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?

Bowdish: 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?

Bowdish: 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?

Bowdish: 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?

Bowdish: 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?

Bowdish: 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.