GUEST COLUMNISTS

• How AI/ML Is Helping Clinical Researchers Investigate Alzheimer’s

  Like many cognitive conditions, Alzheimer’s disease can cause changes to a person’s speech and language. Artificial intelligence (AI) and machine learning scientists are working on automating speech assessments to detect the disease earlier and improve understanding of the efficacy of novel treatments. 

• 3 Key Factors For Selecting Clinical Data Providers

  As the volume and availability of clinical data have increased, so has commercial interest in clinical data. The wide array of data-sharing initiatives makes it difficult for pharma companies to identify and select the right source or sources of data to deliver on their needs. Here are three key factors to consider as you select and engage with clinical data providers.

• Your Guide To Harnessing Clinical Trial Sensor Data Better

  Technological advances in wearables and sensors are speeding the development of digital measures and endpoints. This sensor data is often in native formats unique to each sensor technology and in proprietary clouds owned by the manufacturer. To address this challenge, the Digital Medicine Society released a set of open-access toolkits to support the successful scaling of sensor data to drive better clinical decisions.

• Online Resource Launched To Ease Clinical Trial Participation Fears

  Studies have shown that patients are eager to participate in clinical trials, but they lack the resources to address their fears. Fear remains the main barrier to patient participation. Earlier this year, an independent start-up launched an online resource for patients to access information they need to ease their fears.

• Clinical Research Sites Share Cash & Workforce Shortage Concerns

  As the industry faces unprecedented macroeconomic issues, including substantial staffing challenges and inflationary pressures, resources are desperately needed to support clinical research sites and studies. As a sponsor company, consider ways to help sites right now: Can existing budgets be adjusted? If not, what other solutions may be available? 

• 3 Strategies For Optimal Oversight Of Your Outsourcing Partner

  Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.

• Tips For Clinical Trial Sponsors To Cultivate Meaningful Relationships With Sites

  Sponsors can influence site choices and work better with them by creating a positive sponsor-site relationship from the onset, which includes making design decisions that consider the patient perspective and making execution decisions that alleviate common operational challenges and reduce burden on sites. Here's how.

• Designing A Phase 3 Clinical Trial In Rare Dermatology: Lessons Learned

  Rare dermatologic disease R&D is growing at a much faster rate than other fields in dermatology. Even before the data readout from our Phase 2b study, we began formulating several possible Phase 3 trial designs and asked scientific, operational, and regulatory questions. Here are our lessons learned.