Clinical trials are studies performed on people. They give answers to medical, surgical, and behavioral questions. Researchers use clinical trials to determine whether new treatment like a new drug, medical device, or diet is safe in humans.
Regulating metadata standardisation is at the heart of clinical trial design. It helps researchers to generate reliable. High-quality, and statistically sound data from clinical trials. You should also consider the budget and the safety of people taking these trials, to mention a few.
Here is a list of some of the best practices in clinical trial implementation.
- Implementation Research
When research sheds light on new information that will improve the wellbeing of patients, the findings may take time to adopt. This can be avoided if adequate research is done about a clinical trial before it is implemented. Here are some of the questions to ask yourself whose answers may help close the gap between new information and its adoption:
• How practical can an intervention be delivered in a specific health system?
• How acceptable are interventions to different stakeholders within the health system?
• How much will it cost to integrate intervention into the health system?
• How sustainable is the intervention?
At this stage, you should be able to think beyond the intervention(s) and consider ways to deliver it in a way that people can benefit from. Find out which groups of people are more likely to accept interventions. This decision can be taken into consideration of age, previous treatment history, gender, and other medical conditions.
- Engage The Patients
Take time to understand patient needs and pain points. Remember, the patient is the number one priority therefore whatever technology is used should enhance their journey and not complicate it. Here are ways to try and enhance the patient’s journey throughout clinical trial implementation:
• Conduct patient surveys to identify what patients need to make their journey bearable
• Invest in training documents available to users at any time without having to call user support
• If the study design includes wearables, consider the weight, size, and aesthetics concerning the patient
It’s important to understand the logical requirements from the patients’ point of view to get their commitment from start to finish.
- Site Selection
It becomes easier to determine what kind of site you need for the trial once you get input from your participants. Examples of sites where you could conduct your clinical trial include hospitals, private practices, specialized clinics, and group practices.
You should also consider sight distribution. For the trial to be accessible to many patients, try to ensure the sites you use are geographically diverse. Whether a region’s population fluctuates or stays steady may affect your study. Also, consider how the weather within a region may affect your study.
- Conduct A Pre-Feasibility Assessment
A trial’s previous success at a site does not guarantee another. You need to do research all over again. A feasibility assessment can help give a picture of the place you intend to conduct a trial. To begin with, are the sites interested in participating in your trial? What are the potential threats to your trial in that area? This information will help sponsors plan and budget accordingly.
At this stage, you can collect a site proposed recruitment method. Different recruitment methods are suitable for different sites. If conducting trials in rural areas of developing countries, you will recruit patients more effectively by using more traditional advertising methods. These include newspapers, TV, and radio.
Social media platforms like Facebook, Twitter, and WhatsApp may be for efficient methods of adverting and recruiting for your trial. This is especially the case in urban areas or developed countries.
Find out if the targeted patient population has a strong advocacy group such as the Cystic Fibrosis Foundation. Establishing a relationship with an advocacy group will help in the recruitment of patients if they are willing to do the recruitment for you.
- Conduct Training
Understanding the requirements of both your patients and your staff is the most effective method to determine the quantity of training required and how to offer it. For example, consider if the project is basic enough for onsite staff to comprehend online training.
All staff, investigators, oversight, and management involved in critical trials funded by the National Institutes of Health (NIH) should complete training in Good Clinical Practice (GCP). This training should be refreshed every three years, in line with the principles of the International Conference on Harmonization (ICH) E6 (R2).
Training measures were put in place to minimize risk and enhance the possibility of success of trials. Patients should be protected at all costs. The whole reason for clinical trials is to find new medicines and ways to make their lives better. That is why training is one of the best practices in clinical trial implementation.
A proper foundation should be laid out for clinical trial implementation. People’s lives are very delicate and should be treated as such. Communication, training, research, and patient inclusion are some of the best practices in clinical trial implementation. There are no guarantees in trials, but at least you can budget and plan better when you follow these practices.