The number of widely-renowned PIs in key fields – those long relied-on for public speaking, co-sponsoring published papers, or approaching FDA – is dropping. As research spaces grow more crowded and competitive, pharma needs to encourage career development of new PIs to keep the industry moving forward.
- Build partnerships with medical schools and teaching hospitals on sponsored work, residency programs, and continuing medical education
- Emphasize clinical trial options at healthcare sites
- Broaden work with hospitals in diverse communities so physicians will notice and respond to rising client interest
- Boost the population of researchers who are willing to devote the necessary time for training, clinic work, and running trial infrastructure
The data from your primary and secondary endpoints are critical for your trial, so before collecting them you must thoroughly evaluate any risks that could impact this data. Instead of investing the time to equally focus on all data, you should instead prioritize the key critical endpoint-related data in a risk-based monitoring approach.
- Allocate resources based on inherent risks, which vary across trials
- Establish risk assessment and mitigation strategies from the earliest stages
- Review strategies and tools for risk-based monitoring
Pharma has come to excessively rely on long, detailed feasibility questionnaires as training wheels, and too often has them substitute in for the hands-on site engagement piece that they lack. By re-examining their use and making feasibility determination part of the relationship management process itself, you can focus on information that is more urgently needed and that will be less boring and burdensome to prospective partners.
- Reorient feasibility determination around levels of interest, resources, and database quality
- Spot the warning signs of a site’s patient population being tapped-out
- Clarify how much you need to know about what every study coordinator is doing
Traditional methods for identifying potential participants have not changed in 25 years. The sector still places a huge burden on site coordinator involvement and/or expensive call centers to facilitate and manage the screening process. Is there a new workflow that eliminates these outdated solutions? Yes!!
- What are some of the newer solutions in the space? Effectiveness?
- Do AI coordinators really get at the pain points?
- How generalizable are the solutions across studies, therapeutic areas, sites?
- What are the industry standards/benchmarks in this space?
- Target the questions that best reveal the PI’s understanding and preparation level
- Find out who the favored and trusted partners of consortia members are
- Determine the best approach for remuneration if sites don’t actually have the data they claim
As large PE-funded site networks continue to take over from earlier academic medical and “mom & pop” sites, the sheer number of different execution models can seem overwhelming – and a newfound emphasis on maximizing profit might put data quality at risk. What can you learn from recent surveys on the different models and pain points associated with large site networks?
- Prioritize the site network features that you most want to engage
- Assess the scale of the financial needs that private equity is now placing on networks
- Reckon with how the pressures of private equity will change site preferences on site decisions and ROI
There are so many different site execution models and one size definitely does not fit all. The wrong choice can lead to protocol amendments or delays, or being unable to match your technological needs.
- Compare and contrast urgent care models, mobile research units, large site networks, and others
- Evaluate how essential telemedicine, apps, and digital technologies are for your trial
- Focus on the benefits and drawbacks of more traditional dedicated sites
- Rank sites by level of expertise in your area of interest
- Know in advance what site M&A will do to your trials
Any time sponsors roll out new processes or data portals, they must always remember that the end-users are the sites themselves and that all new systems require user acceptance testing. With the broad spectrum of tools and systems that pharma gives to sites, you cannot assume they will learn everything at the same speed or that it will all work. What are the best ways to gather input from sites?
- Structure partnerships around feedback on the tools and resources you ask sites to use
- Make sure sites have a seat at the table during your process building and incorporate their feedback on protocol design
- Learn key lessons from the Shared Investigator Platform roll-out
- Understand how research organizations integrated within hospitals can play a role in your studies
- Grasp the level of care that IROs can provide and how available their study teams are
- Take the lead among sponsors in working with this new model
- Track improvements in gathering clean data and improving patient convenience
- Recognize the added requirements and burdens of staff experience levels, training, and IT support
- Assess your company’s commitments to breakthrough technologies – and how they may have both advanced and regressed since Covid
Sites increasingly expect to use their own certified, quality-controlled technologies to trials and to have more control over data capture. Yet while they are highly comfortable with the use of their own systems, pharma tends to want more centralized and uniform control over processes and data. These requests are not going to stop, so how can you guide your company past the “no” stage?
- Track the emerging trend of sites pushing for using existing systems that are compatible with pharma and have the same audit trails
- Understand the impact of private equity as it purchases sites and adds new technical teams and expectations
- Take advantage of new options for remote monitoring
- Envision the necessary incentives for change
As your startup procedures evolve past the traditional feasibility questionnaires, you must emphasize gathering perspectives from both sponsors, sites, vendors, CROs, and IRBs. Strongly focus on what they have been able to prove worked and how their data shows it.
- Emphasize critical differentiators for interest
- Keep the theme of your messaging to these key stakeholder groups around data quality
- Spot the signs of success for radical disruption
Many months within study enrollment periods can be taken up through contract management unless you have the necessary arrangements in place with hospitals and sites. By designing templates that meet the needs and capabilities of hospital networks, you speed up your work on feasibility, privacy, and sign-offs.
- Examine the usefulness of blanket CDAs with multi-year lifespans
- Build leeway into contractual language to avoid institutional bureaucracy
- Determine how many contracts are needed for each research institution
