Drug Sponsors and Obligations to Clinical Trial Participants

Clinical trials are a well-known part of the drug development process and after successive stages of research and animal testing, the last phase involves trials on human subjects. Informed consent and other ethical and legal formalities are an essential tool and part of the trial, after which the drug is given (Ashcroft, 2005).

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But complicated and time-consuming these maybe the above-mentioned steps are just the initial steps in the procedures of the clinical trial. The myriad of ethical, legal, and business issues lie underneath these practices, and therefore, for any clinician or investigator, being informed and carefully diligent in all steps is mandatory (Mello and Joffe, 2007). Now, many of the guidelines regarding clinical trials around the world acknowledge the rights of the patients to withdraw from the clinical study if they do not wish to continue (Sofaer et al, 2009). But this is not the only reason why subjects may be removed. If the drug shows negative or side effects or no effects on the subjects, the study or trial may be discontinued. Still, there are many cases where the drugs may show beneficial effects. The complicated pattern of outcomes that may arise from such drug trials has led to the evolution of strong medical ethics, and legal frameworks that support and protect the rights of all the parties that are involved in the process (Piantadosi, 2005).

For example, should the trial prove to be unsuccessful, it is discontinued. The participants may be given the benefits agreed upon, and if such was not the case, no compensation is given (Sofaer et al, 2009). On the other hand, should the trial lead to untoward complications in the health, then it is the responsibility of the sponsor to ensure that the patient is treated accordingly and compensated as per the need. Finally, should the patients find the drug or trial beneficial, it must be “made available to the participants” (Ashcroft, 2005). However, all is not as easily accepted as it seems. Each individual participating in any form has his or her ulterior motive and ambition attached to the trial. To a sponsor, there is the business perspective to developing and launching a new drug. To the researcher, it is a line of study which will give him or her credibility should the trial succeed, and is in need of the financial and other assistance that the sponsor may provide. Finally to the patient, the drug may be a chance of recovering from an illness, which may not be responding to drugs already available in the market. In all cases, the rights and legal aspects are so intertwined that they can get blurred in the boundaries (Sofaer et al, 2009). Therefore, for the most part, certain features should be observed in the clinical trials which can give a balanced and equal share of obligations and consequences to all members of the trial.

Through a rational approach and proper justification of the trial, the sponsor and the researchers can continue with their research provided that they take responsibility for the various procedures they follow and pursue the trial in the ethical frame. In this regard, the entire responsibility does not only fall on the researchers but also on the patients who decide to take part, for they are already made aware of the unpredictability of the outcomes of the trial. The patients reserve the right to back out of the trial should they feel that they are being exploited or are not benefiting from the trial (Piantadosi, 2005).

The complications of such issues can be easily understood by studying the Abney vs. Amgen case, which highlights some of the important issues that involve clinical trials (Mello and Joffe, 2007). The trial points out very clearly that research and clinical trials are a very serious undertaking and therefore, should be carried out by taking all ethical, moral, and legal, and health safety precautions and documentation (Piantadosi, 2005). Secondly, the patients should be given the protection of informed consent and should be given the benefit of a successful clinical trial by the provision of medicine for them after the conclusion of the trial (Ashcroft, 2005, Mello and Joffe, 2007).

References

  1. Michelle M Mello and Steven Joffe, 2007. Compact versus Contract- Industry Sponsor’s Obligations to Their Research Subjects. The New England Journal of Medicine Vol. 356, No. 26, pp. 2737-2743.
  2. Richard Ashcroft, 2005. After the Trial is Over: What are the Sponsor’s Obligations? Policy Briefs, SciDevNet, 2005.
  3. Sofaer N, C Theissen, S D Goold, J Ballou, K A Getz, G Koski, R A Kreuger, and J S Weissman, 2009. Subject’s Views of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results from the Experiences of Participants in Clinical Trials (EPIC) Study. Journal of Medical Ethics, 35: 183-188.
  4. Steven Piantadosi, 2005. Clinical Trials: A Methodological Perspective. Wiley-IEEE, 2005.

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