The Future of Clinical Trials is Now

triage-cancer-blog-future-of-clinical-trialsTriage Cancer believes that everyone should have access to quality cancer care. Sometimes, that care comes in the form of a clinical trial. We have a number of resources on clinical trials, but wanted to share with you a newer resource from one of our partners, that might be helpful for you.


One of the earliest clinical trials can be dated as far back as the famous 1747 scurvy study conducted by James Lind. Almost 200 years later, in 1946, the first randomized controlled trial occurred on streptomycin, an antibiotic we continue to use today. Over time, technology has advanced but many aspects of running a clinical trial have remained the same, until now.

Science 37 has introduced a new model and approach to running clinical trials by combining technology with telemedicine. Participants in a Science 37 clinical trial can join, receive study medications, and participate from the comfort of their home, no matter where the study is being conducted. The goal is to allow participants to join clinical research from home, and reduce the pain of travel or the inability to participate due a patient’s geographic location. For current cancer research opportunities that are being conducted in this way, please visit

Here are some potential scenarios to illustrate the differences between a Science 37 clinical trial and a traditional clinical trial:

Science 37 Clinical Trial                                             Traditional Clinical Trial

1. Initial Search & Signing Up

Jane is newly diagnosed and searches the internet to learn more about her condition. She lands on a virtual trial site.


Jane is newly diagnosed and searches the internet to learn more about her condition. She lands on an academic site’s research study page. The trial site is a 72 mile round trip from Jane’s home.

2. Being Contacted

Jane signs up online to receive more information. A study coordinator reaches out to her the following day.


Jane calls the site & is scheduled for a screening clinic visit.

3. Getting Screened

Jane is screened by phone to determine eligibility.  She answers questions about her condition.


Jane drives to the clinic site, checks in and waits to see the study staff who screen her to determine eligibility.  She answers questions about her condition.

4. Giving Consent

Upon confirming eligibility, Jane is given access to a secure website portal where she can review electronic informed consent documents. She takes time to review them while at home and discusses them with her family. She later contacts the research coordinator to complete the virtual informed consent process via phone & video teleconference. The study coordinator and investigator ensure that she understands the study & is willing to volunteer. Jane was able to schedule her virtual consent process around her busy work schedule.


Upon confirming eligibility, Jane is given the informed consent documents to review.  She decides to take them home so that she has more time to read them and discuss them with her family. She later makes a follow-up visit to return to the clinic where she undergoes the informed consent process. A study coordinator and investigator ensure that she understands the study & is willing to volunteer. Jane had to take time off from work to return to the clinic to complete the informed consent process.


5. Participation and Follow-Up Visits

Jane completes the study baseline procedures at home. These include getting vitals signs and blood work by a mobile nurse. Study medications are shipped to her home and her study questionnaires are completed through the NORA app on the study iPhone.

Jane receives a new shipment of study medications every month to her home and completes monthly study questionnaires on NORA.


Jane returns to the research clinic to complete the study baseline procedures. These include getting vitals signs and blood work by the clinic staff. She completes a paper questionnaire and is given her one month supply of study medication to take home. She is scheduled to return to the clinic every month to get a refill of study medications and to complete the study questionnaires. She has to check with her work to make sure she will be able to take time off for the next study visits.

6. Reporting Side Effects

Jane wants to report noticing a new rash so she calls her study coordinator using NORA on her study iPhone. She is advised to take a photo of the rash through NORA. The study investigator is notified and within a few hours, Jane is given instructions on how to manage the rash.




Jane wants to report noticing a new rash so she calls her study coordinator in the clinic. She describes the rash over the phone to the study coordinator who states that they will need to contact the investigator and call Jane back. After speaking to the investigator, the study coordinator calls Jane and instructs her to return to the research clinic the next day for evaluation. Jane is concerned and must ask her boss to take more time off from work to go to the clinic.

6. Study End

Jane is contacted by the study coordinator to give her instructions about completing the study. She completes some questionnaires on NORA, and ships back the remaining study medications and study iPhone. Jane joins a community of others who share her condition so that she can receive updates on the study and learn about future trials.


Jane takes a day off from work so that she can return to the research clinic for her last visit. She is accustomed to the routine of driving to the clinic, checking in at reception, and waiting to be evaluated by the research staff. During the visit, she complete some questionnaires and returns the remaining study medications to the staff.

The Patient Protections in Clinical Trials

This is the sixth blog in a series on clinical trials.  To read the other blogs in the series, visit:

For more information about clinical trials, visit:

If you are eligible and decide to join a clinical trial, you will be required to review and sign informed-consentthe informed consent forms. This can be an overwhelming process, but it is how you will learn all the details of the trial, including the potential benefits and the possible risks, and give your permission to be treated.

Who Does It Protect?

Informed consent provides patient protection as much as does for health care providers. Included with informed consent comes your right to privacy, as well as your right to a full and complete understanding of the trial.

Am I Signing Away My Rights?

Signing your informed consent papers forfeits none of the rights you might expect.  For instance, you do not forfeit your right to protections if your health care provider acts in a negligent manner.  You also do not forfeit your right to leave the trial at any point, with no penalty.

Will I Have Time to Consider This?

Informed consent is many pages of detailed information.  You will be given time to take that document home to review with our loved ones.  You will also have time to ask for clarification if you do not understand something you read.  Treatment cannot begin without your informed consent and a complete understanding of the details, benefits, and risks of participating in a trial.

By participating in a clinical trial, you are helping to advance medical science.  It is no small gift that you are giving and your rights are going to be protected.  Read your informed consent closely, talk with your health care team, and make sure that you fully understand the study before you sign it.

Clinical Trials and The Cost

triage-cancer-blog-clinical-trials-costOne of the first questions you or your loved one should consider when thinking about participating in a clinical trial is the cost and whether your medical insurance will cover it.  There is not one answer to this question, but let’s look at a big picture.

In most cases, when a patient enrolls in a clinical trial, the study sponsor provides the new treatment at no cost and pays for any tests, procedures, or doctor visits. Some sponsors go even further and pay for things like travel time and mileage.  It is important to find out what cost are covered by the study and if you will be stuck with any of the expense.  At this point, you also should look at your insurance coverage.

Private Insurance

As of January 1, 2014, the Patient Protection and Affordable Care Act required that non-grandfathered health plans (i.e. those that were not in place before March 23, 2010) cannot deny a qualified individual participation in an approved clinical trial, or deny or limit the coverage of “routine costs” in connection with participation in the trial.  An “approved clinical trial” is deemed as one that test ways to prevent, detect, or treat cancer and are funded or approved by the federal government and have submitted an FDA Investigational New Drug application (IND) or are exempt from IND requirements.  Routine costs” are those that would normally be involved in standard of care, such as doctor visits, blood tests, imaging scans, etc.

State laws may go even further in protecting consumers’ rights to participate in clinical trials.  Thirty-seven states and the District of Columbia all have laws on the books regarding clinical trial coverage.  For specific information about your state, go to


Unfortunately, the federal government does not require states to cover clinical trials through state Medicaid plans, so coverage depends on the state in which you live.  For specific information about your state, go to


Like private insurance, Medicare covers routine costs of items and services in covered research studies. Examples of these items and services include room and board at a hospital, the treatment of side effects and complications that may occur as a result of the study, and operations to implant an item that is being tested.  For a full understanding of Medicare coverage for clinical trials, go to

TRICARE and Veterans Affairs

Our military members and families also have some coverage for clinical trials.  TRICARE will reimburse the medical costs related to taking part in National Cancer Institute (NCI) sponsored trials for cancer prevention and treatment.  Veterans Affairs allows eligible veterans to participate in NCI-sponsored clinical trials at VA Medical Centers.

There is good news out there about clinical trial coverage, but you have to your due diligence.  Make sure you ask what the study covers and then get a full understanding of what your insurance covers.

For more information about participating in a clinical trial, visit or read other blogs in this series at

A New Resource for Those Considering a Clinical Trial: About Clinical Trials (ACT)


About Clinical Trials (ACT) is a collaboration between the American Cancer Society and Genentech.  Its aim is to increase patient interest in and awareness of cancer clinical trials through educational patient resources.  The idea is to empower people to understand cancer clinical trials and discuss this option with their doctors and loved ones.

Visit to learn more about clinical trials and ACT, including:

  • Six informational videos
    • Why Should I Consider a Clinical Trial?
    • How Will I Know if a Trial Is Right For Me?
    • How Should I Prepare for Discussions With My Doctor?
    • What Standards Are in Place to Safeguard Trial Participants?
    • What Is Informed Consent?
    • Where Can I Turn for Information and Support?
  • A patient discussion guide
  • Responses to common misconceptions about cancer clinical trials
  • List of helpful resources

If you prefer to talk with someone by phone about your clinical trials options, you can call the American Cancer Society at 1-800-227-2345 to request an ACT patient kit, which contains and educational brochure with a DVD and a USB drive.

Considering a clinical trial can be an overwhelming process.  Take advantage of any and all the resources out there.

For more information about clinical trials, read the other blogs in this series:

The Food & Drug Administration & Compassionate Use

The U.S. Food & Drug Administration (FDA) is the federal agency that is responsible for fda-logoprotecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The FDA recently implemented new developments in their compassionate use (“expanded access”) program in hopes of solving problems that have been created by state efforts to pass legislation making it easier for patients to access drugs that are still in clinical trials. These state laws are often called “Right to Try” laws.

The FDA’s expanded access program essentially allows terminal patients with no other medical alternatives to access investigational drugs (i.e. medical products that have not yet been approved by the FDA).

Many in the patient advocacy community have argued that the expanded access program isn’t effective enough and advocated for state legislation that would permit terminally ill patients the “right to try” investigational drugs.

There are three main problems with the “right to try” laws, however:

  1. The FDA still has complete control of programs more extensive than its expanded access program. In other words, no matter how many state laws are passed, nothing happens unless the FDA approves it.
  2. Manufacturers are constantly threatened with liability, meaning that if someone is harmed by a drug the manufacturer is going to be held liable, even though the drug is still being tested.
  3. The process to provide investigational drugs is simply too precarious for manufacturers. If a very ill patient dies after taking an investigational drug (which maybe more likely given the patient’s health), the adverse event is then reported to the FDA. These adverse events make it harder for manufacturers to get approval from the FDA.

The FDA has attempted to alleviate some of these issues by adopting two new guidelines:

These guidelines include “expanded access protocol,” “new treatment IND,” and the use of institutional review board review. In addition, only a year’s worth of the drug can be charged without the FDA reevaluating and in the case where a manufacturer does not have an active IND, a physician can submit an expanded access IND instead.

The FDA’s new program is also voluntary, and thus cannot compel a manufacturer to supply investigational drugs. More importantly, the FDA’s guidelines still do not grant immunity for participants, as the FDA can still use adverse events against manufacturers in determining whether or not to grant approval of the drug.

There is legislative pending in Congress, the Trickett Wendler Right to Try Act of 2016, which if passed, would prohibit the use of adverse events from negatively affecting possible FDA approval and would not hold a manufacturer liable if there is an adverse event.

It is still unclear how much effect the states can have if the FDA is not in complete accordance with them. Nevertheless, only time will tell how successful these recent developments will be.

For more information about the expanded access program, visit:

New Triage Cancer Resource: Quick Guide to Clinical Trials

For many reasons, becoming a participant in a clinical trial is surrounded by a great deal of Triage Cancer Clinical Trials Quick Guideconfusion. Triage Cancer wants to provide you with information about participating in a clinical trial, understand insurance coverage for clinical trials, and help you find trials that may be available to you.

Triage Cancer has created a new resource: a Quick Guide to Clinical Trials.  The Quick Guide includes information about clinical trials and resources, including:

Finding a Clinical Trial

The first step in your journey is to find a clinical trial. It is important that if you are interested in enrolling in a trial, you work closely with your health care team. Your health care team can help you identify any trials that may be a good fit for you. Sometimes, your first choice for a health care team may not be involved in any ongoing clinical trials, if this is the case and you are still interested in participating, you may choose to seek a second opinion from another health care provider.

You can search for active clinical trials through the American Cancer Society (ACS) Matching Service, the National Cancer Institute, or the National Institutes of Health.

Qualifying for a Clinical Trial

Another thing to keep in mind is that even if you are eligible for a clinical trial, it does not always mean that you will be accepted. Clinical trials must enroll patients that will not skew the final result. This may mean that you have already used a different treatment making you ineligible, the trial may already have enough patients enrolled, or you may not meet other trial criteria. However, if you are still interested in receiving a specific trial treatment, you can request an exception, but your results will not be included in the research study.

Insurance Coverage for a Clinical Trial

Another aspect of clinical trials to consider is whether or not your health insurance will cover treatment or parts of treatment and what your out-of-pocket costs may be. The ACA requires most private insurance to pay for the routine costs involved in your care. These costs include office visits, blood tests, and imaging scans that you would receive if you were already receiving the standard of care. Additionally, insurance companies cannot drop your coverage or refuse to let you take part in a clinical trial. In some cases, however, clinical trials may require additional screenings and tests that your insurance company may not cover.

Clinical trials will often cover these costs. Insurance companies are also not required to cover care from out of network providers or hospitals. The key to avoiding any surprise out-of-pocket costs is to talk with your health care team and your insurance company directly.

For more information, visit our Clinical Trials Resource Page.

Triage Cancer is also hosting a Clinical Trials 101 Webinar on August 31, 2016.

This webinar will be presented by Dr. Susan Love and Monica Bryant, Esq., and will provide tips on how to find clinical trials, dispel common myths, and explain insurance coverage for clinical trials. More information and registration.

Why a Clinical Trial May Matter to You

Triage Cancer - What is a Clinical TrialIf you or a loved one have started considering treatment options, or if you are considering making some changes to your treatment, you may want to know more about participating in a clinical trial.

What is a clinical trial?

A clinical trial is a research study that “prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Practically speaking, clinical trials are research studies that find and test new treatments or procedures (interventions). Without clinical trials, we would not have the medical and scientific advances that we have today.

The most important first step is to understand your diagnosis. Make sure you discuss with your doctor and other members of your health care team the type of cancer you have, the stage of the cancer, and what all your possible treatment options might be.

There are a few things you should know about clinical trials. First, you should know that a clinical trial is an investigational treatment or procedure. This can mean that you may be receiving something not approved by the FDA or is not approved for the specific treatment you are receiving. This does not mean that a clinical trial is a “last resort,” many clinical trials are already in place because research indicates they are likely better than the standard of care. Clinical trials aim to improve the current standard of care, and as a participant, you will receive at least the current standard of care for your diagnosis. For some patients, this means you will get an excellent level of care because they are being carefully monitored and evaluated. But what if I get the “placebo?” When we are talking about cancer care, you will not be receiving “no treatment.” You will receive the current standard of care, which means that you will receive at a minimum what other patients facing the same diagnosis will receive.

Have a conversation with your healthcare providers. If you are interested in learning what clinical trials may be available to you, ask your doctor or other members of your health care team if they offer any trials or if you are eligible as a candidate for any current clinical trials. If you are really interested in getting involved in a clinical trial and your doctor does not have any available, it may be beneficial for you to seek a second opinion or check many of the online resources that list current clinical trials. Http:// and htty:// are great resources for available clinical trials, in addition to valuable information regarding the clinical trial process.

The low down on the safety of clinical trials. There are a lot of safeguards in place for patients who participate in clinical trials. Clinical trials are designed to minimize potential risk and have to abide by a strict set of guidelines. Each trial has a treatment protocol that must be followed. This protocol is reviewed by the Institutional Review Board, or IRB, to ensure patient safety. Throughout the trial, data is reviewed to see how patients are responding to treatments, and it is determined whether or not the trial should continue.

You should also know about informed consent. Informed consent is contained in a document that you sign, which protects you as a patient. You cannot receive treatment until you have signed this legal document. In order for you to give your “informed consent” to participate in the trial, you must receive all of the information about the trial and who you can contact with questions or if you experience side effects. It also contains all of the information regarding the process, whether you will have to take any extra steps or tests during treatment, what the known risks or benefits may be, and detailed information on patient rights. When you sign this document, you are not giving up your rights. You are still able to drop out of the trial at any time and leave without penalty. As with any legal document, it is important to sign it only if you understand what it contains. If you don’t understand any part of it, be sure to ask questions.

Weighing the pros. The best possible outcome of a clinical trial is that the treatment has a positive outcome, and improves upon the current standard treatments. This may mean that patients see a better quality of life with the treatment, or that patients have a positive reaction to an investigational drug or treatment. Participating in a clinical trial gives you the ability to be an active participant in your treatment process by understanding and evaluating your diagnosis. There is a certain level of altruism involved in knowing that you may be helping other people, and are contributing to the advancement of science and research through participation.

Weighing the cons. There may be additional costs to becoming a part of a clinical trial. You may face outside expenses, such as travel, childcare, and your insurance coverage may not cover extra testing that you may need in the trial. From a more practical standpoint, there may be extra time involved that may take away from time spent at work or with your family. You may also experience negative side effects from the treatment, making it more difficult to continue working or affect your quality of life while undergoing treatment. Finally, there is no guarantee that the trial you are enrolled in will be any more effective than the current standard of care.

Taking careful consideration and weighing the benefits and risks is a necessary step in making a decision to participate in a clinical trial. And remember that even if you chose to participate in a clinical trial, you are not obligated to continue if a treatment becomes too difficult or you no longer want to participate.

Regardless of your participation in a clinical trial it is important to know where to turn for information and support. Be sure that you are engaged and educated regarding your care plan and ask as many questions as you can about your treatment. It is always helpful to have family member a friend as a caregiver, who is able to help you along the way. Having someone else join you at your appointments can serve as a valuable “extra set of ears” and they may ask additional questions.

For more information on clinical trials and to hear what patients and experts have to say, visit Triage Cancer’s resource page on clinical trials.

Triage Cancer is also hosting a Clinical Trials 101 Webinar on August 31, 2016, presented by Dr. Susan Love and Monica Bryant, Esq.  This webinar will provide tips on how to find clinical trials, dispel common myths, and explain insurance coverage for clinical trials. Register.

Stay tuned for part 2 in this series

Partner Spotlight: Pancreatic Cancer Action Network

Pancreatic Cancer Action Network’s enhanced patient services and clinical initiatives to transform the fight against pancreatic cancer 

As the leader in the field, the Pancreatic Cancer Action Network (PanCAN) is aiPANCAN - Wage Hopeming to transform the country’s system for pancreatic cancer healthcare delivery and medical research. The Clinical Trial Finder, an online tool that provides patients and healthcare professionals easy access to the most comprehensive and up-to-date database of pancreatic cancer clinical trials in the United States, is the latest initiative the organization is bringing to market for the pancreatic cancer community as part of its increased efforts to double survival of pancreatic cancer.

When dealing with pancreatic cancer, mortality can be swift so finding the right treatment as soon as possible is vital. By participating in clinical trials, patients not only have access to cutting-edge treatment but also have the opportunity to transform the treatment landscape for pancreatic cancer. According to Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network, for years, the organization has had the most accurate database of pancreatic cancer trials and are thrilled to be able to now offer public access to patients and families and the healthcare community.

With a survival rate of just 7 percent, the need for effective treatment options is critical to pancreatic cancer patients. Clinical trials are often the best option for patients facing pancreatic cancer and are the only way to find better treatment options than what is currently available. The Pancreatic Cancer Action Network’s Clinical Trial Finder is the only tool of its kind and aims to assist patients and healthcare professionals alike in finding clinical trials that could be a beneficial course of treatment.

The availability of this service will significantly impact how patients and their healthcare teams are involved in pancreatic cancer clinical trial recruitment. With more people involved in clinical trials, the closer we’ll get to finding better treatments and drugs for our patient population.

The organization’s Clinical Trial Finder and Know Your Tumor initiatives were developed in order to improve the pancreatic cancer patient and caregiver experience and facilitate medical progress. Introduced this past January, the Know Your Tumor personalized medicine service offers tumor profiling to certain eligible patients and provides them access to molecular profiling of their tumor.  The results from the molecular profiling tests are compiled into a report that is reviewed by a pancreatic cancer expert. The report highlights treatment options, including relevant clinical trials which could assist the treating oncologist in more precise and personalized treatment planning.

Personalized medicine is an emerging diagnostic tool for pancreatic cancer. Through the first phase of Know Your Tumor, nearly 50 percent of reports have revealed an actionable finding, meaning the information gained has the potential to impact treatment choices by identifying options that may have particular value in treating the patient’s specific tumor. Later this year, the organization will launch the Patient Registry, a research effort that will collect important information, such as molecular information learned through Know Your Tumor, critical to learning more about the pancreatic cancer patient population.

“By employing our comprehensive and proven approach and focusing our efforts for maximum impact, we are confident that we will make real progress in increasing understanding of and treatment for this devastating disease”, adds Fleshman.

For more information, go to
Follow the Pancreatic Cancer Action Network on Twitter: @PanCAN and #WageHope

4,000 Cancer Clinical Trials: Which ONE is Right for Me?

by David Fuehrer

If you or a loved one needs treatment for cancer how do you know which option is right?  The American Cancer Society says “trying to understand your treatment options can be overwhelming.” There are many types of treatments used against cancer, including traditional therapies and newer forms of treatment in clinical trials.

As a two-time cancer survivor and healthcare professional, I’ve learned a lot about treatment.  The most important lesson I’ve learned is that every person is unique.  What’s right for you may not be right for someone else.

Knowing your options is critical to making informed decisions.
Many physicians and support communities recommend that all patients consider clinical trials when exploring treatment options.

“No matter what stage your disease, you want to find out what all the options are right from the beginning.  The very best treatment may involve a clinical trial.”

Max S. Wicha MD, University of Michigan Comprehensive Cancer Center

Max S. Wicha MD, University of Michigan
Comprehensive Cancer Center

Clinical trials offer access to new treatments that are not otherwise available.  They provide extra check-ups to look for response to treatment and possible treatment side effects.  Clinical trials also offer the possibility of paying for part or all of your medical care during the trial.  They are an important resource for anyone fighting cancer.

But with 4,000 cancer clinical trials enrolling in the U.S., how do we understand the options?  These are FDA-regulated trials; sponsored by the National Cancer Institute, pharmaceutical companies and leading hospitals.  But each trial has a unique purpose, treatment type and patient requirements.  There is a lot to consider.

Ninety four percent of Americans have never been informed by their doctors of clinical trials in which they might participate.  The top reasons doctors don’t refer patients into clinical trials are lack of information on treatments and lack of access. (Source: Center for Information & Study on Clinical Research Participation

A new resource for patients and healthcare professionals.
I co-founded CureLauncher with an FDA-Regulatory Advisor to help patients, caregivers and medical professionals identify their new treatment options.  CureLauncher provides three important resources that previously have been unavailable: CureLauncher Staff

  • Translated trial information so its easy-to-understand
  • Access to 100% of the enrolling clinical trials
  • Matches to clinical trials based on a patient’s unique goals and conditions

Our Relationship Managers start with a simple 10-question conversation about each patient. This information enables us to match people to clinical trials that may be appropriate for them.  Our team then reviews all of the study information with them and sends summaries to review with family and the medical team.

When a patient is interested in enrolling in a trial, CureLauncher is the only service that will call the trial site to schedule an appointment on behalf of the patient. All of our services are provided at no cost to the patient or medical team.  CureLauncher is paid from the clinical trial budgets.

CureLauncher is your personal advocate. Our mission is to empower patients and medical professionals to know all of their new treatment options.  Clinical trials may not be right for everyone.  But they are an important resource that everyone should be able to consider.   To learn more about CureLauncher or clinical trials, you can visit or call our team at 800-488-6632.

Dave Fuehrer is a two-time cancer survivor and President of CureLauncher.  The organization matches people to new treatments for cancer based on their unique goals and conditions. has translated all enrolling cancer clinical trials into easy-to-understand information.  It is the only service that gives people access to ALL enrolling cancer clinical trials.  Prior to CureLauncher, Dave was an Innovation Consultant for Pfizer, General Electric and many others.  He has helped launch new products and services across North America, Europe and China.  Dave has an MBA in Technology Management and has completed Executive Education and Harvard Business School and MIT.