Those who handle day-to-day clinical trial disclosure compliance face a myriad of responsibilities. If you’re part of a disclosure and transparency team, you’re likely hyper-focused on regulatory rule changes, internal and external approvals, study updates, and never-ending deadlines.
However, pharmaceutical companies are businesses. No matter what department you report to – R&D, operations, finance – you contribute to the bottom line. That means your team must be accountable. Although you may be mired in daily tasks, you cannot ignore key performance indicators (KPIs); in fact, you must track them to monitor (and improve) your performance over time.
So what are some of the KPIs you should keep an eye on? It’s easy to come up with countless KPIs, so let’s focus on the ones most relevant for disclosure and transparency:
- Submission deadlines – Is your team meeting its deadlines? Specifically, we’re referring to missed deadlines. What percentage of your initial submissions and updates are completed on time? Late submissions can jeopardize compliance, putting your organization at risk for substantial regulatory fines.
- Roles – Are there too many cooks in the kitchen during the submission process? Examine how many editors, reviewers and approvers are involved in an average disclosure. Trimming the number of staffers involved is a great way to reduce costs, as reviewers and approvers are typically higher on the pay scale. It’s also a great way to increase quality, as our recent research shows that more cooks in the kitchen (i.e., reviewers/approvers), results in a reduction in quality.
- Workload – Is your team overworked? Determine the average number of protocols and results assigned to your global study owners, editors, reviewers/approvers and outsourced vendors. It’s all related; heavy workloads can lead to backlogs which can, in turn, delay approvals and result in missed deadlines. In order to set realistic productivity goals, you must take into account actual workloads and gauge whether they are over-burdening your team. By monitoring this, you can balance workloads between internal staff and external resources.
- Review cycles – Do you feel you’re playing a numbers game when it comes to internal review cycles? Take a hard look at your organization’s average number of edit, review and approval cycles. How long does it take to complete a submission? This can have a direct impact on the first KPI, submission deadlines. Regular reviews of review cycles enable your team to set achievable performance goals.
- Number of QC comments – As with internal review cycles, do your QC cycles seem never-ending? QC comments from ClinicalTrials.gov reviewers are the bane of a clinical trial disclosure team’s existence, so it makes sense to nip them in the bud. The first step is to track how many QC comments are made on protocol and results submissions, across studies, study teams, therapeutic areas. Then develop a plan of attack on how to reduce them going forward. By monitoring QC comments, your team will be in a position to anticipate – and prepare for – issues raised by the PRS team.
In addition to the KPIs listed above, your team must keep tabs on how your organization is perceived externally, both in the US and the EU. These perceptions are based on trial data submitted to multiple registries, studies published in trade journals, industry watchdog group rankings and more. Keep in mind that, even if your organization is 100 percent compliant, it may not be viewed as such by external critics. It’s also important to compare your organization to other pharmaceutical sponsors so that your progress is not viewed in a vacuum. In doing so, you can detect (and diffuse) any major disparities between your organization and your competitors – before upper management does.
More important than merely monitoring these KPIs is analyzing the data and what you do with that information once you have it. Examine your data from various perspectives: on a day-to-day, week-to-week, month-to-month or year-to-year basis. Look for any trends – good or bad – and try to determine factors contributing to them.
By tracking internal KPIs, you can establish benchmarks and then formulate a plan to improve upon them. Prioritize the areas you want to address; if you try to tackle every area at once, you’ll likely end up frustrated. While internal benchmarks are extremely useful in determining progress over time, external benchmarks – informed by watchdog group rankings as mentioned previously, for instance – can reveal where your organization is positioned in the overall industry.
Sponsors are under increased scrutiny from regulatory agencies, advocacy groups, and the general public for greater disclosure and transparency. That means your team may be feeling the pressure. It also means that your team has the opportunity to shine. Transparency will no longer be viewed as a regulatory requirement but as a strategic advantage. That’s why it’s important to take into consideration both mandatory and voluntary transparency efforts. By working more effectively and efficiently, you will demonstrate your team’s ROI to the greater organization. And finally get the validation and recognition you deserve.
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About the AuthorMore Content by Darcy Grabenstein