To set up and execute a clinical study, you have to keep track of many complicated parts and steps, and it’s easy to get lost. Typical causes of failure include problems with safety, production, patient enrollment, and the complexity of laboratory samples and data analyses. The development of ground-breaking pharmaceuticals and therapeutics depends heavily on the efforts of startups and clinical trial consulting companies. Therefore, it is crucial that they work fast and effectively during clinical trials to increase the chances of positive results.
Here are some tips for maximizing your chances of positive outcomes:
Consider adaptive clinical trials
In the past, clinical studies’ procedures were established and finalized before the trial began. Prior to the study, decisions were made on factors like the number of patients to be included, the type of patient demographics, the drugs to be tested, their dosages, and any other variables or desired outcomes. These variables would typically remain stable during a clinical trial. However, data from adaptive clinical trials can often be evaluated in real time, allowing you to adjust to the strategy and procedure as the experiment progresses. Doses can be modified up or down during adaptive clinical trials. You can also proactively respond to participant feedback during the trial, and you can expand the pool of potential participants as needed.
Have your partners start creating databases early in the process
Requesting that vendors and CROs start populating their databases with information from a synopsis is a smart approach. Collaborate with a clinical research organization that has already compiled a library of standard data forms, such as those for patient medical history, demographics, and adverse events, to cut down on the time needed to establish the initial database. Building the databases when the protocol is finalized saves time since systems can be validated and ready for patient information. The same tactic should be used when dealing with suppliers for sample management, pharmacovigilance, and specialty labs. Once a vendor has received a final draft or synopsis protocol, they can start developing their internal systems and procuring supplies. Vendors play a vital role in the smooth running of your study, so it’s crucial that they understand both internal and external timelines that guide their work.
Improve accessibility, convenience, and compliance
Accessibility and convenience are crucial if you want to increase patient retention and adherence to trial protocols in your clinical research. It’s crucial that your clinical trial actively encourages and supports patients to stick around for the duration of the study and follow all of the trial’s protocols. When planning long-term studies, it’s crucial to consider the factors that will encourage patients and volunteers to maintain adherence to trial guidelines as they go about their regular lives. Often, people drop out of clinical studies because of a lack of imaging capabilities, such as the ability to scan and read images quickly and accurately.
Connect with patient advocacy and support groups
Advocacy groups and charities are more likely to back your clinical study and aid in recruitment if you make sure it is patient-focused, easily accessible, and inclusive. Joining a patient support group or advocacy organization can help you learn more about the disease, problem, or limitation outside of a clinical setting. And in doing so, you could get some beneficial support in return.
There are many strategies to optimize your trial’s efficiency and boost its chances of success. Some of the approaches are straightforward, while others require prior preparation.