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    Clinical Trials

    1. What is a Clinical Trial?

      When a pharmaceutical or biotechnology company develops a new medicine, they have to test it extensively to evaluate the effects of the medicine on participants’ health and to make sure it is effective and safe enough for public use. Participating in a Clinical Trial can enable patients to be treated with a medicine before it is approved. There is no guarantee that a medicine which is still in clinical development will improve a patient's condition.

    2. How is a Clinical Trial different from an Early Access Program?

      The purpose of a Clinical Trial is to test a medicine. The purpose of an Early Access Program is to treat patients with an unmet medical need. An unmet medical need in relation to an Early Access Program means for a patient that there is no approved medicine available, or that they have exhausted all approved medicines available.

      Clinical trials normally only take place in a limited number of treating centers in a select number of countries. In theory, Early Access Programs can help patients anywhere.

    3. Are Clinical Trials only an option for patients who have exhausted all other treatments?

      No. Participating in a Clinical Trial is generally possible in every stage of treatment, however, all Clinical Trials have inclusion and exclusion criteria that a patient needs to meet in order to participate. If your treating physician thinks a particular Clinical Trial is suitable for you, and you meet the criteria for participation, you can decide if you wish to take part. Before your decision, your physician will inform you about all the details of the trial, including possible risks.

    4. How can I find a trial I can participate in?

      When you use the myTomorrows platform to search for a trial that matches your condition, we ask you to give us some basic information about yourself, including your age and location. Our search engine will then match this information with the Clinical Trial’s listed inclusion/exclusion criteria that a patient should meet. Based on the information you have provided, our search engine will show Clinical Trials and Early Access Programs that might be suitable for you.

      You can contact the myTomorrows medical team to answer any questions about the search results. You should discuss with your treating physician whether or not the Clinical Trials shown as a result would be a suitable treatment option for you.

    5. What is an Adverse Event?

      An adverse event, or adverse experience, is an unfavorable medical occurrence associated with the use of a drug at any dose. Adverse events can vary in seriousness from slight discomfort to a life-threatening event.

    6. What is “informed consent”?

      This is your confirmation to the investigators of the Clinical Trial that you have received and understood all relevant information about the Clinical Trial you are participating in, including possible risks and benefits and what the treatment will look like. Your consent is given by signing the written informed consent form after you have received all relevant information and you had the opportunity to ask any questions.

    7. Are there any risks associated with participation in a Clinical Trial?

      Yes, participating in a Clinical Trial does involve a certain level of risk. The purpose of a Clinical Trial is to discover the potential risks and benefits of a new medicine that has not yet been approved for public use. This means that during the Clinical Trial not all relevant information regarding safety and efficacy of the medicine is known. However, Clinical Trials cannot start before being approved by a review board to ensure that it doesn’t pose an unnecessary risk to patients. Depending on the phase of the trial, more will be known about the safety profile of the medicine. Before you decide to participate, both your treating physician and the investigators of the trial will thoroughly explain the risks and benefits of participating.

    8. What are inclusion criteria?

      In order to participate in a particular Clinical Trial, you must meet its requirements for numerous factors like age, gender, medical history, and current health status. These eligibility inclusion criteria are in place to make sure that the study is performed on the right people and produces accurate results.

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    Data Information

    1. From which sources does the data in myTomorrows’ web-based platform come?

      Collecting and combining data is at the heart of the myTomorrows platform. We currently collect data from global public registries for Clinical Trials and Early Access Programs as well as medical research repositories.

    2. How does myTomorrows process public data to show on its platform?

      Given the vast amount of data and sources available, we cannot claim to be conclusive. However, we do our best to process as much relevant data as possible to make medical data structured and understandable. In addition, we de-duplicate Clinical Trial and Early Access records, and clear the data through semantic web algorithms.

    3. How recent is the information listed on mytomorrows.com?

      We update our database every day to make sure that it accurately lists all the Clinical Trials and Early Access Programs currently listed on globally-accessible public registries. Please note that we only show you the active Clinical Trials and Early Access Programs that might be suitable treatment options for you based on the information you have provided to us.

    4. Why does myTomorrows ask for my personal information such as age and location?

      We ask for this personal information to help us find suitable treatment options in our Clinical Trial and Early Access database.

    5. Who has access to my personal data?

      During your initial consult, a member of our medical team might ask for additional information to help determine your treatment options. We treat your information as highly confidential and no data will be saved and/or recorded without your express consent. In the event you and your physician would like to pursue an Early Access Program managed by myTomorrows, we will again ask for your express consent to store, process and share necessary personal data with relevant employees to support the process of treatment, receving approval, reimbursement, and organizing delivery.

    6. Will my patient information be collected?

      myTomorrows will not have access to your patient records kept by your treating physician and/or other medical files. Under certain circumstances, we will collect and process your medical information when this is required and necessary for myTomorrows’ medical team to provide you with optimal service, but only after you have expressly given us permission to do so. Your medical information will be stored in a protected and secure IT-system only accessible to myTomorrows’ team members that are providing support. Read more about how myTomorrows protects your information in the Legal section at the bottom of this page.

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    Early Access Programs

    1. What is an Early Access Program?

      Early Access Programs are programs allowed through a special provision in the law that enables treatment with pre-approval medicines of patients with unmet medical needs that suffer from a life-threatening or debilitating disease and which have exhausted treatment options with approved medication.

      Different governments, companies and hospitals may use any of these terms to describe programs that provide access to pre-approval medicines:

      - Early Access Program

      - Expanded Access Program

      - Named Patient

      - Named Patient Use

      - Named Patient Import

      - Named Patient Program

      - Investigational Drug

      - Managed Access Program

      - Patient Specific Drug Import

      - Compassionate Use

    2. What are pre-approval medicines?

      Pre-approval medicines are medicines that have not been approved yet by the relevant authorities in your country. This may be because the medicine is still in the process of being tested in a Clinical Trial. Pre-approval medicines can only be accessed through an exception in the law, such as via a Clinical Trial or an Early Access Program.

    3. How do I qualify for an Early Access Program?

      You might qualify for an Early Access Program:

      - If you have a life threatening or debilitating disease

      - If you have no remaining viable treatment options with registered medicines

      - If you cannot enter an available Clinical Trial with the medicine accessible through the Early Access Program

      - If your treating physician is willing to prescribe the pre-approval medicine

      - If the pharmaceutical company developing the medicine is willing to provide access

      - If the authorities approve access to the pre-approval medicine

    4. Why do I need my doctor’s support for an Early Access Program?

      You need your doctor’s support because you will not only need a prescription for the medicine, but your treating doctor understands your full health history and needs. Your doctor also ensures that the pre-approval medicine you would like to be treated with is suitable, can inform you about how the medicine works, and possible risks and side effects.

    5. Will I be getting a placebo treatment in an Early Access Program?

      No, placebos are never used in Early Access Programs. This is because the goal of an Early Access Program is to create a way in which a patient can get access to a pre-approval medicine.

    6. What are the risks associated to treatment with pre-approval medicines in Early Access Programs?

      Taking any medicine, whether approved or not, involves a certain amount of risk: it might not have the desirable effect, you can suffer from side effects which are known or which were unforeseen. For approved medicines, the authorities have gained sufficient insight into side effects and those are included in the patient information leaflet. Even after official approval by authorities, unforeseen complications can still occur.

      For medicines that are still in development and/or not approved in your country, not all information on safety and efficacy of the product is yet available. However, in the development stage where drugs can become available through Early Access, there is already some information available regarding the efficacy and safety of the treatment. Your treating physician can share and explain the available information with you.

    7. How is an Early Access Program different from a Clinical Trial?

      The purpose of an Early Access Program is to treat patients with an unmet medical need. An unmet medical need could mean for a patient that there is no approved medicine available or, that they have exhausted all approved medicines available. The purpose of a Clinical Trial is to test a medicine.

      Clinical trials normally only take place in a limited number of treating centers in a select number of countries. In theory, Early Access Programs can help patients anywhere.

    8. Are pharmaceutical companies mandated to provide pre-approval medicines to individual patients?

      No, there is no legal requirement to provide a medicine to any patient prior to official approval. However, myTomorrows will contact and ask companies that manufacture promising medicines to see if they are willing to provide their medicine through an Early Access Program.

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    myTomorrows

    1. What does myTomorrows do?

      At myTomorrows, we believe that everyone should have access to all suitable treatment options available. We support this vision by providing three things:

      1. Providing insight into available treatment options:
      Our online platform makes it easy for you to search for treatment options in development through Clinical Trials and Early Access Programs.

      2. Access to medicines:
      Our team uses its experience with regulations, reimbursement, and logistics to help you and your physician to gain access to pre-approval medicines.

      3. Real-world evidence:
      We work with originators and physicians to bring new data from the real world back to the companies who are developing the medicine.

    2. How does myTomorrows create access to medicines?

      We start by identifying unmet medical needs. Then we partner with the medicine manufacturer meeting these unmet medical needs to make the medicine available earlier to physicians and patients.

    3. How does myTomorrows make money?

      When myTomorrows arranges for a physician and their patient to receive a medicine that is available on the myTomorrows platform, the manufacturer of the medicine is reimbursed — usually by an insurer — for providing it. The manufacturer then pays myTomorrows a fixed price for every medicine we help to make available as compensation for safe and timely distribution, and to provide all necessary support to patients and doctors.

      Once a medicine on our platform achieves official approval, myTomorrows also receives a small royalty from the manufacturer on subsequent sales of the drug.

    4. How do I know that myTomorrows is a legitimate business?

      myTomorrows was founded by Ronald Brus, a Medical Doctor who has also worked as CEO of several large pharmaceutical businesses. Our team includes registered physicians, pharma experts, and regulatory and compliance specialists. myTomorrows is fully certified and licensed by the Dutch government and is regularly audited by the national Dutch health authority.

       

    5. Is what myTomorrows is doing legal?

      Yes, it is. We constantly work with our legal experts to ensure that we operate within the boundaries of all the laws and regulations that apply to our business. The Early Access Programs we manage on our platform are based on Early Access Programs which are specifically provided for in the laws of various countries in which we work.

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    Reimbursement

    1. Do the treatments in a Clinical Trial or Early Access Program cost money?

      All medical treatments cost money, since they involve the use of not only a pharmaceutical product, but also medical staff and equipment.

      In a Clinical Trial, the cost of the whole trial, including the medicines needed, is often paid for by the manufacturer, but can also be paid for by an investigating hospital or health institution. Sometimes the patient may be reimbursed for participation in a Clinical Trial.

      In an Early Access Program, the cost of the medicine needed, is often paid for by the treating hospital, health insurance, or by the manufacturer. Additional costs, such as hospitalization or physicians’ fees, are generally paid for by the hospital and/or the health insurance. In some cases, the government will pay for the Early Access Program.

    2. Do I need to pay for my own treatment?

      No, in most cases you don’t need to pay for your own treatment. We do our best to create a situation in which every patient with an unmet medical need can receive access to a pre-approval medicine, regardless of financial status and income. myTomorrows helps to organize reimbursement through hospitals, insurance companies, and/or governments in the country of treatment. This often happens on a case-by-case basis. To find out how reimbursement is set up in your country, please contact us.

    3. Can myTomorrows help arrange reimbursement for the medicine?

      Yes, myTomorrows can help to arrange reimbursement for the cost of the medicine. We know from experience how reimbursement systems in many countries work, so we’re ready and able to facilitate this. This often happens on a case-by-case basis. To find out how reimbursement works in your country please contact us.

    4. Does a physician have any financial or special interest in an Early Access Program?

      No, that is illegal in most countries. In general, physicians and hospitals are not allowed to receive any reward for prescribing a drug, and a drug manufacturer is not allowed to offer an incentive.

Popular questions

Find answers to your questions

  1. What is a Clinical Trial?

    When a pharmaceutical or biotechnology company develops a new medicine, they have to test it extensively to evaluate the effects of the medicine on participants’ health and to make sure it is effective and safe enough for public use. Participating in a Clinical Trial can enable patients to be treated with a medicine before it is approved. There is no guarantee that a medicine which is still in clinical development will improve a patient's condition.

  2. What is an Early Access Program?

    Early Access Programs are programs allowed through a special provision in the law that enables treatment with pre-approval medicines of patients with unmet medical needs that suffer from a life-threatening or debilitating disease and which have exhausted treatment options with approved medication.

    Different governments, companies and hospitals may use any of these terms to describe programs that provide access to pre-approval medicines:

    - Early Access Program

    - Expanded Access Program

    - Named Patient

    - Named Patient Use

    - Named Patient Import

    - Named Patient Program

    - Investigational Drug

    - Managed Access Program

    - Patient Specific Drug Import

    - Compassionate Use

  3. How is a Clinical Trial different from an Early Access Program?

    The purpose of a Clinical Trial is to test a medicine. The purpose of an Early Access Program is to treat patients with an unmet medical need. An unmet medical need in relation to an Early Access Program means for a patient that there is no approved medicine available, or that they have exhausted all approved medicines available.

    Clinical trials normally only take place in a limited number of treating centers in a select number of countries. In theory, Early Access Programs can help patients anywhere.

  4. How do I qualify for an Early Access Program?

    You might qualify for an Early Access Program:

    - If you have a life threatening or debilitating disease

    - If you have no remaining viable treatment options with registered medicines

    - If you cannot enter an available Clinical Trial with the medicine accessible through the Early Access Program

    - If your treating physician is willing to prescribe the pre-approval medicine

    - If the pharmaceutical company developing the medicine is willing to provide access

    - If the authorities approve access to the pre-approval medicine

  5. Why do I need my doctor’s support for an Early Access Program?

    You need your doctor’s support because you will not only need a prescription for the medicine, but your treating doctor understands your full health history and needs. Your doctor also ensures that the pre-approval medicine you would like to be treated with is suitable, can inform you about how the medicine works, and possible risks and side effects.

  6. Can myTomorrows help arrange reimbursement for the medicine?

    Yes, myTomorrows can help to arrange reimbursement for the cost of the medicine. We know from experience how reimbursement systems in many countries work, so we’re ready and able to facilitate this. This often happens on a case-by-case basis. To find out how reimbursement works in your country please contact us.

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