Good clinical trial research is founded by good clinical practice. The research is driven by the need to protect the rights of all the participants. The fundamentals that revolve around clinical trial research were embedded about 50 years ago and have not changed since then. The only difference now is that technology has made it easier to reinforce these fundamentals. With technology, it is easy to collect data from the participants. These fundamentals ensure a CRO like Veristat conducts trials while upholding the rights of all participants. There are various fundamentals of clinical research, and all CROs must ensure they fully adhere to these basics. They include;
Monitoring committee structure and function
Investigators in clinical trial research have the responsibility to monitor the safety and clinical benefits of the study. If at any point Clinical Research organizations discover that the interventions of the study are harmful to the participants, the trials are subject to early termination. Additionally, if the interventions are discovered to have definitive benefits, the trial is also terminated as proceeding would be unethical to the participants. What’s more, if during monitoring the investigator realizes the there are differences between the primary and secondary responses where changes of a clear result are unlikely; it would be in the interest of time and money to stop the trial.
Blinding
In any clinical trial, biases are inevitable. A bias is a systematic error or it can be said to be the difference between the true value and the actual value obtained. The causes of biases in clinical trials can be subconscious, conscious, or both. One of the solutions for these biases is blinding or what one would call masking. The participants and investigator are blinded. Blinding is used in clinical trials to limit the chances of potential problems of biases that may occur during the assessment and data collection stages.
Recruitment of study participants
Recruitment of the study participants is one of the difficult stages of any clinical trial. These trials work on a certain timeline and any delays would affect the whole trial. This is because there is a set time at which the trial needs to be complete or other investigators might find the solution easier. Recruiting of participants may vary due to the type and size of the trial, the timeline, and other factors. For recruitments to be successful there needs to be a carefully made plan with several strategies, flexibility, effort, interim goals, and timely recruitment of the required sample.
What is the question?
A clinical trial is based on a specific question the investigators seek to address. These trails often have a clear objective which is not the question being addressed. There are always secondary and subsidiary questions to be answered. Often, the main question is not well stated. Being clear with the question helps in the planning and design and enhances the credibility of the trial results. Each trial must have a primary question. This question and other secondary or subsidiary questions must be critically selected with a clear definition and stated early enough.
The list of fundamentals for a clinical trial is endless. However, each fundamental must be taken seriously and adhered to. There should be well thought out, defined, and stated questions. Also, recruitment of participants must be done on time and you should have a proper design for the blinding.
