By Débora S. Araujo
Despite the focus on innovation at conferences, TED talks, and other forums in the last few years, as an industry we are still very slow to innovate and even slower to adopt new technologies, best practices, and methods. This intense fear of adoption in our industry is what I affectionately call “adoptaphobia.” Adoptaphobia refers to our industry’s fear of and reluctance to adopting new initiatives, best practices, and technologies to create efficiencies and reduce redundancies. We love to talk about issues and deliberate and discuss new methods, but we are extremely slow to commit and adopt the recommendations and methods that we agree would make everyone’s lives easier and streamline the process.
A historical and very familiar example of adoptaphobia within clinical trials can be seen by our industry’s slow adoption of electronic data capture (EDC). Despite the advantages that EDC showed early on by reducing double data entry, reducing query rates, and overall streamlining the data collection process for clinical trials, it took well over a decade for the industry in general to fully make the adoption. Today, EDC is the standard method for data collection in clinical trials, as even the thought of conducting a trial using paper collection methods seems wildly archaic and unproductive. Can you imagine trying to move into digital and remote trials today without the adoption of EDC? However, one has to wonder how much further along we would be as an industry had we not taken so long to fully embrace this game-changing technology and method. Would we have achieved faster results and gotten needed drugs to market faster? Perhaps. With this in mind, let’s look at some areas within clinical trials where the adoptaphobia syndrome is keeping us from advancing and achieving higher efficiencies in getting needed drugs to patients sooner.
Did you know that the average American spends 2.5 days each year looking for lost items, collectively costing U.S. households $2.7 billion annually in replacement costs?1 While we like to hope our industry is not this disorganized, our lack of standardization around the way we conduct our clinical trials can sometimes resemble the inefficiencies created and the time lost due to misplacing items.
Information is submitted and received in all different formats, with very few standards existing. For an industry that is highly regulated, we do not, unfortunately, have many standard templates across sponsors/CROs and sites, nor firm guidelines or transparent measures in the actual operational conduct of our trials. Any FDA-related tasks are, of course, standardized, but beyond this, how we run our clinical trials differs widely. While I am a firm advocate for flexibility and personal freedom, when it comes to how we run our trials, our lack of agreement, standardization, and commonality contributes to an excessive amount of lost time, frustration, and redundancies. Luckily, organizations such as TransCelerate Biopharma, drawing on the combined expertise of their members and industry collaborators, are promoting standardization with initiatives such as clinical data standards, common protocol template, e-Consent, shared investigator platform, and risk-based monitoring, among many others, to help overcome inefficiencies in clinical research.2 By adopting standards such as those proposed by TransCelerate, the industry can capitalize on efficiencies created by these initiatives to better focus our efforts on future drug and device innovations.
Streamlining Clinical Business Tasks
While much can be gained from the adoption of new methods and standards in clinical trials, one area that is critical and often overlooked area is clinical business tasks, which encompasses things such as clinical contracts, outsourcing and vendor management, and investigator site payments, among others. These seem like simple transactions that do not add great value to the actual clinical study results, and therefore, they have been ignored for many years, unfortunately to the industry’s detriment.
Two tasks in particular that have suffered greatly due to the adoptaphobia syndrome are clinical trial agreements and investigator site payments. Currently, executing a clinical trial agreement (CTA) between sponsors/CROs and sites takes a median of more than three months globally and more than two months in North America.3 Throughout the years there have been multiple initiatives, discussions, and presentations on the value of adopting industry-wide templates and best practices in the U.S. and other countries to speed up the CTA negotiation process, but it seems that very few have been adopted. I can see two distinct camps in this quandary: those who want an industry-wide standardization of CTA language and templates and those who are skeptical. The desire of those wanting the standardization is simple – it will very likely speed up the negotiations and get CTAs executed faster. The reluctance of those who are skeptical likely stems from being averse to being the only adopters of the new standard or method and fear that others may not follow suit. Exploring the adoption of industry initiatives such as CLEAR™ from the Society for Clinical Research Sites (SCRS), which brings alignment of the top negotiated clauses in CTAs or even the adoption of a standard industry template, can bring great efficiencies to this industry pain point.
The other overlooked clinical business task is investigator site payments. Easily one of my favorite topics in the clinical business operations area, the pains of investigator site payments and their impact on the conduct of clinical trials are nothing new. Based on industry surveys and general feedback from investigator sites, issues with site payments are one of the top reasons investigators drop out of clinical trials and one of the top frustrations sites have with sponsors. The feedback has been clear from sites themselves and from surveys in 2011 and 2016 by the Society for Clinical Research Sites showing the top concerns can be addressed by having 30-day payment terms, providing accurate details along with payments, eliminating payment holdbacks, and clear communication pathways to the sponsor.4 For a more in-depth look at this issue, see my previous article on this topic .
Despite site payment issues being acknowledged for over a decade and the solutions being clearly articulated to sponsors and CROs, the actual adoption of processes, positions, and technology to address this industry-wide topic remains slow. With 66 percent of investigator sites reporting having less than three months’ operating cash on hand and 40 percent of sites dropping out of clinical trials, the adoption of solutions by sponsors and CROs to solve this issue is critical.5 By having sponsors and CROs adopt solutions both in processes and technologies to meet sites’ payment needs , we can ensure the sustainability of investigator sites, gain efficiencies, and strengthen the relationship between stakeholders.
Investigator Site And Patient Input In Protocol Design
How many times have we seen a clinical trial have multiple protocol amendments or even end prematurely because despite it seeming scientifically sound and executable, once up and running, it simply was not feasible for investigator sites or patients? How many millions of dollars could have been saved had early input from both investigator sites and patients been obtained? This practice may seem like an obvious step during protocol development, but it is greatly underutilized by many sponsors. Without investigator site and patient input, protocols can be scientifically elegant but not practically feasible.5 By sponsors adopting a consistent practice of obtaining investigator site and patient input early during protocol development, many operational (and costly) hurdles can be avoided and the likelihood of study success can be greatly increased.
Well, what is the traditional treatment for any phobia? If all else fails, psychologists say desensitization through small and steady exposure to the source of the phobia is the way to go. Applying this to the industry would mean small and steady progress toward the adoption of more industry standardization, streamlining of clinical business tasks, and the input of investigator site and patients in protocol design. We can learn from the adoption of EDC that despite paper seeming like an insignificant issue for a trillion-dollar industry, when we decided to adopt a new approach to it, we were able to achieve so much more and prepare ourselves to embark on new frontiers of change never before imagined.
- Our Work in Clinical Development. (n.d.). Retrieved January 21, 2018, from http://www.transceleratebiopharmainc.com/what-we-do/work-clinical-development/
- KMR Group. Site Contracts from Weeks to Months: Results from KMR Group’s Site Contracts Study. Biospace.com. 24 August 2016. Accessed from: http://www.biospace.com/News/site-contracts-from-weeks-to-months-results-from/430240
- Society for Clinical Research Sites (SCRS), Site Payment (White Paper), October 2016
- Myshko, D., “Why Sites Matter”, PharmaVOICE, September 2016.
- Clinical Score. (n.d.). Retrieved January 21, 2018, from https://clinicalscore.com/patient-insights-and-protocol-design/
About The Author:
Débora S. Araujo has over a decade of experience within clinical trial operations with a special focus in the business operations aspects of clinical trials, including clinical financial management, contracting, and outsourcing. Working within organizations such as Novartis Pharmaceuticals, Eisai, Inc., and Merck & Co., among others, has given Débora unique insight into the systemic blind spots sponsors have within the clinical business operations of trials. In her current role as head of the U.S. Site Budgets and Payments group within Boehringer Ingelheim, Débora is responsible for providing leadership and strategic direction utilizing a strong customer-focused approach.
Her upcoming book, The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them, explores the various factors contributing to delays in clinical trial agreement (CTA) negotiations and execution and how to comprehensively deal with these issues. Readers will get an intimate look at each of the different “villains” contributing to clinical trial agreement delays, gain strategies for dealing with each of them, and understand how addressing these villains simultaneously is necessary to truly accelerate the process and comprehensively deal with this industry-wide issue. The book will be released in early spring 2018.
The views expressed in this article are those of the author and not necessarily those of Boehringer Ingelheim Pharmaceuticals, Inc.