Joining A Cancer Clinical Trial? 10 Things Every Patient Should Ask.

What are cancer research clinical trials?

Cancer clinical trials aim to establish better ways to prevent, diagnose, or treat cancer or manage patient symptoms. Every advance in cancer treatment in recent years has come out of a clinical study. Without cancer clinical trials, new treatments could not be approved, so clinical trials are essential for advancing medical progress.

Yet, only 15% of cancer patients are aware of clinical trials as a treatment option and only 5% take part in clinical trials. This low participation rate can be explained by many reasons, one of them being the lack of information about clinical studies and the difficulties that many patients face when navigating the clinical trials jungle in order to find a study suitable for their needs and preferences.

Here are 10 things every patient should ask when looking for a clinical trial:

1. How to participate in clinical trials I’m eligible for?

In order to find a cancer clinical trial, you have the possibility to use governmental registries such as ClinicalTrials.gov or the EU Clinical Trials Register, where you can find studies conducted in a chosen location and for your specific disease. However, most patients find it difficult to navigate these websites as they are primarily made for researchers, scientists, and doctors. You might find it overwhelming to have to go through a very long list of clinical trials.

To know if you may be eligible to participate in a trial, you have to check the inclusion and exclusion criteria that make up "eligibility criteria" in each trial listing. This is where the profile of cancer patients the trial is looking for is described.

• The inclusion criteria are a list of characteristics that allow a person to enlist in a trial. For example, some studies will require that you are not older or younger than a certain age, or that you have a specific genetic mutation or a certain tumor size.
• The exclusion criteria, on the other hand, are all the factors that would disqualify you from participating in a study. For example, you might not be eligible to enter a specific study if you are taking other medications or if you are pregnant.

However, going through the numerous eligibility criteria written in medical jargon can be very time-consuming and confusing.

An easier way of finding a cancer clinical trial matching your needs and patient characteristics is by using a clinical trial search tool, such as Ancora.ai, which will help you narrow down a list containing only the trials you are potentially eligible for and closest to you. The search tool will ask you a list of specific questions around your health status, age, gender, and previous treatments and will automatically filter down to the trials most suitable for you. In order to obtain the most appropriate results, we recommend that you write down any questions you are unsure about and ask your doctor for input. If you are still unsure about whether you qualify for a study, you can ask to be put in contact with the study coordinator, who can then help you assess your eligibility.

Ancora.ai also offers additional features, such as the possibility to save all the trials of interest to you in a dashboard, so that you can easily come back to them anytime in the future. Moreover, you can also directly share a trial listing with someone else, such as a family member or your doctor, by entering their email address. Ancora.ai will also automatically send you a notification to your inbox whenever a new trial you are eligible for is opened, that way you can be sure you don’t miss any new developments.

2. What cancer clinical trials are near me - How often and how far will I have to travel?

Traveling to a clinical trial site can be an unexpected challenge for many cancer patients, especially if you are already feeling unwell because of your disease or side effects caused by treatment. In order to limit the distance you will be required to travel for treatment, you can check if the trial of your choice is available locally. To help you with that, most clinical trial listings and search tools (such as Ancora.ai) offer an option to narrow down your research to studies that are located near your home.

It is also important that you ask the trial coordinator how often you will be required to travel to the trial center. For example, some studies require the patients to receive a daily infusion of an experimental agent, while in others, patients are required to take an oral drug at home and only need to travel for monthly check-ups. Also, keep in mind that phase 3 studies are generally conducted in multiple trial sites, while phase 1 studies are usually more restricted in the number of trial locations. Sometimes, travel costs will be reimbursed by the trial sponsor, however, it is best to verify this is the case by asking the trial staff.

3. What are the goals of the clinical trial, and do they match what I’m looking for?

You will find this information in the study protocol, which is a written plan describing how a clinical trial will be conducted. It is important that you have a clear picture of the differences between the new treatment being tested and the other established standard-of-care treatments that you might otherwise be prescribed. You should also be aware that the new drug might not work as planned.

Moreover, you should make sure you understand what is being studied in the different clinical trial phases and decide which one is the most appropriate for you. For example, if you are concerned about side effects, it might be better for you to enroll in a phase 3 trial, as the most common side effects might already have been discovered in the previous phases. On the other hand, since phase 2 and 3 are conducted to investigate if a new experimental drug is better in comparison with an approved drug, you might end up not receiving the new treatment, but rather receive an established standard-of-care treatment instead. Many studies are blinded, meaning you will not know whether you are receiving the experimental treatment or another standard-of-care treatment.

In some trials, a group of patients will receive a placebo (a treatment with no therapeutic value), however, for ethical reasons, this is rarely the case in cancer trials.

While searching for a clinical trial, you will often find bits and pieces of the information mentioned above in the clinical trial listing available online, however, the amount of detail provided varies widely across studies. Make sure you ask the study coordinator or your doctor if anything is unclear to you.

Ancora.ai offers additional helpful features to its users; each listing shows you if the drug used in the trial has already been approved by the FDA (the FDA is the US regulatory body that approves new treatments before they can be prescribed). Sometimes treatment is approved for one type of cancer already and is then evaluated in trials for additional types of cancers. Previously approved treatments are usually already well-understood in terms of safety and side effects, which can make them attractive choices for cancer patients looking to participate in clinical trials. Ancora.ai also tells you what the route of administration is, i.e. how you will receive the drug (e.g. infusion, oral tablet, injection...). If you have a preference, this can be useful to check. The website also offers a chat function that is ready to answer your questions at any time. 

Before you enroll in a trial, you will be put in contact with the study coordinator. For any clinical trial, researchers are required to submit a study protocol describing in detail how a clinical trial is to be conducted. This protocol is then reviewed by an institutional review board (IRB) that will approve or reject the study of an experimental treatment.

The trial protocol includes the following information:

• Why the study is being conducted and what researchers hope to learn from the study
• What kind of treatment will be administered (e.g. name and dosage of drugs, results of previous studies conducted with the same treatment regimen)
• Which phase of the study is being conducted and how many people will be enrolled
• Who is eligible for the trial (inclusion and exclusion criteria)
• How the treatment will be given
• What tests will be done during the study and how often they’ll be done
• Other information that will be collected on participants
• How long the study will last

4. What does the informed consent document say?

As a patient, once you decide to get involved in a clinical trial, you will have to provide voluntary consent by signing a written consent document. This is a legal document that states that you have received information about your treatment options and that lets your doctor go ahead with the treatment plan for the trial. By signing the informed consent form, you agree that you or your representative fully understand the parameters of a given trial and are willing to participate in the study. Remember, however, that it is your right to leave the study at any time and for any reason.

Informed consent is a process through which you learn details about the trial by asking questions and speaking with the research team, which is made up of doctors and nurses, before deciding whether to take part.

You should make sure you understand the following points:

• The purpose of the research
• How long it is expected to take
• What procedures will be performed on you during the trial
• The risks and benefits that can be expected while participating in the trial

Additionally, the consent form should clarify the following information^[1]:

• A statement saying the study involves research
• Your participation as a clinical research subject is made on a voluntary basis
• Any possible discomfort (e.g., injections, frequency of blood tests, etc.)
• Any alternative procedures or treatment (if any) that might benefit the research subject
• How the participant’s information will be kept private during the clinical trial
• Whether any compensation (payment) or treatments are available if an injury occurs and where that information may be found
• The research subject's rights; such as the right to refuse treatment or stop participation in the clinical trial at any time, without losing any treatment benefits
• Contacts for answers to questions related to the clinical trial and to report any injuries that may occur

5. What about cost? Will my insurance cover it?

It is important to clarify any costs and insurance questions before enrolling in a clinical trial. In most cases, the trial sponsor will provide the treatment at no cost and will pay for any doctor visits, special tests, and procedures. Some trial sponsors might also offer to pay a fee for transport and travel time.

Additionally, there are extra costs that are not part of the treatment, like transportation and accommodation costs, that you should also take into account before accepting to participate in a trial. It is very likely that you will have to commute to get to your trial site. Sometimes trial sponsors cover these types of costs and for the time you spend traveling. It could be either directly paid by the sponsor, or in the form of vouchers or fixed stipends.

Since costs coverage and reimbursement vary from one study to another, make sure you clarify all these points with the clinical trial coordinator, your insurance provider and your doctor, before you enroll in a study.

6. Will I receive any follow-up care after the clinical trial is over?

You may wonder what happens once the trial has ended and whether you will be able to continue the treatment if it has been shown to be beneficial for you. The transfer of care during the trial to after the trial can vary from one study to another. Sponsors are not obligated to offer you access to treatment after the end of the trial, however, they are required to inform you about your options before the beginning of the study.

Different scenarios are possible. For example, sometimes the manufacturer of a treatment will offer compassionate use of the drug on humanitarian grounds, in cases where the trial drug provided significant benefit to the trial patient and/or stopping the investigational treatment would likely lead to deterioration of the patient’s overall condition. If the investigational treatment didn’t show enough evidence that it was better and/or safer than established cancer treatments, then patients will be transitioned to other forms of medical care suited to their specific disease.

7. What is the difference between an interventional and an observational trial?

In order to decide which type of trial is best for you, it is also important that you understand the different clinical research terminology used by researchers.

Clinicaltrials.gov currently lists more than 330,000 clinical research studies in 210 countries. Out of these, about 80% are interventional and 20% are observational. But what is the difference?

• Interventional studies are cancer clinical trials in which participants with the same conditions or disease are (usually randomly) assigned to one of two or more groups. One or more group(s), called treatment or experimental arms, will be given the intervention, which may be a drug, medical device, or another type of treatment. The other group(s), called the control arm, will receive an intervention that is considered effective (the standard of care treatment), a placebo, or no intervention. Outcomes in the treatment arm will be compared to the control arm in order to determine if there was any significant difference, for example in safety or efficacy.
• Observational studies are studies where researchers observe the effect of a risk factor, diagnostic test, or other intervention on a group of participants with the same disease or condition, over a period of time, without influencing who is or who isn’t exposed to specific interventions/treatment. 

8. What are the different types of treatments that can be investigated in a clinical trial?

Clinicaltrials.gov classifies treatments into ten categories: behavioral, biological, combination product, device, diagnostic test, dietary supplement, drug, genetic, procedure, radiation. In order to make things easier for patients, Ancora.ai has created individual icons and filters that are helping users to narrow down the list of trials in your search results according to your preferred type(s) of treatment. For example, if you are interested in receiving a drug rather than with radiation therapy or a dietary supplement, you can filter to only show the clinical trials which test new experimental drugs.

9. Why do some drugs have bizarre or multiple names?

If you scroll down a list of cancer clinical trials, you will probably notice that some drugs have names that sound like they are coming straight out from another galaxy, or that multiple names are referring to the same drug. The reason for this is that drugs often go by several different names depending on the context. At the time of its discovery, a drug is often given a chemical name, which describes its atomic and molecular structure. This name is usually too complex and cumbersome for general use, researchers usually create a shorthand version of the chemical name or a code name (such as CAN04).

Once a drug is approved by the FDA, it receives a generic and a brand name.

• The generic name is chosen by official agencies, such as the International Non-proprietary Names, British Approved Names or United States Approved Names, following specific guidelines. It is usually more complicated and harder to remember than a brand name, as it’s often a shorthand version of the chemical name.
• The brand name is decided by the company that requested approval for the drug. It is usually catchier and easier to remember than the generic name.

As long as a drug is under patent protection, it is marketed under its brand name. Once the drug is off-patent, other companies that have filed for approval are allowed to market the drug under its generic name or under a brand name that they have created. As a result, the same drug can be sold under either its generic name or one of various brand names.

10. What does IRB approval stand for?

All cancer clinical trials must be approved by an Institutional Review Board (IRB), which reviews research protocols and related materials (e.g. informed consent documents) to ensure the protection of the rights and welfare of human subjects of clinical research. We recommend that you ask the clinical trial staff whether the trial of your interest has been approved and/or check whether the Office for Human Research Protections has registered that specific trial.

You should only enroll in trials that have been approved by an IRB.

Enrolling in a cancer clinical trial can seem daunting, however, it can give you access to innovative, cutting-edge treatment options before they are widely available. By joining a trial, you will also help move clinical research forward and contribute to making novel therapies available for other patients in the future.

Remember that it is your right to ask questions to make sure you understand every aspect surrounding a particular trial as they are all unique. In order to make that process easier for you, we have prepared a list of questions you may want to ask the clinical study team before you decide to take part in a trial.

Sources

^[1] Informed Consent for a Clinical Trial | American Cancer Society

Valérie Boujon

Valérie is passionate about healthcare, science innovation and research. She holds a Master’s in Biomedical Sciences and previously worked in experimental stroke research at the Charité in Berlin. She strongly believes in making access to medicine easier for all patients and a world free of cancer and other critical diseases. Valérie’s experience is in startups supporting the development of healthcare products and services, and also as a patient lead.

www.ancora.ai/

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