Trial Design

Dr. Michelle Longmire, Chief Executive Officer and founder of Medable, sits down with Moe Alsumidaie to discuss how the decentralized model will transform how trials are executed for years to come.

Findings from the most recent Biopharma Confidence Index show that the pandemic has substantially influenced biopharma executives’ expectations in key areas like artificial intelligence/machine learning and real-world evidence.

Beyond technology, awareness, and access—cultural competence is key.

A look at how real world data and real world evidence are shaping more decentralized trial designs for potential COVID-19 treatments.

Rasmus Hogreffe, former Head of Virtual Trials at LEO Innovation Lab, and current VP of Decentralized Trial Innovation at Medable, and Morten Kirkegaard, Head of Clinical Operations and Co-founder at REDO-neurosystems, discuss their experiences with decentralized trials.

FDA Commissioner Scott Gottlieb supports approaches that help biomedical research “become more agile and efficient” and reduce the cost of developing therapies, including decentralized trials and how real world data (RWD) and real world evidence (RWE) to support a range of drug development goals.

A recurring challenge in assessing and treating Post-Traumatic Stress Disorder or PTSD is the inherently complex, ill-defined, and sometimes downright puzzling nature of its symptoms.

For sponsors who are pursuing the goal of treating Alzheimer’s disease, understanding the obstacles inherent in Alzheimer’s clinical trials can help in planning for, and overcoming, these challenges.

Columnist Moe Alsumidae speaks to key Synteract executives on their acquisition of a dermatology CRO to augment its own expertise and grow the specific services necessary for this therapeutic specialty.

Here are four trends to watch as researchers continue to make headway in the development of biomarkers for cancer immunotherapy.

Until more sophisticated measures are created, a combination of investigator training and new imaging methods is the best way to create accurate, reproducible data across sites.

Due to a shifting landscape because of faster drug approvals, this article offers strategies for sponsors to design clinical trials.

In the search for more effective treatments and cures, there are challenges that sponsors and CROs must confront when conducting IMID clinical trials.

Drug developers are using surrogate endpoints to monitor the effectiveness of immunotherapies, taking into account the differences between immunotherapy and traditional treatments.

While block randomization has been shown to be a more frequently used form of trial randomization design, the use of dynamic randomization has been shown to have optimal treatment group balancing results.

Immunotherapy drugs have led to successes in the oncology space as the list of cancer survivors continues to grow. However, more work must be done to ensure that all patients who can benefit from these life-saving drugs receive them.

Progress and innovation within oncology has accelerated to a paradigm that includes immunotherapy and bio-genomics. Collaborative approaches in the future will continue to transform treatments in hopes of improving patient quality of life.

With significant technology advances in ECG recording through the years, the need to expand on traditional monitoring baselines-and include new variables such as time when designing clinical trial protocols-is important.

The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism.

Poor understanding of the natural history of the proposed indication due to few observational studies studying disease progression, heterogeneous patient populations with variable phenotypes and clinical courses, geographic dispersion of patients and investigators, regulatory uncertainties, and lack of prior clinical studies to establish a template for study execution, can all prove challenging in creating a pharmaceutical development program for the treatment of a rare disease.

Alzheimer’s disease (AD) is and will remain one of the most unyielding public health crises of the 21st century. Aging global populations translate to a constantly growing prevalence of a disease with no cure and an immense cost of care. In the United States alone, recent estimates1 suggest that 28 million people will develop AD by midcentury. Approximately 25% of the annual Medicare budget will be spent treating the disease – a projected $330B in 2040 – with hundreds of billions more in indirect costs.

Background:

 Clinical trial recruitment and enrollment has presented its challenges in many ways.  For Quintiles’ Phase I Unit in Kansas, clinical trial recruitment was a matter of process and strategy that it improved with innovation and mobile health (mHealth) technology applications. This article and case study will delineate the challenges that Quintiles’ Phase I Unit underwent, and what it did to achieve transformative results in recruitment, study visit adherence, and operational efficiency.

The concept of the human challenge model (HCM) originated from early societal attempts to halt the spread of acute diseases within their own communities