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Clinical Trial using Artificial Intelligence

Currently, the numbers of participants in clinical studies are low. Studies show that there is a myriad of reasons for these low numbers. But, some of the largest determining factors are the overwhelming amount of possible trials, the lack of ability to sort and find related trials, and the difficulty in making travel arrangements. An AI-based website could help potential participants sort through the thousands of studies to determine their best matches. This proposed website, AClinicalTrial.com, could also use its AI functionality to provide additional services such as travel planning and financial aid inquiries.

Introduction

Clinical trials or interventional studies are experiments conducted in clinical research. These trials study how human subjects react to certain biomedical or behavioral interventions such as vaccines, drugs, and treatments. They are also meant to test reactions to new ways of using already known drugs and treatments. Their purpose is to determine if these interventions are safe, efficacious, and effective. Clinical trials require approval from their relevant countries prior to their start. This approval does not mean that the intervention being tried is safe just that the clinical trial can begin. In fact in the US, only approximately 10% of drugs which started in clinical trials on humans are approved by the FDA. The process for developing new drugs takes on average 10 years. The clinical trials alone last six to seven years. This lengthy timeline is one reason why there is so much planning put into conducting a clinical trial.

Normally trials run in four phases. The first three are the most important phases where the number of human participant goes from a small group to several hundred or thousands. With many trials, in the early stage, a number of healthy participants are needed to test if the medicine or the intervention can be tolerated. In further stages, the clinical trials need patients who are affected by the condition, which the intervention is designed to address. This is needed because more precise measurements are required for the dosage and the timing. There are many specific requirements based on the nature of the condition being studied and the finding the right group of volunteers. It takes months or even years to find suitable volunteers, this is especially true for trials which are focused on rare diseases or those focused on children where a number of legal and ethical questions arise regarding participation. The last phase is designed to monitor the effect on the whole population and possible side-effects in widespread usage. This phase happens when the intervention is already available in the marketplace.

Information can be accessed on both public and private clinical studies on websites such as ClinicalTrials.gov. This platform is run by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Their database contains information about studies conducted throughout the US, as well as, 201 other countries around the world. The study records include information about the:

· Disease or condition in question.

· Intervention (for example, the medical product, behavior, or procedure being studied).

· Title, description, and design of the study.

· Requirements for participation (eligibility criteria).

· Locations where the study is being conducted.

· Contact information for the study locations.

· Links to relevant information on other health websites.

· Scientific articles on the topic.

Some records also provide information about the results of the study, the participants, the outcome and any adverse effects.

Clinical Trial Search Interest

As previously noted, clinical trials depend on a large number of participants, both those that are affected by the conditions, as well as, healthy participants. Studies show that while people hold positive attitudes toward clinical trials there is a low level of participation. For example, less than 5% of adults with cancer participate in clinical trials related to the illness and only between 5 and 12% of healthy volunteers participate in trials. This is an ongoing issue with clinical trials and is one of the reasons why the trials can take so long to complete. The National Cancer Institute has determined that the two main reasons why cancer patients do not want to participate are fear of getting a placebo and not wanting to be used as “guinea pigs”.

Given that clinical trials are a necessary step for developing new and better treatments, participation levels need to increase. Of course, trials must not override the rights and needs of patients, therefore it is of utmost importance that any enrolment is done with as full consent as possible. Because of possible infringement of patients’ rights, doctors are sometimes hesitant to talk to patients about clinical trials. As well, they need to find a balance between giving too little information, which can lead to confusion, and too much information, which can lead to anxiety and perhaps despair. One proposed way on how to circumvent this problem is to focus on motivating possible candidates to actively seek information about clinical trials so that they are better prepared to discuss the information with their doctors and make an informed decision.

The access to information and motivation to actively seek out trials seems to be critical. One study suggests “that patients who use the cognitively effortful information seeking and information-processing decisional strategies are more effective in coping with life-threatening illnesses.” Past research has shown that a lot of individuals who join clinical trials do so not because of information about the study but because they are mostly influenced by “non-rational” factors. These factors include the relationship with their doctor, general beliefs about clinical trials, and even message cues. All this shows the importance of introducing a simple and efficient way for interested parties to access clinical trial databases and find the actual information they need.

While there is no single unified worldwide register of trials, ClinicalTrials.gov is the biggest database available with approximately two-hundred and forty thousand registered trials. However, one study shows that it is far from easy to conduct a proper search of this registry or others that are available. The study developed four different search strategies — very precise, precise, sensitive, and very sensitive. These strategies differ on the basis of how many specific conditions and how many specific interventions were mentioned. The study determined that none of the strategies was very good, but that the best results were with the sensitive one. Their conclusion was that the most efficient search approaches, in terms of finding as many of the available relevant trials and the fewest irrelevant trials, remains to be established.

The people who are searching for clinical trials have different motives. A number of healthy volunteers are needed, and while their motives might be purely altruistic, at least some see it as a matter of gaining extra income. Indeed, in some trials, individuals are compensated for the risk they take. One website claims that a volunteer can earn hundreds or even thousands of dollars. But, those participants who are affected by the condition in question have many more potential benefits. They will most likely be treated at leading medical facilities often for free and will receive treatment which is not widely available. Moreover, they can take a more active role in their own healthcare, help future generations, and all those suffering from the same condition. Clinical trials are especially important for those suffering from chronic, rare, and life-threatening medical conditions. It should also be noted that not only do the patients receive medical treatment but in cases where the technology has not yet found a cure, clinical trials are helpful as they can provide a better quality of life for those who cannot be fully cured. Furthermore, without clinical trials developing vaccines would be much more difficult. These vaccine studies, while controversial to a degree as they are often conducted in underdeveloped countries which are the most affected ones and involve a number of placebo methods as well, are the number one way of eradicating certain diseases.

International Clinical Trials

ClinicalTrials.gov is the biggest registry and it lists 262,570 trials from all over the world. As of January 01, 2018, it includes 47% Non-US only trials, 36% U.S. only trials, 5% of the trials which are conducted both in the US and Non-US, and 12% are trials where the location is not provided. After the US as the number one country with 107,579 total trials, Europe has around 70 thousand trials, and China with around 27 thousand clinical trials. More importantly, out of all of the trials, there are 45,551 studies which are recruiting volunteers. They break down to 57% are outside of the US (25,838), 38% are in the US (17,367) and 5% are both in and out of the US (2,346).

ClinicalTrials.gov started their registry in 2000 and had only around 5.5 thousand trials in the registry that year. But from 2006 and 2007, there has been a steady sharp rise of registered trials, because of the decision by International Committee of Medical Journal Editors to require trial registration as a condition of publication from 2005, and the FDA expanded registration requirements from the end of 2007.

There are currently several million people taking part in clinical trials worldwide.

Both private and public sectors are involved in clinical trials. In the US by law, trials can be funded by pharmaceutical companies, academic medical centers, even voluntary groups, as well as Federal agencies such as the National Institute of Health. The costs of running a trial and developing a new medicine are huge and can be in the billions of dollars. Reportedly 60% to 70% of the costs of development are for clinical trials. This amounts to 80 to 90 billion dollars per year. In 2000, it was reported that around 70% of the money from clinical drug trials in the US comes from the pharmaceutical industry and not the public sector. In the EU, the situation is similar where around 61% are sponsored by the pharmaceutical industry and around 39% by non-commercial sponsors. Taking into account the huge prices for developing and the small percent of these medications making it to the market there has even been accusation that the private sector tries influencing the results of the trials.

But while it is true that pharmaceutical companies fund trials and they might have their own interests at heart, the companies themselves are not the ones who directly conduct that clinical trials. They are done and tested by independent organizations according to protocols and designs which are approved by the review boards. All the results are in the end reviewed by the regulatory agencies, such as the FDA (US), EMA (Europe), and PMDA (Japan).

In the last decade, a lot of those interested in conducting clinical trials have started to outsource them to so-called Contract Research Organizations (CROs). These basically privately-owned companies are specialized in research and help with clinical trials, as well. They provide services for pharmaceutical industries, as well as, governmental institutions. This outsourcing has been a huge trend in the past years and many major corporations are using CROs. Around 50% of CROs perform outsourced clinical trial for the pharmaceutical industry. Using CROs arguably cuts down the costs and time when specific trials are conducted. It is reported that top areas of their research are oncology, metabolic disorders, cardiovascular, and infectious disease. Some of the CROs manage only a part of the trial, for example reviewing the clinical trial data collected by a clinical investigator. Others are specialized in regulatory support, data analysis, or clinical trial management. Bigger CROs offer to manage all aspects of the trials. And while they perform the trial, the sponsor is the one responsible for the integrity of the trial and the data behind it. Cutting costs on the development of new medicine arguably allow pharmaceutical companies not only to lower prices but also to develop drugs and treatments for rare diseases which have a smaller market.

There are over a thousand companies in the world that are contract research organizations. Most of them are small and have a revenue below ten million dollars, but there are large companies too. The top 10 in 2016 controlled around 80% of the market. Not all of their revenue comes from clinical trials, but the top 5 companies in this field in 2016 were:

1. IQVIA which reported revenues of 7.8 billion USD. It has facilities across the globe in 100 countries, which includes a wide portfolio of clinical research and post-research services (92), and employs 50 thousand people.

2. Laboratory Corporation of America Holdings is second on this list with a bigger revenue of 9.4 billion, but with a smaller portfolio of services (31).

3. Parexel which has the second number of services (79), and a revenue of 2.4 billion.

4. Pharmaceutical Product Development, LLC is present in 47 countries with 89 offices and 19 thousand employees.

5. Inc Research Holdings, Inc. which is very focused on Phase 1 to 4 of clinical trials, with 6800 employees in over 50 countries on six continents.

PRA Health Sciences, Inc. is another expert in clinical development with 70 offices all around the world, with over 13 thousand employees.

Not all pharmaceutical companies outsource their clinical trials, partly or in full. Reportedly, in 2013 two large European pharmaceutical companies Roche and Novartis each had almost 1000 active trials, spending between 5.5 and 7 billion dollars on this alone.

Clinical Trials in Developing Countries

In the last few years, there has been a shift from conducting clinical trials in developed countries toward those conducted in developing and emerging nations. It is very common that clinical trials are conducted in different countries at the same time. There are different reasons for shifting to developing nations and while there are some practical reasons, as for example to test a vaccine you need the population to be in great number subjected to the disease at hand, there are financial reasons as well. One NGO claims that currently one in every two drugs sold in Switzerland has been at least partly developed on the basis of clinical trials conducted in developing or emerging countries. The reasons they mention for this change is that it’s not only cheaper, but there are much fewer regulations, or at least they not as strict. This fact might lead to a serious breach of ethical standards, however. Almost half of these trials are never made public and therefore we have no idea what kind of risk the volunteers have been subjected to. In their conclusion, they claim that in the case of Switzerland, one of the most developed nations of the world, it is impossible to determine which clinical trials ultimately lead to the approval of specific drugs.

A joint study by a number of organizations from December 2016 in Egypt illustrates how clinical trials are run in developing countries. Egypt has become a very attractive destination for clinical trials for a number of reasons, leading it to host the most trials in the Middle East and North Africa. The country itself has a good research infrastructure and a fast-growing population, which has been described as “treatment-naïve”. In other words, most of the population is not fully aware of the risks from participating in these trials. The costs in Egypt are also lower than other similar countries. In addition to this, almost 50% of the population has no health insurance and the costs of treatment represent a huge burden on the affected population. This leads to the problematic situation in which poor people are joining clinical trials because this is the only way for them to have access to medical treatment. Even if the results of the trials are not certain and can be risky. This opens the door for possible exploitation of these populations.

Luckily, most of the trials are late-stage ones with products which have already been available in developed countries. In fact, this is in accordance with Egyptian laws which only allows testing products that have already been approved in other countries. Still, around 16% of the trials in Egypt are in phase 1 and 2. The problem in Egypt is that there is no robust legislation governing trials and the governmental bodies can interpret differently the conditions necessary for the trial to be conducted. Furthermore, one of the biggest problems is that the drugs on trial are not systematically available to most of the population. This fact goes against certain ethical standards by not allowing participants to more freely choose if they want to volunteer in the trial or not.

The problems from the example of Egypt are present in many other cases, as well. In 2013, a similar report was presented regarding phase 3 trials in Argentina. Similar to the case of Egypt, a lack of clear legislation rules led to certain companies taking advantage of enrolment of babies in trials who are from very poor segments of the population. Another problem is an improper use of placebo trials and most importantly the discontinuation of treatment after the trial was over, not to mention the lack of any compensation from problems arising from the trials.

More reports show that there are no exceptions. One of them reporting on Zimbabwe, stresses the same problem that “limited access to health care and weaknesses in clinical trial oversight in these countries leave room for possible violation of the rights of vulnerable test subjects”. The story is similar as with other cases involving a bad health care system which is incapable of addressing major health challenges, such as a very high morbidity and mortality rate, high levels of almost 15% of adult population is infected with HIV/AIDS, tuberculosis is the second leading disease in Zimbabwe and malaria. The high number of patients is very suitable for clinical trials to be conducted especially in later stages.

One of the most famous cases of trial abuse happened in India when a vaccine for rotavirus infection was tested. Rotavirus is responsible for about 5% of yearly deaths of children around the world. The trial was funded by a number of private and governmental institutions, including the US National Institute of Health. Around 6800 infants have enrolled in the study and two-thirds of them received the new vaccine. One third got a placebo drug. The problem is that at the time there were two other highly effective vaccines previously developed. Under such circumstances, using a placebo seems morally wrong. And it could never happen in developed countries like the US.

Clinical trials in developing and emerging nations do not have to be on their own problematic, but as we see there seem to be a number of concerns. The trend of moving trials toward the “less-developed” world will only grow for a number of reasons. As previously said, the number of volunteer and participants in developed countries is not very high which makes trials hard to conduct and last longer. While there are clear problems with consent in previously reported cases of Egypt, Argentina, India, and Zimbabwe, it is also clear that recruitment there is much easier and higher in numbers. Sadly, the cost of the studies also dictates where they will be conducted. Lower costs mean moving clinical trials into those areas of the world. It should also be said that legislation in most of these countries does indeed put high obligations towards those conducting the trials, but the general lack of funds put the regulatory commissions in a situation in which they cannot properly do their work.

To address the problems of ethical principles in human experimental research there have been different proposals and declarations. The Declaration of Helsinki has been regarded as the most important one, developed by World Medical Association. Sadly, the declaration is still broken in countries where the governmental agencies are unable to fully control the trials.

Clinical Trials in Developed Countries

In developed countries, the guidelines and laws regarding clinical trials are followed more strictly and each country has a governmental agency in charge of overseeing compliance with local laws. It is also true that in the developed world the chances for litigation are much higher. This is because of the more regulated legal systems and also because of the possibility of bad publicity.

In the US, the Food and Drug Administration is the body which oversees how the trials are conducted. The clinical trial for drugs comes as the third step in drug development process. First, we have the discovery and development process, where thousands of compounds are tested and only a few look promising for further study. After the initial discovery, the development includes further experiments to determine the biochemical potential of the compounds, the possible dosage, side effects, and interactions with other drugs. The second step is the preclinical research. At this stage of testing anything on humans, researchers must know if there is the potential for serious harm. The research is done both in vitro and in vivo. During the preclinical research, there are already very serious regulations under good laboratory practices. These define the minimum criteria for the personnel, facilities, and equipment, as well as, operating procedures and protocols. The researchers must develop a system of quality assurance according to the FDA regulations.

The clinical research comes as the third step. The FDA makes great efforts to protect volunteers who participate in these trials from unreasonable and significant risk. When a trial is submitted, it is either approved, delayed, or stopped. These decisions are made in thirty days. The reasons for the delays are normally high-risk factors, investigators not being qualified enough, misleading participant information, or that there is not enough information regarding the risk. This shows that FDA cares greatly that the participants are aware of any possible risk or harm from the study. Normally, the FDA does not stop a trial instead it provides comments about how the study can be improved.

The clinical trials are conducted in accordance with good clinical practices, including adequate human subject protection. Good Clinical Practice (GCP) is an international ethical and scientific quality standard of conduct, performance, monitoring, analysis, and reporting of clinical trials. Compliance with GCP is now a legal obligation both in the US, as well as, the UK/Europe for all trials involving the investigation of medicinal products. The GCP considers side effects as it determines that a trial can only be conducted if the anticipated benefits justify the risks. It also includes having an informed consent is necessary from every subject and that the rights and safety of individual participants prevail over the interests of science or society.

In the EU, The European Medicines Agency (EMA) is not the one which is responsible for approving the trial. Instead, each state member has its own national agency, but it does work on harmonizing exactly the coordination of GCP in the EU. As well, most trials are conducted in more than one-member state the EMA is then the one responsible for helping and coordinating the work of other institutions involved.

Artificial Intelligence and Medicine

Artificial Intelligence (AI) has become a hot topic in recent years. Articles detail the potential of AI to solve numerous problems and to create new opportunities. However, often it is not truly clear what is meant by AI. One of the founders of the field of AI, John McCarthy, defined AI as the science of making intelligent machines that are mostly computer programs. AI replicates the ability that humans have, and some non-humans, to take in different information, calculate different odds, and make strategies to achieve the set goals. Given that computers are more available and sophisticated the applications of AI will increase in the near future. AI might not be suited for every task, but it has a number of advantages over human intelligence. First, machines can do the computational work much faster than humans. For example, we use navigation system on our phones to get the fastest or shortest route. Humans have been using maps for hundreds of years, and in principle could do the same calculation, but it would take us much longer. And getting the information on traffic, as well as processing it, would take us hours. Also, computers don’t get tired, they don’t get emotional, and they don’t have biases. There is no deviation in their application of an algorithm for computers. With the same input, you get the same output from a computer. Humans are far from that fast or consistent.

AI is everywhere these days from the keyboards of our phones, which guess what we are about to write using predictive text, to self-driving cars, and recently developed AI that predicts what kind of real-estate you want to buy. Google has enhanced its application and services (search engine, Gmail, YouTube, Google Street view, and others) with AI obtained from the DeepMind’s. DeepMind’s AlhpaGo project made a breakthrough with deep learning and recently has developed an algorithm which can learn solely from reinforcement without human help or input.

In April 2017, The New Yorker published an article describing how AI can help with medical diagnostics. In fact, for the last twenty years, different computer interpretations have been introduced to track electrocardiograms, the machines that track hearts electric activity. In mammography, computers have had a great impact on a study from 2007 showed that these machines had problems detecting small, invasive breast cancers, which are the hardest to detect. The detection of these kinds of cancers further decreased with the introduction of computer aid. The problem was that machines could not “learn” from examples. These limitations are becoming solvable. A paper in Nature from February this year shows that AI outperforms dermatologists on skin cancer diagnostics and that it can help with detection of early skin cancer with competency levels comparable to real dermatologists. The researchers further claim that this so-called deep neural network AI can be used on smartphones, which would extend the reach of dermatology tests outside of clinics for a very small cost. In the UK at the University of Nottingham, researchers developed a system that scanned patients’ routine medical data and predicted which of them would have heart attacks or strokes within 10 years. The accuracy of the software was higher than ordinary diagnostic methods. New research from the University of Adelaide in Australia helped in developing a computer-based analysis that can predict which patients would die within five years with 69% accuracy. This percentage is comparable to predictions made by real doctors. But while doctors need to spend years of practice to achieve this level of accuracy, the AI can be applied with more ease and to a larger number of patients. The researchers predict that with more data the accuracy of the AI will get higher.

In general, the application of deep-learning will have a great impact on medical diagnostics and treatments. Computer scientist Geoffrey Hinton claims that it is just a matter of years before we have learning algorithms which will be capable of reading CT scans, X-rays, and MRIs better than doctors are. In fact, very soon in Denmark an AI will be listening to all calls to emergency services to help detect cardiac arrest. The software uses speech recognition to transcribe the call before analyzing the text for specific possible cardiac arrest signs. Determining cardiac arrests has been difficult for human operators because of the distress of the callers and their lack of medical training.

But, AI does not have to fully exclude medical professionals from diagnostic procedures. It can help by being a second opinion as if another doctor. The Human Dx platform aims to help with that and to improve the accuracy of individual doctors. The application uses machine learning to automatically learn from patterns in data and then crowdsources to get the best medical knowledge from thousands of doctors from seventy countries. The application helps in providing specialist advice to general medical doctors, which offer care to many people. The physician can, before starting any treatment, post a question and even upload photos, test results, and any other relevant data, so that other doctors who are part of the network can give their opinion. The software, over a couple of days, analyses all the answers and aggregates them into a single report, after collating the most likely diagnoses.

The functionality of A Clinical Trials Platform

AClinicalTrials.com is an AI involved platform designed to provide help to anyone interested to participate in clinical trials. The website will offer the unique service of searching a database of over three hundred thousand trials from all over the world. It will use AI to determine which trials are suitable for the individual in question. The AI will capture the information and any behavior of users to recommend solutions to the next user. In time, it will become proficient and will mimic the role of a medical expert. The algorithm will use millions of inputs from users, medical experts, and crawling websites related to a particular condition in a matter of seconds. The way our search engine works is that the user searches for a condition and the results are then displayed via a network of branches showing annotations from each country with statistics for each trial, the history of a certain trial, the past results, and the institution’s reputation. The AI application then guides the user to find out exactly what they are looking for with questions such as what stage is your condition at, and what are the timelines for your treatment. Using these inputs, the AI application then looks for the best possible option for the user to make sure the correct trials are recommended. The AI application suggests more solutions and asks questions in sequence until it has determined that the user is finished their search. The AI then saves these logs to be utilized later with similar conditions and also keeps logs of each search conducted so that it can learn from it. Over time, the AI will get better and faster in recommendations. It will also be able to “understand” which questions are more informative than others thereby making the whole process smoother and more precise.

This platform will be able to offer a second opinion from professional medical experts. It will also assess published work in medical journals and be able to compute all the data to determine the success rates for each recommended trial. Not only that users will be able to quickly search the database, they will also be able to upload their medical information, while their privacy is completely protected, and the AI will use this data as well when searching the database of suitable clinical trials. The platform using AI for searching clinical trials will have a number of benefits for users. The amount of time needed to find the right clinical trial will be lower, which is very important when life-threatening conditions are in question. There will be no need to see a human doctor and the search itself will be much faster. We have already seen that AI diagnostics work even better than real life humans, moreover, AI is not biased in any way and no possible ethical misconduct is possible when a trial is recommended. This is important as doctors have been under pressure to behave in the most ethical manner when suggesting clinical trials. The AI in the platform has no possible conflict of interests. The platform will also help with other practical issues when a trial is chosen such as helping with possible travel arrangements and any costs of a particular trial.

Individuals could cut costs for their treatments by using this AI driven platform. The AI would be able to find the best possible deals for travel to another country for trials. Many people get discouraged by the travel costs associated with some trials and therefore stay with trials provided by their local health institutions. But, an algorithm could find much better deals for travel and present them on the same site alongside the trials themselves. Currently, there is a lack of concern for those who are not able to afford their health insurance. In the US, citizens pay 3.4 trillion dollars a year for medical care. In 2012, this came out to almost 10 thousand dollars per person. The numbers are steadily growing so that it is expected to be 15 thousand dollars per person in 2023. The cost of medical care in the US is growing twice as fast as that in any other developed nation. A patient diagnosed with breast cancer, depending on the stage of their illness, will have to pay between sixty thousand, and one hundred and thirty-four thousand dollars on average in the 24 months after being diagnosed. In general. the costs of drugs and treatment are much higher in the US than in the rest of the world. From simple drugs to MRI scans and hip replacements, the US is the most expensive country in the developed world for medical care. But, medical costs do not seem to follow other costs of living or income, so there is a strange discrepancy.

It is the costs of traveling, the difficulty of arranging such trips, and the uncertainty of the quality of services at the trials which are the main factors that discourage people from the US from considering participating in trials in other countries. And, those who do not have health insurance in the US are at the greatest risk. But a platform that helps with all this plus takes into account the experiences of previous patients and the success rate of the treatments globally, all these hurdles would lessen. With many options, the average individual would be in a much better position to make the best decision for their well-being. The AI technology which is now being developed could add longevity by providing quicker solutions.

Therefore, the users of this platform will be able to make the best decision on the potential success rate and other information about the trail which they may find important. All this will be possible without any special consultation or any medical background. In general, the process of participating will become much easier than it is now, which will boost the participation rate in trials which is very important for the later stages of the trials. In this way, not only will the individual participants gain a lot from this platform, but the platform will also help to increase the successful running of the trials.

Story of Kathleen Barnard

Kathleen Barnard’s story is a powerful example of the potential positive impact that a platform like A Clinical Trials could have. In 2003, Ms. Barnard was told that the lump in her arm was just fatty tissue. However, a second lump turned out to be cancerous. She was diagnosed with Stage 4 Metastatic Melanoma. Her instinct was to fight the cancer even though she was aware of the fatal potential of her diagnosis. After six months of standard treatment including chemotherapy, her cancer had spread to her lung. At this point, her family pushed hard to see if she could get access to experimental treatments. Cost of these treatments was high, but she was able to participate in a clinical trial. This treatment was able to eventually put her cancer into a state of remission. The trial protocol did help her for a time but in 2007 her cancer reemerged. In between her two bouts with cancer, she had become an advocate for treatment options for cancer patients. For her second cancer treatment, she once again accessed newer treatment options. Her advocacy includes dealing directly with the government and the pharmaceutical industry to make treatment options available to cancer patients. She also works to help cancer patients fundraise to cover the cost of their treatment. Had Ms. Barnard had access to a platform such as A Clinical Trials she would have potentially been able to locate and access these experimental treatments quicker. The added elements of assisting with travel set-up and the possibility of help with costs are also aspects of the platform that could have greatly assisted her and other cancer patients. Her cancer journey began in 2003, but her advocacy work shows how many cancer patients still need the help that she struggled to find. This help could potentially exist in the A Clinical Trials platform.

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