing undermining the success of clinical trials?

It is the job of marketing to persuade us to change our opinions or behaviour in favour of the object or service being promoted. This is markedly different from science, of course, which does not seek to persuade us of anything; instead, it uncovers the truth through objective analysis and demonstration.

Is marketing undermining the success of clinical trials

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According to a recent paper by Alastair Matheson PhD, however, marketing is insinuating itself into the clinical trials process. As evidence for this, Matheson cites the pharmaceutical industry’s attempts to gain acceptance for an ‘adaptive pathways’ system. This would be used to allow the sale of drugs that did not have strong evidence that they were effective. The idea is that the evidence would be collected once the drugs were on the market and being taken by a large cohort of patients.

Distinguishing legitimate marketing from unfair influence

Matheson does not think that marketing and clinical trials must always be completely separate; for example, if a clinical trial is successful, the company involved will be keen to use the trial results as part of the marketing effort for the drug. This is legitimate and does not affect the conduct of the trial or the validity of its results.

His concern is trials in which marketing concerns have influenced the research question and the way the study has been designed, altering the number of sites involved and – crucially – the way in which the research is described and reported after the conclusion of the trial. In the UK, these processes are the subject of guidelines by the NHS Health Research Authority.

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Sponsors taking on the authorship role

Not all countries have such specific rules; for example, there appear to be numerous instances where the sponsoring company has involved itself in ways more appropriate to the author’s role in the study.

Another issue causing concern is ‘seeding’, whereby small numbers of patients are enrolled at multiple sites; however, there are often genuine difficulties in enrolling patients and even prestigious studies may need to use patient recruitment services such as http://www.richmondpharmacology.com/patient-recruitment.php to obtain the numbers they require.

A final worry is that unpromising or disturbing initial results can cause the company to shut down the study. No one can then access the data, as it is owned by the sponsoring company.

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