December 12, 2022
Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Worldwide Clinical Trials has partnered with the leading medical genetics company, Invitae, making Worldwide the first CRO to use Invitae’s Explorer tool. Explorer provides us with access to data insights for diseases based on prevalence, incidence, demographics, geography, and epidemiology for patients. This enables us to recruit patients quickly and pinpoint optimal study locations to help our sponsors uncover new and potentially lifesaving treatments for people suffering from rare diseases. As a leader in the use of genetic testing in clinical trials, particularly in rare disease trials, we have engaged in many conversations with sponsors about how to utilize genetic testing and the concerns associated with them. Our Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Diseases, teamed up with Invitae, to answer a few of those questions. 1. What are the benefits and limitations to using genetic testing? Genetic testing may help confirm a clinical diagnosis, help predict disease prognosis and progression, facilitate early detection of symptoms, allow for family planning and genetic counseling, inform optimal treatments and therapies, and/or promote enrollment in clinical trials. However, genetic tests can be expensive and may not be covered...
November 14, 2022
Psychiatry has long embraced treatment options other than pharmaceuticals. So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. This is called “psychedelic-assisted psychotherapy” (PAP). But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data? Worldwide Clinical Trial’s Rolana Avrumson, MS, Vice President, Clinical Projects, Clinical Assessment Technologies has supported the psychedelic trials Worldwide has conducted, working with therapists and raters to understand and deliver their roles in accordance with the protocol. We connected with her to answer a few questions about how these roles function: When should a psychedelic trial utilize a therapist? Rolana: In a psychedelic clinical trial, therapists should be utilized if the dose is high enough to produce a hallucinogenic effect in the patient. This effect can last for several hours, so patients must stay onsite under close monitoring for their safety and the safety of those around them. A therapist will remain in the room with the patient, providing psychological support throughout the experience. Under the influence of a psychedelic, a patient may have troubling feelings or difficult memories arise. The therapist will help them work through it and process the inner...
November 3, 2022
BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. This plan, designed to help make clinical trial enrollment more representative, stands to support diversity, equity and inclusion (DEI) initiatives in R&D — a sector that certainly needs more attention across all clinical trials. But for rare disease trials, which are already challenging to enroll, the new guidance introduces nuances that speak to broader recruitment trends in orphan drugs, suggested Derek Ansel, executive director, therapeutic strategy lead, rare diseases at Worldwide Clinical Trials. “We’re seeing more sponsors getting requests from agencies to include more diverse populations across ethnicities, socioeconomic statuses and other groups,” he said. “The challenge within rare disease is that we’re now ‘rarifying’ an already rare disease by expanding into rarer subtypes of the disease.” In turn, the FDA’s guidance recognized the difficulty in recruiting for rare diseases and encouraged sponsors to become more resourceful and intentional about trial enrollment. At the very least, it suggested that sponsors align enrollment goals to the demographics of the disease — if not the general — population. But how? Here’s what rare disease sponsors should consider as they go from here: Globalizing the rare disease...
October 26, 2022
Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “Demystifying Complex Operations in Psychedelic Research,” available on-demand now. If you missed it, you can watch the full webinar and read a high-level recap of what we covered: 1. Psychedelic trials need to be done with scientific rigor. Even though some natural psychedelics have been used for a long time and current data suggest a favorable safety profile, there is still much to be known and understood about efficacy and their safety profile in different populations. As we look to study psychedelic compounds in larger and more generalized populations, we need to execute these studies with rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials. You can find their full article, here. 2. Sites bear a lot of responsibility and need to be carefully selected. In any clinical trial, a portion of the success or failure of the trial can be attributed to the site selection strategy and site participation, and this holds true even more...
October 19, 2022
BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. Psychedelic products are having a renaissance moment. As evidence emerges about their potential for PTSD, depression, cancer-related distress and more, the market for psychedelics could swell from $2 billion in 2020 to $10.75 billion in 2027. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. “Everywhere you turn, there’s some news piece about it,” said Christine Moore, Ph.D., Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. “It’s not too surprising given the mental health crisis. We have a huge unmet need, so there’s a lot of enthusiasm about the potential of these products.” But despite the momentum for psilocybin and other psychedelics, challenges remain. Of note, these programs differ significantly from conventional psychiatry trials. Aside from the obvious complexities of managing a drug that alters the mind, the regulatory and ethical nuances can hold ill-prepared developers back. “These studies take time to do well,” Moore said. “Between the regulatory input, licensing to handle controlled substances, therapist training, site identification, and many other steps, there’s a lot of effort going into these programs and many barriers that must be addressed.” That doesn’t mean new sponsors shouldn’t explore psychedelics. In fact, opportunities await many companies...
October 17, 2022
BioPharma Dive sat down with our Gary Fishbein for a conversation on how to de-risk trials without sacrificing cost or speed. Phase 3 oncology studies have approximately a 35% likelihood of leading to regulatory approval. There are particular challenges for oncology studies, in view of the fact that the overall likelihood of non-oncology Phase 3 studies leading to approval averages 65%. Oncology medical monitors play a critical role in the clinical development and execution of pivotal oncology trials, and often have strongly influenced the therapeutic area in which the compound will be most active, along with identifying and managing drug-related toxicity. These measures, applied across the continuum of a compound’s development, can improve the likelihood of successful late phase trials. In recent years, strategic and data-centric tools have provided physicians and other medical experts the ability to assess safety and efficacy signals earlier in the course of the clinical trial. Doing so can set programs up for success by optimizing enrollment, assessing safety signals and working with sites — all while informing protocol changes in real time. “Every sponsor company of every size should pay attention to how they perform medical monitoring,” said Gary Fishbein, MD, MPH, Vice President, Therapeutic Area Lead for Oncology at Worldwide Clinical Trials. “This process contributes to data integrity throughout the trial, from making sure...
By Dave Bowser, Chief Operating Officer,
November 10, 2021
I look back on my days as a Captain in the United States Marine Corps, and the skills I learned have driven my career success in healthcare, first working at Pfizer running drug development programs, and now at Worldwide Clinical Trials leading clinical research to bring drugs to market. There are three things that I attribute to my success and, this Veteran’s Day, I’m asking military veterans to join me in improving patients’ lives at Worldwide Clinical Trials. Exceptional project management skills Clinical trials are complex, so it is essential to have exceptional project management skills to ensure that trials are set up, enrolled, conducted, and reported on time and on budget. Military veterans typically possess this ability. The project management skills I used as a combat engineer to build bridges, roads, and explosives gave me the discipline that has been a common thread throughout my career. Commitment to a cause bigger than themselves Along with discipline and project management talent, military veterans have the commitment to a cause bigger than themselves. People at Worldwide care about the patients and want to see drugs get to market that can improve patients’ lives and drive healthcare forward. Along with this commitment comes the dedication and work ethic to spend the time. It’s easy to have a work ethic when you believe...
By Shannon Kellner, Senior Director, Strategic Feasibility and Laurie Witherwax, Sr Vice President, Site Activation,
December 7, 2020
The following blog outlines strategic decisions to consider at the feasibility stage of a proof-of-concept study.