Before we can match you with clinical trials, we need your medical records. Fill out the consent form on the left. Have any questions about consent?Call 844 627 7246
Request for Clinical Trial Matching System (CTMS)
Services from Massive Bio, Inc.
Clinical trials are a great opportunity for advancing medicine and allowing patients the possibility for being treated with the newest advancement for treatment. However, patients can find sorting through the complex terminology and determining eligibility for clinical research studies overwhelming, and doctors are not always knowledgeable about all currently available studies. Massive Bio, Inc (MBI) is a healthcare data analytics firm that uses their Clinical Trial Matching System (CTMS) to aid in comparing an evaluation of a patient’s existing clinical information to current research enrollment characteristics in order to identify possible matches. Massive Bio provides a report of these potential matches for further review by the patient and his/her healthcare provider.
Although the report will suggest possible matches, MBI does not guarantee acceptance or enrollment in any clinical trial. After review of the report, it is the patient’s responsibility to work with their healthcare provider to reach a final decision, prepare documents, and apply directly to the sponsor of the applicable trials. No patient is obligated to enroll or complete any of the research suggested in the report. Through their concierge support service, MBI will help answer questions regarding clinical trials and help prepare paperwork to minimize as many barriers to enrollment as possible.
This document will serve as a description of CTMS services and limitations and my consent to these services.
I (the Patient) understand that Massive Bio’s CTMS includes these services (“Services”):
- Collection of my medical records, treatment history, scans, and clinical information relevant to my disease, for the purposes of extracting the necessary information for anonymized review and analysis by MBI’s CTMS technology tool. The CTMS output will be reviewed by their team of experienced oncologists and researchers relevant to the specific disease subtype in order to finalize the possible matches of my records to applicable clinical trials.
- A representative from MBI will review that report through a customer support call to me and my healthcare provider to answer any relevant questions and clarifications regarding the released analysis report. My healthcare provider can choose not to be present during the customer support call to me.
- My healthcare provider, in his/her sole discretion, may find it necessary to amend the reports from MBI due to details from my medical history that were not available at the time the report was generated.
- After review of the report, although I will need to work with my healthcare provider and the specific study coordinator to formally enroll in the trial, MBI concierge services/customer support will be available to help assist with enrollment but cannot guarantee enrollment into any clinical trial.
- In the event that I am eligible for a clinical trial as determined by CTMS report, MBI will assist me with the following Concierge Support services:
- Working with my primary healthcare provider to discuss trial option(s)
- Helping me connect directly with a local study site or working with Just in Time network to initiate a site near me.
- Overcoming logistics and barriers for enrollment such as transportation. MBI cannot pay for my expenses but will assist me finding support with sponsor of the trial.
- Working with the trial site research team and insurance group to determine benefits verification and coverage to decrease any potential trial-related out of pocket expenses.
- Initial customer support activities should be completed within 90 days (3 months) from the date of the first report After that, if I desire another CTMS analysis, I can reach out to MBI to request such services.
I also understand the following disclaimers and limitations of the Services:
- MBI is not practicing medicine and is not licensed, registered, certified, and/or otherwise qualified to practice medicine or deliver medical services in any of the United States of America.
- MBI is not a healthcare provider and no patient-provider relationship is established by this request for services from MBI.
- Treatment decisions are made at the discretion of the treating physician. MBI is not responsible or liable for these decisions or outcomes from any prescribed diagnostic or treatment interventions under the order of that provider or any clinical trial sponsor.
- MBI does not make any absolute claims or representations regarding the accuracy, completeness, or reliability of its report.
- MBI does not provide medical advice or opinions and our reports are for clinical trial guidance, educational and informational purposes only.
- MBI does not physically observe or examine me, test my blood or tissue samples, or take any anatomical images for diagnostic or therapeutic purposes.
- MBI does not guarantee to find a clinical trial match to my medical records, nor do they promise to be able to search all possible clinical trials and research studies pertaining to kidney cancer. As new clinical trials become added to the system, I may be recontacted at any time to discuss a report.
- Signing this form does not enroll me in a research study. I understand that I cannot be entered into any research study without further discussion with that study coordinator (outside of MBI) and separate consent specific to that study.
- My records will remain part of the CTMS system until I request, in writing, to have them removed.
- MBI’s report is the product of a proprietary knowledge base and top expert medical oncologists’ input on my anonymized clinical data. Due to proprietary and confidentiality agreements, MBI reserves the right not to disclose the names of the specialists who contributed to the CTMS development.
- After an initial review of my clinical information, if MBI concludes, in its sole discretion, that the Services would not be useful to my healthcare provider or me, MBI may decline to process my request to analyze my anonymized clinical data through CTMS and I will be notified and removed from future match analyses.
- MBI will retain and use my protected health information in anonymized, aggregated form after the Services for research and maintenance of the MBI research database. This Request for Services constitutes the entire agreement between MBI and me with respect to this subject matter and shall be construed under the laws of the United States of America and the State of Delaware. All disputes shall be resolved exclusively by binding arbitration held in New York City.
Massive Bio’s Customer Support can be reached at email@example.com or 844-627-7246.
Please initial each below:
I represent that the medical records and clinical information provided by me or my healthcare providers are, to the best of my knowledge, accurate and complete and Massive Bio is not responsible for, or liable to, anyone for incorrect or incomplete reporting due to inaccurate, incomplete, or unreadable information received from me or my healthcare providers.
Although Massive Bio may run periodic checks for new clinical trial matches to my medical records and notify me of the updated results, it is my responsibility to request a new report if I am not able to find a good match within the first 90 days.
I understand that Massive Bio will perform these services at no cost, and agree I had the opportunity to review this agreement and clarify all questions before its signature.
I WOULD like my contact information (will not include medical records) to be shared at this time with the Kidney Cancer Association (KCA) to receive additional information and services related to living with kidney cancer and to learn about any research they are conducting.
call 800-544-3522, or email firstname.lastname@example.org
By signing and submitting this document, I am requesting the Services described above from Massive Bio;
I give my informed consent to Massive Bio to provide the Services to my healthcare provider, and
I acknowledge that my electronic signature used will result in a legally binding contract under applicable state or federal law.
Authorization to Release and Disclose Medical Records (HIPAA Agreement)
By signing below, I am authorizing my health care provider to disclose my protected health information (PHI) to Massive Bio and its medical review subcontractors. I authorize the release of all medical records, treatment history, medical data, including laboratory test results, tumor measurements, CT scans, MRIs, x-rays, and pathology results, and other clinical information relevant to my disease, along with records from other medical conditions that may affect my treatment, information on side effects (adverse events) I may experience, and how these were treated, and long-term information about my general health status and the status of my disease. Data that may be related to tissue and/or blood samples collected from me; and numbers or codes that will identify me, such as my medical record number may also be included.
My approval is necessary to receive clinical trial matching services from Massive Bio, and my signature below will mean I understand and agree to the following:
- This authorization is voluntary and has no expiration date. I have the right to remove consent at any time for any reason and/or refuse to sign it without affecting (1) my ability to obtain treatment from my healthcare provider, (2) payment for my health care, or (3) my eligibility for healthcare benefits.
- To protect my privacy and accurately identify each patient, I will need to confirm my identity (name, date of birth, and zip code) and verbally agree to a disclaimer statement at the start of each customer support call.
- Any information received as a result of this agreement will be used and disclosed by Massive Bio on my behalf in order to complete the services and maybe no longer protected by federal or state law.
- I have a right to review and/or obtain a copy of my records kept by Massive Bio, but I have no right to any other data kept by Massive Bio or other researchers.
- I understand I have the right to take back my consent for Services at any time without it affecting my care or eligibility for healthcare benefits. In order to remove my consent, I need to notify Massive Bio about my wishes and send my request in writing.
To remove consent, please contact the Clinical Research Manager –
- Phone: 917-336-3319 Fax: 844-742-8837 Email: email@example.com
- From the date I remove my approval, no new personal health information will be obtained for research or trial matching. However, I still allow MBI to subsequently deidentify my data to keep and use in aggregate form with the exception of records relating to mental healthcare, communicable diseases, HIV or AIDS, and treatment for substance abuse.
- If Massive Bio stops offering services for kidney cancer patients or all patients in general, I will be notified with alternative options for maintaining records for future clinical trial matching through the Kidney Cancer Association (https://www.kidneycancer.org/)