Have you ever wondered how new medications and treatments make their way to the market? Well, a clinical trial is a crucial step in the process of bringing new medical approaches to patients.
A clinical trial is a research study that evaluates the safety and effectiveness of new drugs, medical devices, and treatments in people. It involves human volunteers, also known as participants, and is intended to advance medical knowledge.
However, conducting a clinical trial is not an easy task, and it requires careful planning and execution to ensure its success.
Let’s take a look at some of the best practices for conducting successful clinical trials, so keep reading to learn more!
1. Develop a Clear Protocol
Creating a plan that describes how the trial will be done is the first thing you need to do to increase the probability of success of a clinical trial.
This plan is called a protocol, and it should be clear, detailed, and based on science. The protocol should explain what the trial is trying to achieve, how it will be done, how the results will be analyzed, and how quality will be checked.
The protocol should outline the study design, inclusion, and exclusion criteria, interventions, outcome measures, and statistical analysis plan.
It should also be well-organized, easy to read, and free of errors. A clear protocol will help ensure that everyone involved in the trial understands what is expected of them.
2. Choose the Right Site and Investigators
Opening an investigator site can be expensive (the average estimate is $50,000), and not all sites are successful in getting enough participants for a study. 11% of sites fail to accrue even one participant.
That’s why choosing the optimal location to maximize resources, time, and funds associated with each clinical trial is crucial. It’s also vital for improving clinical trial recruitment.
To select appropriate sites for a study, it’s important first to identify key site criteria from the study design. This includes important factors like the types of people you want to study, the number of people, how long the study will take, and where the study will be done.
Once potential sites have been identified based on these criteria, sponsors should analyze the site’s historical performance and feasibility.
This analysis should consider factors like:
- eligible participants’ availability,
- their condition,
- similar ongoing trials,
- recruitment capabilities, and
- resources available for conducting research.
Sponsors should check whether the key staff is still working at a site they have previously worked with, as losing staff can impact the clinical trial.
They should also check whether the site offers webinars and training, which shows that they are committed to delivering research at the highest standard.
Selecting the right investigators is also crucial for a successful clinical trial. They should be engaged, and qualified by education, training, and experience to conduct the trial, have appropriate facilities to conduct it, and have access to all necessary resources.
3. Train Site Staff and Investigators
To conduct clinical research, the team involved, such as the Principal Investigator (PI), sub-investigators, and study staff, must be trained to protect human subjects.
The PI is responsible for overseeing the clinical trial but may delegate certain tasks to other team members, such as data coordinators, study coordinators, or clinical research coordinators.
Training is usually done by the PI, sub-investigator, or other members of the team who have been trained previously or attended the SIV.
Various training programs are available to help researchers gain the knowledge and skills needed to conduct clinical trials following FDA regulations and guidelines.
The Office of Clinical Research offers courses that train investigators and others involved in clinical research. It teaches how to improve protocol compliance, study quality, and patient recruitment.
4. Monitor the Trial Regularly
Monitoring a clinical trial is very important. It helps to make sure that the trial is safe and ethical and that the data collected is of high quality. This process starts at the beginning of the trial and goes all the way until it is finished.
Trained professionals called clinical trial monitors check that data is collected correctly and that everything is being done according to the plan. In addition, they make sure that any problems or adverse effects are recorded accurately.
Data and safety monitoring is required by the FDA and is needed for all types of clinical trials, including physiologic, toxicity, dose-finding studies (phase I), efficacy studies (phase II), efficacy, effectiveness, comparative trials (phase III), etc.
The level of monitoring depends on how risky the trial is. If the trial is very risky, there is a committee that will help with the monitoring. The Office of Clinical Research can help researchers get monitoring services from Penn vendors. Also, there are many resources available for clinical trial monitoring guidance.
5. Collect High-Quality Data
Following the Good Clinical Practice guideline is a way to ensure data quality.
When planning a clinical trial, it’s important to think about how data will be collected. Data collection means gathering information about a specific subject.
There are many ways to collect data in a clinical trial, such as using questionnaires, reviewing medical records, and taking physical measurements.
Collecting data electronically has many benefits, such as better data quality and real-time monitoring of patient progress. However, electronic systems require access to telephone lines or wireless networks to work well.
6. Ensure Participant Safety and Welfare
Participant safety and welfare should be a top priority in any clinical trial. To protect participants, several safeguards are used to help reduce risk, but there are still risks involved with any study.
So, participants have the right to leave the study at any time and should be informed of the goal of the study, all known risks, and possible benefits.
They can ask questions about any aspect of the study and know who will have access to their information. Their identity remains confidential and protected.
Research involving people is based on three values: respect for persons, beneficence, and justice. These values ensure that research staff and government groups make sure that participants are protected, and that federal laws are followed.
Before starting any clinical trial, it must be reviewed by IRBs to make sure that people are protected and federal laws are followed. The informed consent process is a key part of patient protection, which describes what it means to be in a clinical trial.
7. Manage the Trial Budget Effectively
A budget is like a plan for how much money you’ll need to do the trial. Here are some tips for managing your budget:
- Start with a budget that makes sense and is realistic.
- Be prepared to pay for the people who help run the trial, like CRAs.
- Choose wisely when you need to hire someone from outside your team to help with the trial.
- Make sure you have agreements in place that make it clear how much everyone will get paid and what they will do.
- Keep track of all the people and companies involved in the trial and how much they are costing.
- Invest in a system that will help you keep track of the information about the trial.
Not choosing your budget well could cost more money in the long run. There are two types of budgets when it comes to clinical trials: overall and site. If you have multiple sites for your trial, you need to budget for all of them while also managing costs for each site. This includes costs such as enrolling patients, starting up the trial, and closing it out.
When negotiating, you will also need to think about how to pay for everything and when to pay for it to maintain the cash flow.
It’s also important to be prepared to walk away, if necessary, as negotiation is a two-way process. Payment terms are crucial for managing your finances during the trial.
8. Communicate Effectively with All Stakeholders
Clinical trials involve many stakeholders, including sponsors, CROs, support professionals, site staff, policymakers, funders, participants, and the media. Therefore, building relationships of trust between stakeholders is crucial for effective communication.
This can be achieved by sharing personal stories and asking questions about a person’s family life, even when working virtually.
The most effective communication starts with internal stakeholders such as trial staff, sponsors, and funders. These people are not just staff members but advocates for the clinical trial. Keeping them informed throughout every stage of the trial maximizes their contributions.
The Communications Handbook for Clinical Trials is a useful guide for clinical trial staff and research partners on how to communicate effectively with a range of stakeholders.
The handbook offers practical guidance on anticipating and responding to the special communication challenges posed by clinical research, including strategies for ongoing communication, managing controversy-crisis communications, and disseminating trial results.
Since clinical research is conducted internationally, communication must be culturally respectful to avoid misunderstanding and build better relationships.
Effective communication is well-structured and compelling, avoiding long stories that make it difficult for the receiver. Feedback from evaluations can be used to improve future engagement activities.
9. Future Plan and Documentation
A plan should be in place to disseminate the results, including publication in peer-reviewed journals and presentation at conferences. Plans should also be made for future research based on the results of the trial.
Documenting should include the trial design, the protocol, the data management processes, and the analysis plan. This can be invaluable for future reference and can help to ensure that the trial is conducted in a transparent and reproducible manner.
ISO 14155:2011 provides guidelines on good clinical practice for medical devices for human subjects, including documentation procedures.
Conclusion
Clinical trials are complex and challenging undertakings, but by following these ten best practices, you can help ensure your trial’s success.
By focusing on careful planning, effective communication, and regulatory compliance, you can ensure that your trial produces reliable and useful results that can be used to improve patient care and advance medical knowledge.
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