Will some of the many changes we’ve seen in clinical trials be with us after the pandemic subsides, or will they fade away as we return to what is familiar? There’s a lot to unpack in that one question. However, one trend experts believe will remain for a variety of reasons – including cost, efficiency and outcomes – is that of Decentralized Clinical Trials.
And while that is a good thing, there are some key issues to review to maximize its benefit and ensure we don’t go back in time.
Identifying the optimal patient population: follow the comorbidity
Since the pandemic, decentralized clinical trials have taken center stage in the marketplace. Faced with a growing need to conduct trials remotely, researchers are working diligently to develop guidelines, especially when it comes to the recruitment of patients.
We’ve found the best approach is to follow the comorbidity, which will lead to patients with the prevalence of wounds suited for a trial. For example, most patients who develop chronic wounds have diabetes. Many are also disenfranchised from traditional healthcare due to various obstacles, such as traveling to a wound clinic.
When the wound becomes untenable, they are forced to find a care center. These referral sources become centers for study recruitment. However, staff is often too busy with screening and enrolling to participate fully and ensure the right patients are tapped. Automated tools managed by experienced researchers can help to identify clinicians who help find appropriate patients. Those individuals can then be efficiently enrolled in trials, saving time and money for the sponsoring organization.
Preventing the proverbial pickle
Study sponsors must be aware of patient needs to keep them enrolled and engaged in a study. Patient centricity, or developing trial protocols that keep the patient in mind, is critical. We must ensure trials are convenient and simple for patients who enroll.
That same concept also applies to study administrators, who carry many responsibilities. They often have to guide the sponsor on how to execute the trial for success. They are the ones that have to encourage the sponsor to try new things while also mitigating risks.
As a result, trial administrators are often in a proverbial pickle because they have the pressure to ensure success. That pressure may make it tempting to go back to the “old school” ways of clinical trials. Partners who make the clinical trial process efficient and seamless for study sponsors will encourage the ongoing expansion of decentralized clinical trials.
Steps to ensure virtual clinical trials continue to grow
There are other steps to consider to ensure decentralized clinical trials continue to grow. It starts by focusing on three basic principles.
- Always keep in mind the primary outcome measures so that the study protocols are focused on end-goals.
- As a plan sponsor, ensure you select the right partners (CRO, Investigator, etc.) for each specific trial. Not all CRO/Investigators are alike. Some are more experienced in specific conditions than others. Find the ones that best meet your goals.
- Ensure the trial is designed and executed to conform to the realities of today. We continue to live in a pandemic- and post-pandemic era. Digital tools and patient monitoring must be considered to continue to enjoy the benefits of these advancements and #notgoingback, a now trending hashtag in the industry.
The expansion of decentralized clinical trials should be welcomed by all in the industry, including researchers, study administrators and patients. If we follow basic principles and keep our eyes on study goals, patient outcomes, and sponsor needs, we’ll all benefit and establish a new standard of excellence for clinical trial research.
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