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DE&I

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1rem

Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.

Podcasts

What Can ClinOps Learn from Pre-Clinical?

By using engaging visuals, researchers and companies can better communicate complex concepts, increase trial participation, and foster public trust in science.

Animated Explainers Can Be Game-Changers in Cohort Recruitment

Recommending two enlightening books to introduce the science of thinking, learning, and doing for clinical research professionals.

Why Mindset Matters in Clinical Research

Palmese, executive director, site relationships and DCT solutions, discusses the practice of incorporating decentralized elements in a study rather than planning a decentralized trial from the start.

Moving Towards Decentralized Elements: Q&A with Scott Palmese, Worldwide Clinical Trials

The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.

FDA Finalizes Decentralized Clinical Trial Guidance

The current lack of clinical trial professionals is a serious concern that's compromising the ability to conduct high-quality clinical trials, but it's not irreversible. 

Can Clinical Trials Overcome Their Staffing Problem?

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discusses how some stakeholders view DCTs only as fully remote trials.

Industry Perceptions of Decentralized Clinical Trials

, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized clinical trials (DCTs) including misconceptions and the rapid adoption of DCT elements. Myles also highlighted DTRA's initiatives on site adoption, operational planning, and the integration of digital health technologies.

ACT: What are some trends and challenges you’re currently seeing with decentralized clinical trials (DCTs)?

I would say that maybe people are a little bit allergic to the term DCT, which doesn't mean they're not using DCT elements. What I mean by that is there are a lot of people who hear DCT and react just to the acronym, and many of them are potentially thinking DCT means fully remote, which, as we know, it doesn't. When they hear DCT, it conjures up these concepts of site-less trials and fully virtual and nobody ever sees a doctor, and we know now that is not the case for the vast majority of trials where DCT elements are used. It's even reflective of how the FDA guidance on DCTs changed from draft to final form. The terminology DCT is an allergen, but the adoption is actually going pretty quickly. I would say, realistically, there's still challenges implementing DCT elements across different regions of the world, just because they need to look like the actual processes are a little bit different in different places, but I wouldn't say that it's because there's a technology gap, or even a will to use gap in any one region.

Videos

In a fireside chat with ACT editor Andy Studna, Bowdish, from a clinical research cancer center, shares her experience with these relationships and how to streamline clinical operations. 

2024 Veeva R&D and Quality Summit: Tina Bowdish Highlights the Importance of Site-Sponsor Relationships

ACT: You’ve been in the clinical research industry for more than 25 years. Can you please tell us a little about your experience?

 Yeah, I've been in research for more than 25 years, and I have held just about every role you can in clinical research that doesn't require a license. I'm not a nurse, I'm not a physician, but I have worked at three academic medical centers now, a couple of pharma companies, and a CRO, so I have seen it from all three sides of the table over the last 25 years.

ACT: Having worked on the execution of trials and partnered with other sites and sponsors, what opportunities do you see to improve the way sites and sponsors work together?

 Communication and relationships are really the biggest area, and I think as a society, sometimes we forget that relationships are really important, especially in this work from home era where everything is done via Zoom, so conferences like this are great to be able to make those connections. It’s kind of the press the flesh, but it's reminding you that we're all serving a common goal, and we're all human, and we're all working together. One of the areas, specific into the communication, is just making sure that that communication is streamlined, it's getting to the intended audience, and then it's truly understood. That goes both ways from sponsor to site and from site to sponsor.

ACT: If there is one piece of advice you would give to sponsors to make life easier for sites, what would it be?

 The one single piece of information I could give is to truly be ready when you are approaching your sites to launch a study. It's great to go to sites before you're ready to launch that study and get their feedback, but when you're trying to initiate a trial and get that trial started, when the sponsor or the CRO doesn't have all of their individual vendors and all of their documents completed, it makes it really difficult on sites, and it only lengthens the process of our startup. If we could make sure that we are truly ready before we are approached about a study and to get started on that, I think we could significantly cut down on the long timelines for startup that exist in our industry.

ACT: In your experience in research, how have you seen the enablement of site-sponsor collaboration, and could you share any examples?

 Yeah, so it's really at these conferences. It's having these roundtable discussions and tackling issues that have been around for 25 years. They've only become more challenging with technology and trials becoming more complex, so it's really tackling how can we do this for the patient? Everything that we do has a patient or a subject at the end of the day and that is why we all got into this industry in one way, shape, or form. We had a session this morning where we talked about how can systems across different sponsors and all the multiple systems that are used in any given trial be streamlined to make it easier for sites so that we can spend more time with those subjects?

ACT: What are some aspects of a clinical trial that you can prioritize to streamline operations?

 This is a difficult question, because every study is different. As I just said, trials are becoming more and more complex. Science is exponentially getting better, but that makes it harder and harder to find patients because your populations are narrowing down. If we can ensure that we keep a patient-centric approach to designing these trials when we're in protocol development, and thinking about what are the patients or the subjects going to be doing at a given visit at a particular time, and then taking into consideration what that population is, is it a rural population that doesn't have access or stable access to internet to be able to do e-questionnaires from home, or something like that? Is it a population that has to drive for 500 miles to get to the next site because they have a rare disease? What can we do in a remote basis? What can they do locally? How do we tackle that as an industry, because who's responsible? Is it the site that's responsible? Is it the sponsor that's responsible? I think the ultimate answer is we all have to come together and we both probably need to take a little bit more responsibility in that and work towards that goal.

Latest Conference Coverage

Aligning Decisions with Clinical Trial Timelines

ACT: Is there any potential for the use of AI when it comes to decision-making and enrollment?

Lwoff: In the trial development process, AI algorithms can analyze existing data to predict trial outcomes and identify optimal trial designs. It's already occurring and when it comes to patient recruitment and enrollment, AI can accelerate recruitment efforts by analyzing electronic health records and other data sources to identify potential participants who may meet the eligibility criteria for one trial. It's already occurring and when it comes to patient recruitment and enrollment, AI can accelerate recruitment efforts by analyzing electronic health records and other data sources to identify potential participants who may meet the eligibility criteria for one trial. Some site networks are already working with AI to check on their medical records to identify patients. However, we need to be mindful of how this data is being used at hospitals. There are some data privacy considerations. AI can process also and analyze data in real time and detect anomalies and potential issues more quickly than the traditional methods. Last but not least, AI may also be used to analyze previous trials data to start using it for site selection and to predict which sites may perform optimally in a given trial based on the previous experience with those sites.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the potential for artificial intelligence in clinical trial decision-making and enrollment. 

Video Series

The Use of Artificial Intelligence in Clinical Trial Enrollment

Key Considerations in Rare Clinical Trial Timelines

ACT: What are some key considerations sponsors should be mindful of when aligning their decision-making process with the timeline of a trial?

Ultimately, understanding the need to have some flexibility with timelines. It’s a good idea to include built in buffers for unexpected delays or changes that happen often, such as delays in the supply chain additional time needed for study, and document preparation. They must understand that the timelines for regulatory submissions, review, and approval to measure the interactions with regulatory agencies accordingly and prevent potential delays in obtaining the necessary approvals.

Budgeting and financial planning should align with the study timeline to ensure the financial resources are available when needed throughout the study and the time required for data collection, monitoring and analysis should be considered and should be realistic. Sponsors must ensure that data management processes are efficient and that there are provisions for monitoring and addressing any data issues promptly.

When talking about timeline, it's also important to consider that recruitment rate in a rare disease study will decrease throughout the course of the study, because, again, the population is limited in a rare disease clinical trial. As recruitment progresses, the number of available participants is reduced.

ACT: What do you think are currently the greatest obstacles for patient enrollment in the rare disease space?

There are a small number of individuals diagnosed with rare diseases, so it can be challenging to recruit enough eligible participants to a robust clinical trial. As noted before, the limited participant pool can extend the timeline for reaching enrollment targets. The criteria for enrolling patients in rare disease can be very specific, which can further limit the pool of eligible participants a rare disease trial, and very often involves complex procedures, frequent visits or other long-term commitments that patients and caregivers may be hesitant to enroll due to the potential impact that these may have in their quality of life. We also need to consider that currently, there may be no available treatments for most rare diseases. Depending on the severity of the condition, patients may be open to participate in clinical trials due to the clinical benefit that they may obtain in their condition.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, director, clinical operations, Rho, offers her thoughts on key considerations that sponsors should be mindful of during the decision-making process with the timeline of a clinical trial. 

Clinical Operations & Strategy

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