Launching and running a successful clinical trial can be tricky. You must comply with several governmental regulations, have a stable financial source, draft a contingency plan, ensure fast patient recruitment (and low drop rate), and more. With many barriers to overcome, clinical trials are full of uncertainties despite having the right Veristat oncology trial design. Failure to handle these uncertainties can be a heavy blow to your research.
So how do you future-proof your trials? How do you identify and prepare for invisible problems to make your research resilient? Whether you’re testing a cancer therapy using an oncology clinical trial design or a drug through other clinical research models, here’s how to be immune to common invisible problems in a trial.
Connect with the Right Patient
Recruiting the right patient is a critical success driver in your clinical trial, without which getting desirable results are impossible. For instance, advertising recruitment opportunities for a breast cancer trial might attract dozens of patients with the disease who may not meet the trial’s specifications. This results in longer enrolment periods and delayed trial launching. To connect with the right patient, be specific during enrollment in your trial. Mention the age requirement, sex, ethnicity, demographic factors, and others in the application forms to filter out applicants unfit for the research. If this sounds like a hassle, you can employ a trial recruitment company to get eligible patients fast for the research.
Compliance with All Clinical Trial Regulations
In 2017, the US government set a new rule regarding clinical trials (reporting trial results within one year of completion). But come January 2020, more than half of clinical trials ignored the new rule. This proves that compliance is the top challenge in clinical trials. Understandably, coordinating between trial partners, vendors, sites, and other stakeholders is a tangled web of compliance regulations. But it is critical to adhere to all of them. You don’t want to complete the trial only to face legal issues that disapprove of the results.
Contingency Planning
With dozens of uncertainties that come with clinical trials, it’s hard to predict when a problem might arise. The only way to stay immune is planning ahead. Examine every section of your trial in launching preparation by listing the possible future problems. For instance, low patient enrollment can be a challenge during recruitment. You can have a backup method to boost enrollment if the current one becomes inefficient — if you were recruiting offline, online enrollment could be your backup method. The point is, identify a potential problem in your trial and be ready to tackle it once it occurs.
Note: If you create a long list of potential problems, use probability distribution to arrange them from those with the highest chances of occurrence to those with the least likelihood of happening.
Clinical trials are expensive and cumbersome (to some extent). But with proper planning, you can improve your chances of running a successful clinical trial. Therefore, have a picture of the worst that can occur in your clinical research and create ways to mitigate the potential issues.
