In a world where healthcare budgets are being constantly squeezed, it’s incredibly important to ensure that one of the most fundamental steps in medical device development – the clinical trial – is planned as effectively and efficiently as possible. Therefore, we enlisted the help of Molly Blake-Michaels to enlighten us on the challenges unique to designing medical device clinical trials. In this interview, Molly shares her expertise regarding the planning, forecasting, and tracking of medical device clinical trials and the concepts that can be employed to help overcome the associated hurdles.
Okay, so who is Molly Blake-Michaels? She is Senior Director of Clinical Services for ClearTrial. And what exactly is ClearTrial? ClearTrial provides Clinical Trial Operations (CTO) software that makes the planning, forecasting, and tracking of clinical project and financial performance faster and more accurate. Before joining ClearTrial, Molly spent over 20 years in clinical trial operations with companies like Abbott, Fujisawa, Hospira, and Delta Pharma.
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The 10 Action Points:
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The Heterogeneous Nature of Medical Devices Poses Unique Protocol Design Challenges
While there are many similarities between medical device and pharmaceutical clinical trials, there is much more variability within medical devices, a factor that must be taken into account when designing a study. One of the major challenges posed by medical device trials is that of placebo-control and blinding, even in trials with an active control. A second equally important issue is that of the reimbursement costs associated with medical devices.
There is a Reduced Need for the Involvement of Contract Research Organizations (CROs) in Medical Device Clinical Trials in Comparison to Pharma Trials
As you probably already realize, a CRO can provide additional ‘outsourced’ support during a clinical trial. This assistance can come in the form of data monitoring, study management, medical writing, etc. The primary reason for the lack of CRO involvement in medical device trials is because of the size of the patient populations within the trials themselves. Large device studies rarely include more than a few hundred patients in comparison to the thousands of participants often enrolled in a drug trial.
Data Safety Monitoring Centres Can Reduce Bias in Medical Device Trials
Achieving scientific validity in a medical device study is not always easy due to the aforementioned difficulties associated with placebo-control and blinding. In many instances, it can simply be unethical to have a control group within medical device trials as a large percentage need to be implanted by the surgeons themselves. A data safety monitoring board and/or data coordinating centre can be an effective way of reducing some of the bias by masking global study results. Although investigators will most likely be aware of the outcomes at their study sites, a data monitoring board or coordinating centre will minimise exposure to overall results while the study is ongoing.
Reimbursement Issues Should be Considered Early on Due to the High Cost of Medical Devices
Medical devices can be extremely expensive. As such, reimbursement should be a key consideration when planning a trial. Molly Blake-Michaels advises companies to think about this as early as possible, as obtaining approval without first obtaining reimbursement coverage can introduce crippling financial difficulties when it comes to commercializing the particular device.
Working With Experienced Consultants Can Help Companies Understand the Unique Challenges Posed by Medical Device Clinical Trials
This is particularly an issue for a startup company or a new type of medical device. Employing consultants can help in the crucial understanding of medical device trial design and reimbursement issues. Consultancies can prevent common pitfalls and save companies from having to endure the trial and error method of ‘learning as they go’ which often proves to be extremely expensive.
Activity-Based Planning is a Key Step in Efficient Trial Design
Molly Blake-Michaels describes activity-based planning as the only effective method of evaluating the impact that different study approaches can have on your budget and timeline. But what is activity based planning? It is a relatively simple concept that many of us apply in our everyday lives without even realizing it. In essence, activity-based planning means taking the time to adequately plan tasks by forecasting what needs to be done in advance. When applied to clinical trials, activity-based planning involves clearly defining the work that needs to be performed within each trial. For example, the pre-study visit can be broken down into preparing for the visit, travel to the site, on-site work, subsequent report writing, and the follow-up on certain action points. Using this planning method will ensure you have the people and funds available when you need them. A critical advantage of using this technique is that it can be replicated for studies of a similar type so you don’t have to ‘re-invent the wheel’ each time.
Utilizing New and More Efficient Technology Allows for Accurate Financial Planning and Budget Management
Unlike large pharma companies who can handle bigger swings in their budget, smaller medical device companies usually need to keep tighter control of the expenses of their clinical trial. With the impending medical device tax and the potential ramifications of the Sunshine Act, it has never been more important for medtech companies to plan their work efficiently in an effort to reduce costs. Despite this, Molly Blake-Michaels sees ineffective software like Microsoft Excel and Microsoft Project programs used frequently and often not even to their full advantage, resulting in inefficient planning and wasted time. Molly advocates the use of new technology such as ClearTrial, when planning trials in order to accurately forecast study costs and headcounts.
Software Can Manage Global Head Counts in a Multitude of Locations
Molly explains that consolidated systems like ClearTrial allow for the application of an hourly rate to easily calculate the total costs over time. Some companies even set up internal groups who are experts in the software, to obtain a detailed analysis on the people required on both an annual and rolling basis. Companies with offices or sites in multiple geographic locations can obtain the necessary headcounts all from one place. As long as the input assumptions are in line with reality, users should be presented with an accurate headcount and budget prediction.
Evaluating the Clinical Trial Monitoring Strategy Can Reduce Costs and Shorten Timelines
Clinical trial monitoring is the practice of physically going to study sites to verify the accuracy of data. Some of Molly’s clients have found taking a risk-based approach (using a percentage of the data for verification rather than all of it) can reduce monitoring and traveling expenditures – which can account for up to a third of the study costs. By improving your monitoring plan, you can still obtain accurate data without excessive site visits. Changing or modifying the monitoring strategy can also shorten the overall timeline.
The Implications of Reducing Healthcare Costs on Clinical Trials
Unfortunately, healthcare costs are now being squeezed from all angles. Despite this, clinical trials are obviously needed to identify new medical devices that will drastically enhance or prolong people’s lives. Molly Blake-Michaels believes that medical device companies can overcome these modern financial challenges by planning efficiently from the beginning in addition to assessing the associated costs and benefits in advance of undertaking certain projects.