By Débora S. Araujo
By Débora S. Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim
Imagine that after a tedious job interview process you are finally offered what promises to be a fulfilling and rewarding position with a new company. However, after working there for a while, you notice that the employer is only really paying you every three to six months, which has made it difficult to keep up with your bills and to stay financially afloat. You also notice that when you do receive a check from the employer, you have no way of verifying for which days or hours you have been paid since no explanation is sent with the check and you were never told who at the company you could contact for these types of questions.
To top it all off, the employer has decided it is appropriate to hold back 10 percent of all you earn until your last day on the job — whenever that may be. Of course, the employer still expects you to provide your top performance every day and wonders why at some point you no longer want to continue working for them. Most of us would not want to continue a working relationship with such an employer. Unfortunately, this scenario is similar to the way many sponsors and CROs treat clinical study payments with investigator sites.
Sixty-six percent of investigator sites report having less than three months’ operating cash on hand, and lengthy delays in payment result in high turnover rates among clinical investigators1. With 40 percent of sites dropping out of FDA-regulated clinical trials, it is critical that we — as an industry — address investigator site payment issues head-on.2
It is important that as an industry we first align on the basics. The sky is the limit when it comes to innovation and advancements in this area. However, before reaching for the stars on this topic, sponsors and CROs must commit to aligning and standardizing on the following site payment concerns. Doing so is critical to assuring our investigator sites remain financially viable and engaged, so they can continue bringing life-saving drugs to patients who need them.
1. 30-Day Payment Terms – Align the payment frequency terms in your clinical trials agreement (CTA) with more widely acceptable 30-day terms. With the advancements in clinical technologies and specialty service vendors, there is no longer a need for antiquated terms like quarterly payments that keep sites at a financial deficit.
2. Accurate Payment Details Along with Payment – Provide accurate payment details clearly itemizing what is included in the payments sites receive. Whether through site interfacing technology or traditional methods, it is important that sites receive, along with prompt payment, details that help them clearly understand what they have been paid for versus what they have not.
3. Elimination of Payment Holdbacks – While payment holdbacks have been around for as long as quarterly payment terms, they have proven to be more of a financial burden on investigator sites than a motivation to complete a trial. Some sponsors and CROs have commented that these terms are the only insurance or leverage they have in ensuring sites complete end-of-trial queries and other close-out activities. However, the percentage of problematic sites that have trouble with end-of-study close-out activities and queries is small compared to the percentage of sites that perform all these tasks effectively. In choosing to utilize payment holdbacks as leverage over investigator sites, sponsors and CROs may be jeopardizing the relationship with our site partners by punishing the great majority of sites for the wrong actions of a few. Perhaps better site selection should be the focus to solve this problem.
4. Clear Communication Pathways for Issue Resolution – It is important that all parties have a clear communication pathway available for any site payment issues within the CTA. It is true that the goal for sponsors, CROs, and site payment vendors should be to provide a seamless site payment experience to our sites. However, from time to time, honest mistakes happen, technologies have glitches, and changes occur that require communication between the parties to resolve the issue. During these times, it is important that all parties involved can escalate and resolve issues as soon as possible.
If, as an industry, we can align and standardize solutions for these basic yet highly important site payment concerns, we can achieve more lasting and engaging relationships with our investigator sites by ensuring they remain financially viable as they partner with sponsors and CROs to bring life-saving and life-changing drugs to patients.
- Society for Clinical Research Sites (SCRS), Site Payment (White Paper), October 2016
- Myshko, D., “Why Sites Matter”, PharmaVOICE, September 2016.
About The Author:
Débora S. Araujo has over 10 years of experience within clinical trial operations with a special focus in the areas of global clinical contracting and clinical financial management. Her previous roles include both large and small pharmaceutical sponsors, as well as the investigative site side of clinical trials. 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 regarding clinical contracting and clinical financial management, particularly investigator site payments. In her current role as associate director of clinical contracting services within Boehringer Ingelheim, Débora manages, from both a strategic and tactical level, driving global harmonized processes for clinical contracting and clinical financial management with a strong customer focus.
The views expressed in this article are not necessarily those of Boehringer Ingelheim Pharmaceuticals, Inc.