When startup biotech or pharma companies are conducting their first substantial phase I/II, phase II or phase III oncology study in the U.S., it’s common for timelines to extend.
Oncology studies are complex, and even experienced clinical development leaders can suffer from missed patient enrollment deadlines. This has become more common with the growth of new immunotherapy treatments which require more experience from the in-house clinical operations team, sites and all of the CRAs and PMs.
For sponsors in Asia or Europe conducting their first study in the U.S., the risk is even higher – and amplified by the COVID-19 pandemic.
If your study is off track, whether you’re using another CRO or managing in-house, we recommend conducting an in-depth investigation of four main areas.
Have you chosen the right investigators and sites for the specific protocol and indication? Do they access to the right patients? Have they completed all of the internal setup procedures in a timely manner? Is the study a priority for the site, or is it on a long list of studies? Do the sites have the proper training for drug safety and handling?
Are the sites properly promoting the study to patients? Are you keeping it top-of-mind for the investigators?
Are the CRAs and PMs properly trained for the drug and protocol requirements? If you’re using a CRO, are they giving your study the appropriate attention? Are you high on the priority list?
Are you focusing on the most effective methods for the collection, organization and submission of the study data?
With COVID, enrollment pauses and subsequent delays in patient visits have created additional stresses on clinical research teams. Some studies, such as immune-suppressing studies, were deemed too risky to continue during the pandemic. Most new studies scheduled for launch during Q2 and Q3 of 2020 were delayed. In-person monitoring restrictions caused delays. Biostatisticians are now evaluating the effectiveness of remote assessments compared to in-person assessments. And supply chain issues have caused delays from drug shipments coming from overseas.
Getting a study back on track often requires an in-depth understanding of
If you’re unsure whether your CRO or clinical team is performing efficiently, we’re able to analyze your study in confidence, so you can gain a fresh perspective about the real causes of your study delays.
Medelis’ oncology clinical research management team and members of our Medical Advisory Board can review and assess all of your study elements. We’ll identify the key issues preventing your study from meeting your timelines and develop a study rescue plan focused on resolving current bottlenecks and study challenges.
Our analysis provides you with a complete solution to regain lost time and momentum. In virtually every case, the Medelis team has been able to reverse almost all problems, and regain most of the lost time, with minimal additional expense to the client.
By engaging Medelis in our Troubled Study Analysis and Recommendations offering to get your study back on track, you gain a fresh perspective on how to alleviate trial challenges.
Getting your trial back on track allows you to
A US client contracted Medelis to conduct a complex phase II trial using an engineered bacterium in a combination therapy in patients with pancreatic adenocarcinoma. The client had some enrollment challenges with their phase I study conducted by another CRO and looked for better success with their phase II study.
Due to the nature of the treatment, Medelis had to work closely with institutional Biosafety Committees to gain site approvals, prepare an extensive site training program that included instructional videos for the preparation and administration of the treatment, manage diligently just-in-time drug shipments, and carefully design data capture forms to ensure proper collection of adverse events associated with the treatment administration and multiple attributions due to it being a combination therapy.
Despite these challenges, Medelis exceeded the study start-up goals by two months. Using our previous experience, Medelis effectively selected highly-motivated sites with the patient population, the capabilities and experience, and a commitment to success. As a result, study enrollment was completed six months ahead of schedule and the treatment received a breakthrough therapy designation from the FDA.
An existing client requested Medelis to take over a phase III global study. Significant backlog of data existed at the sites, the quality of monitoring was poor, regulatory documentation and Trial Master File were in disarray and patient enrollment had significantly dropped due to upset investigators.
The client was internally preparing for the critical interim analysis to be delayed an additional 6-9 months to allow time for the required clean-up. Not only did Medelis successfully clean up the project, the team was able to deliver the interim analysis according to the original timeline without any additional delays.
Furthermore, Medelis was able to repair the relationships with the sites and double the monthly enrollment rate. Patient enrollment is on track to be completed ahead of schedule.
Contact Medelis if you’d like to discuss your study or learn more about how we work with sponsors from Asia and Europe.