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Discuss about the:-

Patient autonomy and incidental findings in clinical genomics.

Ethics and regulatory complexities for pragmatic clinical trials.

PCORI perspective on patient-centered outcomes research.

Overview of Clinical Trials

A clinical trial refers to research studies that explore the safety and effectiveness of certain treatment, medical strategy or device, for humans. These trials might also help in the identification of certain medical approaches that have been found to work best for a group of disorders or illness among people (Pocock 2013). In other words, clinical drug trials have the potential of producing best available data that guides the process of clinical decision making. They are piloted only after obtaining an approval from the ethics committee or health authority, who are responsible for inspecting the trial’s risk:benefit ratio.

Drug testing or device testing usually begins by the conduction of extensive laboratory research that most often involves several years of testing in human and animal cells. After obtaining success in the laboratory, the data are sent by the researches to the FDA (Food and Drug Administration), with the aim of gaining a sanction for continuing research and subsequently testing it on humans. Following an approval, the human trial of experimental drugs is most commonly conducted in four stages. Each stage forms a separate trial, after completion of which, the researchers are expected to submit the extracted data, in order to gain FDA approval, before beginning the next phase (Junod 2014). Phase I studies focus on assessing the safety of a drug and get completed in several months. The primary aim of the phase I is to explore the impacts of the drug on humans and its absorption, metabolism, and excretion. The efficacy of the drug is tested in phase II that involves an experimental group and a control group, in order to provide a comparative information on the safety of the drug (Piantadosi 2017). Randomised and blind trials are conducted in thousands of patients in phase III for gaining a deeper understanding on the drug effectiveness, followed by Post Marketing Surveillance Trials in phase IV, after obtaining approval for consumer sale of the drug. Thus, these prospective biomedical researches on human volunteers provide answers to specific questions on the intervention or novel drug and/or vaccine.

The field of medicine is constantly evolving and dynamic. Some of the major advantages of human drug trials are listed below:

  • Helps in gaining access to a novel and possibly more operational and harmless treatment, than what is presently available to all people.
  • Provides access to certain treatment methods that have been identified to pose less severe or fewer side effects than those of drugs that are used in current practice.
  • Helping others by providing assistance to the pharmaceutical companies in obtaining the necessary data that is essential to gain an approval for the drug in question (Smith and Rawlins 2013).
  • Even when the drug fails to stand true to the hypothesis, these trials also provide significant information and guide the researchers on the rewarding treatment approaches.
  • The costs of the drug, medical professional fees and costs of all tests are free of charge. This particularly helps people who cannot afford the medical care.
  • The participants also get reimbursed for travel-related expenses, in addition to obtaining modest stipend.
  • The group of participants might be one of the few patients to gain benefit from the intervention (Lurie and Morgan 2013).
  • They are provided with the opportunity to play an active role in their own healthcare.
  • Fear of adverse impacts of the novel drug on health outcomes
  • Lack of understanding regarding the clinical trial
  • New treatment might not be beneficial than the conventional treatment, and might show more side effects.
  • In most trials, every human patient does not get the active drug under evaluation.  Some are placed in the placebo group such as, sugar pill.  Patients volunteering to participate in the trial do so for an improvement of health condition. However, if there is a high probability of not receiving the active treatment, the volunteers often do not elect to participate (Lurie and Morgan 2013).
  • Sometimes the research sites are located at long distances from the place of residence of the participants and create several challenges in terms of means of transportation and time to reach the place (Department of Health 2014)
  • These trials also result in an inconvenience due to daily commitments or work.
  • The health insurance provided to all patients might fail to cover all associated costs of the trial (Kean and Reilly 2014).
  • Allocation of the patients to a randomised blinded study will not allow them to select the treatment that they intend to receive.

All international and national guidelines lay stress on the code of conduct that must be followed by all researchers and key stakeholders, participating or conducting a drug trial, in order to uphold the simple commitment of safeguarding the rights of all research participants and providing them safety (Chandler and Shapiro 2016). The primary problem associated with ethics of drug trials originates from the fact that the patients who commonly stand to obtain benefit from the results of the trials are not those who bear the burden and risk of their participation in such research activities. Human participation in a scientific trial necessitates an augmented level of risk, when compared to normal clinical care, owing to the fact that the former has a potential for increasing the exposure of the patients to unanticipated impacts of the new treatment (Blehar et al. 2013). These risks are essentially not balanced by the prospective clinical profits, since the main aim of the trial is not to provide treatment services to the trial participants, but to produce a generalizable clinical knowledge on a particular drug. Past medical research history has been found to feature a range of episodes where the burden of participation in a drug research were disproportionally positioned on the trial participants (Nhmrc.gov.au 2018). This occurred either by intentionally concealing from them that they were participating in a drug research or directly misleading them by promising a cure for the disorder they were suffering from (Muthuswamy 2013). One of the most vital ethical concepts of contemporary biomedical ethics is informed consent. Written approval forms must be submitted to the participants in all phases of medical experimentation. It acts as a device that ensures the compliance of the subject, rather than any manifestation of concern regarding their welfare (McCambridge, Witton and Elbourn 2014).

Advantages of Human Drug Trials

This is in accordance to the principles of the government of Victoria that elaborates on the fact that most people are presumed to be in possession of the capacity to provide their informed consent for medical treatment, regardless of their legal status or age, under the Mental Health Act 2014 (Health.vic.gov.au 2018). Similar principles are also followed by the Victoria University that emphasises on the need of providing a consent form for all patients involved in a research. Information making a consent as valid includes an understanding of the perils and profits of the drug that the patients will receive, an understanding of clinical procedures, randomisation and blinding. However, clinical trials face an issue because aim of study is not always a benefit of the participants. Participants most often fail to identify that the purpose of the trial is not to discover the best drug, thereby being subjected to therapeutic misconception (Mak, Evaniew and Ghert2014). Personal expectations of the patients in a drug trial play a large role in the treatment. Patients recruited to the placebo arm of drug trials should be made to believe that a working treatment is being administered upon them, even though if it is not, in order to make the placebo effect to create an impact (Boot et al. 2013). Moreover, there lies a possibility of the patients being harmed by a placebo, in place of an active treatment. Furthermore, not receiving any form of active treatment most often exposes patients to pain, an aggravation of adverse effects, or death.

The principles of autonomy are also related to a range of issues such as, confidentiality and privacy, and the right of all participants to refuse the treatment, without citing reasons (Faden et al. 2013). Furthermore, the patients can also withdraw from the trials without disturbing their normal treatment at hospitals or clinics. There exist clear difference between confidentiality and privacy. Although privacy relates to the person concerned, confidentiality relates to the information/data about an individual (Wolf, Annas and Elias 2013). While preparing the participant information sheet, all these issues need to be mentioned clearly including the mechanism to protect the privacy and confidentiality and the possibility of withholding some information for the sake of validity of research (Health.vic.gov.au 2018). Protection of patient priority is also considered as a major prerequisite by the health department and states that doctors and research laboratories must notify all patients regarding the diagnosis of diseases, under regulations and legal acts. The Health Records Act 2001 was formulated with the aim of protecting the privacy of health information and its management. Failure to adhere to this act raises major ethical concerns in a human drug trial (Health.vic.gov.au 2018). Additionally, embedded in principles of fairness, contribution in research must be accessible to all, regardless of their socioeconomic rank (Winland-Brown et al. 2015).

Challenges in Conducting Clinical Trials


Hence, participant recruitment is a major issue that ensures that both benefit and burden of research are borne by similar individuals and no vulnerable group are exploited, owing to the their ethnic, socioeconomic, and cultural status (Nhmrc.gov.au 2018). At times the administrative authorities involved in the trials fail to provide adequate compensation or reimbursement to the participants, thereby resulting in financial burden on the enrolled patients (Herrett et al. 2015). Another concern is that payment might acts as some form of undue inducement, and cloud the judgment of individuals such that they become temporarily overawed by the potential of health benefits and decide something that is contrary to their health. Following revisions made in the Helsinki Declaration (2000), sponsors, researchers, and ethics committees have the prime responsibility of considering whether an effective intervention should be continued on the research participants and local community in the form of a post-study measure (Beronio, Glied and Frank 2014).

In addition, participation in drug trials also lead to undesirable changes in emotions and thought processes such as, episodes of confusion, depression, and hallucination as a result of drug action. These subsequently result in loss of self-worth and stress, and the changes are either recurrent or permanent (Sugarman and Califf 2014). Stress is also induced when the environment gets manipulated, such as fake treatment. Furthermore, an invasion into patient privacy or a breach of confidentiality results in embarrassment in social groups and the community, in addition to unemployment, and/or criminal prosecution (Nhmrc.gov.au 2018). Some of the major areas where such ill effects of drug trials are observed include drug or alcohol abuse, illegal activities, mental illness and sexual disorders. Failure to protect confidential information most often leads to a stigmatising attitude towards the patients, thereby threatening their health and wellbeing.

The aforementioned issues can be prevented or counteracted by providing complete information in the research protocol regarding the study design and rationale that underlies the proposed trial, in addition to the results obtained from previous human and animal studies. Assembling a research team that has a wide range of expertise to conduct the different trial phase are imperative in preventing unexpected adverse outcomes (Kaye et al. 2015). Efforts must be taken to ensure that the projected size of the sample participants are adequate for yielding useful results regarding the proposed intervention. Collecting data from standard trial procedures will help in avoiding unnecessary risks. Furthermore, adequate standards must be incorporated into the trial design such as, data safety, respecting autonomy of patients, reimbursement and monitoring the research plan, whilst adopting measures to protect privacy and confidentiality of patient data (Lindberg et al. 2014). This can be achieved with proper utilisation of encryption, passwords, and codes. Obtaining prior approval from the IRB will help in determining the ethical acceptability of the trial. Furthermore, including processes that are able to provide relevant information, thereby promoting the enrolment of patients, while minimising their vulnerability and maximising their benefits is another essential step (Frank, Basch and Selby 2014).

Importance of Participant Autonomy

Conclusion

Thus, it can be concluded that the dynamic nature of clinical trials can be attributed to the dedicated and innovative work undertaken by the medical researchers, pharmaceutical companies and institutions. This helps them gain a sound understanding of the different approaches that can be put to practice for treating a range of medical conditions, prevailing in the population. This is the scenario where clinical trials on humans come into play. Although the data obtained from the experiments are particularly beneficial in making extrapolations regarding the effectiveness and potential safety of the drug in question, it must ultimately be assessed in different people, since they will be using it for curing their illness.

References

Beronio, K., Glied, S. and Frank, R., 2014. How the Affordable Care Act and Mental Health Parity and Addiction Equity Act greatly expand coverage of behavioral health care. The journal of behavioral health services & research, 41(4), pp.410-428.

Blehar, M.C., Spong, C., Grady, C., Goldkind, S.F., Sahin, L. and Clayton, J.A., 2013. Enrolling pregnant women: issues in clinical research. Women's Health Issues, 23(1), pp.e39-e45.

Boot, W.R., Simons, D.J., Stothart, C. and Stutts, C., 2013. The pervasive problem with placebos in psychology: Why active control groups are not sufficient to rule out placebo effects. Perspectives on Psychological Science, 8(4), pp.445-454.

Chandler, J. and Shapiro, D., 2016. Conducting clinical research using crowdsourced convenience samples. Annual Review of Clinical Psychology, 12.

Department of Health, E., 2014. The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. The Journal of the American College of Dentists, 81(3), p.4.

Faden, R.R., Kass, N.E., Goodman, S.N., Pronovost, P., Tunis, S. and Beauchamp, T.L., 2013. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Center Report, 43(s1), pp.S16-S27.

Frank, L., Basch, E. and Selby, J.V., 2014. The PCORI perspective on patient-centered outcomes research. Jama, 312(15), pp.1513-1514.

Health.vic.gov.au., 2018. Health legislation. [online] Available at: https://www2.health.vic.gov.au/about/legislation [Accessed 14 Aug. 2018].

Health.vic.gov.au., 2018. Informed consent. [online] Available at: https://www2.health.vic.gov.au/mental-health/practice-and-service-quality/mental-health-act-2014-handbook/recovery-and-supported-decision-making/informed-consent [Accessed 14 Aug. 2018].

Health.vic.gov.au., 2018. Protecting patient privacy in Victoria. [online] Available at: https://www2.health.vic.gov.au/public-health/infectious-diseases/protecting-patient-privacy [Accessed 14 Aug. 2018].

Herrett, E., Gallagher, A.M., Bhaskaran, K., Forbes, H., Mathur, R., van Staa, T. and Smeeth, L., 2015. Data resource profile: clinical practice research datalink (CPRD). International journal of epidemiology, 44(3), pp.827-836.

Junod, S.W., 2014. FDA and clinical drug trials: a short history. US Food and Drug Administration.

Kaye, J., Whitley, E.A., Lund, D., Morrison, M., Teare, H. and Melham, K., 2015. Dynamic consent: a patient interface for twenty-first century research networks. European Journal of Human Genetics, 23(2), p.141.

Kean, J. and Reilly, J., 2014. Item response theory. Handbook for Clinical Research: Design, Statistics and Implementation.(pp195-198). New York, NY: Demos Medical Publishing.

Lindberg, C., Fagerström, C., Sivberg, B. and Willman, A., 2014. Concept analysis: patient autonomy in a caring context. Journal of advanced nursing, 70(10), pp.2208-2221.

Lurie, J.D. and Morgan, T.S., 2013. Pros and cons of pragmatic clinical trials. Journal of comparative effectiveness research, 2(1), pp.53-58.

Mak, I.W., Evaniew, N. and Ghert, M., 2014. Lost in translation: animal models and clinical trials in cancer treatment. American journal of translational research, 6(2), p.114.

McCambridge, J., Witton, J. and Elbourne, D.R., 2014. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. Journal of clinical epidemiology, 67(3), pp.267-277.

Muthuswamy, V., 2013. Ethical issues in clinical research. Perspectives in clinical research, 4(1), p.9.

Nhmrc.gov.au., 2018. National Statement on Ethical Conduct in Human Research. [online] Available at: https://www.nhmrc.gov.au/printpdf/book/export/html/51613 [Accessed 14 Aug. 2018].

Piantadosi, S., 2017. Clinical trials: a methodologic perspective. John Wiley & Sons.

Pocock, S.J., 2013. Clinical trials: a practical approach. John Wiley & Sons.

Smith, S.E. and Rawlins, M.D., 2013. Variability in human drug response. Elsevier.

Sugarman, J. and Califf, R.M., 2014. Ethics and regulatory complexities for pragmatic clinical trials. Jama, 311(23), pp.2381-2382.

Winland-Brown, J., Lachman, V.D. and Swanson, E.O.C., 2015. The new'Code of ethics for nurses with interpretive statements'(2015): Practical clinical application, Part I. Medsurg Nursing, 24(4), p.268.

Wolf, S.M., Annas, G.J. and Elias, S., 2013. Patient autonomy and incidental findings in clinical genomics. Science, 340(6136), pp.1049-1050.

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