Translational hurdles with cannabis medicines

Internationally, there has been widespread medical use of cannabis medicines before rigorous evaluations in randomised controlled trials (RCTs). Some advocates of medicinal use of cannabis argue that real‐world evidence (RWE) can be a substitute for or at least supplement evidence from RCTs. We explore the utility, limitations and impact of RWE in the translation of cannabis medicines research into clinical practice using the established literature.

[1]  W. Hall,et al.  Ensuring access to safe, effective, and affordable cannabis‐based medicines , 2020, British journal of clinical pharmacology.

[2]  Louise Bowman,et al.  The Magic of Randomization versus the Myth of Real-World Evidence. , 2020, The New England journal of medicine.

[3]  A. Chit,et al.  Hybrid clinical trials to generate real-world evidence: design considerations from a sponsor's perspective. , 2020, Contemporary clinical trials.

[4]  A. Vannacci,et al.  Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database , 2020, British journal of clinical pharmacology.

[5]  F. Gengo,et al.  A Review of Cannabis and Interactions With Anticoagulant and Antiplatelet Agents , 2019, Journal of clinical pharmacology.

[6]  J. Wise.  Medical cannabis registry launched to build up evidence base , 2019, BMJ.

[7]  J. Caulkins,et al.  Public health implications of legalising the production and sale of cannabis for medicinal and recreational use , 2019, The Lancet.

[8]  K. Broich,et al.  Cannabisarzneimittel in der Schmerztherapie , 2019, Der Schmerz.

[9]  K. Broich,et al.  [Cannabis medicines in pain management : Interim analysis of the survey accompanying the prescription of cannabis-based medicines in Germany with regard to pain as primarily treated symptom]. , 2019, Schmerz.

[10]  M. Fitzcharles,et al.  Medical cannabis: strengthening evidence in the face of hype and public pressure , 2019, Canadian Medical Association Journal.

[11]  Brad A. Roberts.  Legalized Cannabis in Colorado Emergency Departments: A Cautionary Review of Negative Health and Safety Effects , 2019, The western journal of emergency medicine.

[12]  M. Ueberall,et al.  Effectiveness and tolerability of THC:CBD oromucosal spray as add-on measure in patients with severe chronic pain: analysis of 12-week open-label real-world data provided by the German Pain e-Registry , 2019, Journal of pain research.

[13]  M. Bloomfield,et al.  Medicinal use of cannabis based products and cannabinoids , 2019, BMJ.

[14]  D. Zylla,et al.  Impact of Medical Cannabis on Patient-Reported Symptoms for Patients With Cancer Enrolled in Minnesota's Medical Cannabis Program. , 2019, Journal of oncology practice.

[15]  D. Clauw,et al.  Qualifying Conditions Of Medical Cannabis License Holders In The United States. , 2019, Health affairs.

[16]  G. Schmidt-Wolf,et al.  [Interim analysis of the survey accompanying insurance-covered prescriptions of cannabis-based medicines in Germany]. , 2019, Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz.

[17]  C. Lucas,et al.  The pharmacokinetics and the pharmacodynamics of cannabinoids. , 2018, British journal of clinical pharmacology.

[18]  E. Kalso,et al.  European Pain Federation (EFIC) position paper on appropriate use of cannabis‐based medicines and medical cannabis for chronic pain management , 2018, European journal of pain.

[19]  I. McGregor,et al.  Medicinal cannabis in Australia, 2016: the Cannabis as Medicine Survey (CAMS‐16) , 2018, The Medical journal of Australia.

[20]  Jung-Han Kim,et al.  Stereotactic Core-Needle Biopsy of Non-Mass Calcifications: Outcome and Accuracy at Long-Term Follow-Up , 2003, Korean journal of radiology.

[21]  F. Blyth,et al.  Effect of cannabis use in people with chronic non-cancer pain prescribed opioids: findings from a 4-year prospective cohort study. , 2018, The Lancet. Public health.

[22]  L. Marsch,et al.  Studying Cannabis Use Behaviors With Facebook and Web Surveys: Methods and Insights , 2018, JMIR public health and surveillance.

[23]  E. Balka,et al.  Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study , 2018, JMIR public health and surveillance.

[24]  G. Habib,et al.  Medical Cannabis for the Treatment of Fibromyalgia , 2018, Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases.

[25]  E. Yom-Tov,et al.  Adverse Reactions Associated With Cannabis Consumption as Evident From Search Engine Queries , 2017, JMIR public health and surveillance.

[26]  Sengwee Toh,et al.  Pharmacoepidemiology in the Era of Real-World Evidence , 2017, Current Epidemiology Reports.

[27]  Till Bärnighausen,et al.  Quasi-experimental study designs series-paper 4: uses and value. , 2017, Journal of clinical epidemiology.

[28]  Eric E. Smith,et al.  Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research? , 2016, Journal of clinical epidemiology.

[29]  S. Wright,et al.  An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray , 2016, Therapeutics and clinical risk management.

[30]  E. Heerdink,et al.  The prevalence and incidence of medicinal cannabis on prescription in The Netherlands , 2013, European Journal of Clinical Pharmacology.

[31]  J. McNeil,et al.  Monitoring drug safety with registries: useful components of postmarketing pharmacovigilance systems. , 2012, Journal of clinical epidemiology.

[32]  K. Jenpanich,et al.  [Drug administration]. , 1976, Thai journal of nursing.