The latest updates from THREAD
Unlocking the Potential of eConsent: Demystifying Electronic Signatures
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…
Factors Shaping Study Timelines: Screenshots, Localized Content, and the Complex Role of IRB Submission Timing
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.
The Friction Factor: Solving Delays in Clinical Trial Efficiency
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.
What Biology Can Teach Us about Patient-Centric Research
The push to make clinical trials more patient-centric from regulatory bodies and innovative organizations has led to many claims: "Listen to patients," "leverage decentralization," "engage more ethnically diverse Principal Investigators to access ethnically diverse participants." Each of these claims have merit, yet for all the patient panels convened, patient-centric consultants hired, and internal initiatives launched, data has yet to fully realize meaningful shifts in the accessibility of clinical trials to most folks. I’d like to suggest that is because even the most valuable initiatives, while necessary, are rarely sufficient to create patient-centric clinical trials.
BYOD: Enabling Omni-Channel Success
With the increasing complexities of launching clinical trials and the noisy vendor landscape offering ePRO/eCOA solutions, there are many perspectives on how we can best serve the sites and patients to protect data capture as an absolute. Most companies offer a blend of provisioned and Bring Your Own Device (BYOD) strategies, and in some instances, companies that started as an EDC platform and evolved into capturing patient data have a web offering as well.
Co-Creating Research with Patients
On this episode of Healthcare Uncomplicated with Joao Bocas, he talks about ‘Co-creating research with Patients’ with John Reites, CEO of THREAD. In the short video, they discuss how the industry is bringing patients into the study process earlier and some of considerations to take when co-creating a clinical trial.
3 Considerations for Creating a Patient-First eCOA Solution
Researchers are working hard to create more accessible activities (think inputs) for patients so they can get in and get out quickly - but what if we did both? Unfortunately, it's not as simple as it sounds but the reality is any truly functional eCOA strategy will require a creative approach to both inputs and processes. Here are three ways you can get started on your journey of putting the patient first in your eCOA.
Rare Disease Clinical Research Trials
There are more than 7,000 distinct and identifiable rare and orphan diseases affecting up to 400 million people worldwide. More “common” rare diseases are likely to be well known, including cystic fibrosis or hemophilia, whereas ultra-rare diseases (those the EU considers to be less than 1 in 50,000) will be less well known. Due to advances in genomics, there are around 250 new rare diseases being identified annually, most likely with only a few individuals or families affected worldwide. Rare disorders are often debilitating and life-threatening, having a significant impact on the daily lives of patients and their families. Most rare diseases have an established genetic link (72 - 80%), however, they can manifest in other ways, such as an immunogenic response, the consequence of an infection, reaction to a toxin or an adverse drug reaction, as examples. While this category of diseases is often referred to collectively, rare diseases span across all therapeutic areas and often affect multiple organs. Even for those that study rare diseases, understanding causes, impacts and how to gather data through clinical studies is often challenging.
How Voice Response Technology Can Aid Clinical Trials
Why the gap between spending and impact? Patient awareness, inconvenience, and rationale remain limited, debilitating, and confusing. It seems pharma companies often design clinical trials without first talking to patients and determining their needs and expectations.
The Benefits of Using eCOA in Clinical Trials
eCOAs are not new, but despite being recommended by regulatory authorities like the U.S FDA, many study teams still choose to collect assessment data with pen and paper. Find out why paper COAs add unnecessary risk, especially with trials becoming more advanced and the industry acknowledging the need to reach more diverse and widely dispersed populations of patients.
Realizing The Potential Of AI And Machine Learning In Clinical Research
Over the last few years, talking about artificial intelligence (AI) and machine learning (ML) could drive customer interest, make something sound more innovative or even appear to boost a company’s valuation. Unfortunately, many of these AI/ML talking points were general, potentially premature and not yet ready to offer results. The clinical research industry was not immune to these discussions and may largely still view many AI and ML approaches as something on the horizon rather than as something available today.
Enhancing Patient Engagement with eCOA
One aspect of study design to consider when building better research experiences for patients is a genuinely patient-centered eCOA program. Here are some tips for ensuring that your eCOA is built with the needs of patients in mind and able to deliver the kind of engagement necessary for successful trials.
Three Ways that eCOA Improves Data Quality
Moving to eCOA is not only more patient-centric, but regulators like the FDA are also recommending eCOA over traditional, paper-based methods because of the clear benefits in terms of data accuracy. Learn more about the key ways in which eCOA works to help all study stakeholders produce better data.
3 Ways to Improve Clinical Trial Efficiency
Clinical trials introduce innovation in medicine. However, they can be very inefficient. There are multiple factors that slow progress and increase costs. Here are three ways to improve the efficiency of a clinical trial.
How to Remove Obstacles to Patient Enrollment
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. Find out how decentralized clinical trials can help sponsors expand their pool of potential trial participants while also increasing diversity within their clinical trials.
How eCOA Improves 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. Find out how eCOA can improve patient experience in clinical trials.
Supporting Staff Through the Transition to Hybrid Studies
Find out how decentralization allows for greater participation in clinical trials and about the opportunities that are created for a more patient-centric trial design.
Three Keys To Building Effective AI-Driven Products
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.
Combining Patient-Centric Technology and RWD for Comprehensive Evidence
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.
AI-Driven Automation: Understanding Its Power to Transform Clinical Research
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.
How a Decentralized Clinical Trial Model Can Enhance Diversity in Oncology Research
The main difference between oncology research and every other therapeutic research area is that for a cancer patient, a clinical trial is the only option left after standard of care options are exhausted. The unfortunate fact is that most cancer patients still do not have access to clinical trials as further hope for treatment because of where they live.
Increasing Diverse Clinical Populations: Geography
Decentralized clinical trials (DCTs) and the digital approaches they employ bring research opportunities to a more diverse geographic population. Find out more.
Unlocking the Patient’s Voice – The Benefits of Patient Co-Creation in Clinical Research
While it may seem simple and obvious, one answer to making research work better for patients is through listening to them. This goes beyond simply asking them questions and recording responses (passive listening), but engaging in mindful and intentional active listening, often aided by technology, to capture insights that can lead directly to solutions that improve how clinical studies work.
Increasing Diverse Clinical Populations: Race & Ethnicity
The lack of representation and diversity in medical research is partially driven by a lack of access to clinical trials. Studies with limited diversity can create significant limitations on the conclusions drawn from study data. Attracting a diverse population of patients for a clinical trial is critical for patient health and long-term community wellness.
Ultra-Rare Disease and Clinical Research– Different Approaches for Unique Studies
In a previous blog, we discussed ultra-rare diseases and the unique research challenges they pose to the development of new therapies. The nature of rare and ultra-rare disease means that drug development pathways and the types of studies commonly conducted can differ from the pathways and approaches used for more common diseases.
Increasing Diverse Clinical Populations: Sex
In Part I, we’ll look at how research can better address often overlooked gender based differences as an underappreciated variable in the evidence generated in the clinical development lifecycle and why extrapolation of results from one gender to another is objectionable.
Ultra-Rare Diseases: Decentralized Solutions to Tackle Challenging Clinical Studies
Though there are few individual patients with ultra-rare diseases, the total number of patients affected runs into the millions and that number grows each year as advances in genome sequencing improves the ability to diagnose them. Whatever definition is used, the extreme rarity of such patients presents unique challenges to their diagnosis and treatment paradigms.
How to Give Your Clinical Trial Participants More Control, Convenience & Comfort
Some estimates indicate 80% of trials are delayed due to participant retention challenges. However, sponsors and CRO’s can curb this attrition by focusing their trials on patient comfort, convenience, and by ensuring they feel in control of their participation. Adopting a truly patient-centered study design means acknowledging that every patient comes in with differing needs surrounding these three tenets and addressing them throughout trial design and execution.
Decentralized Clinical Trials: How to Balance Technology & Humanity
Hybrid and decentralized clinical trials (DCTs) are becoming more prevalent as they can better address the constraints associated with in-person visits including: mobility, proximity to research sites and the time or cost associated with attending the clinic. Although DCTs can be more convenient than in-person trials, is there a risk of relying too much on technology at the expense of person-centered communication?
Navigating the Changes to the EU Clinical Trials Regulations 536/2014 – Managing the Application and Authorisation Process
The processes for applying for and authorizing clinical trials in Europe have, traditionally, held numerous inefficiencies. Currently governed under the Clinical Trial Directive 2001/20/EC, trial sponsors have been required to submit separate applications for each member state in the European Economic Area (EEA) where they planned to conduct a study.
Managing the New EU Clinical Trials Regulation 536/2014 – Guidance for Navigating the Clinical Trial Information System (CTIS)
Staying on top of global regulatory guidelines and compliance is challenging for every organization working in the clinical research industry. Leaders from THREAD recently attended a comprehensive training session around the new Clinical Trial Regulation 536/2014 held by the European Medicines Agency (EMA) in order to help our global customers effectively navigate the changes associated with the new guidelines.
How To Overcome Operational Challenges with DCT Implementation
One of the challenges some sponsors face in designing decentralized clinical trials (DCTs) is getting the data to flow through the trial efficiently from multiple sources. How do you get data passed smoothly from digital recruitment to eConsent to enrollment? What happens when you need data from both EDC and DCT platforms to synchronize for a specific participant?
How Rare Diseases Were Affected by the COVID Pandemic
The latest issue of Raconteur (published as a supplement in The Times, UK) took a deep look at the rare disease landscape, including how rare diseases were affected by the COVID pandemic, and how patients who are engaged in the drug development process through clinical trials can build connections through digital platforms.
How to Scale Successful Decentralized Clinical Trials
When evaluating how to maximize trial success, especially given the growth of DCT methodology, scaling studies on a global level provides significant opportunity to enhance health outcomes and improve study timelines in the life sciences industry.
Clinical Trial Trend Outlook 2022
The global clinical research industry is expected to increase exponentially in the coming years. With rapid growth and shifting trends it is critical that sponsors, CROs, sites and researchers have a clear focus on trends that will impact the evolving trial landscape.
Decentralized Clinical Trial Tools that Increase Patient Retention
Sponsors and CROs alike understand the potential to bring trials out of the clinic and to geographically dispersed patients for better recruitment, retention and trial success. Decentralized clinical trials (DCTs) are becoming one of the most dynamic ways to expand clinical research opportunities and health outcomes globally.
Understanding and Navigating Changes to EU Clinical Trial Regulations – Guidance from THREAD
A major change to clinical trial regulations (CTR) in the European Union (EU) will be implemented in early 2022. A significant regulatory revision will go into effect as the Clinical Trial Regulation (CTR) No. 536/2014 EU will become the new standard by which clinical trials in the EU must be conducted.
How to Use Real World Data to Maximize Patient Recruitment in DCTs
In the clinical trial space, RWD helps support research design, protocol and patient engagement goals. Perhaps the most immediate way clinical research leaders can harness the power of RWD is as a tool for optimized patient recruitment.
3 Tips for Applying DCT Approaches in Rare Disease Trials
Decentralized clinical trial (DCT) approaches can be extremely useful in helping to facilitate clinical research participation for rare disease patient populations. That said, many sponsors new to conducting studies that include DCT elements may need some help getting started. Following are some tips based on THREAD’s experience helping sponsors to select and execute DCT approaches for their rare disease studies.
How to Integrate Patient Voice Into Your Clinical Trial
Ensuring clinical trials are truly patient-centered is critical for the life sciences field. While the intention to incorporate patient input and feedback can be seen throughout the industry, clinical research studies often don’t rise to this challenge in practice.
3 Ways that Technology Can Help Make Clinical Trials More Representative
Representation in clinical trials is a hot topic. The historical lack of representativeness and diversity in research came to greater attention recently as the world raced to develop safe vaccines that would work for everyone. Healthcare and political leaders needed to ensure that they could say with confidence that the resulting vaccines would work for everyone…
Third-Party Credentials for Selecting the Best DCT Platform Partner
While there has been significant DCT information in the marketplace for some time, recently market researchers have begun to quantify offerings and provide pharmaceutical companies ways to evaluate partners as they shift their business models towards a decentralized approach.
5 Ways You Can Shorten Clinical Study Timelines
In this global pressure cooker, reducing study times while meeting heightened expectations for data depth and quality is a monumental task. However, certain targeted and intentional changes can have a big impact on the overall trial duration. Here are five ways you can shorten study timelines:
Making Global Local: Tips for Localizing eCOA in Your Global DCTS
eCOA is a common and accepted methodology for global data collection and is among the most oft-used features of decentralized clinical trials (DCTs). One of the reasons eCOA is so useful is that it can be conducted in a variety of ways while maintaining the “fit-for-purpose” validation requirements set by regulators all over the world.
How to Navigate the Global DCT Landscape
One of the benefits of running a decentralized clinical trial (DCT) is its scalability on a global level. Global adaptation of decentralized clinical trials allows sponsors and CROs to maximize operational efficiency, engage with a wide swath of participants and improve study outcomes
Value of DCT Approaches in Rare Disease Trials
Clinical trials for rare disease therapies pose unique challenges. Rare disease studies tend to be complex, due to a lack of historical data, well-defined clinical endpoints and available comparators. Rare conditions, inherently, mean that the pool of potential study candidates will be small which causes challenges to recruitment, as does the fact that these participants are often managing debilitating conditions. All of this increases pressure on the study team to keep enrolled participants engaged and to try to prevent dropouts.
Tracking Enrollment & Retention Data in Decentralized Clinical Trials
DCTs offer many advantages related to enrollment and retention that traditional, site-based studies cannot match. By minimizing or eliminating the need for participants to visit clinical trial sites, we can greatly expand the geographic reach of a study. Additionally, the ability for remote technologies to provide always-on support and easy-to-use channels for engagement between participants and clinical teams can reduce stress and burden for participants and improve overall retention.
Three Tips for Successful eCOA in Global, Decentralized Oncology Trials
The idea behind implementing decentralized clinical trial (DCT) approaches in oncology trials is to improve the participant experience. While participants may still need to visit clinics to receive infusion medications in most oncology studies, DCT elements can ease their trial burden by collecting data remotely in between visits. A key component of this strategy is the effective use of electronic clinical outcome assessments (eCOA).
Reduce Clinical Trial Costs - 5 Ways that Decentralized Clinical Trial Approaches Save Money
The use of decentralized clinical trial approaches (DCTs) is on the rise. One reason for this growth is the ability of DCTs to help reduce study costs. Following are five ways that DCTs can make research more cost-effective.
From Intern to Full-time Employee: Celebrating Two Years at THREAD
Working in clinical research presents an exciting opportunity to be a part of something impactful and life changing. With more advanced technologies in the market, changes to drug development and the industry’s enormous growth, it is a great time to be a part of this dynamic landscape.
Addressing the slow adoption of decentralized clinical trials (DCTs)
Decentralized approaches provide a more patient-centric strategy, and many industry leaders and subject experts want to move forward with the technology, however, this transition results in extra challenges and questions when it comes to the those examining the operations, protocol design or feasibility of a study…
Consider a DCT provider that collaborates
To better serve the customer to help combat the difficulties faced in early 2020, DCT providers like THREAD, started to partner with organizations in a few key areas to enable additional use cases. But when it comes to recruitment or data and analytics for example, you want to know that DCT provider that you are using can meet the needs of your study.
A look into the hyper-acceleration of life sciences with Sean Vassilaros
We are obviously concerned about the safety and efficacy of clinical research, but we also want to make sure we are going down the right path when it comes to the goal of life sciences: taking care of the patient. In fact, Sean Vassilaros, COO of THREAD uses the phrase, ‘appropriate-effort’ to discuss the matter when asked how he believed this process was able to be expedited. "We just learned in the last year, that if you use appropriate effort to bring something to production, you're allowed to move at lightning speed."
The real value of eConsent in clinical trials
There is still a reluctance to adopt more innovative approaches among sponsors and clinical research organizations (CROs) because sometimes the clinical trial model just isn't compatible with those innovations and other times, they feel it is too complicated to introduce different technologies into clinical trials. Adding eSource into your clinical trial is one way to get started with decentralized technologies and the potential burdens are outweighed by the value…
How do you incorporate the caregiver in your clinical trial?
Caregivers are the biggest support system for many patients and are often working adults who provide care in their off-work hours to family members, spouses or children. Caregivers also look like the elderly providing care for a spouse, parents of children with disabilities, and home health aides. It’s these responsibilities that they already face in their daily routines that are making it difficult get participants enrolled to in-clinic site visits and typically, traditional trial designs create competing priorities for caregivers and their patients.
Make the most of data collection with these 4 simple steps
Questions have always existed around data from patients, and it's largely due to the ongoing challenges that are faced that make it difficult to detect noise such as recall bias, observer-expectancy effect, and response bias. The capability to overcome these challenges within the industry is an innovative process of combining these data collection methods into one cohesive offering.
We Need Descriptive and Predictive Metrics for Advanced Trials - The Time is Now
If we continue to measure and monitor performance of decentralized trials using traditional metrics that don’t fit, we can never be sure how effective these studies are. DCTs and Hybrid DCTs are simply too different from site-based trials for older study metrics to fit well. Traditional studies rely on clinic visits, where doctors and clinical staff collect various types of data derived from participant interviews, lab tests, and point-of-care instruments (e.g. blood pressure cuffs, pulse oximeters, etc.). A standard metric used in these types of trials is time from visit to data entry.
Scaling your global hybrid-decentralized study
Whether you're planning your next clinical trial or looking to gradually expand your current hybrid-decentralized trial there are numerous decentralized clinical trial approaches and steps you can put in place for your projects, such as virtual visits within protocol, schedule of events (SoE), and ICF’s that can make scaling your study become a turn-key process.
What we've learned after conducting 100 DCTs
How do you, in a measured way, conduct and scale a decentralized trial? We may not have decentralized trials entirely figured out as we are still learning, adapting, and trying to optimize the decentralized clinical trial approach to be a better experience for everyone involved, however, we can share what we have learned after conducting 100 decentralized studies with THREAD.
Maximizing participant engagement in your clinical trial
Some estimates indicate 85% of trials are failing to recruit enough participants and 80% are delayed due to recruitment challenges and high dropout rates.1 This challenge has been long-standing within the industry, and the adoption of decentralized approaches offer a promising strategy towards maximizing participant recruitment.
Virtual visits provide these 4 benefits in your clinical trial
There are simple, yet effective changes that you can make in your clinical trial not only to mitigate risk but to enhance processes that can improve the outcomes of your study. Virtual visits can be used to supplement some in-clinic visits and to create a flexible and patient-centric model. Not only will you keep your clinical trials moving forward during unprecedented times, but you'll also improve patient engagement within your trial.