Critical Focus Areas for Clinical Operations in 2018
May 4th, 2018
Since late 2016, there has been increasing attention on reducing the time to get new drugs to market. Between the FDA’s 21st Century Cures Act and new FDA Commissioner Scott Gottlieb’s agenda, much more agency support is available to drive this objective.
Since late 2016, there has been increasing attention on reducing the time to get new drugs to market. Between the FDA’s 21st Century Cures Act and new FDA Commissioner Scott Gottlieb’s agenda, much more agency support is available to drive this objective. What does this mean to Clinical Research & Development for this year and the future?
In a recent webinar, Comprehend outlined some key events and potential results that could weigh in favor of Sponsors and their alignment to the FDA’s guidelines. In review, there are four important changes taking place in the pharma/biotech market:
- Direct impact of the Cures Act, including FDA attention, funding and exposure
- An emphasis on patient-recorded data, including a focus on being able to maintain patient provided data, the ability to derive this data whether manual or electronic, and a better understanding of the data
- How wearables are affecting patient data, such as the information they are providing, and the difficulties involved in integrating that data into patient records
- How data integration itself has become so much more complex with added sources, challenging timelines, and the increased pace of business overall.
The Changing Pace of Clinical Data
If you look at the pace of change in the pharmaceutical market itself, there are some significant indicators that help us understand trends and where to focus. The time to deliver drugs to market is being constrained – where it took 10 years in the past, is now being scrutinized by both the FDA and sponsors alike. With the help of technology this timeline can be reduced while improving data accuracy and delivering insightful information. However, new and added challenges are all contributing to the new normal of high complexity in clinical trials. Sponsors need to address areas such as an increasing number of source (and new digital wearable) systems, new types of data (such as from wearables), and the demand for digital approaches to managing and understanding data.
External and Business Influences
Another factor to consider is how Sponsors and their vendor partners are changing their business models – this includes everything from new forms of contracting to extremely large mergers and acquisitions. All of these changes affect the pace and success of clinical trials.
Advances in Trial Design and Inputs
The webinar provided some interesting thoughts on where to focus for 2018 and beyond. Commissioner Gottlieb is focused on supporting the delivery of new, innovative methods of clinical trial designs as well as speeding the approval of mHealth devices. Sponsors can benefit from evaluating the adoption of adaptive trial designs, for instance, should they be involved in trials for indications such as oncology, where speedy results are highly desirable. As well, if there is an opportunity to discover positive results for additional indications, adaptive trials can help speed and manage the process for multiple interim analyses. In the case of mHealth devices, the challenge to Sponsors is the integration and harmonization of device data in a timely way to be able to make proper and safe patient assessments based on their entire profile, not just on the device inputs.
A Deep Dive on Patient-Recorded Data
One of the areas of discussion in the webinar was on patient-recorded data and how that impacts study timelines and results. This is a growing area of attention – as a matter of fact, Comprehend called out that online patient-recorded data processing and analysis is fast overtaking legacy SDV methodology for maintaining accurate information. As well, more than 65% of mobile phone users are accessing health applications daily. This is a change that is increasing daily as more people want to take charge of their health, from both a preventative as well as reactive perspective. If you look at the process of managing ePRO and eCOA data, there are many areas where potential problems can develop in assessing patient information. As an example, one issue is regarding who is actually inputting the patient data. If a CRA or other medical personnel is responsible for recording the data at the site on behalf of the patient, what are the ways that information can be validated? If the patient records it on a device that is connected to a system of record, what are the ways that the system differentiates between the time the information was recorded versus the time of the actual dosing? If the Sponsor depends on 100% SDV for validation of these results, then the system won’t be able to tell the difference if there was an error in time inputted versus time dosed, for instance. As long as a correct time format was entered, SDV validates the information.
In the webinar, Comprehend presented an interesting case study that highlighted issues like these. In the example, technology that tracked an overview of all sites’ results across a study was able to see one site (and down to one subject), where pain threshold reporting occurred on a very odd schedule – unlike any of the other subjects – and ultimately it was discovered that a site was inputting false patient data to save time. By seeing this information visually, and being to drill into details in the technology, this information saved the Sponsor from having to completely redo the trial.
Data Harmonization Can Solve Complexities
Many of the issues brought up in the webinar involved managing data with ongoing and increasing complexities. Data integration as a whole continues to plague Sponsors and their vendors – particularly if the organizations are focused on getting a “single source of truth” across all systems, sources and studies. Timely data harmonization is clearly the needed action if Sponsors are to be able to speed milestones and continue to innovate on insights gained from cross-system, cross-portfolio and cross-study data. Ultimately, faster cycle times (while maintaining compliance and safety) as required by the specialized and high demand drugs that Commissioner Gottlieb and the FDA want to address, is the goal – now and in the future.
To view the webinar, click here.