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

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...

Read More

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

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...

Read More

What the FDA’s guidance on diversity means for rare disease sponsors

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...

Read More

6 Operational Considerations You Need To Know for Psychedelic Trials

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...

Read More

Psychedelic clinical trials: What sponsors should know when designing new protocols

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...

Read More

De-risking Oncology Trials with Medical Monitoring

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...

Read More

The ABCs of Transitioning PK Assays from Preclinical to Clinical

By Dr. Tom Zhang, Chief Scientist, Large Molecule Bioanalysis ,

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse. This is because the stages differ both in scale (small vs. large) and focus (safety vs. safety and efficacy). Here are a few points to jumpstart your thinking as you approach this challenge. Preclinical and clinical PK assay formats serve different goals Preclinical assays designed to assess drug toxicity and safety must detect total drug. For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), a typical format is: receptor/target as capture with a generic binding reagent as detection (e.g., anti-human IgG). In contrast, clinical trials focus on both safety and efficacy — the relationship between drug concentrations and pharmacological effects. As such, free drug level is the preferred measure for investigating target engagement in these studies. To measure free drug only, anti-idiotype (anti-ID) mAb testing may be the best choice. If so, it’s important to plan for development of this assay as within the project timeline. Consider matrix interference, as assays must work in both preclinical models and humans Preclinical studies are performed in animal models, while clinical studies are performed in human subjects. While...

Read More

Beyond the Hype: Addressing Safety Challenges in Psychedelic Trials

Emerging evidence showing therapeutic benefit of psychedelics for mental illnesses such as major depressive disorder, substance use disorder, and post-traumatic stress disorder, has captured the interest of clinical researchers, the general public, and Netflix-watchers. Researchers exploring psychedelic trials are faced with unique safety challenges for protecting patients and site staff because of the profound nature of the psychedelic experience and the requirements for psychotherapy that accompany psychedelic-assisted therapy treatment models. Patients participating in any psychiatric trial have a degree of vulnerability due to their illness. In psychedelic research, this vulnerability is amplified when patients receive consciousness-altering drugs, even in a highly controlled setting. Session Safety Measures Setting agreed-upon boundaries between therapists and patients helps protect all individuals. For example, it’s possible a psychedelic session could become difficult for a patient and if agreed to, physical touch or other interventions to calm the patient may help. Therapists need training to deliver these interventions in a way that keeps the patient and themselves safe while maintaining integrity of the study. An appropriate psychedelic-assisted psychotherapy protocol should account for safety measures and may include things like ensuring a dyad of trained therapists are in the room throughout the dosing session and those sessions are videotaped and actively monitored. Sites should also be carefully selected for their ability to safely execute your protocol and...

Read More