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    MS 19 - Global Nursing Issues in Lung Cancer (ID 37)

    • Event: WCLC 2015
    • Type: Mini Symposium
    • Track: Nursing and Allied Professionals
    • Presentations: 1
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      MS19.05 - Ethical Challenges in Conducting Clinical Research in Lung Cancer (ID 1935)

      14:15 - 15:45  |  Author(s): P. Allmark

      • Abstract
      • Presentation
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      Background This paper will reflect upon some of the ethical challenges in conducting clinical research into lung cancer and mesothelioma. Lung cancer care, treatment and research operate in a complex environment. Characteristics of lung cancer that contribute to this complexity are that, in comparison to other cancer sites, it has a limited evidence base, high mortality, late presentation, diagnosis at advanced stage, few curative treatments, complex trial designs and nihilistic attitudes regarding treatment and research. As a result, people delay reporting lung cancer symptoms because of fear, fatalism and poor knowledge of treatment.[1] Such beliefs and attitudes may also influence decisions or prevent people from participating in research. When they are asked to participate, they are often in a situation of advanced illness with fear and/or fatalism in their minds. As such, they may be desperate volunteers.[ 2] Desperate Volunteers An example of a study involving desperate volunteers might be a surgical intervention for mesothelioma, such as the procedures in Mesothelioma And Radical Surgery (MARS)Trial[3] study or the new feasibility study of MARS 2. Treatment options in lung cancer and mesothelioma are increasing, but remain limited, especially regarding curative treatment. In mesothelioma, surgery will not be curative, but might be seen as the only palliative treatment that can make a substantial inroad into the disease pogression. Research treatments may therefore be seen as “the only treatment in town”. Both the multidisciplinary team and the patient may not see any other viable treatment. If the intervention is only available within research then research emerges as the only option. So what are the ethical challenges here? The ethical principle of voluntariness comes into play. Might recruitment into a trial be experienced as coercive – even if this is not the intention of the person recruiting? Is the experience of being approached about trial participation seen as coercive, or is it a decision in difficult circumstances? We need to ensure it is the later. It may be a decision taken under pressure, but needs to be made in a voluntary capacity. Other factors that will impact on levels of desperation, and the balance between coercion or decision, include whether the intervention is available outside the trial or not, and the trial design i.e. does it involve randomisation. Both these things will impact on someone’s readiness to participate in research and whether they will seek treatment outside of a trial. Finally it is necessary to consider whether the level of distress or desperation is impacting upon mental capacity.[4] Trials for all As previously stated, the evidence base for lung cancer is limited when compared to other cancer sites. There is also a drive in the UK cancer and health research community to ensure all patients have a right to access any appropriate trial. In the historical context of lung cancer being the “poor relation” in terms of research activity, caution is required to avoid being over-zealous in putting this right. People have the right to have access to appropriate trials but this does not mean every patient should be on a trial. There are many reasons why people will not want to embark on the journey of being a research participant. This should be respected. There is a theoretical argument that an over-zealous “trails for all” approach could have two other impacts. First, it may lead a desperate volunteer to misinterpret or inflate what the trial may offer in terms of treatment, cure or symptom impact; second it may change perceptions of equipoise. Equipoise Clinical equipoise provides the ethical basis and justification for medical research which involves assigning or randomising patients to different treatment arms of a trial. The term was first used by Benjamin Freedman in 1987.[5] If clinical equipoise exists there is genuine uncertainty over whether a treatment will be beneficial. It follows that it is reasonable for a clinician in equipoise to assign a patient to one arm or the other of a randomised trial. The challenge lies in deciding whether equipoise exists and whose interpretation it is based upon. Usually the decision is made according to the best evidence.[6] An ethical window of opportunity will exist within which it is justified to conduct a randomised trial. That is until evidence is generated to demonstrate whether an intervention is better than standard treatment or not. However, there is a value-based element to equipoise. As such equipoise may vary between researcher, clinician, and patient – and between different patients. For example, on the basis of best evidence it may be justified to randomise between a surgical intervention and standard care, as clinical equipoise is seen to exist. However, if standard treatment is NO treatment, will the patient view equipoise in the same way as the scientist? Implications The above challenges will apply in different ways to different patients and contexts. However This paper focuses on some key messages for clinical and research practice. These can be summarised as: · Information and consent: The process of providing participants with sufficient information, and obtaining informed consent, need to be actively managed in these complex situations. Sufficient time needs to be allowed in times of heightened emotion and a cooling off period is recommended in between information and consent. Also, consent should be approached in a staged or continuous manner, where willingness to continue participation in research is verified at different stages in the study. [· ]Research designs: Where possible, patient preference trial designs should be considered.[7,8] · Availability of research intervention outside of the trial: Consider the impact of this at the design stage. Is an agreement possible to cease delivery outside of a trial until evidence is generated? · Equipoise: Whose equipoise is the trial based on? It is necessary to consider patient/participant values as well as the judgements of the scientist and clinician. · Patient experience: It is worth including a qualitative component in trials to understand what is going on for the participants, and trial staff, in terms of decisions to participate and be randomised, response to allocation, and experience of intervention. 1. Tod AM. Allmark P. Craven J. Diagnostic delay in lung cancer: a qualitative study. Journal of Advanced Nursing. 2008. 61(3), 336-343 2. Allmark P (2006) Should desperate volunteers be included in randomised controlled trials? JMedEth 32, 548-53 3. Treasure T, et al. Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study. Lancet Oncol. 2011 Aug;12(8):763-72. doi: 10.1016/S1470-2045(11)70149-8. Epub 2011 Jun 30. 4. Mental Capacity Act Code of Practice (2005) online Chapter 11 5. Freedman B (1987) Equipoise and the ethics of clinical research NEJM 317(3), 141-5 6. Kurzrock J, Stewart D (2014) Equipoise abandoned? Randomization and clinical trials. Ann Onc 24(10), 2471-74 7. Ismalia A, Walter S 2014 Review of designs for accommodating patients' or physicians' preferences in randomized controlled trials. In Montfort K van. et al Developments in Statistical Evaluation of Clinical Trials Sedgwick P (2013) What is a patient preference trial? BMJ 347:f5970

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