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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.,

Jeffrey A. Moscow

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.,

and the James J. Peters VA Medical Center, 130 West Kingsbridge Road, Bronx, New York 10468, USA.,

Richard L. Schilsky is at the American Society of Clinical Oncology, 2318 Mill Road, Suite 800, Alexandria, Virginia 22314, USA.,

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The Bladder Cancer Action Network Bladder Cancer Genomics Consortium

Multiple Myeloma Research Foundation COMMPASS registry

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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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In a conversation with Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, we explore the company’s cutting-edge strategies to maximize its expansive pharmacy network for clinical trials conducted at retail pharmacies. This interview illuminates the ways in which Walgreens integrates technological advancements and engagement tactics to revolutionize the process of enrolling participants and decentralizing clinical trials.

Collaborating with community partners, we design and build outreach and engagement activations to break down barriers e.g. the lack of awareness about trials, mistrust of research, and logistical obstacles that prevent equitable access across sub-groups.

The 2024 SCOPE Summit, a pivotal event in clinical trials, showcased innovative strategies to transform patient recruitment and trial conduct. At the forefront of these discussions was John Campbell, Head of Decentralized Trials for Walgreens, who shared profound insights

Less than two years after entering the clinical trials business, Walgreens has made strides in increasing diverse representation in pharmaceutical trials, according to Ramita Tandon, the company’s chief clinical trials officer. The retail pharmacy giant opened a clinical trials arm in June 2022 with the goal of diversifying trial participants, which have historically been overwhelmingly white and male.

Clinical trial recruitment has historically been centered in larger urban areas near established medical institutions, leaving out the nearly 61 million Americans that live in rural locations where healthcare access is limited. Walgreens is proud to be an industry leader in increasing access to clinical research across the country, and is committed to reaching vulnerable and marginalized populations that are often excluded from

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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Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • Forms of psoriasis other than PsO
  • Drug induced psoriasis
  • Positive QuantiFERON-tuberculosis (TB) Gold Test
  • Presence of significant comorbid conditions
  • Chemistry and hematology values outside protocol specified range
  • Major systemic infections

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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).

Publication types

  • Antineoplastic Agents*
  • Brain Neoplasms* / drug therapy
  • Drug Discovery
  • Pharmaceutical Preparations*
  • Proteasome Inhibitors
  • Antineoplastic Agents
  • Pharmaceutical Preparations

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VitaMed Research

Leading the way in pain management and neuroscience research.

Our accomplished team of physicians and research specialists have over 50 years of combined experience and are endlessly devoted to producing superior and quality clinical research.  View our work .

Pain Studies

Device trials, stem cell research, we have a strong team of double board certified physicians at the principal investigator and/or the sub-investigator level..

Our physicians and staff are dedicated to advancing the field of medicine by participating in cutting edge clinical trials. All our physicians have the experience needed to provide quality research data.

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NovaMedica

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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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

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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.

… we have a small favor to ask. As you may have heard, The Moscow Times, an independent news source for over 30 years, has been unjustly branded as a "foreign agent" by the Russian government. This blatant attempt to silence our voice is a direct assault on the integrity of journalism and the values we hold dear.

We, the journalists of The Moscow Times, refuse to be silenced. Our commitment to providing accurate and unbiased reporting on Russia remains unshaken. But we need your help to continue our critical mission.

Your support, no matter how small, makes a world of difference. If you can, please support us monthly starting from just $ 2. It's quick to set up, and you can be confident that you're making a significant impact every month by supporting open, independent journalism. Thank you.

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Remind me next month

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Russia Says Found Link to Ukraine on Concert Attack Suspect’s Phone

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6 Children Confirmed Killed in Crocus Attack, Official Says

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‘Endless Wave of Violence’: Leading Russian Anti-Torture Activist on Concert Attack Suspects’ Treatment

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Russian Terror Suspects Detained Under Guise of ‘Coronavirus Test’

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  18. Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque

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  19. Brain Cancer Drug Discovery: Clinical Trials, Drug Classes, Targets

    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 ...

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  22. The Moscow Department of Clinical Research processed 78 applications

    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 ...

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