In this engaging blog, we sit down with Dr. Onthatile Serehete, the esteemed Medical Study Manager at Atlantia Clinical Trials, to explore the dynamic world of clinical research. From the impact of GDPR and the rise of decentralized trials to the importance of diversity and the role of AI, Dr. Serehete shares her unique perspective on the industry's past, present, and future.
Table of Contents
- A Day in the Life of a Medical Study Manager
- The Evolving Landscape of Clinical Research
- The Value of Diversifying Study Populations
- The Cost of Doing Nothing: Addressing Diversity and Inclusion
- The Future of Clinical Trials: Remote Trials and the Impact of AI
- Key Takeaways
- FAQ
A Day in the Life of a Medical Study Manager
Ever wondered what it's like to be a Medical Study Manager at a clinical trials clinic? Dr. Onthatile Serehete shares a glimpse into her busy and varied days at Atlantia Clinical Trials.
Morning Routine
The day typically starts with patient or participant visits at the clinic. These visits often involve physical exams and various procedures that need to be carried out. The mornings are dedicated to these essential tasks to ensure that participants receive the attention they need early in the day.
Afternoon Activities
Afternoons are reserved for reviewing safety blood results, X-rays, MRI reports, and other crucial data. Dr. Serehete also holds meetings with her team to discuss training on safety issues and to stay updated on the latest clinical trial protocols.
Team Collaboration
Collaboration is a key part of the role. Dr. Serehete frequently interacts with the science team, sales teams, and other colleagues to ensure that every aspect of the clinical trials runs smoothly. She provides input on the inclusion and exclusion criteria for participants and collaborates on clinical study reports.
Travel and Continuous Learning
Travel is another exciting aspect of the job. Dr. Serehete values the opportunity to meet peers and colleagues in the industry, staying updated on the latest medical information and advances. This continuous learning helps bring new insights back to Atlantia Clinical Trials.
The Evolving Landscape of Clinical Research
Clinical research has undergone significant changes over the years. Dr. Serehete reflects on the evolution of the industry and its current state.
Impact of GDPR
One of the most notable changes is the introduction of GDPR. In the early years of Dr. Serehete's career, there were fewer regulations around data handling. Today, the stringent requirements of GDPR ensure the protection of sensitive participant information.
Click here to find out more about GDPR and how it applies to EU and all around the world.
Decentralized Trials
Another significant shift is the move from centralized to decentralized trials. Initially, all procedures had to be carried out at the clinic site, making the process quite hands-on. Now, with decentralized trials, there is more flexibility, allowing for some procedures to be conducted remotely.
Global Influence
Even though Dr. Serehete started her career in South Africa, the global nature of clinical research means that regulations like GDPR have an impact worldwide. This global perspective has enriched her understanding and approach to clinical trials.
The Value of Diversifying Study Populations
Diversity and inclusion in clinical trials are crucial for ensuring that the products tested truly reflect the general population. Dr. Serehete emphasizes the importance of diversifying study populations.
Reflecting the General Population
For any product to be effective, it should work for the entire general population. Testing a product on a limited profile of people does not provide a true representation of its efficacy. Diversity in study populations ensures that the product can be marketed to everyone with confidence.
Challenges in Inclusion and Exclusion Criteria
Clients often push for very tight inclusion and exclusion criteria, which can be unrealistic. Dr. Serehete questions whether such specific populations even exist in the real world. It's crucial to be realistic when defining population criteria to ensure that the study results are applicable to a broader audience.
The Cost of Doing Nothing
Ignoring diversity and inclusion in clinical trials has significant costs. It can lead to the exclusion of markets that would benefit from the products being tested. This, in turn, can result in false advertising, as the product may not work for everyone if the trials only included a limited subset of the population.
True Representation
For a product to be genuinely effective, it must be tested on a diverse population. Without this, the results are not a true representation of its efficacy. Ensuring diversity in clinical trials is not just a matter of ethics but also of scientific accuracy.
The Cost of Doing Nothing: Addressing Diversity and Inclusion
Ignoring diversity and inclusion in clinical trials comes with significant costs. Dr. Onthatile Serehete emphasizes the importance of broad and inclusive study populations.
Excluding Beneficial Markets
Failure to address diversity can lead to the exclusion of markets that would greatly benefit from the products being tested. This exclusion can result in products that are not truly effective for everyone. To find out more about the benefit of diversity in clinical trials and how it might help you, Click here.
False Representation
When trials only include a limited subset of the population, the results may not accurately represent the product's efficacy. This can lead to false advertising, claiming a product works universally when it does not.
Broad Populations vs. Target Populations
Dr. Serehete advocates for starting with broad populations. This approach ensures that the benefits of the product are tested across diverse groups, reflecting real-world scenarios better.
Opportunities in Nutraceuticals
Nutraceuticals, which offer healthier, natural alternatives, have the potential to fill gaps for those unable to afford pharmaceuticals. Trials in this field should be inclusive to truly benefit everyone, click here to get started on Nutraceutical trials.
The Future of Clinical Trials: Remote Trials and the Impact of AI
The future of clinical trials is being shaped by remote technologies and artificial intelligence (AI). Dr. Serehete shares her insights on these emerging trends.
Remote Trials
Remote trials are becoming more prevalent. While offering convenience, they also pose challenges, particularly in terms of medical oversight and inclusivity. To understand the effectiveness of hybrid clinical trials through real-world evidence, check out this article on Science Direct.
Challenges of Remote Trials
Remote trials may exclude certain groups, such as older generations and low-resourced communities. This digital divide could widen the gap in diversity and inclusion.
The Role of AI
AI is a double-edged sword in clinical trials. It simplifies many tasks but cannot replace the expertise of human professionals. A balanced approach is essential.
Combining AI with Human Expertise
AI can assist but should not replace human roles in clinical trials. The combination of AI and human expertise ensures the accuracy and reliability of trial results.
Key Takeaways
1. Changing Research Landscape : Decentralized approaches to clinical trials are becoming more accessible and flexible.
2. Value of Diversity : Including a range of demographics in clinical trials guarantees that the findings apply to all and improves the efficacy of the product.
3. Impact of GDPR : Clinical research procedures have been greatly impacted by the stricter data privacy laws brought forth by GDPR.
4. AI with Remote Trials: While remote trials are convenient, they may not be available to all populations. AI helps with data analysis and patient monitoring.
5. teamwork and Learning: In order to stay current with new developments, the medical industry requires teamwork and ongoing learning.
FAQ
Here are some frequently asked questions about clinical trials, diversity, and AI.
Why is diversity important in clinical trials?
Diversity ensures that the trial results are applicable to a broader population, enhancing the product's effectiveness and marketability.
What are the challenges of remote trials?
Remote trials can exclude certain groups, such as older generations and low-resourced communities, due to the digital divide.
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