Methods for data collection and distribution

• US 10,559,048 B2
• Filed: 07/11/2012
• Issued: 02/11/2020
• Est. Priority Date: 07/13/2011
• Status: Active Grant

• Current Assignee: Multiple Myeloma Research Foundation, Inc.
• Original Assignee: Multiple Myeloma Research Foundation, Inc.
• Inventors: Giusti, Kathryn E., Capone, Walter M., Perkins, Louise
• Primary Examiner(s): Cobanoglu, Dilek B
• Application Number:
  US13/546,780
• Publication Number:
  US 20130185096A1
• Time in Patent Office: 2,771 Days
• Field of Search: 705 2, 705 3, 435 723
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 10/101 Collaborative creation, e.g. joint development of products or services
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 70/20 relating to practices or guidelines
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Provided are methods of performing research in which participation is incentivized by early access to the data and samples collected. Also provided are methods for distributing research data.

Claims

1. A method comprising:

(a) enrolling a subject with multiple myeloma in a longitudinal research study;

(b) collecting a biological sample at a time-point from the subject with multiple myeloma;

(c) storing the biological sample at a tissue bank;

(d) analyzing a portion of the biological sample to produce a profile for the subject with multiple myeloma, wherein the biological sample is a bone marrow sample, a biopsy, a blood sample, a plasma sample, a bone marrow aspiration, a hair sample, a urine sample, a stool sample, a breath sample, a skin sample, a fine-needle aspiration, a tissue biopsy, a spinal fluid sample, a tear sample, a mucus sample, an amniotic fluid sample, a sperm sample, or a tissue sample;

(e) collecting, through an observational study platform, clinical data from the subject with multiple myeloma at two or more additional time-points, and storing the clinical data in an electronic case report form in the observational study platform, wherein the clinical data comprise interpreted data, wherein;

(1) raw molecular data are retrieved by a molecular results data export module;

(2) the molecular results data export module sends the raw molecular data to an analysis pipeline; and

(3) the analysis pipeline processes the raw molecular data to provide the interpreted data;

(f) providing electronic access through a community portal to a user over a network to a module configured for user update of information about a health of the subject with multiple myeloma into a health management tracker of an information technology portal through a web based user interface, wherein the user update updates the profile of the subject with multiple myeloma;

(g) correlating by a computer using computer-executable code the clinical data and the profile via a user profile synchronization module to identify a subset of subjects with multiple myeloma to which the subject with multiple myeloma belongs;

(h) determining by the computer using computer-executable code a personalized therapy for multiple myeloma based on the subset to which the subject with multiple myeloma belongs, wherein the personalized therapy is more likely to prolong survival when administered to a patient belonging to the subset than when the personalized therapy is administered to a patient that does not belong to the subset and wherein the personalized therapy is immunomodulatory therapy, proteasome inhibitor therapy, stem cell transplantation, chemotherapy, radiation therapy, or surgery; and

(i) administering the personalized therapy to the subject with multiple myeloma.

2. The method of claim 1, wherein the biological sample is collected from the subject with multiple myeloma prior to beginning a course of treatment for multiple myeloma.

3. The method of claim 1, wherein the two or more additional time-points comprise one or more time-points prior to beginning a course of treatment for multiple myeloma, one or more time-points during a course of treatment for multiple myeloma, one or more time-points after a course of treatment for multiple myeloma, one or more time-points after a relapse of multiple myeloma, or a combination thereof.

4. The method of claim 1, further comprising providing the subject with multiple myeloma enrolled in the longitudinal research study with access to the information technology portal.

5. The method of claim 1, wherein the information technology portal comprises a community portal, a research portal, an observational study platform, a sponsor website, or a combination thereof.

6. The method of claim 1, wherein the information technology portal comprises a secure messaging facility for communicating with physicians and study administrators.

7. The method of claim 1, wherein the profile comprises a value associated with the subset to which the subject with multiple myeloma belongs.

8. The method of claim 1, wherein the personalized therapy is a drug.

9. The method of claim 1, wherein the personalized therapy targets a microenvironment.

10. The method of claim 1, wherein the personalized therapy is an immunomodulatory therapy.

11. The method of claim 1, wherein the personalized therapy is a combination therapy.

12. The method of claim 1, wherein the personalized therapy targets multiple mechanisms with synergistic effects.

13. The method of claim 1, wherein the biological sample comprises a cell, wherein flow cytometry is performed to assess viability of the cell of the biological sample.

14. The method of claim 1, wherein the biological sample is used to generate a cell line.

15. The method of claim 14, wherein the cell line is treated with a therapeutic agent.

16. The method of claim 15, further comprising treating the subject with multiple myeloma with the therapeutic agent.

17. The method of claim 15, wherein the therapeutic agent is personalized to the subject with multiple myeloma.

18. The method of claim 1, wherein at least two biological samples are collected from the subject with multiple myeloma at a given time.

19. The method of claim 18, wherein the biological sample is a tissue sample, wherein at least one tissue sample is from a diseased tissue, and at least one tissue sample is from a healthy tissue.

20. The method of claim 18, wherein the at least two biological samples collected from the subject with multiple myeloma at the given time are collected from a diseased tissue.

21. The method of claim 1, wherein the biological sample is a biopsy.

22. The method of claim 1, wherein:

a) the clinical data is data collected by a medical care provider, data generated from a diagnostic test, patient-reported outcome data, demographic data, medical history, co-morbidity data, treatment data, medication data, symptom report data, complete blood count (CBC) data, glucose level data, calcium level data, blood urea nitrogen (BUN) level data, creatinine level data, total protein level data, albumin level data, lactate dehydrogenase level data, M-protein level data, quantitative immunoglobulin data, free light chain (FLC) level data, beta-2-microglobulin level data, C-reactive protein level data, urine immunology lab data, 24 hour total protein level data, bone assessment data, skeletal survey data, magnetic resonance imaging (MRI) data, computerized tomography (CT) data, positron emission tomography (PET) data, disease staging data, multiple myeloma disease staging data, assessment of treatment response data, number of doctor visits, time spent per doctor visit, amount of time hospitalized, number of times hospitalized, use of outpatient care facilities, adverse effect data, survival information, or cytogenetic analysis data;

b) the two or more additional time-points are one or more time-points prior to beginning a course of treatment, one or more time-points during a course of treatment, one or more time-points after a course of treatment, or one or more time-points after a relapse event; and

c) the personalized therapy is autologous hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation, melphalan, thalidomide, bortezomib, lenalidomide, a steroid, doxorubicin, or radiation.

23. The method of claim 1, wherein the biological sample is a bone marrow.

24. The method of claim 23, further comprising measuring an amount of plasma cells in the bone marrow.