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- Published: 19 December 2017
The evidence framework for precision cancer medicine
- Jeffrey A. Moscow 1 ,
- Tito Fojo 2 , 3 &
- Richard L. Schilsky 4
Nature Reviews Clinical Oncology volume 15 , pages 183–192 ( 2018 ) Cite this article
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- Cancer genetics
- Cancer genomics
- Clinical trials
- Personalized medicine
- Targeted therapies
Precision cancer medicine (PCM) is a concept in which oncologists increasingly strive to tailor the use of targeted therapies in order to match the complexity of the cancer genome. This approach contradicts the historical framework used to support oncology practice that requires evidence from randomized controlled trials in order to change standards of care. This contrast demonstrates the irony of PCM: the therapies themselves are more precise than standard cytotoxic agents, although the clinical evidence supporting the benefits of these therapies is often considerably less precise. Nevertheless, the implementation of PCM should still be based on a framework of evidence-based development that supports clinical decision-making; this approach should not be simple off-label prescription of drugs following sequencing of a tumour biopsy sample. The clinical validation of increasingly complex diagnostic tests, the development of novel methods of evaluating efficacy, and the re-assessment of the standards of evidence sufficient to demonstrate the benefit of precision cancer therapies are all needed before PCM becomes the standard of care for patients with tumours harbouring genomic abnormalities of uncertain clinical significance.
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Jeffrey A. Moscow is at Room 5W524, National Cancer Institute Shady Grove, 9609 Medical Center Drive, Bethesda, Maryland 20892–9739, USA.,
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Tito Fojo is at the Division of Haematology Oncology, Department of Medicine, Columbia University, Herbert Irving Pavilion 9–936, New York, New York 10032, USA; and the James J. Peters VA Medical Center, 130 West Kingsbridge Road, Bronx, New York 10468, USA.,
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Richard L. Schilsky is at the American Society of Clinical Oncology, 2318 Mill Road, Suite 800, Alexandria, Virginia 22314, USA.,
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Moscow, J., Fojo, T. & Schilsky, R. The evidence framework for precision cancer medicine. Nat Rev Clin Oncol 15 , 183–192 (2018). https://doi.org/10.1038/nrclinonc.2017.186
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Diverse participation in clinical trials is critically low. At this year’s Black Women’s Expo, Walgreens sponsorship centered on educating the community and sparking change for better health outcomes.
In this session at DIA, John Campbell, head of decentralized trials, Walgreens began with emphasizing that much of industry does not yet understand the role of pharmacy in clinical trials.
Retail pharmacy giant Walgreens inked another partnership to recruit participants for research as it continues to build out its clinical trials business. The company signed a deal with biotech startup Freenome to advance clinical trials of its blood-based tests for the early detection of cancer.
The commitment of pharmacy to address clinical trials has been a recurring topic this week. Craig Lipset was joined by Kendal K. Whitlock, MPH, Head of Digital Optimization, RWE Clinical Trials from Walgreens to discuss the state of the industry, commitment to the field, and progress to-date.
In the digital age, technology has become an important tool to improve involvement in clinical trials. Watch this discussion with Kendal Whitlock, Head of Digital Operations at Walgreens Boot Alliance
Walgreens Clinical Trials Events
Leveraging rich real world data (RWD), Walgreens delivered patient referrals that improve on the national averages of diverse participation, also demonstrating that our referrals are 20% more likely to enroll in study compared to other recruitment providers' referrals.
Walgreens leveraged rich and diverse real world data (RWD) and was able to deliver referrals that exceeded the targeted goal of our study partner by 23%, all within a two-week recruitment period.
Walgreens identified and engaged the right patients using our unparalleled RWD to enable a significant recruitment of Black/African American (17%) and Hispanic/Latino (19%) population in this clinical trial. These results are a significant improvement when compared to nationwide historical averages of clinical trial participation (as of 2020 of 8% and 11% respectively).
Walgreens leveraged their unparalleled real-world data insights to identify eligible patient populations within 20 miles of study sites.
Walgreens leveraged our unparalleled patient insights and community presence to identify and engage potential participants so efficiently that we outperformed other recruitment partners--64% of qualified referrals and 62% of randomized patients.
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Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (PsOsim)
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This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO.
The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.
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- Male or female adults
- PsO diagnosis for 6 months
- Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5),
- Body Surface Area (BSA) involved with PsO greater than or equal to 10%
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Brain Cancer Drug Discovery: Clinical Trials, Drug Classes, Targets, and Combinatorial Therapies
Affiliations.
- 1 Department of Neuroscience, Functional Pharmacology, Uppsala University, Uppsala, Sweden (A.V.S., S.A.D., M.M.A., H.B.S.); and Department of Pharmacology, Institute of Pharmacy (A.V.S., S.A.D., A.A.K., A.A.I., A.S.N., A.A.L., V.N.C., V.V.T.) and Institute of Translational Medicine and Biotechnology (V.V.T., H.B.S.), I. M. Sechenov First Moscow State Medical University, Moscow, Russia.
- 2 Department of Neuroscience, Functional Pharmacology, Uppsala University, Uppsala, Sweden (A.V.S., S.A.D., M.M.A., H.B.S.); and Department of Pharmacology, Institute of Pharmacy (A.V.S., S.A.D., A.A.K., A.A.I., A.S.N., A.A.L., V.N.C., V.V.T.) and Institute of Translational Medicine and Biotechnology (V.V.T., H.B.S.), I. M. Sechenov First Moscow State Medical University, Moscow, Russia [email protected].
- PMID: 34663683
- DOI: 10.1124/pharmrev.121.000317
Brain cancer is a formidable challenge for drug development, and drugs derived from many cutting-edge technologies are being tested in clinical trials. We manually characterized 981 clinical trials on brain tumors that were registered in ClinicalTrials.gov from 2010 to 2020. We identified 582 unique therapeutic entities targeting 581 unique drug targets and 557 unique treatment combinations involving drugs. We performed the classification of both the drugs and drug targets based on pharmacological and structural classifications. Our analysis demonstrates a large diversity of agents and targets. Currently, we identified 32 different pharmacological directions for therapies that are based on 42 structural classes of agents. Our analysis shows that kinase inhibitors, chemotherapeutic agents, and cancer vaccines are the three most common classes of agents identified in trials. Agents in clinical trials demonstrated uneven distribution in combination approaches; chemotherapy agents, proteasome inhibitors, and immune modulators frequently appeared in combinations, whereas kinase inhibitors, modified immune effector cells did not as was shown by combination networks and descriptive statistics. This analysis provides an extensive overview of the drug discovery field in brain cancer, shifts that have been happening in recent years, and challenges that are likely to come. SIGNIFICANCE STATEMENT: This review provides comprehensive quantitative analysis and discussion of the brain cancer drug discovery field, including classification of drug, targets, and therapies.
Copyright © 2021 by The Author(s).
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The Moscow Department of Clinical Research processed 78 applications for drug trials over two years
21 May 2024
A single center for supporting clinical research (CT) has been operating in Moscow for two years now – the Department of Clinical Research of the Moscow Center for Innovative Technologies in Healthcare. During this period of time, the department accepted and processed 78 applications for drug research in 16 therapeutic areas received from 15 pharmaceutical companies. All applications were accepted and the companies received full support for them. This was reported by the ANO “Moscow Center for Innovative Technologies in Health Care”.
The most common therapeutic areas: oncology, hematology, immunoprophylaxis, rheumatology, endocrinology and orphan diseases. Studies of the drug commissioned by companies are carried out in leading clinics in Moscow. This is the Loginov Moscow Clinical Scientific Center, Moscow City Oncology Hospital No 62, City Clinical Hospital №1 named after N.I. Pirogov, the Kommunarka Moscow Multidisciplinary Clinical Center (MMCC), City Clinical Hospital No. 15 named after O.M. Filatov.
“Moscow plays a significant role in the rapid development of domestic biotechnologies. Since the beginning of this year alone, 12 applications from 5 pharmaceutical companies have been processed for organizational support for research in the field of oncology, rheumatology and orphan diseases, and financial support has been provided for the development of 5 unique drugs aimed at treating diseases. approved in the field of oncology, neurology and rheumatology,” said Anastasia Rakova, Deputy Mayor of Moscow in the Moscow Government for Social Development.
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16 May 2024
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The number of conducted clinical trials in Russia is growing
17 May 2024
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Russia Extends Pre-Trial Detention of Crocus Attack Suspects
A Moscow court ruled Thursday to extend the pre-trial detention of eight men accused of organizing and carrying out the deadly Crocus City Hall concert attack in March.
Law enforcement agents arrested four gunmen the day after the March 22 attack, which left 145 people dead and hundreds more wounded. A total of 11 people were eventually arrested in connection with the deadly shooting, which was claimed by Islamic State affiliate ISIS-K.
Moscow’s Basmanny District Court ruled in separate decisions on Thursday to extend the detention of Muhammadsobir Faizov , Dalerjon Mirzoyev , Saidakrami Rachabalizoda , Shamsidin Fariduni, Yakubjoni Yusufzoda, Dzhumokhon Kurbonov, Muhammad Zoir Sharipzoda, and Nazrimada Lutfulloi until Aug. 22.
In a video shared by the Moscow court system, one of the suspected gunmen, Rachabalizoda, could be seen sitting inside a defendant’s box with part of his right ear cut off, seeming to corroborate previous claims that he was tortured by Russian law enforcement agents.
Another suspected gunman, Faizov, was brought into the courtroom in a wheelchair and did not appear fully — if at all — conscious.
The four suspected gunmen, who are all Tajik nationals, previously showed signs of having been tortured, sparking protests from Tajikistan, a Moscow ally in Central Asia that is a source of many of Russia ’s migrant workers.
At Thursday’s hearings, journalists were asked to leave the courtroom, according to the independent news website Mediazona.
Moscow has blamed radical Islamists, Ukraine, and the West for the Crocus City Hall attack, the deadliest in Russia since the 2004 Beslan school siege, which resulted in the killing of more than 300 people.
Russia ’ s Investigative Committee has claimed it has evidence that “Ukrainian nationalists” were ultimately behind the attack and financed the gunmen with cryptocurrency payments. However, it has yet to bring forward evidence to back the allegations.
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ResearchMatch is a free and secure tool that connects people interested in research studies with researchers from top medical centers across the U.S. You can find a clinical trial or research study near you, or across the country, by entering a health condition or joining as a researcher.
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23 Clinical Research Assistant jobs available in Moscow, IA on Indeed.com. Apply to Research Assistant, Clinical Research Associate, Research Associate and more!
The Experimental Therapeutics Clinical Trials Network (ETCTN) is the clinical trials network administered through the IDB that performs clinical studies of the agents that are approved through NExT. Dr. Percy Ivy is the Program Director for the ETCTN and Kim Witherspoon is the Senior Program Specialist. In these partnerships, NCI:
M.F. Vladimirsky Moscow Regional Clinical Research Institute (clinical studies of endoscopic methods of hemostasis) N.V. Sklifosovsky Research Institute of Emergency Medicine (development of methods of emergency gastroenterological care) A.N. Rychikh Scientific Research Center for Coloproctology (colorectal surgery, endoscopy)
Clinical trials. The Moscow Center for Diagnostics & Telemedicine is certified by the Moscow Health Care Department to conduct clinical trials as per the Unified Register of Organizations Authorized to Conduct Trials (Testing) of Medical Devices for the Purpose of their Registration on the Territory of the EAEU, the Roszdravnadzor Register of ...
Idaho. Paid Clinical Trials. A listing of 372 clinical trials in Idaho actively recruiting volunteers for paid trials and research studies in various therapeutic areas. ... Idaho is currently home to 372 active clinical trials, seeking participants for engagement in research studies. These trials take place at a variety of cities in the state ...
Conduct a focused search of studies by matching one or more words entered in specific fields. See also How to Use Advanced Search. Find studies in categories such as condition, drug intervention, sponsor, or location. See also How to Find Studies by Topic or on a Map. Find studies by clicking on a country or region on a map.
Adfress: 119991, Moscow, Trubetskaya street, house 8, building 2, Russia Phone: +7 (969) 283-48-20 Email: [email protected]
INVITRO has more than 15 years of experience as Laboratory for clinical trials. Offering more than 1000 tests menu. Processing more than 100.000 laboratory samples for 27.000 patients daily. Quality laboratory testing available 24 hours per day, 7 days a week, 365 days a year. More than 9000 employees. INVITRO is headquartered in Moscow, Russia.
Advocates of PCM are likely to believe that evidence is currently accumulating from a combination of clinical trial reports, small research studies, case reports and clinical anecdotes and that ...
Sechenov of the Ministry of Health of Russia (Sechenov University) is an advanced research, educational and clinical center in the Russian healthcare system. The university trains scientists, doctors and health care managers of international level - leaders for all branches of medical science and practice in the field of life sciences (life ...
Clinical trials are research studies that look at new ways to prevent, detect or treat diseases. They rely on human volunteers, known as participants, and aim to find out if a new medical approach is safe and effective. Clinical trials often test new drugs or new combinations of drugs, new surgical procedures or devices, or different ways to use existing treatments.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Brain cancer is a formidable challenge for drug development, and drugs derived from many cutting-edge technologies are being tested in clinical trials. We manually characterized 981 clinical trials on brain tumors that were registered in ClinicalTrials.gov from 2010 to 2020. We identified 582 unique therapeutic entities targeting 581 unique ...
Clinical trials for Moscow, Arkansas. More than 850,000 individuals seeking clinical trial participation have joined us. Get started today! Clinical trials for Moscow, Arkansas. More than 850,000 individuals seeking clinical trial participation have joined us. ... Services for Research Sites; Study Listings; Clinical Ad Network™ ...
At VitaMed Research, we are resolved to advancing medicine by conducting superior phase 1 to phase 4 clinical research trials in pain management and neuroscience. OUR RESEARCH SERVICES Our principal and sub investigators are physicians who are fellowship-trained MDs, double-board certified in Pain Medicine and Anesthesiology.
A single center for supporting clinical research (CT) has been operating in Moscow for two years now - the Department of Clinical Research of the Moscow Center for Innovative Technologies in Healthcare. During this period of time, the department accepted and processed 78 applications for drug research in 16 therapeutic areas received from 15 pharmaceutical companies. All applications were ...
Britain's GSK will keep supplying essential medicines and vaccines in Russia but halt clinical trials, following sanctions against Moscow for its invasion of Ukraine, joining other drugmakers that ...
Outsourcing Clinical Trials RUS Ltd Jan 2005 - Feb 2006 1 year 2 months. Education Georgetown University Biology. Activities and Societies: President, Russian Club ...
A Moscow court ruled Thursday to extend the pre-trial detention of eight men accused of organizing and carrying out the deadly Crocus City Hall concert attack in March.