Clinical trials play a key role in moving the healthcare world forward and providing innovative therapies to patients. A well-executed trial takes large groups of unorganized volunteers and organizes them, with a goal of producing quality data that can further inform future research and advancement.
However, when clinical trial activities don’t meticulously follow guidelines and protocols, it can lead to compromised data, inspection findings, patient safety issues — and, ultimately, putting the research participants at risk with no benefit.
If you are in the clinical trial space, here are three key strategies to consider as a way to increase the likelihood of your trial’s success.
1. Focus on Compliance and Oversight
In order to provide quality data, ensure human subject protection, and protect subject safety, a clinical trial protocol must be written with a high level of detail in a very rigid framework. These strict protocols are the foundation for generating objective results that aren’t influenced by outside factors.
While acknowledging the critical nature of structure in executing a trial, it is also important to consider how to maintain a sense of flexibility in your trial program over time. If you are managing the drug development in a small-to-medium pharmaceutical company, you likely are working with significantly limited resources compared to your larger competitors. In turn, the very nature of a clinical trial on a corporate level (aside from successful trial outcomes) is likely to ensure the approval of your drug, while growing a brand and scaling a company. With that in mind, you want to be cognizant of your goals while recognizing potential limitations that may impact your success.
This is why the clinical compliance experts at Just In Time GCP emphasize the need to “right-size” a clinical compliance program. They elaborate that a small company’s quality assurance and compliance group, for instance, might consist of a single compliance officer or manager. Smaller companies might need to outsource key functions, like working with external monitoring or auditing experts. Even when this is the case, it’s important to set up a sustainable oversight model and create a basic structure that can adapt as a company grows.
Specific details will always vary from one company, setting, and trial to the next. However, you should consider the capabilities of your internal resources and utilize trusted vendors as partners to ensure quality and compliance.
2. Invest in a Quality Trial Master File
Good Clinical Practice dictates the codes and requirements that a team must follow as they perform their clinical trials. Following GCP guidelines requires careful oversight and management of a trial’s data. The trial management file demonstrates sponsor oversight and tells the story of the study. However, if you aren’t careful, your TMF can include gaps that may lead to inspection findings. Keep in mind, the perspective of the regulatory agencies (e.g. FDA, MHRA, EMA, etc.) is if it wasn’t documented, it didn’t happen.
The EMA TMF Guidance states that the “trial master file (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors. The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the protocol, the trial’s safe conduct and the quality of the data obtained.”
To avoid missing any of the details, make sure you have a robust high quality TMF management strategy in place. Implement oversight compliance and quality control measures that consider key factors, such as data integrity, accuracy, and confidentiality.
In fact, Sponsor Oversight information exists in Section 3.9 of the ICH E6 (R3) guidelines. Use this guide for the information required to establish elite oversight of data monitoring and related trial factors, including the Trial Master File.
3. Prioritize Sites and Participants
The “where” and the “who” are critical aspects of every trial. The way you select your location and participants is vital to a successful outcome.
The National Institute of Health reports that poor quality site selection can “result in low recruitment and bad data quality.” The federal agency adds that even though site selection is critical to study quality, “currently no specific guidelines are available.”
Even if guidelines don’t exist on a common level, you can still create them for yourself. Raising the standards by looking for sites with the right infrastructure, experience, and track record will naturally improve the quality of your clinical trial.
Take a similar approach to participants. Clearly delineate your ideal study participant through the thoughtful development of protocol inclusion and exclusion criteria that support the goals of your trial and timely recruitment. In some cases, organizations find it useful to conduct centralized recruitment and conduct thorough, multi-channel outreach to find candidates who fit those parameters. In these situations, use patient registries, healthcare providers, and even online advertising to quickly and effectively get your trial opportunity in front of the right people.
Failing to invest in finding the right site with access to the appropriate participants for your clinical trial can lead to significant delays and increased costs. A quality clinical research environment with experienced, appropriately trained staff and access to qualified participants leads to higher-quality data. Make sure there are key strategic elements guiding every clinical trial you conduct.
Improving Clinical Trial Success
If you want your clinical trials to produce high-quality, impactful data, you must invest in the right strategies for success. Prioritize sponsor oversight, including the maintenance of a quality Trial Master File. Set up a robust data management strategy to preserve and protect your results. Consider the best clinical research site(s) with access to the appropriate participants for each study.
These up-front considerations often spell the difference between success and failure. What could be worse than having an amazing, effective treatment for patients who truly need it, but not being able to utilize the clinical trial data due to quality and compliance issues?
This is a sponsored post
Digital Health Buzz!
Digital Health Buzz! aims to be the destination of choice when it comes to what’s happening in the digital health world. We are not about news and views, but informative articles and thoughts to apply in your business.
