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Does participation in clinical trials influence the costs of future management of patients?

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Abstract

Background

An earlier study showed that from a societal perspective it was less expensive to encourage patients to self-regulate their medication for GERD (gastro-esophageal reflux disease) by treating patients on-demand.

Objective

The objective was to investigate whether physician involvement in a clinical trial financed by the pharmaceutical industry subsequently results in higher health care costs.

Study design

An open, observational, multicenter study compared direct medical costs and total costs for three groups of patients with different exposure to the clinical trial; (1) Dual exposed, where both the patients and the GP participated in the former clinical trial, (2) GP exposed, where only the GP participated in the former clinical trial and (3) nonexposed, where neither the patients nor the GP participated in the former clinical trial.

Results

We did not find any statistically significant differences in neither direct medical nor total costs. However, we did observe a numerical difference in direct medical costs of 24% higher in the dual exposed group compared to the nonexposed group mainly due to a higher consumption of prescribed medication. The higher direct medical cost in the dual exposed group was however counterbalanced by lower observed direct nonmedical and indirect costs.

Conclusion

Although we did not find any statistical significant differences in health care costs, we did observe a higher consumption of prescribed medication and lower costs of work hours lost if both patient and GPs participated in a former clinical trial. The results may be limited due to a lower number of patients included than expected.

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Notes

  1. From now on referred to as “the former clinical trial”.

  2. The study assessed differences in direct medical costs and total costs for 3 different esomeprazole treatment strategies: On-demand treatment (patient controlled), Intermittent 2 weeks treatment (GP controlled) and Intermittent 4 weeks treatment (GP controlled).

    .

  3. See Table 1 for the kind of cost data included in the analysis.

  4. Reasons for exclusion: Less than 3 days of symptoms (6), history of disease, that should exclude patient (13), did not use effective contraception (12) other reasons (8).

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Acknowledgments

AstraZeneca, Denmark has supported the study financially.

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Authors and Affiliations

  1. Danish Institute for Health Services Research, 27-29 Dampfaergevej, 2100, Copenhagen, Denmark

    Anne Hvenegaard & Henrik Hauschildt Juhl

  2. Signifikans ApS, Rundforbivej 2 (Trørød), 2950, Vedbæk, Denmark

    Andreas Habicht

Authors
  1. Anne Hvenegaard
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  2. Henrik Hauschildt Juhl
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  3. Andreas Habicht
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Corresponding author

Correspondence to Anne Hvenegaard.

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Hvenegaard, A., Juhl, H.H. & Habicht, A. Does participation in clinical trials influence the costs of future management of patients?. Eur J Health Econ 13, 569–574 (2012). https://doi.org/10.1007/s10198-011-0359-2

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  • DOI: https://doi.org/10.1007/s10198-011-0359-2

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