Laurie WItherwax - phaware® interview 195

Oct 5, 2018

Laurie Witherwax is the Vice President of Project Management at Worldwide Clinical Trials, which provides drug development services from Early Phase and Bioanalytical Sciences, through Phase II, III and IV. In this episode, Laurie discusses the role of CROs (clinical research organizations). Laurie was the Program Director for global Phase III cardiovascular trials encompassing 38 countries across 620 sites, including 3,400 patients, and other trials involving complex and rare diseases. Her responsibilities have spanned the full duration of studies, from start-up to project close-out and review.

Hi. I'm Laurie Witherwax. I'm Vice President of Project Management at Worldwide Clinical Trials, which is a clinical research organization. My connection to pulmonary hypertension is that I work on PH studies and am very interested in working with our patients, and enjoy working, and learning more about pulmonary hypertension through our patients.

Clinical trials are paramount, and I would say I'm especially interested working through CROs or clinical research organizations because through clinical research organizations, we're able to get the drugs and treatments to the market faster to patients who need them. In fact, based on a Tufts study, we're able to get drugs to market 30 percent faster than if they were not done through a clinical research organization.

A clinical research organization really accelerates the scientific and medical innovation by bringing all of the touch points that happen in clinical research into one organization. For example, CROs are composed of physicians, scientists, and multiple people with therapeutic, data, science, regulatory experience, operations experience, and that's all brought into one organization. Then with that expertise, we're able then to collaborate with academic institutions, physicians out across the globe, and then also work with biotechnology, pharmaceutical companies, and then from there, all of that's brought together under a clinical research organization, where we can then share that information as we continue clinical trials in accumulative fashion.

What makes a clinical research organization different is that we have all of those people with expertise that I mentioned. We got the scientific expertise. We've got the operational expertise, and because we work with a variety of pharmaceutical and biotechnology companies and organizations, we're able to replicate clinical trials, we're able to become more efficient at it, and then we're also to take the knowledge that we learn from those clinical trials such as import/exporting across the globe with devices or drugs. We're able to do that and improve upon it each time.

We act as a hub for clinical research through many touch points. With a clinical trial, we gain a specific therapeutic experience, so we might not just do one PH study. We may do several, and we may do several that are interrelated, and we may do several that use devices or use other modes of delivery, and we're able, again, to learn what patients like, what they don't like, and we're also able to learn how best to execute those studies, so we get them done with greater accuracy. We get them done with more understanding of what the patient needs, and also we develop relationships with the physicians who are participating in these clinical trials.

I think it's important for the patients to understand that we're governed. We're governed by strict regulatory and quality processes that are really designed to focus on patient safety and prioritize patient safety as number one. For example, we have a complex set of documents that we have to get regulatory approval for before we can even begin a clinical trial, and then we also are required to monitor very closely the data that's collected from patients from clinical trials to ensure the safety, and then also we collect all of the data so that it can be analyzed to ensure patient efficacy, as well.

A lot of patients, first of all, will ask, "I'm just going to get a placebo, right?" And it's not always the case. A patient may get a standard of care. Clinical trials do not put the patient's safety in jeopardy at any point, so it's really designed to make sure that we're looking at the standard of care and being able to determine the effect and safety of a new drug versus not having it out on the market. I think, number one, patients just assume that they're just not going to have adequate access to maybe a drug that's working quite well. The other thing is that often times, drugs are provided after their participation in the treatment, so if they are on placebo for any point in time, after the treatment period is up, they do have access to the active drug.

And then number two, I think people just ask, "What's in it for me? And how can I know that I'm advancing the research in my particular condition or disease?" I think what's in it for them is, of course, they get enhanced care. They often will see their physician more often, or they'll certainly be monitored more often. They'll learn more about their care, and then also I think it's good. It gets their caregivers involved often times so that their caregivers understand the disease a little bit better.

I would like to say just at the end of the clinical trial though, I think it's important that patients understand that we pull in all the data, it's analyzed, and everybody looks to have just the expectation, and hope that the patient will actually have access to this drug. It sometimes takes a long time. It's a long effort, and I just want to thank the patients, any patients who participate in clinical trial for doing that. It's important.

My name is Laurie Witherwax, and I'm aware that I'm rare.

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