First, let’s clarify what we mean by eConsent. eConsent is just an electronic version of the existing informed consent process, a process that in itself is often mistakenly viewed as the same as getting a participant’s signature on the consent form. In reality, the signature is only part of the process.  The consent process itself comprises two elements:  Presentation of the Informed Consent Form (ICF): This involves providing participants with the ICF electronically, allowing them to review it and seek clarification by asking questions.  Participant's Acknowledgment of Un ..read more

Imagine a time when Sponsors and CROS can manage the study submission process without any dependencies on external parties. Having part of a process dependent on external parties adds risk and undue pressure on all parties and ultimately impacts patients who are waiting for the treatments that are to be tested.    In this scenario, the external parties are eCOA vendors, and the reality is that eCOA vendors are asked to develop studies to get to a point where they can generate materials that are used to support regulatory submissions. This means that the development work is done ..read more

Friction exists in every multi-stakeholder endeavor. Imagine the stakeholders in clinical trial design and implementation as a chain that links together participants lived experiences and biological responses into data that demonstrates outcomes. Multiple stakeholders from Pharmaceutical companies to patient panels, clinical research organizations (CROs) to technology vendors, interact as “links” to innovate better health outcomes for patients through better research outcomes.   The challenge is that each of these parties can be considered an added link in the chain of partners withi ..read more

Healthcare Uncomplicated Episode #110 with with John Reites, CEO of THREAD ..read more

Common Enrollment Obstacles There are many obstacles that prevent people from enrolling in clinical trials. Travel time, distance to trial sites and lack of trial awareness are a few of the primary examples. Travel for clinical site visits becomes more challenging with every added mile of distance. Over the years, in order to help improve the odds of getting enough clinical trial patients, sponsors relied heavily on study sites with access to large groups of patients, often in or near large cities. However, this approach has led to homogenous participant populations across all therapy research ..read more

The Importance of a Good Patient Experience It is critical to ensure clinical trials are truly patient-centered. Although the intention to incorporate patient input and feedback can be seen throughout the clinical research industry, clinical research studies often don’t rise to that challenge. In order for clinical trials to be designed in a way that is truly patient-centric, sponsors and contract research organizations (CROs) must acknowledge that every patient comes in with differing needs, expectations and backgrounds. Although it may not be possible for today’s clinical research studies to ..read more

Traditional Clinical Trials Most clinical trials were conducted in person up until the last decade. People who wanted to participate had to travel to a research site for every test and procedure. That could be across the country or their local doctor’s office. Traditional clinical trials are slower, less efficient, and often more expensive than hybrid and fully decentralized trials. Additionally, there are also time and financial barriers for patients, which can lead to a lack of diversity among clinical trial participants. As a result, certain populations may not be accurately represented in ..read more

Artificial intelligence, while already at work in many applications, remains a mystery and even a buzz term for many working in technology. AI will only continue to evolve, and its use will increase. For companies developing products that will utilize AI, it is critical to have clear objectives. In clinical research at my company, we use AI in our mission of making trials more efficient while increasing access to study participants globally. Through our work, we have gained practical experience when it comes to developing and augmenting a software platform to utilize AI, including allowing our ..read more

Digital Technologies & Decentralized Research Digital technologies that have primarily been used to decentralize clinical trials can be used to optimize the capture and curation of certain types of real world data (RWD) from patients. By combining these digital technologies with secondary RWD, researchers can gather a more holistic understanding of the patient.  The term “digital technology” encompasses a broad suite of potential technologies. Digital technologies typically used to run decentralized clinical trials (DCT) focus on facilitating data capture outside of a research site us ..read more

Recently, THREAD announced its collaboration with Amazon Web Services (AWS) and their combined work to introduce AI-powered enterprise-scale automation into THREAD’s decentralized clinical trial (DCT) platform. There are so many announcements made every day about different corporate collaborations, that it may not immediately be clear what it means that THREAD will be working with AWS. For those involved in conducting clinical trials, it means a significant step forward in efficiency and data quality. Leveraging the power of artificial intelligence, the industry can now take an evolutionary le ..read more