Transformational Relationships: How a Consultative Approach from a CRO Adds Value to Your Development Program

March 1, 2023

The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. Through the 1990s, sponsors required a more sophisticated offering from CROs who were required to master fundamental study operations and processes, offering scalability to sponsors’ operations departments. As innovative science targeted more nuanced patient populations in the 2000s, CROs were required to anticipate a sponsor’s needs, forming sponsor-CRO relationships which would evolve into true “partnerships” in the next decade. Today, we see the need for innovative and strategically focused CROs that appreciate the value of the sponsor’s assets and can guide the optimal development route, integrating science and methodology with regulatory affairs and operational excellence. These new partnerships transcend traditional commercial relationships, which limit the ability of a CRO to add value to a development program. Instead, a CRO offering consultative services and strategic development elevates the full development program. The Benefits of Early Engagement The most successful sponsor-CRO partnerships begin with early engagement during the outsourcing process, which enables a more systematic and thorough evaluation by the sponsor and allows the CRO to develop the optimal operational strategy. From those early conversations, the engaged CRO members can ensure the goals and assumptions of the sponsor are integrated into the proposals and planning activities...

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Before Clinical Trials: The Long Game of Rare Disease Research

February 28, 2023

95% of rare diseases don’t have a treatment approved and won’t anytime soon. Uplifting Athletes (UA) is on a mission to change that. Back in 2010, Rob Long was a 22-year-old football player at Syracuse University on the path towards his dream career of becoming a punter in the NFL. But just a few months before his college graduation and the start of his career, Rob’s dreams fell to pieces. He found out he had brain cancer — a rare, aggressive brain cancer with only a 15% chance of living even another five years. “To say it was devastating is an understatement. By all appearances, I was healthy. Though cancer ran in my family, we definitely weren’t expecting this news, and the survival rates left little to be hopeful for,” says Rob. Miraculously, there was an approved treatment. “Just 36 months before my diagnosis, a chemotherapy had been approved for my cancer. I consider myself very, very lucky in a number of ways, but especially this one. It saved my life.” Rob’s Serendipitous, Full Circle Moment Rob has been cancer-free for 12 years. Three months ago, he realized he knew little about the drug that saved his life, and he decided to look into how his chemotherapy was created. What he was about to uncover would add new meaning to...

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Meet the Patient Advocate Panelists in Our Upcoming Webinar: Rare Disease Day 2023 Wrapped, What You Need to Take Away

February 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. With so many important discussions happening this year between stakeholders, it is impossible to be a part of them all. Our rare disease team at Worldwide will be hosting a panel discussion webinar with patient advocates active in Rare Disease Day events to synthesize the most salient conversations taking place. Panelists will answer questions such as: What are the greatest challenges holding patients back from enrolling in trials? What will have the greatest impact on rare disease patients in 2023? What does our industry still need to consider in order to create more accessible treatments? Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. Katie recently caught up with our speakers to learn more about the work they are doing in the rare disease space. See their conversation below and register for the webinar to hear more from these advocates! Katie Nichols: What is your connection to rare disease communities? Kyle Bryant:...

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To Share or Not to Share Failed Genetic Screening Results with Patients

February 6, 2023

When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. At Worldwide, this topic arises frequently in discussion with rare disease sponsors. As genome-wide association studies to identify genetic markers for common diseases increase, these questions will surface even more. Consider a known Alzheimer’s disease (AD) patient who undergoes screening for a variant of APOE (apolipoprotein E) that a study is targeting. If the patient does not screen positive for the variant, is it advisable or is there any obligation for the study team to disclose the results or explain why the patient was ineligible to join the trial? The best course of action will depend on many variables, such as the disease or population being studied and the genotype/phenotype relationship, risk, and impact on care. Obtaining appropriate assistance to facilitate planning up front for the complexities involved will save sponsors time and effort in the long run. For a deep look into the best practices and considerations for including genetic testing in your clinical development strategy, read this article by our Aman Khera, Vice President, Global Head of Regulatory Strategy and Derek Ansel, MS, CCRA, Executive Director,...

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8 Frequently Asked Questions About Genetic Testing in Clinical Trials

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...

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Raters & Therapists: Protecting the validity of your study’s data in a psychedelic trial

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...

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From U.S. Air Force Captain to CRO Leader: Karl D. Kendall Shares His Story

November 8, 2022

Celebrating our Veterans on this Veterans and Armistice Day.   At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice for veterans, military members, and their families, by creating an organizational environment where these individuals feel recognized, understood, and supported​. Karl D. Kendall is a testament to this. Since joining the Worldwide team in 2021, Karl has made a tremendous impact on our organization as Senior Director Project Management. In this role, he supports and guides study sponsors, while providing a high level of leadership and oversight by coaching and mentoring our project teams. Karl keeps everything running in an organized, efficient, and effective manner while operating with a strong sense of ownership, tenacity, and a constant “can-do” attitude – characteristics he honed during his time in the U.S. Air Force. Karl was a Captain for 10 years, during which he focused on structural airframe maintenance and repair, as well as offensive and defensive flight avionics (F-4, F-111, A-10, F-16 aircraft) while deployed at Ramstein AFB, Germany. In this Q&A, Karl shares how the skills he learned while in the Air Force catapulted him to success at...

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