Author: Aurélie Chuong, MPH, MS, Purdue Alumni – [email protected]
Earlier this year in the State of the Union address, President Obama announced that 1 billion dollars will be pledged to a new initiative spearheaded by Vice-President Joe Biden: the Cancer MoonShot 2020. For those who are not familiar with the cause,
The National Cancer Moonshot will work to accelerate these research efforts and break down barriers to progress by enhancing data access, and facilitating collaborations with researchers, doctors, philanthropies, patients, and patient advocates, and biotechnology and pharmaceutical companies. The initiative aims to bring about a decade’s worth of advances in five years, making more therapies available to more patients, while also improving our ability to prevent cancer and detect it at an early stage [1].
The Cancer MoonShot focuses on combination immunotherapy [2, 3]. In simple terms, immunotherapy utilizes a person’s immune system to prevent and/or fight a disease [4]. A great example of that are vaccines, where once administered (vaccination), an individual will start building immunity against a disease (immunization) [5]. It is important to note that vaccination is not equivalent to immunization; everyone’s immune system is different and therefore may respond differently to the vaccine, and the same holds true with other immunotherapies. But back to cancer immunotherapy, many drugs from various competing pharmaceutical companies are already out on the market and are somewhat effective but, according to experts, these drugs may be able to work better together, so the Cancer MoonShot will help in accelerating approval so these collaborations and testing of hypotheses can occur [6].
Via the Quantitative Integrative Lifelong Trial (QUILT), Cancer MoonShot 2020 aims to target 20 types of cancers, where 100,000 cancer patients will be diagnosed and their genomes sequenced, 20,000 patients assigned to next generation immunotherapy care, with an ultimate goal of a vaccine-based immunotherapy [3, 7, 8]. Data sharing will occur through a “secure web-based portal” [7], the National Cancer Institute’s Genomic Data Commons (GDC), which will house genomic (sequencing of tumors) and clinical (response to treatment) data [9, 10]. Additionally, the American Society of Clinical Oncology’s (ASCO) CancerLinQ program will be a resource for oncology professionals to learn and provide patients “the highest possible quality of care” by collecting and analyzing de-identified patient encounter information [9, 11]. In short, by interweaving the GDC’s scientific and CancerLinQ’s patient care data in the QUILT, the Cancer MoonShot 2020 will break down barriers in order to accelerate and facilitate collaboration in cancer research and care.
One of my previous PHSA blog topics focused on who owns medical data; is it the patient, the doctor, the medical institution? Now, with the Cancer MoonShot offering a new hope for cancer immunotherapy development through data sharing and collaboration, the medical data ownership question is still up for debate. But also, what about the security and confidentiality of patient medical data?
Prior to participating in a clinical trial and signing the consent form, the patient should have a thorough discussion of the protocol, the risks and benefits of participating, and what is expected of them, with the site study team. Regardless of participation in a clinical trial or not, any patient should be aware of their rights per the Health Insurance Portability and Accountability Act of 1996 (HIPAA) [11].
To keep things simple, I will not go into too much detail. However, please keep in mind that there is an extensive paper trail and everything needs to be documented as there may be audits by the government (e.g. the Federal Drug Administration (FDA)), the sponsor (e.g. pharmaceutical/biotech company), others (e.g. Institutional Review Board (IRB), fund granters), etc. After doing a quick Google search, I found Boston Children’s Hospital’s Clinical Research Center’s Research Practice Manual’s Guideline for Study Document and Data Handling [12]. In it are the data management procedures to follow at Children’s where it is clearly stated in the Procedure section that “[i]n the case that is necessary to store source documents with subject research data files, all subject identifiers and protected health information (PHI) must be removed or blacked out from the source document” [12]. In clinical trials, a patient or subject ID will be assigned so that protected health information (PHI) such as name, date of birth, medical record number, etc. is not used. In the same Procedure section of the Manual, assigning a patient or subject ID and keeping record of who is who is crucial so that no two patients are to receive the same subject ID [12]. Assigning this unique ID can depend on the institution and/or the study protocol [13]. Just as important as preserving the subject’s anonymity is how the data will be stored (i.e. in a locked area, for authorized staff only or as specified by the sponsor [12]).
Now that our society is moving towards electronic health records (EHRs) and system-to-system compatibility, how safe really is all of this, especially with cybersecurity increasingly becoming a threat in our everyday lives? One solution is the Security Risk Assessment (SRA) Tool, which is a 156-question survey, evaluating the administrative, physical, and technical safeguards as part of the HIPAA security rule [14]. The SRA tool also includes resources and explanations of potential risks if some criteria are not met [14].
What are your thoughts on the subject? If you are involved in clinical trials (as a patient or staff), what has your experience been? What are your suggestions for any other potential solutions to protect our medical records, especially in such a grand effort as the Cancer MoonShot 2020?
Special thanks to Sarah Wallace from the Mesothelioma + Asbestos Awareness Center for reaching out and Merissa Hawkins for review and edits.
[1] “FACT SHEET: Investing in the National Cancer Moonshot.” Office of the Press Secretary, The White House. Published 01 Feb 2016. Accessed 01 Aug 2016. <https://www.whitehouse.gov/the-press-office/2016/02/01/fact-sheet-investing-national-cancer-moonshot>
[2] “About Cancer MoonShot 2020.” Cancer MoonShot 2020, National Immunotherapy Coalition. Published N. D. Accessed 01 Aug 2016. < http://www.cancermoonshot2020.org/about-us/>
[3] “Cancer & Big Data.” CloudTweaks. Published 29 Jun 2016. Accessed 19 Jul 2016. <http://cloudtweaks.com/2016/06/curing-cancer-big-data/>
[4] “Immunotherapy: Using the Immune System to Treat Cancer.” National Cancer Institute at the National Institutes of Health. Published N. D. Updated 14 Sep 2015. Accessed 01 Aug 2016. < http://www.cancer.gov/research/areas/treatment/immunotherapy-using-immune-system>
[5] “Basics.” U.S. Department of Health and Human Services. Published N.D. Accessed 03 Aug 2016. <http://www.vaccines.gov/basics/>
[6] Graham, D. A. “What is the Point of Joe Biden’s Cancer ‘Moonshot’?” The Atlantic. Published 11 Feb 2016. Accessed 01 Aug 2016. < http://www.theatlantic.com/politics/archive/2016/02/biden-cancer-moonshot-duke/462288/>
[7] Cancer MoonShot 2020. “What is Cancer MoonShot 2020?” YouTube. Published 19 Jan 2016. Accessed 01 Aug 2016. < https://www.youtube.com/watch?v=WJXLHhWsS14>
[8] “What is the QUILT Program?” Cancer MoonShot 2020, National Immunotherapy Coalition. Published N. D. Accessed 04 Aug 2016. <http://www.cancermoonshot2020.org/quilt-program/>
[9] Lambert, J. “Vice President Joe Biden Discusses Cancer Moonshot Initiative During ASCO 2016.” American Society of Clinical Oncology (ASCO). Published 06 Jun 2016. Accessed 02 Aug 2016. < https://am.asco.org/vice-president-joe-biden-discusses-cancer-moonshot-initiative-during-asco-2016>
[10] “Genomic Data Commons Data Portal.” National Cancer Institute at the National Institutes of Health. Published N.D. Accessed 09 Aug 2016. <https://gdc-portal.nci.nih.gov/>
[11] “Health Information Privacy.” U.S. Department of Health and Human Services. Published N.D. Accessed 20 Aug 2016. < http://www.hhs.gov/hipaa/>
[12] Berry, M. “Guideline for Study Document and Data Handling – RPG-08.” Research Practice Manual. The Clinical Research Center, Boston Children’s Hospital. Date of Origin Aug 2008. Reviewed/Revised 28 Aug 2013. Published N.D. Accessed 20 Aug 2016. < http://www.childrenshospital.org/~/media/Research%20and%20Innovation/Clinical%20Research%20Center/RPG0892613.ashx>
[13] Van Quathem, K. “Controlling personal data in clinical trials.” Covington & Burling, LLP. Published Apr 2009. Accessed 05 Sep 2016.<https://www.cov.com/~/media/files/corporate/publications/2009/04/controlling-personal-data-in-clinical-trials.pdf>
[14] “Security Risk Assessment Tool.” Health IT, U.S. Department of Health and Human Services. Updated 06 Sep 2016. Published N.D. Accessed 08 Sep 2016. < https://www.healthit.gov/providers-professionals/security-risk-assessment-tool>
Earlier this year in the State of the Union address, President Obama announced that 1 billion dollars will be pledged to a new initiative spearheaded by Vice-President Joe Biden: the Cancer MoonShot 2020. For those who are not familiar with the cause,
The National Cancer Moonshot will work to accelerate these research efforts and break down barriers to progress by enhancing data access, and facilitating collaborations with researchers, doctors, philanthropies, patients, and patient advocates, and biotechnology and pharmaceutical companies. The initiative aims to bring about a decade’s worth of advances in five years, making more therapies available to more patients, while also improving our ability to prevent cancer and detect it at an early stage [1].
The Cancer MoonShot focuses on combination immunotherapy [2, 3]. In simple terms, immunotherapy utilizes a person’s immune system to prevent and/or fight a disease [4]. A great example of that are vaccines, where once administered (vaccination), an individual will start building immunity against a disease (immunization) [5]. It is important to note that vaccination is not equivalent to immunization; everyone’s immune system is different and therefore may respond differently to the vaccine, and the same holds true with other immunotherapies. But back to cancer immunotherapy, many drugs from various competing pharmaceutical companies are already out on the market and are somewhat effective but, according to experts, these drugs may be able to work better together, so the Cancer MoonShot will help in accelerating approval so these collaborations and testing of hypotheses can occur [6].
Via the Quantitative Integrative Lifelong Trial (QUILT), Cancer MoonShot 2020 aims to target 20 types of cancers, where 100,000 cancer patients will be diagnosed and their genomes sequenced, 20,000 patients assigned to next generation immunotherapy care, with an ultimate goal of a vaccine-based immunotherapy [3, 7, 8]. Data sharing will occur through a “secure web-based portal” [7], the National Cancer Institute’s Genomic Data Commons (GDC), which will house genomic (sequencing of tumors) and clinical (response to treatment) data [9, 10]. Additionally, the American Society of Clinical Oncology’s (ASCO) CancerLinQ program will be a resource for oncology professionals to learn and provide patients “the highest possible quality of care” by collecting and analyzing de-identified patient encounter information [9, 11]. In short, by interweaving the GDC’s scientific and CancerLinQ’s patient care data in the QUILT, the Cancer MoonShot 2020 will break down barriers in order to accelerate and facilitate collaboration in cancer research and care.
One of my previous PHSA blog topics focused on who owns medical data; is it the patient, the doctor, the medical institution? Now, with the Cancer MoonShot offering a new hope for cancer immunotherapy development through data sharing and collaboration, the medical data ownership question is still up for debate. But also, what about the security and confidentiality of patient medical data?
Prior to participating in a clinical trial and signing the consent form, the patient should have a thorough discussion of the protocol, the risks and benefits of participating, and what is expected of them, with the site study team. Regardless of participation in a clinical trial or not, any patient should be aware of their rights per the Health Insurance Portability and Accountability Act of 1996 (HIPAA) [11].
To keep things simple, I will not go into too much detail. However, please keep in mind that there is an extensive paper trail and everything needs to be documented as there may be audits by the government (e.g. the Federal Drug Administration (FDA)), the sponsor (e.g. pharmaceutical/biotech company), others (e.g. Institutional Review Board (IRB), fund granters), etc. After doing a quick Google search, I found Boston Children’s Hospital’s Clinical Research Center’s Research Practice Manual’s Guideline for Study Document and Data Handling [12]. In it are the data management procedures to follow at Children’s where it is clearly stated in the Procedure section that “[i]n the case that is necessary to store source documents with subject research data files, all subject identifiers and protected health information (PHI) must be removed or blacked out from the source document” [12]. In clinical trials, a patient or subject ID will be assigned so that protected health information (PHI) such as name, date of birth, medical record number, etc. is not used. In the same Procedure section of the Manual, assigning a patient or subject ID and keeping record of who is who is crucial so that no two patients are to receive the same subject ID [12]. Assigning this unique ID can depend on the institution and/or the study protocol [13]. Just as important as preserving the subject’s anonymity is how the data will be stored (i.e. in a locked area, for authorized staff only or as specified by the sponsor [12]).
Now that our society is moving towards electronic health records (EHRs) and system-to-system compatibility, how safe really is all of this, especially with cybersecurity increasingly becoming a threat in our everyday lives? One solution is the Security Risk Assessment (SRA) Tool, which is a 156-question survey, evaluating the administrative, physical, and technical safeguards as part of the HIPAA security rule [14]. The SRA tool also includes resources and explanations of potential risks if some criteria are not met [14].
What are your thoughts on the subject? If you are involved in clinical trials (as a patient or staff), what has your experience been? What are your suggestions for any other potential solutions to protect our medical records, especially in such a grand effort as the Cancer MoonShot 2020?
Special thanks to Sarah Wallace from the Mesothelioma + Asbestos Awareness Center for reaching out and Merissa Hawkins for review and edits.
[1] “FACT SHEET: Investing in the National Cancer Moonshot.” Office of the Press Secretary, The White House. Published 01 Feb 2016. Accessed 01 Aug 2016. <https://www.whitehouse.gov/the-press-office/2016/02/01/fact-sheet-investing-national-cancer-moonshot>
[2] “About Cancer MoonShot 2020.” Cancer MoonShot 2020, National Immunotherapy Coalition. Published N. D. Accessed 01 Aug 2016. < http://www.cancermoonshot2020.org/about-us/>
[3] “Cancer & Big Data.” CloudTweaks. Published 29 Jun 2016. Accessed 19 Jul 2016. <http://cloudtweaks.com/2016/06/curing-cancer-big-data/>
[4] “Immunotherapy: Using the Immune System to Treat Cancer.” National Cancer Institute at the National Institutes of Health. Published N. D. Updated 14 Sep 2015. Accessed 01 Aug 2016. < http://www.cancer.gov/research/areas/treatment/immunotherapy-using-immune-system>
[5] “Basics.” U.S. Department of Health and Human Services. Published N.D. Accessed 03 Aug 2016. <http://www.vaccines.gov/basics/>
[6] Graham, D. A. “What is the Point of Joe Biden’s Cancer ‘Moonshot’?” The Atlantic. Published 11 Feb 2016. Accessed 01 Aug 2016. < http://www.theatlantic.com/politics/archive/2016/02/biden-cancer-moonshot-duke/462288/>
[7] Cancer MoonShot 2020. “What is Cancer MoonShot 2020?” YouTube. Published 19 Jan 2016. Accessed 01 Aug 2016. < https://www.youtube.com/watch?v=WJXLHhWsS14>
[8] “What is the QUILT Program?” Cancer MoonShot 2020, National Immunotherapy Coalition. Published N. D. Accessed 04 Aug 2016. <http://www.cancermoonshot2020.org/quilt-program/>
[9] Lambert, J. “Vice President Joe Biden Discusses Cancer Moonshot Initiative During ASCO 2016.” American Society of Clinical Oncology (ASCO). Published 06 Jun 2016. Accessed 02 Aug 2016. < https://am.asco.org/vice-president-joe-biden-discusses-cancer-moonshot-initiative-during-asco-2016>
[10] “Genomic Data Commons Data Portal.” National Cancer Institute at the National Institutes of Health. Published N.D. Accessed 09 Aug 2016. <https://gdc-portal.nci.nih.gov/>
[11] “Health Information Privacy.” U.S. Department of Health and Human Services. Published N.D. Accessed 20 Aug 2016. < http://www.hhs.gov/hipaa/>
[12] Berry, M. “Guideline for Study Document and Data Handling – RPG-08.” Research Practice Manual. The Clinical Research Center, Boston Children’s Hospital. Date of Origin Aug 2008. Reviewed/Revised 28 Aug 2013. Published N.D. Accessed 20 Aug 2016. < http://www.childrenshospital.org/~/media/Research%20and%20Innovation/Clinical%20Research%20Center/RPG0892613.ashx>
[13] Van Quathem, K. “Controlling personal data in clinical trials.” Covington & Burling, LLP. Published Apr 2009. Accessed 05 Sep 2016.<https://www.cov.com/~/media/files/corporate/publications/2009/04/controlling-personal-data-in-clinical-trials.pdf>
[14] “Security Risk Assessment Tool.” Health IT, U.S. Department of Health and Human Services. Updated 06 Sep 2016. Published N.D. Accessed 08 Sep 2016. < https://www.healthit.gov/providers-professionals/security-risk-assessment-tool>