This article is the second of a two-part series looking at principal investigators and the challenges they are facing in their profession.
In the previous article, I called attention to some of the challenges facing clinical trials such as the shortage of principal investigators and causes behind the high turnover for this role. This post will focus on potential solutions.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Can generals really be made? While efforts to attract and train new investigators are certainly important, they do not address the root cause of the experienced investigator shortage. To adequately address the problem, we must develop solutions to the fundamental causes of the problem that were detailed in the previous section.
“While efforts to hire and train more investigators are helpful, they are not addressing the root causes of the problem,” according to Ken Getz, associate professor and director of sponsored research at Tufts CSDD. “They are point solutions — they touch on areas downstream, but don’t touch on root causes like regulatory burden and performance inefficiencies, and it is that protocol or blueprint that needs to be improved.”
A fundamental shift by stakeholders is required to address the root cause of this problem in many different aspects of the logistics of running clinical trials. Some suggested changes include:
- Provide a support structure for new investigators in areas such as the completion of contracts and regulatory documents.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
- Sponsors need to make sure that new investigators understand the technical, ethical and business differences between clinical research and their regular medical practice. Meetings with new investigators early on should facilitate this.
- Investigators need to perform due diligence to identify all the hidden costs involved in performing the study before budget negotiations with the sponsor commence. Sponsors need to understand that including these costs in the budget is in their own best interest.
- Payment schedules from sponsors to site need to be timely and accurate. Guaranteed investigator payment within a reasonable timeframe should be standard.
- Sponsors need to start treating investigators as partners in their business, investing in and developing long-term relationships with investigators.
Regulatory agencies need to take steps to streamline and reduce unnecessary complexity in the regulations which govern clinical trials.
- Provide support structures that enable practicing physicians to more easily serve as PIs.
- Sponsors should seek a more integrated approach to IT technologies that are designed to aid clinical trials. The presence of multiple applications and platforms that are not connected to each may serve to add unnecessary complexity to the business of conducting clinical trials.
- Regulatory agencies could create a centralized website accessible to all study sponsors where investigators could upload their GCP training credentials, thus avoiding the need for repeating this training unnecessarily for every study.
Fortunately, some companies are developing technology solutions specifically designed to address site and CRO engagement needs. Study start-up activities from site activation through patient recruitment and into first subject first visit (FSFV), can be particularly challenging for PIs and study staff. They want to deliver high levels of performance but may be overwhelmed in the flurry of startup activity. To perform well, sites need timely access and visibility into workflow steps, including key documents and crucial tasks. Additionally, sites need objective evidence of the key drivers of study startup (and metrics) to meet sponsor expectations and make the right service quality investments. The same can be said for CRO engagement. Visibility into the operational workflows, key tasks, documents, and bottlenecks are critical elements in fueling the partner ecosystem required to deliver clinical trials successfully.
Technology solutions, particularly cloud-based, are increasingly becoming a key differentiator for sponsors looking to invest in sites and CRO engagement, ultimately resulting in lower costs and less turnover. Aiding this technology adoption is much needed regulatory agency support to eliminate duplicate, time-consuming tasks and improved supported structures for PIs needed to move the industry forward.
Photo: Getty Images
