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Welcome to the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. Update your topic preferences to receive additional Clinical Leader newsletters on:
- Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Outsourcing Models | Regulatory & Compliance (Thursday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
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Clinical Trials In APAC: Challenges And Opportunities
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From The Editor |
By Ed Miseta, chief editor, Clinical Leader
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For several years, the APAC region has been one of the hottest growth regions for clinical trials. In June 2022, I had the opportunity to sit down with three experts on the region. They were able to discuss the growth of trials in the APAC region, the opportunities presented to sponsor companies, and the challenges that still exist.
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Clinical Trials And TMF 101 Learning Series
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Webinar |
Phlexglobal
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Spark a deeper and broader understanding of the world of drug development, clinical trials, regulations, the trial master file, and much more, for the industry novice as well as the guru.
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Scale Your Training Program: Three Successful Models
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Article |
By Miranda Schramm, Ph.D., Advarra
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A well-trained, effective, and efficient team is key to a successful clinical trial. This blog reviews the breakdown of types, goals, principles, and strategies for ensuring you have a trained and effective team.
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Mitigating Trial Risk In ALS Clinical Development
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White Paper |
IQVIA Research & Development Solutions
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The development of new treatments has been slow, with only two approved disease-modifying drugs that offer limited benefits. But significant advances in immuno-neurology have set the stage for promising novel treatments that could offer hope to patients and change the course of this disease.
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Global Landscape Of Advanced Therapies In 2022
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Infographic |
Informa Pharma Intelligence
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The continued development of genetic technologies gives rise to a broad and diverse pipeline, pioneered by biotechs, encompassing a range of novel drug platforms.
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Predictors Of Severe CRS In Longitudinal CAR T-Cell Clinical Trial Data
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Case Study |
Medidata Acorn AI
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Cytokine release syndrome (CRS) is a life-threatening toxicity of chimeric antigen receptor (CAR) T-cell therapy and there is a limited understanding of its risk factors. Find out how laboratory tests were analyzed with repeated measurements to identify differences in trends that persist across a variety of study designs, sponsors, and indications.
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An Approach To Countering Bias In Clinical Trial Design
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Article |
By Ben Baumann, OpenClinica
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There are plenty of ways to randomize the order of options in clinical trial design. You could, as many do, create multiple code lists containing the same options in a different order. But there is a more efficient way.
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How Continuous Improvement Ethos Serves Patients And Clients
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Article |
By Malcolm Horsley, MRN - Medical Research Network
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Years of experience, bolstered by continuous improvement efforts, have positioned MRN at the forefront of decentralized clinical trial execution, from in-home care to the eClinical suite of technology.
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ePremier Study Start-Up: Where A Successful Trial Launch Begins
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Video |
Premier Research
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Industrywide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed the Premier One Ecosystem to create a paperless, electronic data process, start to finish. Watch this video to see how the Study Start-Up application delivers fast, efficient, and accurate trial management.
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Supporting Your Complex Immuno-Oncology Trials
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Brochure |
IQVIA Biotech
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IQVIA Biotech offers extensive immuno-oncology (IO) expertise that spans across multiple treatment modalities (vaccines, bispecific antibodies, adoptive cell therapies [ACT], etc.) and numerous indications across hematologic malignancies and solid tumors.
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Laboratory Processing Services
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Brochure |
Thermo Fisher Scientific
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Fisher Clinical Services, a part of Thermo Fisher Scientific, offers a global network of cGMP-compliant facilities that provide biobanking and laboratory processing services that support personalized medicine and accelerate the discoveries that lead to innovative, effective, and safe healthcare products.
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Are Clinical Sites Seeing Cost Reductions As A Result Of DCTs?
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Video |
YPrime
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When the COVID-19 pandemic hit the U.S. in March 2020, many drug developers were caught by surprise. With clinics overwhelmed by COVID-19 patients, and the reluctance of some patients to venture out to those clinics, many trials faced the prospect of being delayed or canceled. Decentralized clinical trials (DCTs) and hybrid trials, which can take studies from the clinics to the patients, seemed to be the solution to keep things on track.
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Decentralized Clinical Trials: Balancing Patient And Site Needs
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Article |
By Beth Harper, Pro-ficiency
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When it comes to decentralized clinical trials, explore why sponsors and research sites might need to do better in looking closely at their specific patient cohorts to determine what individuals in those groups truly need.
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Enhancing DCTs Through Advanced Digital Platforms
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Article |
By Edward Triebell, MRN - Medical Research Network
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The central goal of decentralized clinical trials is to ease the patient burden and maximize participation, and innovations in digital platforms and technology offer an entirely new level of empowerment and engagement in implementing a decentralized trial.
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Risk Mitigation In Direct-To-Patient Clinical Trials
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Article |
By Nicole Gray, Catalent
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The direct-to-patient (DTP) model can help mitigate risks in patient enrollment (including diversity), patient retention, and adherence to overall study timelines and budget. Explore how to mitigate risk in DTP studies.
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Self-Collection Safety Liver Panel
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Datasheet |
Q2 Solutions
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Clinical trials are becoming increasingly decentralized, and Q² Solutions is committed to discovering innovative ways of improving the patient and investigator experience.
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