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Knol Utility for Clinical Trials

The Knol Platform potential for patient generated/initiated clinical trial data collection, biomarkers and clinical research is discussed. Clinical trials currently are mainly sponsored, initiated and managed by pharmaceutical, biotechnology, diagnostic, medical device and equipment companies. Patient input, electronic diary and assessments are routinly obtained through cell phones and internet. Patient and Invesigator Initiated clinical trials with approved and marketed drugs with high safety margin for new indications and long term follow up trials can be managed on the web. Similarly trials of single dose drugs, OTC, vaccines safety biomarkers, genome, topical self application and some vaccines can be shifted to knol. Patients and healthcare providers organize into online communities, use telemonitoring, obtain drugs and funds to test new hypothesis in healthcare. The ongoing shift from web to knol is becoming significant and is cost effective. Pfizer has started the first clinical study in 2011 where patients can participate from their homes thus validating the concept first discussed here.

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Image from National Institute of Biomedical Imaging and Bioengineering

www.nibib.gov

Cells growing in a Nanofiber based scaffold

From National Cancer Institute ID 4155 Microarray

Copied from office.microsoft.com Clip Art and Image Library

Antarctica Glaciers j0437226.jpg

Introduction

During the past 30 years, clinical trials have become more complex, increased in duration (from 1-3 months to 3-5 years), number of patients enrolled (from few hundred to 100, 000), regulatory burden, multiple ethical reviews, independant drug safety monitoring boards, central laboratory, drug analysis and incresed biostatics inputs, trial registries, cGMP and payments to investigators. The cost of doing clinical studies increased by over 1000 times and CT account for a major part of drug development projects. Failures in clinical trials are carried and covered by high price of new drugs. Lack of sufficient patient enrollment and high costs per patient in the USA led to the shift in clinical trials to Europe, Australia, South Africa and then into Eastern Europe, China and India. Doing studies in developing countries have reduced the cost of trials and increased patient enrollment but raised questions about the quality of data. Ethical questions have been raised about testing high priced drugs far away from the Western countries which remain the major market. The advent and increasing use and spread of internet and cell phones has provided new means of obtaining patient own input into the data base as listed in the Box.

Clinical trials in patients are required to establish the safety and efficacy of new drugs in development. FDA, EMEA and national health and regulatory authority require proof of efficacy and safety for market authorization of new products with specific health claims. All products are considered dangerous unless backed by data insufficient number of patients for specified treatment period. This may vary from a few hundred for life savings treatments in diseases with high mortality to few thousands for chronic diseases. The treatment period can vary from a single dose, 6 month double blind period or 1-5 years of treatment. Clinical trials currently are mainly sponsored, initiated and managed by pharmaceutical, biotechnology, diagnostic, medical device and equipment companies.

The web and knol platform offer new opportunity in management and creation of patient initiated clinical trials, market research, drug combo, drug switch and treatment survey and instant feedback. However the web based patient centric system can only be used for trials with existing drugs or drug combinations in new additional indications. These trials are called Phase IV trials. Trials for registration of new drugs with unknown safety and efficacy require intense monitoring and medical supervision and require a hospital setting and are thus not suitable for web based systems.

UK Swine Flu HotLine.

Check your flu like symptoms at National Pandemic Flu Service

• Telephone: 0800 1 513 100
• Minicom: 0800 1 513 200

http://www.nhs.uk/AlertsEmergencies/Pages/Pandemicflualert.aspx

http://www.direct.gov.uk/pandemicflu

The UK Flu Symptom Checker website had over 9 million clicks per hour. This was probably due to intense media interest and curiosity. Most of the visitors started the symptom checklist but soon gave up. NHS estimate that there were probably 20, 000 cases of flu like symptoms. The hot line and the web site have relieved pressure on the NHS, GPs and hospitals. Visitors were warned not to abuse the system. After checking the symptoms, a prescription for antiviral drug was issued by internet or a 12 digit code by phone and patients directed to the nearby pharmacy.

Informed consent and virtual worlds: The avatar will see you now

A way of helping the mentally impaired to give informed medical consent http://www.economist.com/sciencetechnology/ June 25th 2009

Internet and Cell Phone to follow up heart attack survivors and cardiac high risk patients monitored to improve cardiac health. The death rate was reduced by 1/3 and participants BP and cholesterol were reduced and many quit smoking. In a restrospective analysis of 22 smoking cessation trials, use of web and mobile technology doubled the success rate vs the group without mobile tech use. In Psoraisis study, an online support group improved quality of life and reduced disease severity in 40% of the patients. Acholoic consumption was reduced by 40% in another study.

NCI Funded Web Trials in Telehealth and Telemedicine

NCI funded $100 million for 430 studies in 2008.

http://fundedresearch.cancer.gov/search/get?sic=Telehealth&fy=PUB2008

Telemedicine

NCI provided $15 million for 92 studies in 2008.

http://fundedresearch.cancer.gov/search/get?sic=Telemedicine&fy=PUB2008

Only outlines and selected possibilities are discussed for business reasons.

• Investigational New Drug (IND) Application Not suitable for knol
  
• New Drug Application (NDA) Not suitable
  
• Abbreviated New Drug Application (ANDA): Generics Potential safety uses
  
• Therapeutic Biologic Applications (BLA) Not suitable
  
• Drug Applications for Over-the-Counter Drugs Potential uses
  

Types of Trials

Open label, single blind (patient), double blind randomized (patient and doctor), parallel, crossover

Drug Administration : Oral, injection (iv, sc, im), topical, inhalation, spray, suppositoire

Commercial data

Sponsor Obligations/Duties

Under Creative Commons Attribution 3.0 License

Patient Initiated Clinical Trials

Investigator Initiated Clinical Trials.

There is some ongoing debate in the healthcare providers to move into a "patient centric" system, where patient calls the shots and the doctor is merely an invited guest. Patients learns about his conditions, diagnosis, treatment or surgical options, gets 2-3 different medical experts opinion and decides the best course and treatment option in consultation with doctors and his family. Patient preference must be respected and current gold standard treatment option or evidence based care may take a back seat. Patient will take the medication if there is clear benefit and can stop if there is no benefit and explore or switch to other treatment.

Letting the Patient Call the Shots. http://www.nytimes.com/2009/06/04/health/04chen.html?_r=1&hpw=&pagewanted=prin

Berwick D M. What 'Patient-Centered' Should Mean: Confessions Of An Extremist.

Health Affairs 28, no. 4 (2009): w555-w565 (published online 19 May 2009; 10.1377/hlthaff .28.4.w555)] Health Affairs, doi: 10.1377/hlthaff.28.4.w555 (Published online May 19, 2009).

DeCode Genetics in Iceland has done several gene hunting studies by collecting biological samples from the country with more than 10000 patients with a disease through patient help groups. The 23and Me company owned by wife of Sergey Brin (Google founder) has started a gene hunt study in 10, 000 parkinson Disease patients in the USA. The patients will organise into an online community and will be helped by Parkinson Institute and clinical center and Michael J Fox Foundation for Parkinson's Research. Patients will fill an online form, give informed consent and their own assessment of the disease, symptoms and lifestyles and send a biological (saliva) sample for DNA analysis. Patients in the study will pay $25 for full genomic analysis instead of normal $400 price. About 1.5 million patients suffer from Alzheimer's Disease in the USA. By comparing the DNA of patients with normal controls across the human genome, genetic variations involved in the disease can be discovered. The data might be of poor quality as only patients report and score their disease and symptoms which can be adressed by providing a learning video and slide show.

Owned by wife of Sergey Brin, one of Google founder

https://www.23andme.com/

Parkinson Disease genetic search through patient based initiative

Google Co-Founder Backs Vast Parkinson's Study

http://www.nytimes.com/2009/03/12/business/12gene.html?pagewanted=print

There is a very high drop out of patients on the standard 6 month tuberculosis treatment course because the disease symptoms disappear after 2 months of treatment. The drugs have unpleasent adverse reactions. There is little incentives for TB patients in poor countries to continue treatment after 2 months leading to emergence of drug resistant strains. YoutTB patch has been developed to confirm treatment compliance by detecting traces of drug in urine of treated patients. Patients can send a message by cell phone if the test is +ve (the medication was taken) and receive a microcredit finance, high energy food supplements or additional conversation time.

www.xoutb.info/

Sensors and sensitivity. http://www.economist.com/science/tq/displaystory.cfm?story_id=13725679

http://instedd.org/

Global map of disease like WHO and CDC/NIH can be supplemented by using computers and cellphones as sensors for collection of healthcare related data, finding and remote monitoring of patients, tackle disease outbreaks. Similarly healthcare facilities can be mapped and disease specialists can be identified through Biomedical Citation Index and from editorial board members of Medical Journals and advisors to WHO, FDA, NIH and healthcare charities.

The Industry major companies have established internal controls to capitalize on such opportunities initiated by patients associations, advocacy groups and investigators.

These clinical trials provide healthcare companies with the low cost clinical data and new mode of action of their drugs. Results of these studies may expand on- and off-label usage, reach new patient populations, generate data for publication and establish new relationships with opinion leaders. These trials can become critical pieces of product development strategy. Pharmaceutical and biotechnology companies have established centralized management groups and processes to deal with approval process, drug supplies and trial oversight.

Psoriasis PASI

The National Psoriasis Foundation Psoriasis Score System versus the Psoriasis Area Severity Index and Physician's Global Assessment : a comparison

Journal of Drugs in Dermatology , June, 2003 by Alice B Gottlieb, Umesh Chaudhari, Daniel G Baker, Michelle Perate, Lisa T Dooley

Assessment: domains and instruments. Psoriasis assessment tools in clinical trials

S R Feldman and G G Krueger

Annals of the Rheumatic Diseases 2005;64(Supplement 2 ):ii65-ii68; doi:10.1136/ard.2004.031237

Copyright 2005 BMJ Publishing Group Ltd & European League Against Rheumatism.

Annals of the Rheumatic Diseases 2005;64:ii65-ii68

http://www.rheumatology.org/publications/guidelines/ra-activitymeasures/Disease_Activity_Measures_RA_Clinical_Trials.pdf

http://www.rheumatology.org/publications/guidelines/ra-improvement/Prelim_definition_improve_%20RA.asp

Alzheimer Dis Assoc Disord. 2004 Oct-Dec;18(4):236-40

The Alzheimer's Disease Assessment Scale: patterns and predictors of baseline cognitive performance in multicenter Alzheimer's disease trials

PM Doraiswamy, F Bieber, L Kaiser, KR Krishnan, J Reuning-Scherer and B Gulanski .

Neurology, Vol 48, Issue 6 1511-1517,

Copyright 1997 by American Academy of Neurology

http://www.annals.edu.sg/pdf_july00/chulw.pdf

• Investigational New Drug (IND) Application Knol is unsuitable
• New Drug Application (NDA) Not suited for knol or online
• Abbreviated New Drug Application (ANDA): Generics Potential applications through knol
• Therapeutic Biologic Applications (BLA) Not suitable
• Drug Applications for Over-the-Counter Drugs Potential uses

Jung-Won Suh, Bon-Kwon Koo, Shu-Ying Zhang, Kyung-Woo Park, Joo-Youn Cho,

In-Jin Jang, Dong-Soon Lee, Dae-Won Sohn, Myoung-Mook Lee, and Hyo-Soo Kim
Increased risk of atherothrombotic events associated with cytochrome P450 3A5

polymorphism in patients taking clopidogrel. Can. Med. Assoc. J., Jun 2006; 174: 1715 - 1722 ; doi:10.1503/cmaj.060664

- Align with corporate strategy
- Timelines and best practices SOP for proposal evaluation and approval
- Develop and Improve ongoing oversight
- Discover management trends
- Benchmark structures and investments

Selection Criteria
Strategic alignment: will the study help to accomplish the company's strategic objectives?
Scientific merit: how valid is the study hypothesis?
Originality: is the study concept a novel one?
Feasibility: how achievable are the study's specific aims?

http://www.researchandmarkets.com/product/ad995c/investigatorinitiated_trials_building_super

http://clinicaltrials.gov/ct2/show/NCT00477334

Increasing Antimicrobial Resistance and the Management of Uncomplicated Community-Acquired Urinary Tract Infections
Kalpana Gupta, Thomas M. Hooton, AND Walter E. Stamm

Annals Int Med 2001 135: 41-50. [ABSTRACT][Full Text]

Editorials
Helping Patients Take Responsibility for Their Own Health
Andrew Herxheimer

Annals Int Med 2001 135: 51-52. [Full Text]

Summaries for Patients
Patient-Initiated Treatment of Recurrent Urinary Tract Infection in Women

Annals Int Med 2001 135: S18. [Full Text]

Some commercial data has been deleted to protect copyright

Table 2 Clinical Trial Approval Timelines in the USA and Europe (in months) Approval FDA/EMEA IRB/ERC Bioethics Genetic/BIMO Review RISK Benefit etc IND/CTC 6 1-3 3-6 1-3 Phase I 3 1-2 Clinical Phase II-III Drugs 3-6 1-3 1-3 Biologics 6-12 3 6 2 NDA/PLA/BLA/MA New Drugs 6-24 Biologics 9-24 Orphan Drugs, Drugs for rare and neglected disease, Life saving drugs get priority and faster review and approvals Global Health & Public Private Partnerships (PPP) United States Cancer Statistics http://apps.nccd.cdc.gov/uscs/ http://www.cdc.gov/nchs/ Heart Diseases and Stroke Maps http://apps.nccd.cdc.gov/giscvh3/ http://www.cdc.gov/DHDSP/library/aian_atlas/maps_aian_women.htm http://www.cancer.gov/cancertopics/understandingcancer/cancer/Slide25 Procedure WHO/CDC/NIH Global Map to find and locate patients Google Malaria Search to find patients and interested parties Google Scholar Malaria search to find and locate experts Local PC and Mobile/Cell phone network management system to connect patients, sponsors and experts Develop cell phone forms, patient diary, disease assessment, webcam, video to exchange data Google Analytics to analyse data and provide rapid feedback. Set up controls and check ups to improve quality Patient Initiated Trials Slides Patient Initiated Clinical TrialsPatient Initiated Clinical Trials Paradigm Clin trials Books and Monographs Clinical trialsClinical trials Acknowledgements Thanks are due to Mr. Jean-Antoine de Mandato (PDP, Geneva) for providing office facilities and administrative support. Clinical Trial Registries http://clinicaltrials.gov/ http://www.centerwatch.com/ http://www.uhhospitals.org/PatientsVisitors/ClinicalTrialsListing/tabid/1104/Default.aspx http://www.clinicaltrialssearch.org/medical_research_laboratories_international_clinical_trials.html Drugmaker Pfizer Inc. is running the first US clinical study in which patients participate from home via the Internet, rather than repeatedly visiting a participating hospital. Clinical Trial by Pfizer Conducted Remotely ThirdAge Pfizer Starts First US "Virtual" Clinical Study ABC News A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease The BARI 2D Study Group Published at www.nejm.org June 7, 2009 (10.1056/NEJMoa0805796) http://content.nejm.org/cgi/content/full/NEJMoa0805796 Oldfield V, Dhillon S, Plosker GL. (2009) Tocilizumab: a review of its use in the management of rheumatoid arthritis. Drugs. 69(5): 609-32. doi: 10.2165/00003495-200969050-00007. GMP Guidelines http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm GLP Guidelines http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135197.htm IRB http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046745.htm Informed Consent http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm European Medicine Agency http://www.emea.europa.eu/ ICH http://www.ich.org/cache/compo/276-254-1.html Google Search Results June 20, 2009 Scholarly articles for alzheimer's disease assessment score A new rating scale for Alzheimer's disease - Rosen - Cited by 1353 A controlled trial of selegiline, alpha-tocopherol, or ... - Sano - Cited by 1570 Efficacy and safety of galantamine in patients with mild ... - Wilcock - Cited by 318 1. Nature Clinical Practice Rheumatology | Self-reporting instruments ... Both assessor and patient self-report measures are recommended in the assessment of disease activity in patients with rheumatoid arthritis. Top of page ... www.nature.com/nrrheum/journal/v3/n2/full/ncprheum0402.html - Similar by T Sokka - 2007 - Related articles - All 3 versions 2. The Harris hip score : : Comparison of patient self-report with ... Each patient completed a self-report Harris Hip Score (HHS) 30 days before a ... and disease-specific instruments, such as the Western Ontario McMaster .... patient self-report and physician assessment of pain and function based on ... linkinghub.elsevier.com/retrieve/pii/S0883540301266340 - Similar by NN Mahomed - 2001 - Cited by 54 - Related articles 3. A Coronary Heart Disease Risk Score Based on Patient Reported ... To develop a simple, patient self-report based coronary heart disease (CHD) ... FRS and the European SCORE and has the potential for easy self-assessment. ... www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1931421 - Similar by AG Mainous III - 2007 - Cited by 10 - Related articles - All 6 versions 4. Neuropsychological assessment - Google Books Result by Muriel Deutsch Lezak, Diane B. Howieson, David ... - 2004 - Medical - 1016 pages Whenever possible, the interview is conducted with a spouse or care- giver present to provide realistic information when the patient's self-reports are ... books.google.com/books?isbn=0195111214... 5. A Coronary Heart Disease Risk Score Based on Patient-Reported ... To develop a simple, patient self-report-based coronary heart disease (CHD) ... the FRS and European SCORE, and has the potential for easy self-assessment. ... www.ajconline.org/article/PIIS0002914907001464/abstract - Cached - Similar by AG Mainous III - Cited by 10 - Related articles - All 6 versions 6. A patient-derived disease activity score can substitute for a ... the Disease Activity Score (DAS), integrates the number of our study was to examine whether ..... patient self-assessment and we conclude that a PATDAS ... rheumatology.oxfordjournals.org/cgi/reprint/38/1/48.pdf - Similar by DA Houssien - 1999 - Cited by 23 - Related articles - All 4 versions 7. 287 Cardiology patient self-weighting of SF-36 subscales ... Evaluating HIV disease health outcomes in alternative settings: ... instruments included MOS-HIV; General Health Self-Assessment Scale; ACTG ... Charts (Lizan and Reig, 1998, 1999) was referred (score 4 and 5) for 13% caregivers in ... www.jstor.org/stable/4037277 - Similar by RA Berzon - 1999 - Cited by 1 - Related articles - All 2 versions 8. Time to Score Quantitative Rheumatoid Arthritis Measures: 28-Joint ... 1 Mar 2008 ... Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ), ... The MDHAQ includes 10 activities self-assessed for physical function, ... patient self-report questionnaire routine assessment of patient index ... www.tripdatabase.com/spider.html?itemid=688396 - Similar 9. The Uses of Disease Activity Scoring and the Physician Global ... Patients self-reported their tender joint counts on a homunculus based on a ..... Patient-derived global arthritis score (pGAS) as a practical assessment ... www.jrheum.org/content/36/5/925.full - Similar by JT HARRINGTON - 2009 10. Rehabilitation of the spine: a practitioner's manual - Google Books Result by Craig Liebenson - 2006 - Medical - 972 pages Functional Assessment Methods There are two major approaches in assessing physical function: patient self-reports and clinician-measured tests. ... books.google.com/books?isbn=0781729971... Market Research Reports Click on the link Krishan Maggon / Krishan MAGGON's knols I Top Ten Monoclonal Antibodies 2010 I Top Ten/Twenty Drugs 2008 I Top Ten/Twenty Best Selling Drugs 2009 I M&A Review: Pharmaceutical & Biotechnology Industry I I High Priced Prescription Drugs I Top Ten/Twenty Best Selling Drugs 2010 I Stem Cell Therapy Market I M&A Biotechnology I Knol First & Second Year Odyssey I Global Vaccine Market 2010 ITop Ten Monoclonal Antibodies 2010 I Global Pharmaceutical Market Review & World Top Ten/Twenty Drugs 2008 I Global Cardiovascular Market Review 2008 (World Top Ten CV Drugs) I Global Monoclonal Antibodies Market Review 2008 (World Top Ten mAbs) I Global Vaccine Market Review 2008 (World Top Ten Vaccines) I Global Market Intelligence Overview Monograph 2009 I Global Biotechnology Market Review & World Top Ten Biotech Drugs 2008 I Global Cancer Market Review 2008 (World Top Ten Cancer Drugs) I Global Brain Drugs Market Review 2008 (World Top Ten CNS Drugs) I Global Diabetes Market Review 2008 & World Top Ten Diabetes drugs I Global Biologic Market Review & Top Ten Biologics 2008 I Global Antiviral/Antibiotics Market Review 2008 (World Top Ten Antimicrobial Agents) I Global Angiotensin II Receptor Antagonists Market Review 2008 I Billion Dollar Generics & Global Generic Market Review 2009 I Global Respiratory Market Review & World Top Ten Respiratory Drugs 2008 I Global Pharmaceutical Market Intelligence Monograph I Global Biotechnology Market Intelligence Monograph I Top Selling Human Medicinal Brands of 2007 I Influenza ( 2009 H1N1 ) Vaccine Market I Influenza Antivirals Market 2009 I Pharmaceutical and Biotechnology Industry Overview 2009 I Top Selling Human Medicinal Brand and Global Pharmaceutical Market 2009 I Market Research Reports Review (Data Discrepancies) I Vaccine Market 2009 I | Share and Comment Share |