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Olivia Robinson

Dr. Cassell

English Composition II

04 July 2017

The Effects of Clinical Trials on Patients

In August of 2014, my boyfriend, Janson, began feeling pain in his lower back and belt-

line. He tried several different at-home remedies and solutions, until the pain just became

unbearable. Finally, after months of putting it off, Janson went to the doctor. In November, he

was diagnosed with cancer. To be more specific, he was diagnosed with anaplastic large cell

lymphoma. This type of cancer is a more rare form than others, and Janson was put on a clinical

trial for treatment. The doctors told him that this trial would help them help others who had this

type of cancer in the future. Honestly, Janson didnt have much of a choice. The doctors gave

him this one and only option, so, naturally, he agreed: anything to stop this excruciating pain. I

was by his side through the entire process, and I watched him hurt and suffer as the doctors

continually told him that this was his only choice. He was sick, and he needed help, but the

doctors were more focused on conducting this trial as some sort of research experiment. I am

aware that clinical trials can be effective, but I feel that things need to be changed when

preparing for and conducting them. Doctors need to work with patients and discuss the best

solutions for them and their condition, before putting them on a clinical trial. There are so many

side effects and outcomes that can arise from clinical trials, and patients often arent aware of

these things until after they have began the trial. Therefore, doctors need to better educate

patients on the effects that clinical trials can have on them.

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The National Cancer Institute defines clinical trials as research studies that involve

people. Researchers design clinical trials to test new ways to treat, find and diagnose, and

prevent cancer, as well as manage symptoms and side effects from chemotherapy. Clinical trials

are important because, today, people are living longer lives from successful cancer treatments,

that are the results from past clinical trials. Through clinical trials, the doctors can determine

which new treatments are safe and effective, and work better than current treatments (National

Cancer). The National Institutes of Health states that clinical trials related to drugs, like many of

the cancer-related clinical trials, are classified into four phases. The trials at each phase have a

different purpose and help scientists answer different questions. First is a phase one trial, which

tests an experimental treatment on a small group of people to judge its safety and side effects,

and to find the correct drug dosage. Sometimes, the study is in healthy people, and uses a

placebo (a non-active substance). However, if the trial is in people with a disease or condition,

they receive the experimental treatment, rather than a placebo. A phase two trial uses more

people (than a phase one) to find out if the experimental treatment is effective and safe. This
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phase can last a long time: up to several years. Phase three trials are usually large studies with

many participants. They compare the experimental drug or procedure to a placebo or standard

treatment, to make sure it is safe and works well. The U.S. Food and Drug Administration will

then consider the results of the clinical trial when determining whether to approve a new drug.

Fig 1.1 Clinical Trial Phases. Cern Foundation. 2017.

Finally, a phase four trial takes place (after the U.S. Food and Drug Administration approves use

of a drug). In the phase four trial, a drug's effectiveness and safety are monitored in large, diverse

populations, to ensure that no unknown or undiscovered side effects of the drug appear (NIH

Medlineplus).

In an article written by Mary C. Politi, the decision-making process of clinical trials is in

question. Cancer clinical trials are essential to evaluate new therapies and advance evidence-

based treatments, but despite the widespread availability of these trials in both, academic and

nonacademic settings, patients often are not well informed about the trial and do not make

informed decisions about participation. Without an adequate understanding of trials and trial

procedures, patients cannot make a fully informed decision about participation, a principal tenet
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of the ethical conduct of clinical research. Although a number of interventions have been

developed to improve clinical trial informed consent, nearly all focus exclusively on improving

patients knowledge. A recent meta-analysis found that participant understanding of important

concepts essential for informed consent has not increased during the last 3 decades of studies

examined (Politi et al). To improve cancer-related clinical trial decision quality, interventions

must go beyond knowledge provision to address aspects such as preference deliberation and

decision preparedness, guiding patients through the trial decision-making process.

Its tempting, but dangerous, to plan a clinical trial to only obtain information on the

biological activity of a therapy (for example, the effect of a drug on tumor size in cancer). Such

information can be obtained quickly and easily, but biological activity is only a surrogate for a

meaningful outcome of interest in a clinical trial that reflects clinical effectiveness. Clinical

effectiveness unmistakably affects patients in a tangible way; for example, by lengthening life

(survival time) or increasing quality of life. These outcomes take much longer to discover, but a

valid clinical trial should be able to determine the true clinical outcome of patients on a therapy

(Rosenberger and Lachin). Invalid clinical trials happen more frequently than most people

seem to think. Often, clinical trials are used in cancer treatment, simply to see whether a certain

drug will affect the size of the tumor. If the outcome is not what was desired, medical

professionals will simply treat the patient with the drug(s) that is already known to treat the

patient. This should not be something that patients have to go through. When doctors know that a

drug will work, but insist on putting the patient on a trial instead, the patient should be fully

informed of the doctors intentions. It is not fair for the patient to not receive information on their

treatment and treatment process.

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Clinical trials involve many risks. When weighing the risks of research, two important

factors to consider are the chance of any harm occurring, and the degree of harm that could result

from participating in the survey. Some study participants experience complications that require

Fig 1.2 Manage Your Risks. Project Management. 03

June 2017.
medical attention. In rare cases, participants have been seriously injured or have died of

complications resulting from their participation in experimental clinical trials. For a patient in a

clinical trial, there may be unpleasant, serious, or even life-threatening side effects to the

experimental treatment. Also, the study may require more time and attention than standard

treatment would, including visits to the study site, more blood tests, more treatments, hospital

stays, or complex dosage requirements. Clinical trials are not always the best option for patients.

However, there can be benefits to participating in a clinical trial, such as gaining access to new

research treatments before they are publicly available and receiving regular and careful medical

attention from a research team to ensure the best outcomes possible. Also, by participating in a

clinical trial, you can help others by contributing to medical research. When discussing the idea

of being put on a clinical trial, doctors need to emphasize both, the good and the bad, effects that

the trial can have on the patient.

The National Cancer Institute conducted a survey and asked clinical trial participants to

estimate the frequency that their pharmacies performed the services that were supposed to be
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provided to them and the perceived importance of the services. Then, they asked the pharmacy

directors how often the services were being provided and how important the pharmacy directors

thought these services were. In the end, the surveys revealed a significant gap between what the

participants considered important pharmacy services and what the pharmacy directors considered

important, as well as the actual performance of these services (Khandoobhai et al). In order for

clinical trials to be at optimal effectiveness, this needs to be changed as soon as possible. With

any form of treatment, especially a clinical trial, it is crucial that both the patient and the medical

professionals are on the same page. It has been suggested by numerous different studies that the

involvement of patients in their health care has positive effects. For example, a study conducted

by the National Institutes of Health revealed that participation of patients in health care has been

associated with improved treatment outcomes. This participation can cause improved control of

diabetes, better physical functioning in rheumatic diseases, enhanced compliance of the patient

with secondary preventive actions and improvement in health of patients with myocardial

infarction (heart attack). With enhanced patient participation, and considering patients as equal

partners in healthcare decision making, patients are encouraged to actively participate in their
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own treatment process and follow their treatment plan and thus a better health maintenance

service would be provided (Vahdat et al).

When speaking with Janson Bowers, a former clinical trial participant, this is what he had

Fig. 1.3 Pharmacist & Patient. Tennessee Board of Pharmacy. 2017.

to say about his experience:

I saw so many doctors before I was diagnosed, and to be honest, I was kind of

happy when I was diagnosed, because it meant I would only have to see one

doctor, and they could get rid of that terrible pain. Well, at least, I thought they

would. A few oncologists told me that my cancer was rare, and that a clinical trial

was my only option. I didnt mind too much in the beginning, because they told

me that my trial would help them treat other people too. It sounded like a really

nice thing to do. What I didnt realize was how awful it was actually going to be. I

think I was in more pain during the trial than I was before I had started. They

never told me how many different side effects and issues I would have. I had so

many problems, like the drugs would make my skin super sensitive. I work on a

farm, and Im out in the sun all day, and one day, it was only about 75 degrees,
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but my skin got super red and sensitive, like a really bad sunburn...but worse. I

could hardly move. I had to have my boss drive me home and then I stood in the

shower for almost two hours just letting the cold water run over my skin. That

was the only thing that helped. As soon as I would try to leave the shower, my

skin would start burning again. All I could do was stand there and hope that we

wouldnt run out of water. It was the worst pain Ive ever had. I went to the urgent

care, and they said that it was a common side effect of the drug that I was on, but

no one had told me that before. If I had known that I couldve worn extra

sunscreen or something. I had a lot of other side effects, like peeing out blood,

and I had no idea that it was a side effect at the time, so I freaked out and looked

it up online, only to find out that it was another side effect (Bowers).

It is evident that clinical trials, much like the one that Janson Bowers was on, are often

not explained to the patients. As mentioned earlier, there are many effects that a clinical trial can

have on a patient, and it is only fair that the patient is informed of all of this before agreeing to be

put on the trial.

Doctors should have to educate their patients on all of the possible effects that a clinical

trial can have on them. Because of the many risks that clinical trials can present, and the making

of invalid clinical trials, educating the patient is more important than ever when conducting

these trials. Had my boyfriend been aware of the possible side effects that his trial would present

him, perhaps he could have taken the proper precautions to prevent his side effects from

worsening. I think this issue is very important in the healthcare field today, because clinical trials

are becoming more and more common ways of treatment. Yes, these trials can be effective, but

they can be more effective if the patient is fully aware of all aspects of the treatment.
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Works Cited

Akst, Jeff. More Than 1 Percent of Clinical Trial Reports Appear Flawed. The Scientist. The

Scientific and Medical ART Imagebase, www.the-

scientist.com/?articles.view/articleNo/49594/title/More-Than-1-Percent-of-Clinical-Trial-

Reports-Appear-Flawed/. Accessed 22 June 2017.

Bailey, Linnie Frank. Participation in a Medical Clinical Trial: One Mans Story. Washington

Informer. EBSCOHost, Accessed 22 June 2017.

Bowers, Janson. Interview. 25 June 2017.

Khandoobhai, Anand, et al. National Survey of Comprehensive Pharmacy Services Provided in

Cancer Clinical Trials. The Oncologist, 31 May 2017. EBSCOHost. Accessed 22 June

2017.

National Cancer Institute. www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-

trials. Accessed 22 June 2017.

National Institutes of Health. www.nih.gov/health-information/nih-clinical-research-trials-

you/basics. Accessed 22 June 2017.

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NIH Medlineplus. Vol. 5, 2010. EBSCOHost. Accessed 22 June 2017.

Politi, Mary C., et al. Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a

Randomized Trial. The Oncologist. EBSCOHost. Accessed 22 June 2017.

Rosenberger, William F., and John M. Lachin. Issues in the Design of Clinical Trials. Wiley

Online Library,

onlinelibrary.wiley.com.sinclair.ohionet.org/store/10.1002/9781118742112.ch2/asset/ch2

.pdf?v=1&t=j48nfaey&s=3c7998c965e1f5fc8d223c665113ac794bf28064. Accessed 22

June 2017.

Swan, Norman, performer. Clinical Trials. Produced by Australian Broadcasting Corporation,

2011. Infobase,

fod.infobase.com.sinclair.ohionet.org/p_ViewVideo.aspx?xtid=49560&loid=199565&tSc

ript=0. Accessed 22 June 2017.

Vahdat, Shaghayegh, et al. Patient Involvement in Healthcare Decision Making: A Review.

U.S. National Library of Medicine. NCBI,

www.ncbi.nlm.nih.gov/pmc/articles/PMC3964421/. Accessed 1 July 2017.