Running Head: CLINICAL TRIALS IN ONCOLOGY

Oncology
Clinical Trials and their importance to the study of Oncology
Alexandra Beard
The University of Texas at El Paso
Rhetoric and Composition II
Dr. Vierra
October 16th, 2016

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Abstract

It is within our basic knowledge to understand that the study of Oncology is one that
encapsulates the treatments of tumors and anything relating to the concept of cancers. Because it
is such a significant subcategory in the medical field, it is important to be able to identify and
fully understand the treatments given to those affected by cancer and the means in which the
therapies are being provided. Clinical trials have played a key role in the development of general
medicine, but have played an even bigger role in trying to find a cure for several illnesses, in this
case, cancer. Shedding light on the issue at hand will not only bring awareness, but it will
simultaneously persuade individuals to do their part and contribute their time and efforts to
clinical trials. Their hard work will pay off in the long run when we will have finally found a
cure for the devastating illness that is cancer.

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Clinical Trials in Oncology: A Literature Review

Medical oncology, surgical oncology, and radiation oncology are types of treatments that
categorize clinical oncology as one disease. Despite their different approaches towards treatment,
all three disciplines can be pin pointed back to their genesis and the beginning of their research.
Clinical trials are the most integral and necessary components of the ongoing process that is the
study of oncology.
1. What are clinical trials, and how do they play into the study of oncology?
2. How are ethics incorporated into this issue?
3. How does one decide he/ she wants to partake in these studies?
4. What are the emotional aspects that come along with both participating in and
administering a clinical trial? (patient/ physician)
Clinical trials have played a crucial role throughout the development of medicine and its
practices. It is then appropriate to state that clinical oncology and its contributing factors are
significantly dependent of clinical trials and research studies. Different sources will be analyzed
throughout this literature review that will either support or reject the claim.
What are clinical trials, and how do they play into the study of oncology?
Clinical trials are the backbone to finding new research and the first step in the process of
creating new knowledge. To be more specific, they are any research study that uses individuals,
or a group of individuals for health based interventions that will result in the evaluation of certain
effects and medical outcomes. There are several treatment options for cancer patients, all of
which were at one point under scrutiny in a clinical trial. Vredevoe (1981) agrees that cancer
affects one out of four to five Americans, and is present in people of all races, ethnic groups,

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social strata, occupations, and ages (p.1). Because this source is significantly older than other
sources, the statistics might be less accurate for this time of day. The concept, however, remains
the same. Feelings of helplessness, fear, anxiety, etc. kick in when the mind cannot get past the
idea that cancer has invaded their once healthy bodies. Diagnosis not only disrupts a patients
physical health, but it damages their psychological health as well and that will be discussed
further along in this literary review. The figure below is a visual representation of the severity of
cancer and its effect in both men and women. Our ability to estimate new cases of cancer and
amount of deaths caused by it give healthcare professionals an advantage when trying to find a
cure for the disease.
Figure 1. Ten Leading Cancer Types for the Estimated New Cancer Cases and Deaths by
Sex, United States, 2016.

Source: Diamond, O. (2015, November 23). Blog. Retrieved October 14, 2016, from
http://medrio.com/partners/overcoming-patient-recruitment-and-retention-hurdles/

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Constant and rapid medical advancements are encouraging oncologists and qualified
physicians to come up with alternative treatments to treat cancer. This is pushing them to
conduct as many clinical trials as possible to get one step closer to a cure. Although the idea of
innovation and new treatments may seem refreshing, there are reasons to believe one should be
cautious. Block (1982) claimed that new cancer treatments and therapies may bring in new risks
to the patient, and can alter the patients support system and financial responsibilities. If Block is
right that reports of therapeutic advances are frequently based on results of comparative clinical
trials that have been poorly controlled, then it is necessary to reassess the popular assumption
that new treatments and drugs will benefit the patient more than the usual cancer treatments
(p.39). To prevent misunderstanding, clinical studies must be well controlled and programmed in
a way that will eventually improve the physicians judgement. In most cases, a cancer patient
will have most likely known of another cancer patient who has died not too long after treated
with chemotherapy. Due to this, patients lean towards trying new therapy, rather than the normal
route of drug treatment. The healthcare provider must be aware of any bias the patient might
have against cancer chemotherapy. Regardless of the situation, physicians have a legal obligation
to provide the needed information on all available therapeutic approaches to the patient without
hesitation.
Argued by numerous authors and healthcare professionals, precision medicine is now
considered a promising method in oncology. This concept is one that matches targeted therapies
and alters them according to the specific cancer patient. The National Cancer Institute (NCI)
recently put it to the test where their research included the sequencing of the entire coding
region of up to 315 cancer-related genes and rearrangements in introns from 28 genes (Bowel,
2015). Not only is this a big step forward for medicine, but for patient care as well. By working

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cancer therapies around the patients qualities and symptoms, physicians are minimizing the
room for error during their treatment process.
Kantarjian and Wolff (2016) worked together under The MD Anderson oncology program
to prove that personalized medicine is the most effective way to treat a cancer patient. Their
claim is valid for this discussion, because it supports the previously stated argument regarding
precision medicine. Both Kantarjian and Wolffs claim is supported by their research, where they
concluded that the development of productive therapeutic methods, carefully designed clinical
trials, and combined efforts amongst skilled physicians is promising for curing cancer. Neither of
these findings would be of any value had it not been for the proper research and applications to
medicine.
How are ethics incorporated into this issue?
The moral issues that determine a persons behavior are ethics, and that is a concept
everyone is well aware of, whether they are patients, family members, or physicians. The biggest
problem faced in these trials tends to be ethical ones that have the ability to either make or break
the research. Dupont (2016) conceded that all decisions, whether they regard finances, treatment,
or care for a patient with cancer must come from strong ethical backgrounds. Anyone involved in
the matter must keep in mind that non-ethical behavior will lead them to run the risk of conflicts,
reckless decisions, and obtaining bad reputations. Agreeing with this claim comes naturally
because it applies not only in the medical and research fields, but in real life as well.
Weijer, Shapiro, Glass, and Enkin (2000) have reinforced the fact that the main factor that
separates the ideas of pro clinical trials from those against clinical trials is simply ethics. Like
previously stated, a trials outcome depends solely on the physicians ethics and ability to
randomize the process to obtain valid results. These findings challenged Meinerts common

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assumptions that all clinical trials have the potential to succeed. This academic journal pointed
out that the physician must have uncertainty throughout the entirety of the trial. If the healthcare
provider is the slightest bit certain of any aspect of the trial, the results will no longer be viable.
Not only are a persons morals tested during clinical trials, but after, during the process of
interpreting and presenting results. Tannock (2016) claims that several clinical trial reports run
the risk of biased alteration to favor one side of the experiment instead of simply stating the facts
obtained throughout the trials. It seemed like Tannocks claim was hard to prove at first, until
supportive and legitimate evidence presented itself. According to the original research, about
60% of clinical trial reports showed signs of biased opinions towards one specific factor. After
studying the results, stating that physicians prescribe drugs with no proven benefit to extend
survival or improve quality of life due to biased reporting seems appropriate. Not only does this
affect the authors credibility, but it also puts the patient at risk for improper medicinal use.
There is simply no room for error when conducting any type of health based research
experiment.
How does one decide he/ she wants to partake in these research studies?
The effectivity of a clinical trial depends on several factors, one being the magnitude of
participation. Different sources in this literature review describe the process of taking part in
such research studies. Lemon (2015) eloquently informed us about how cancer research works
and how someone might go about participating in a clinical trial. Dr. Stephen Lemon gave the
selected audience a credible explanation of how clinical trials are research studies that determine
if certain cancer treatments work, and what the side effects are. Although this source is credible,
it must be pointed out that the Community Clinical Oncology Program (CCOP) might have
different approaches to the topic.

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These trials consist of cancer patients taking part of new research and drugs before the FDA
has approved them. Because it can be a risk, it is required that each patient sign a consent form
stating that they are fully aware of the possible outcomes. For this reason also, there is no
participation cost, and many times the treatments are provided to the physicians without a cost,
which can be considered an advantage for those participating.
There are several phases in a clinical trial, and those would include Phase 1, Phase 2, and
Phase 3 trials. A trial is considered Phase 1 or 2 when a treatment is being done with a new drug
by itself only. Unlike this one, Phase 3 occurs when a trial takes place with a cancer drug that
was pre-approved, combined with a new clinical trial drug. Phase 1 studies focus on side effects
and safety while Phase 2 and 3 studies focus more on treatment effectiveness instead of just side
effects. Because of this, Phase 3 is considered to be the most important, because it tests the
effectiveness of the drug being tested. Patients cannot be forced into a clinical trial; only
volunteers are allowed to participate. To be eligible, one must meet the requirements of that
specific trial. An advantage that patients have over the clinical trials is that they can remove
themselves from the study when they deem necessary. If serious side effects occur, however, the
physician has the right to remove that patient at any time.
Meinert (2011) stresses the importance of understanding clinical trials by breaking down its
composition into the factors that make up this tedious process. The two main things needed to
continue with a clinical trial are a sponsor to fund the project, and a person willing to perform the
trials with enough full awareness that the outcomes might not be the most convenient. Besides
the glaringly obvious requirements, one will also need the proper documents to keep up with the
proper protocol and patients willing to undergo certain experimental tests and examinations.
Green (2012) reported that clinical trials are composed of numerous elements that make these

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experiments credible and useful. Green is correct in making this claim; however, it really
depends on the physician and the Community Clinical Oncology Program (CCOP) to specify
what the qualifications are for a clinical trial. Greens major elements include the following:
stating the objectives clearly, determining eligibility, and including the choice of an appropriate
control group. Deciding whether it will be a randomized or blind trial depends on those
administering the clinical trial. Another factor would include deciding whether independent
review is required, and considering an independent data monitoring committee. Like any trial,
ethical consideration is also a mandatory requirement.
Leroy (2011) emphasized that barriers to enrollment mostly deal with general concerns
about clinical trial methods, the possible reduction of the patients quality of life, the relationship
between patient and doctor, and a negative overall attitude towards research studies (p.32). This
argument matters and is significant because it gives insight as to why so many patients have yet
to partake in clinical trials. To keep themselves from stressing out, individuals involved in trials
implement strategies of emotion regulation. In other words, they influence how they feel and
choose what emotions to express. Physicians are usually aware of when patients regulate their
emotions in an unhealthy way and use that as an opportunity to either allow them to participate
or keep them away from their clinical trials. Jacobs and colleagues (2014) hypothesized that
several organizational factors would influence physicians feelings towards taking part in the
CCOP. These factors will surely determine the enrollment of that particular clinical study. Their
hypothesis would later prove to be correct, for some factors sis in fact determine the productivity
of specific clinical trials. This article proved that physicians with positive attitudes towards the
CCOP had a better turnout in their patient enrollment numbers compared to those with negative

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attitudes. Studies like these can help take down the barriers that keep patients from participating
in cancer clinical trials.
Roth (2016) argued that slow moving outcomes for adolescent and young adult cancer
patients was due to the lack of enrollment onto clinical trials. His argument is a valid one,
considering the fact that nothing is effective unless there is participation or support of some sort.
This source narrowed its focus on the enrollment of adolescents and young adults, but the
research can also apply to other cancer patient groups. This source enforces the idea that there
should be a promotion and more awareness of clinical trials for any type of medical diagnosis.
The figure below is just a small representation of what is wrong with our medical society. There
is hardly any involvement, and when there is, most of the time the clinical trial is interrupted or
inconclusive.
Figure 2. Clinical Trial Awareness.

Source: Sukhoterina, Y. (2016, January 16). Anyone who tells you we're "winning the war
on cancer" is lying through their teeth- here's why. Retrieved October 14, 2016, from

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http://althealthworks.com/9170/news-outlets-celebrating-drop-in-cancer-death-ignorant-of-thefacts-and-ignoring-these-horrifying-statisticsyelena/
The National Cancer Institute (2016) has made it their priority to inform the public about the
protocol and regulations that take place behind the scenes of clinical trials. Information like this
is necessary when discussing trials and their effects on medicine from a professional stance.
Through institutions like the NCI, interested individuals find the resources needed to take part in
clinical trials focused on oncology. Because of this, more people are living longer and much
healthier lives from cancer treatments that were once a part of clinical trials. When a person
participates in this process, they are adding to their common knowledge of oncology and
applying that new knowledge into improving cancer for future patients.
What are the emotional aspects that come along with both participating in and
administering a clinical trial?
The primary research for this literary review consists of a professional interview with
pediatrician Dr. Rich. He was interviewed on the subject of clinical trials and his experience with
research studies. In his field of study, many patients are asked to participate in clinical trials that
help other doctors come up with effective drugs. In his own words, Dr. Rich explains how
clinical trials are basically a process in which you compare medicine x with a placebo and
determine what improvements can be taken into consideration when developing new treatments
and drugs. His experience from medical school has taught him about the statistical,
professional, medical, and emotional aspects of clinical trials and has made him fit for the
recommendation of such studies. According to authors Cohen, Cullen, Martin (1982), the
diagnosis of cancer results in a number of emotional responses such as fear of life and death,
vulnerability, and a combination of hopefulness and hopelessness. Soon after cancer diagnosis,

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several questions arise regarding treatments, drugs, and quality of life. During these first stages,
those involved fail to acknowledge the psychosocial issues that come along with cancer. As
stated in Psychosocial Aspects of Cancer, We in the health profession must impact on the total
person and thereby on society, concerning ourselves with the maintenance of wellness through
emotional and social support as well as the cellular cure or remission(p.5). The claim made here
matters and is of great importance because there must be a willingness to incorporate social and
emotional interventions after being treated for cancer.
Marino (1981) has continuously stated that a patients recovery and quality of life postcancer depends on the caregivers sensitivity and involvement in his/her mental, emotional, and
physical needs. Although Marino is correct up to a point, her overall conclusion that a patients
health depended entirely on a psychological aspect was flawed. Emotional acceptance of cancer
is only the tip of the iceberg when dealing with such illness. At the end of the day, the
caregivers emotional support can only go so far when dealing with a terminal illness.
Under the same anthology and school of thought, Terrill (1981) emphasizes that being
considerate when communicating with patients and their families goes hand in hand when
allowing the patient to cope. Opinions from experienced healthcare workers like Marino and
Terrill shed new light on the importance of the emotional connection between the patient and
caregiver, which previous scholarly studies had not addressed. Burns (1981) observed that caring
for patients with chemotherapy is more common now than it was years back. The reason why is
because like diseases, medical treatments have advanced in a way that is obtainable to any
patient. As a healthcare provider, understanding the treatments and proper protocols can help
the patient cope with the uncomfortable effects of chemotherapy, and maintain his/her hope it its
beneficial effects (p. 45). Not only do clinical trials have an emotional effect on the patient, but

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on the physician as well. He/she must face the realities that come along with dealing with family
member and most importantly, the patient. It is important for the healthcare provider to
understand the fine line that falls between his/her professional and personal lives to prevent from
getting too attached.
Conclusion

These questions narrowed the purpose of this literature review by providing the
background of clinical trials, their involvement in oncology, and their effects on cancer patients.
The different types of sources and significant time between them come to show that clinical
oncology and certain thought processes have changed and adapted to modern society. With the
help of medicinal advances and clinical trials, we as a community are able to see a ray of hope
that symbolizes a cure to cancer in the near future. Patients are not only giving themselves a
fighting chance to find a cure, but they are contributing to medicine one trial at a time.

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