The Ethics of Clinical Trials: A Deep Dive into Clinical Equipoise

This essay delves into the core principles of biomedical ethics, with a specific focus on the concept of clinical equipoise within the context of randomized clinical trials (RCTs). The essay explores the ethical dilemmas that arise from the conflict between research goals and the physician's responsibi...Read More

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BIO MEDICAL ETHICS
Institutional Affiliation
Angeline Arutpiragass
1002805431
march 30,2018

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PART A
Introduction
Clinical trials are a basic component of contemporary scientific research. The participants
in clinical research are selected on a voluntary basis and it is the responsibility of a physician to
ensure that the trials adhere to professional standards. Randomized clinical trials must involve
the allocation of patients to different treatment options by chance. A physician is also tasked with
the responsibility of offering treatment that is consistent with the value of their profession. The
actions of physicians must at all times be geared towards the promotion of the best interest of
their patients (Lim, Mihye, and Park, 2014). Evidence gathered from randomized clinical trials I
either used in licensing new drugs or facilitating critical changes in the clinical practice.
However, ethical concerns may arise as a result of conflict between the goals of clinical trials
and professional goals. Some of the principles emphasized in biomedical ethics include the
principle of justice the principle of nonmaleficence, the principle of respect for autonomy and
principle of beneficence. This essay will focus on the debate over the principle of equipoise.In
the essay, I will show whythe requirement of researchers to be in a state of clinical equipoise
during RCT’s is the correct position.
The equipoise principle offers an ethical basis for research in medicine that usually
involves the use of patients in the clinical trials where patients are assigned to different arms of
treatment. Equipoise refers to a state of uncertainty of the therapeutic merits ofeach arm of trial
in clinical research (Beauchamp,2007). Irrespective of where a trial is being carried out, both the
patients and investigators have particular interests in the trial. Patients always have an interest in

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receiving satisfactory medical care.On the other hand, doctors have a duty to provide care that
meets professional standards. However, these interests have been found to conflict with the goals
of a trial in randomized trials. The debate over equipoise has gained momentum with various
points of view being proposed by different proponents
Researchers are not required to be equipoise but must respect autonomy. Respect for
Patient’s safety is regarded as paramount in clinical research. The principle of respect for
patient’s autonomy is focused on the ability of research subjects or patients to make autonomous
decisions regarding their involvement in clinical research. Equipoise requires that researchers
carry out their research with genuine uncertainty over the outcome of the research (Beauchamp,
2009). Researchers are also required to maintain professional standards. It, therefore, means that
there should be self-determination of research participants or patients whereby they make
informed choices that are in line with their personal plans, beliefs,and values. Researchers are
therefore required at all time to respect the autonomy of research participants by allowing them
to make a decision regarding their involvement in clinical experiments or the course of their
treatment. Any decision to be taken by the researcher must, therefore, be informed by informed
consent, intentionality voluntariness and voluntariness. Although researchers are not required to
be equipoise, they must respect the autonomy of the patients because they are mandated to abide
by the ethical principles that guide their professional. By being moral agents, they are able to
respect individual’s autonomous decisions. However, Patient’s autonomy must be respected for
as long as it does not cause any harm to others. Although it might not be practical for the
researcher to be entirely uncertain about the outcome of a research, they should at all times
prioritize personal decisions made by their researchsubjects or patients. I clinical trials where all

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treatment options are balanced in terms of their potential outcomes equipoise may not be
necessary. (Ebbesen and Pedersen, 2007) .
Researchers are required to be in a state of clinical equipoise and respect autonomy.
Clinical equipoise refers to a situation where honest professional disagreements concerning the
preferred treatment exist among the community of experts. It is a situation whereby the overall
benefit or harm for a treatment to a patient is not known prior to the trial. Clinical equipoise is a
major consideration in random controlled trial’s ethical implications. It is regarded as a central
requirement in clinical trials. It requires that no participant in the trial should be randomized to a
treatment that is already known by the researcher. It also requires that none of the patients
involved in the study should be randomized to a treatment that is thought to be superior to the
established care standards. This shows that the interest of a patient should always be prioritized
by the researcher(Ha, Kim and Hwang, 2009).
Clinical equipoise is founded on the acknowledgment that a practitioner’s obligation of
care to the patient is a social norm that is synchronized by a community of experts. Clinical
equipoise allows patients to be enrolled in clinical trials in a situation where there are honest and
professional disagreements by a community of professionals regarding the preferred treatment
option. Other names used to describe this state include uncertainty state or honest null
hypothesis. The community of expert professionals is therefore required to have no preferences
or personal perceptions about the ability of one or two of the available options to have better
results than the rest of the options. All clinical researchers involving the use of patients is
founded on Clinical equipoise (Karlsen andSolbakk, 2011). However although researchers are
required to have genuine uncertainty and have no preference towards any of the options, they are
supposed to do uphold patient’s autonomy by having them consent to their involvement in

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clinical trials among other factors touching on patient’s autonomy. As per clinical equipoise,
ethical conduct on the part of the researcher during clinical trials is mandatory. Researchers are
expected to assign different patients to different arms of treatment without a prior knowledge of
what the possible outcome of each of the options would be. In a situation where the outcome of a
treatment is known, the trial should be discouraged as it can result in potential biases(Yaffe et al,
2010).
Researchers are required to be in a state of theoretical equipoise and respect
autonomy.Theoretical equipoise is said to exist when there is a balance between two alternative
treatment options. The evidence between two options in this state is said to be balanced. It differs
with Clinical Equipoise is that while it assumes that the evidence from various treatment options
is assumed to be balanced; in clinical equipoise a disagreement exists among the community of
experts concerning the preferred treatment. Also, as compared to clinical equipoise, the
assumption of theoretical equipoise is much stronger. According to theoretical equipoise, a
researcher can derive information from multiple sources including uncontrolled experiments,
literature data, and instincts or even gut feelings. A researcher is therefore required to treat all the
available options in a similar as they carry equal importance according to theoretical equipoise.
Treating either optionpreferentially by the researcher disturbs the concept of theoretical
equipoise (Mappes and Ballard, 2011).The assumption by the researcher that the evidence based
on two alternatives is exactly the same excludes ethical concerns in controlled clinical trials. As
per theoretical equipoise, the researcher should assign research participants to random groups.
This allows the researcher to be fully convinced about the outcome of the trial without having to
worry about potential ethical issues that would have otherwise arisen. It also avoids the possible
blame of bias on the part of the researcher concerning the groups into which different

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participants are placed. Questions have however arisen about the existence of theoretical
equipoise. The possibility of two treatment groups being exactly balanced looks like a far-
fetcheddream(Yooand Shon, 2012). Theoretical equipoise with its emphasis that all options are
exactly balanced, it provides prior information about the option involved in the study. This has
the possibility of affecting the attitudes of participants towards the clinical trial at hand. On the
other hand, there is high frangibility involved in this equipoise as it can be easily affected by any
slight evidence that seems to favor one arm of the trial against the other arms. Research should,
therefore, be in a state of theoretical equipoise at all times by ensuring that all trial arms are
treated as equally balanced. They should, however, do this while maintaining the autonomy of
patients involved (Steinbock, London and Arras, 2013).
Physicians have a responsibility of promoting the welfare of their patients. However,
during clinical trials, this responsibility might conflict with demands for the study. In some
situations, researchers might be forced to bribe participants in order to have enough subjects for
the study. This is already in conflict with the ethical responsibility which requires research
subjects to be admitted on a voluntary basis. Solutions for maintaining fidelity to the research is
however solved through the uncertainty principle. It can also be argued that clinical equipoise is
wrong because it failed to solve the dilemma of Randomized clinical trials for which it was
proposed. It fails to add up on how a physician can subject a patient to a trial out of which
treatment will be determined by probability. Equipoise only makes sense when viewed as a
normal aspect of clinical trials in situations where researchers are therapeutically obligated to
their patients. According to (Cook and Sheets, 2011), Clinical equipoise ensures that there is the
lack of personal preconceived preferences of any intervention by the researcher. This view has
alsobeen supported by (Jeon, 2011).

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Conclusion
In conclusion, biomedical ethics is an important consideration by researchers in the medical
field. Acting in an ethically responsible manner does not only lead to reliable findings of a study
but also enables researchers to conform to professional standards. The autonomy of participants
should at all times be upheld by the researcher. This means that the patient should consent to
their involvement and be the final decision makers. Researchers are required to abide by the
decisions made by patients unlike in situations where such decisions have the possibility of
harming others.

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