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Articles

Our training places heavy emphasis on site selection: The entire study may suffer if sites are chosen poorly.

Hands-On Therapeutic Training

The CRO industry is on a course for continued rapid growth with the rise of genetics and genomics, as well as the push toward partnering and more postapproval research.

Progress and Potential: Evolution of the CRO Industry

The idea for this ACT CRO Retrospective came from the first SoCRA meeting I attended in 2003, just as I took over the position of Editor-In-Chief. I had the good fortune to hear PRA International's President and CEO, Patrick K. Donnelly speak about the CRO industry, and I was inspired by what he had to say. The CRO industry has exploded over the last 12 years. It has endured growing pains and it continues to develop. Therefore what better time than now to hear from the thought leaders who have been involved in the transformation taking place.

Looking Back, Moving Forward: A CRO Retrospective

Use case explores the arrangement’s effectiveness in the biometrics setting.

Implementing a Gold Standard FSP Strategic Partnership 

A data-fueled framework for sponsors and CROs in navigating this shifting terrain.

The Strategic Emergence of Site Networks in Clinical Research

CRO-sponsor relationships are key as industry moves towards new age of outsourcing.

Blending Models for Better Sourcing Solutions

With investors embracing the new regulations, a look at the progress CROs are making in their sustainability efforts 

In Focus: Amid Heightened Industry Rules on Sustainability, How are CROs Faring?

Why constant communication and transparency are paramount to successful partnerships between pharmaceutical companies and CROs

Tips to Rescue a Clinical Trial Before It’s Too Late 

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.

Videos

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In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements. 

Potential Challenges with FDA’s Multiregional Clinical Trials Guidance

, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA's new guidance for multiregional oncology trials, emphasizing the need for diverse patient populations in clinical trials. The guidance requires companies to proactively plan trials to ensure data applicability to the US population, considering factors like patient characteristics and healthcare systems. The expected outcome is better-designed trials with broader access and representation.

A transcript of Kahsoki’s conversation with

ACT: What does the guidance mean for sponsors and other stakeholders involved in trial design?

I mentioned sites and regions in Africa, Latin America, and the potential relevance of populations there to the US population. There's a little bit of a what I think is a contradiction in the guidance in terms of what companies must do, so on the one hand, the FDA is saying, yes, you could consider expanding to those sites, it's going to help you with your diversity and your population. At the same time, the guidance is also saying you must ensure that wherever you were conducting the study, the standard treatment that's provided in these other regions is reflective of the US standard of care, so that now limits where you can go. I think as companies are considering broadening to what I'm terming, non-traditional regions, they may have to go to specific countries. A very commonly cited example is South Africa, in Africa as an example.

Then, as a last thought, the guidance does pose, I think, a little bit of a challenge if a company is thinking that it's multiregional trial will allow for a more streamlined approach, or more streamlined overall development program. We know that regulators in different regions have requirements for their populations. They too, want to make sure that the trials that are conducted have data that will be relevant to their regional populations, so those regulators will themselves impose region specific requirements, etc., so companies are left in this bind of, how do I meet multiple requirements? It could end up being that a company, depending on how strict the FDA and or any other regional authority is, that could end up being that companies have to do multiple trials, so a global trial, a mix of persons, but if that is not satisfactory to the FDA, then the FDA might say, actually, you need to do another study with a population that is indeed representative. This is why I believe the FDA says first, work through your plan for how you're going to ensure that you're pulling together a representative population and then make sure you talk to us very early on so that we can negotiate, liaise, guide you through that thinking.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how sponsors will need to plan ahead even further for their oncology trials. 

Planning Ahead for FDA’s Multiregional Clinical Trials Guidance

Staying on the theme of diversity and ensuring diversity, it means that companies must begin to plan their global oncology programs much earlier than they probably were thinking, probably as early as Phase I, definitely before Phase III. In the oncology space, we know that companies are often seeking accelerated approval, so they might be seeking approval on a limited number of trials or Phase II study results, so it's important that their study population, even up to the phase of Phase II is appropriately representative. They've also got to be thinking about ensuring diversity of their Phase III trial populations, because the Phase III trials which are confirmatory and completed post-approval in the accelerated approval circumstance, these Phase III trials must be underway at the time of the accelerated approval decision, so companies must be proactively planning very early. How do we enroll an appropriately representative population for the US right as soon as possible in our program, if we're planning a global program?

I mentioned that the FDA is encouraging expansion of the types of sites for multiregional clinical trials. This, in turn, means that companies must think how we actually run these trials in a community-based site, just to keep that as the example, how will we collect the data? Often, these are not sites that have incorporated clinical protocol, clinical trial protocols, into their practice, so there is some learning first, but there's also the matter of data capture and especially in the community setting, you want the protocol to be as streamlined and as least burdensome as possible to the investigators as well as the patients, so thinking about, how do you incorporate the data capture that's happening as a matter of clinical care into your clinical trial protocol becomes an important consideration. It was interesting to me that very shortly, either before or after the multiregional clinical trial guidance came out, the FDA also issued a guidance called integrating randomized control trials for drug and biological products into routine clinical practice, and that provides recommendations on how to best collect data in a clinical trial such that it is reflective of routine clinical practice. I'm sure there was a lot of internal conversation within the FDA about how to tie all of the recommendations together, but I think for companies, when they are planning their global trials, thinking about their sites, they now have to think even further. How are we going to design the study of data collection so that it's easy to do in those additional sites.

Relationship Between CRO and Trial Site

ACT: How important is it for CROs to form strong relationships with sites, especially in the rare disease space?

If the CRO has a strong relationship with sites, the sites will be more proactive in addressing issues, providing timely feedback and ultimately ensuring trial success. In addition to this, fostering a good side relationship can lead to long term ownership, which can streamline processes and improve overall efficiency for future trials that we want to do.

First and most importantly, addressing issues and providing prompt feedback is the most important piece. I think those relationships will affect how far they go to get patients enroll and the care they give to them to retain them in the study afterwards. This is especially important in their rare disease space, considering the challenges that we have for enrolling patients due to the small population available. They’ll put in more effort when the CRO is working closely with them.

ACT: What are currently some key drivers influencing the decision-making process of sponsors?

Clinical trials are often expensive. Before engaging in a clinical trial, sponsors weigh the cost of the trial with its potential benefit and seek ways to optimize resources and reduce expenses without compromising quality. The main driver for selecting sites in rare disease is where the patients are, as well as timelines to have those sites activated once this is known. Regions and countries are selected and within those sites having the experience and capabilities to conduct the study with high quality are identified. An important consideration to be made by sponsors is trying to keep a balance between a sound and detailed protocol and ensuring that they are not excluding too much of the population by having eligibility criteria that is too restrictive, leading to a declining number of sites participating in clinical trials.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the importance of CROs building strong relationships with trial sites. 

CRO/Sponsor

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