Clinical trial sponsors and their study partners provide the hope of treating and even eradicating diseases for millions of people annually. Their research and development provide the opportunity for people to live healthier and longer lives, alleviate overcrowded hospital waiting rooms and reduce overall healthcare costs to society, among other benefits.
These healthcare achievements, however, don’t come easy, as upwards of 90% of clinical trials fail to advance to the approval stage. Obstacles can include trial design, complexities of trials, costs, regulations, technology and even access to patients.
Over the past few weeks, I asked clinical professionals from across multiple pharmaceutical and biotech companies what they thought the greatest challenges are for completing clinical trials in 2023. Their responses are summarized below, in order of frequency of response.
1. Patient enrollment
It is getting more and more competitive to enroll patients given the multitude of ongoing studies and sites.
“The biggest challenge in executing a clinical trial in my experience has always been accurately predicating enrollment and continues to be the case. While most people will say that COVID is ‘over’, regular routines have still not gone back to normal and finding eligible patients continues to be a struggle. It’s obviously improved from 2 or 3 years ago, but from what I’ve been seeing in our trials, enrollment is even more unpredictable than pre-COVID. Unpredictable enrollment means uncertainty in timelines and budgets which extend to the program and even portfolio level.”
2. Generating and managing sufficient data
The generation of high-quality, reliable, and statistically sound data from clinical trials is paramount to trial success.
“Generating sufficient data in an increasingly demanding environment without overwhelming protocols and patients.”
3. Trial diversity
Diversity and inclusion in clinical trials benefit scientific discovery and are essential to promote health equity and reduce health disparities.
“Ensuring adequate diversity and inclusion of minority patients in clinical trials to better reflect real-world patient composition.”
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4. Accurate adverse event reporting
Clinical trials are all about the participants. Those who voluntarily participate in trials are putting their faith and trust in the sponsor, the clinical investigator, and the trial personnel to safeguard their health and well-being. Safety reporting systems are a critical part of the process as they help catalog drug-associated events throughout the clinical trial process.
“Ensuring that sites provide timely and appropriately detailed information about adverse events (serious, severe, and adverse events of special interest) so that the information is available for clinical as well as pharmacovigilance databases.”
Some of the other responses we heard regarding challenges clinical teams might face in the upcoming year that could keep them awake at night include faster trial cycle times, the use of new technology to generate accurate data and keeping patients engaged in ongoing trials.
As we’ve heard from many of our client partners, patient enrollment continues to be a daunting challenge in today’s market, given the vast number of clinical trials available to patients. Here, they were the number one and number three most frequently mentioned challenges.
The solution we have found to work at Six Degrees for the patient recruitment and retention challenge is a combined trial branding and integrated communications program. In other words, applying sound branding and marketing techniques to clinical trial programs.
At Six Degrees, creating awareness for these trials, helping to educate patients about clinical trials and making it easier for patients to enroll in clinical trials is the heart of what we provide sponsor companies and their CRO partners through our clinical trial branding and patient engagement services. Visit us at www.six-degrees.com/clinical-trial-branding to learn more about how we can help you amplify your clinical trial branding and patient engagement initiatives.
We hope these findings are both interesting and helpful as you plan your studies. Please let us know if you have anything to add that will help other clinical teams as they plan for their upcoming studies.