Newsletter | October 26, 2022

10.26.22 -- Are DCTs Making Trials More Or Less Expensive?


Welcome to the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial ManagementUpdate 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)
Trial Management
Clinical Trials In APAC: Challenges And Opportunities

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.

Driving Fundamentals: Ensuring An Efficient Clinical Research Process

Gain insight into drawing constant parallels to clinical research teams and how easy it is for anyone executing the same processes every day to take the fundamentals for granted.

Clinical Trials And TMF 101 Learning Series
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.
Scale Your Training Program: Three Successful Models

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.

Mitigating Trial Risk In ALS Clinical Development
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.
Drug Safety And Product Protection Driving Blister Packaging Growth

Learn why the trends in packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market. 

3 Simple Steps To Manage Multiple Protocol Versions In A Single Study

Managing protocol versions at the site level and the broader protocol amendment at the sponsor level go hand-in-hand. Learn why neither is simple, but both sides of the equation must be taken into consideration when designing the study.

Global Landscape Of Advanced Therapies In 2022

The continued development of genetic technologies gives rise to a broad and diverse pipeline, pioneered by biotechs, encompassing a range of novel drug platforms.

Driving Change In Cell And Gene Therapies: Learnings From The SITC Summit

Chris Learn, head of cell and gene COE at Parexel, discusses his participation at the recent Clinical Research Virtual Summit hosted by the Society for Immunotherapy of Cancer, and the implications for clinical research.

Predictors Of Severe CRS In Longitudinal CAR T-Cell Clinical Trial Data

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.

An Approach To Countering Bias In Clinical Trial Design

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.

How Continuous Improvement Ethos Serves Patients And Clients

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.

ePremier Study Start-Up: Where A Successful Trial Launch Begins

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.

Supporting Your Complex Immuno-Oncology Trials

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.

Single-Source Supply Chain Solutions For Today’s Clinical Trial Ecosystem
Marken provides a best-in-class quality management system, a global GMP depot network, direct-to/from-patient, home healthcare nursing services, and industry-leading expertise, all under one single-source provider.
Laboratory Processing Services
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.
Decentralized Trials
Are Clinical Sites Seeing Cost Reductions As A Result Of DCTs?

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.

Switching To Direct-To-Patient Rapidly In The EU

Explore the logistical risk management factors to consider when deciding to switch to direct-to-patient shipments in the EU.

Decentralized Clinical Trials: Balancing Patient And Site Needs

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.

Enhancing DCTs Through Advanced Digital Platforms

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.

Risk Mitigation In Direct-To-Patient Clinical Trials

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.

Accelerate Trials With Better Access To Patients, Physicians, and Sites

Only Elligo accelerates clinical trials through healthcare with direct access to known patients, their trusted physicians, and extensive site support. Gain insight into how this is done in this brochure.

Self-Collection Safety Liver Panel

Clinical trials are becoming increasingly decentralized, and Q² Solutions is committed to discovering innovative ways of improving the patient and investigator experience.