Clinical trials are critical, and as a result, their management involves complicated procedures due to many players involved – volunteers, government agencies, sponsors, and site management organizations. It takes an effective CRO that offers exemplary clinical research management services like Veristat for a successful trial.
As a sponsor or an agency that funds the clinical study, you should ensure you can count on the Clinical Research Organization for ideal management services. Therefore, when looking to achieve tremendous success in the study, you should follow the following ways to launch successful clinical trials.
Ensure 100% patients compliance to the clinical trial protocols or routines
At the onset of a clinical trial, there are routines or prompts the patients must follow. These rules are important as they contribute to the success of a clinical study. Patients’ non-compliance comes to the picture when they deviate from the physicians’ recommended behaviors in the trial. This might include going against the advice on diet, smoking, or even failure to attend scheduled visits for check-ups. Also, failure to adhere to prescribed drugs under test is considered non-compliance, which may be the primary cause of unsuccessful clinical research.
Non-compliance is mainly associated with poor communication between the physicians or investigators and the patients. Therefore, the Principal Investigator (PI) should see that the communication between the physicians and the patients is clear and straightforward. This way, the patients will know what is expected of them, resulting in compliance, which is critical in bringing success to the clinical study.
Proper Contingency Planning
Contingency planning is taking account of possible future risks and how to tackle them when they occur. As the study sponsor, it’s recommendable to initiate a proactive contingency plan right from the start rather than a reactive one. Proactive planning helps in anticipating a future threat to the clinical study. Thus, you will get equipped earlier to deal with or avoid such incidents.
On the other hand, reactive planning means you’ll deal with problems after they have occurred – which is unsuitable for a long-term project. This type of planning is inappropriate since it poses a great danger to the research. For instance, if you opt for a reactive contingency plan and then a threat befalls the clinical trial, it might take up lots of time when handling the situation or set it up once more. With a proactive contingency plan, you’ll avoid the threat or have an instant remedy.
Accurate Data Collection and Analysis
Accurate data collection and analysis are vital in ensuring the success of the trial. Data collection includes taking enrolment rates of volunteers for the test, ultimate sites to conduct the research, or the right physicians or investigators. Most importantly, the observations during the trials contribute to achieving genuine results. After the collection and recording, the next step is flawless analysis. You must have the appropriate data analysis tools to enable you to use the collected data to your maximum advantage. Using flawless analytics tools will account for variables that heavily affect the clinical trial allowing you to come up with the actual results.
A successful clinical trial is all about obtaining authentic results. To do so, you can ensure patients’ compliance with the trials protocols, develop appropriate contingency planning, and, lastly, accurate data collection & analysis.