The Best Advice I Ever Got: On The Job
As told to Abby Proch, executive editor of guest columns, Clinical Leader
As compared to other industries I’ve worked in, the clinical research folks are among the most willing, enthusiastic even, to share what they know. Every call and Zoom meeting I’ve had with professionals in the field has gone quite well. No one’s spilling their guts exactly, but everyone is happy to impart words of wisdom from their own little industry niche. Now that I think about it, it does seem a bit at odds with the way the pharmaceutical industry works — you know, holding some things close to the vest and wanting to be first to market and all.
Nonetheless, to commemorate Clinical Trials Day 2024, Clinical Leader tapped its community of clinical research professionals to share their insights. Here’s what they had to say:
Take Personal Responsibility
Teri Crumb, project manager, TLC Research
“Learn time management. As a coordinator, I plotted out my calendar one month at a time: study visit dates, meetings, IRB deadlines, EDC data entry, freezer shipments, etc. (Picture the big whiteboard at my desk.) This helped me see what prep time I needed and what items were most pressing. Time management also includes a healthy work/life balance. There was a time that I found I was answering emails at home in the evening, or even reading protocols. Once I realized the work stuff creeping in, I went cold turkey! No more reading emails once I had clocked out. No exceptions.”
Jessica Fritter, DHSc, MACPR, ACRP-CP, faculty, The Ohio State University College of Nursing, and chief clinical research officer, BJE Consultants
“Always do your own research in all aspects of your career and daily tasks. Whether you’re wanting a career change, preparing a study budget, conducting site visits, or recruiting subjects, do your research and ask the tough questions. Clinical research is an incredible field making huge impacts. Embrace your journey and being part of the impact!”
Todd Albin, Cedar Health Research
“Having spent over 25 years in the clinical research industry, I’ve learned invaluable lessons. Chief among them: Resilience and adaptability are essential for a successful long-term career. Daily challenges, often beyond our control, test our mettle. Collaborating effectively with study teams, and responding objectively and creatively, leads to positive outcomes. Most individuals choose this path to impact patients’ lives positively, necessitating orchestration across companies and teams. While perfection eludes us, history shows our innovation-driven impact. Stepping back from daily frustrations, we appreciate progress and focus on continuous improvement. As Albert Einstein aptly put it, ‘If we knew what we were doing, it would not be called research, would it?’”
Kayci Becker, manager, eCOA product, SAFIRA Clinical Research
“Always maintain thorough documentation. This ensures that every aspect of the study is accurately recorded, from protocol adherence to patient data. Detailed documentation not only maintains compliance with regulatory standards but also enhances the reliability and credibility of the research findings. By meticulously documenting all study-related activities, decisions, and outcomes, researchers can demonstrate transparency, facilitate effective communication within the team, and provide a clear audit trail for regulatory authorities. Ultimately, thorough documentation serves as the foundation for sound data analysis, interpretation, and dissemination, thereby advancing scientific knowledge and improving patient care.”
Partnership Musts
Janet Qi, CEO, PurMinds Neuropharma
"Having navigated the complexities of psychedelic clinical trials across international borders, my advice is to partner closely with experienced CROs who deeply understand the unique logistical and regulatory nuances involved. From securing proper licenses and ensuring stable product transport to designing trials that account for the consciousness-altering effects, having experts on the ground who have successfully threaded this needle before is invaluable. Don't go it alone — leverage the hard-won knowledge of those who have paved the way. Following in their footsteps allows you to focus on sound science and developing potentially transformative new therapies for patients in need, while they clear the operational hurdles.”
Larry Blankstein, senior consultant, Blankstein Consulting Group
"It is so important for small and virtual biotech companies with limited funds to have a process in place to select a CRO partner that has the same commitment and passion for the study as the company. In your CRO selection process, it is critical to have the CRO in their RFP answer specific questions critical to your study's success. Finally, small biotechs need to have in place a process, that collaboratively, enables you to ‘trust and verify’ all key vendor contributions to your study data."
Alexandria Clark, BSE, CCRC, and Anna Fehr, RN, BSN, CCRC, co-owners, One of a Kind Clinical Research Center LLC
“Celebrate the differences between clinical trial sites. All good sites will ensure GCP and FDA guidelines are followed and will follow the protocol and collect quality data, but beyond that, each site has its own unique characteristics. Characteristics, encompassing both patient and staff composition, which result in a need for diverse cultural approaches, various SOPs, and distinct processes. What works for one site may not always work for another and to be open to the various needs that sites might have and not expect them to be perfect puzzle pieces for your chosen vendors.
The most successful trials we have seen are those that ask the patient-facing team, the clinical trial site, for honest and blunt transparency on what is and is not working. Many sites are afraid of telling the truth if there are issues with the protocol or vendors, as they are afraid of backlash from the sponsor. Pharmaceutical companies should want to find these pain points and success stories to be able to design a more successful study, lowering costs for all parties and allowing Investigational products to get through their protocol phases more efficiently. Our industry should strive for partnership on all levels of the clinical trial family tree.”
Dr. Susan Hewlings, vice-president of research affairs, Radicle Science
“Transparency is key for effective clinical research, whether you are facing difficult internal decisions or external engagements with clients and consumers. Any time you are questioning the best approach, let transparency guide you. It will always steer you the right way.”
Let Data Be Your Guide
Michael W. Young, principal & founder, biomedwoRx: Life Sciences Consulting
"Having the opportunity to advise on clinical trial design, my years as a board of directors-level patient advocate have reinforced how important it is to ensure patient needs and expectations are met in every therapy we clinical trialists develop. In a clinical development discipline in which study endpoints are becoming more complex and numerous every day and we are incentivized to meet the demands of regulatory dossiers, we should be guided by the north star(s) of real-world evidence (RWE), patient adherence, and treatment compliance that will judge the merit of our work."
Pelin Thorogood, co-founder and executive chair, Radicle Science
“The principle of ‘all data is good data’ leads to invaluable insights and unexpected breakthroughs. Every data point, whether it supports or challenges our hypotheses, deepens our understanding, adds new dimensions for consideration, or provides signals for deeper dives. Let’s not forget how “serendipity” has played a pivotal role in scientific discoveries in the past. We now have the opportunity to increase the odds of manifesting serendipity with ever richer data sets, powerful analytical tools, and the curious mindset of a scientist!”
Miruna Sasu, PhD, CEO, COTA
"Clinical trials require a lot of hands-on work and many people to shepherd every step of the process, including data management. If that trend continues, clinical trials will always be one of the most expensive and time-consuming parts of bringing needed medicines to patients. Many emerging innovative solutions have been crafted by specialty companies to aid in steps along this complex process. A challenge for life science companies is they often don’t have dedicated individuals to fine-tune the process end-to-end.
My advice: Think about drug development with an ‘optimization’ mindset. Optimize your trial by using real-world data (RWD) before it begins, infuse real-world evidence (RWE) into trials (so that patients don’t need to be put on control arms), and invest in making teams knowledgeable about the solutions offered by external partners who may be smaller and more agile. They can potentially speed up and simplify a lot of the process.
Don’t fight innovation — get creative about solutions that you need even if they aren’t available ‘off the shelf.’ A lot of small and medium-sized companies would love the opportunity to work with teams that need new solutions. You just have to be a little open, have a few interesting ideas, trust a smidge, and provide feedback to make them real."
Rahlyn Gossen, founder and principal, Revise
“Sponsors need to think of their work with sites as a system. Typically, sponsors have used a piecemeal approach to coordinating study delivery with sites. They may use ad hoc methods like email to communicate, perhaps attaching documents and trackers. They may send printed materials. They may hire a central recruitment vendor to generate referrals. They may use specialized technology, or a point solution, to replace ad hoc methods.
Nothing is inherently wrong with these solutions, and they all can have an important role in study delivery. The problem is that research has changed, and these solutions are no longer enough. In fact, layering on solution after solution has created a larger problem—unnecessary complexity. Adding is no longer additive. It's frustrating to site and sponsor study teams, and it's inefficient.
The trends that have changed research show no evidence of reversing. Protocols continue to get more complicated. Sites continue to deal with workforce shortages. The number of registered trials continues to grow. And as a society, our attention spans continue to decrease.
Given this challenging reality, sponsors must make it easier for sites to work with them. There is no other way. The first step is to focus less on tactics and more on finding a better system. By looking at site coordination as a system, from recruitment through study execution, sponsors have an opportunity to bring some much-needed simplicity to study delivery.”
Think Through Tech Use
Michael Margiotta, chief strategy consultant, iHealthSync
"Embrace innovation and leverage technology to drive efficiency and effectiveness in trial operations. In today's rapidly evolving landscape, adopting advanced technologies can significantly streamline processes such as record aggregation, patient enrollment, and data management. By embracing these advancements, we not only enhance the quality of our research but also improve patient experiences and ultimately accelerate the development of life-saving treatments. Stay open-minded to new technologies and innovative solutions that can revolutionize how we conduct clinical trials and advance healthcare outcomes."
Heather Johnson, principal, OutWord Bound Communications
“When evaluating new software and platforms, prioritize user experience for ClinOps, sites, and (when applicable), patients. The bells and whistles won’t do much good if it takes extensive training to build a case report form or if the platform is so cumbersome that it raises the risk of human error. Drag-and-drop functionality and true mobile compatibility are two of several user-friendly features that make it easier (and faster) to build and run studies in multiple environments. You may find that the winning solution isn’t one of the major players: it could be a small- to midsize SaaS company that provides a comprehensive platform and dedicated service for a reasonable cost.
Second, keep an eye out for causal AI-based tools. I’ve heard of at least one emerging tool that allows sponsors to simulate different scenarios to see whether they will help or hinder a clinical trial. This type of information could help a study either get to the finish line successfully and faster or help the sponsor decide whether to even start at all.”
Trial Design Checklist
Justin Hanka, CEO, MindBio Therapeutics
“It's vital to design trials that prioritize patient safety while still enabling an experience reflective of real-world use. Through careful formulation work to develop a sub-hallucinogenic compound and comprehensive clinical protocols, we were able to evaluate at-home self-administration in a rigorously controlled study. This allowed us to gather critical data on efficacy and tolerability in a practical setting. Continuing to merge scientific best practices with patient-centric models will be key to unlocking new paradigms of care that are safe, effective, and accessible for those in need."
Eyal S Ron, Ph.D, managing partner, Sensei Ventures
“Reflecting on my clinical research experience, here are some key pieces of industry-specific advice and best practices that I would like to share with my peers:
Patient-Centric Approach — Prioritize the well-being and ethical considerations of the patients. Ensuring their comfort and addressing their concerns can significantly enhance study compliance and retention.
Thorough Protocol Design — Invest time in designing a robust and clear protocol with your medical advisory board, CRO, and all other stakeholders. Anticipate potential challenges and incorporate contingency plans. A well-thought-out protocol can prevent many issues during the study.
Regulatory Compliance — Start the clinical planning process by running the protocols by the regulatory agencies before finalizing the protocol. Incorporate their input and insights to ensure compliance and streamline the approval process.
Reimbursement Strategy — Develop a well-defined reimbursement strategy and roadmap, incorporating the goals into the clinical design. This ensures a faster financial return post-approvals.”
Peter Hendricks, university professor and Heersink Endowed Chair of Psychiatry, University of Alabama, Birmingham, and co-founder, Equulus Therapeutics
“As many medications that look very promising in clinical trials fail to realize their potential in the real world, I think the best approach is to design trials that will both meet regulatory expectations and provide data that is relevant to real-world contexts. In essence, to find a balance between efficacy and effectiveness — to show that the pharmacotherapy in question has an effect on the targeted condition and that the pharmacotherapy might be effective in more complex day-to-day clinical settings.