Make your study fail-proof
When entering into clinical research, the greatest concern is typically whether or not the study will provide evidence that the product works at its intended purpose. But a far greater risk is the study itself failing. Clinical research in integrative health is a fraction of the cost of pharmaceutical research, but it is still a significant investment. When a clinical trial fails, that entire financial investment is lost. There is also a hefty loss of labor and marketing potential.
In today's integrative health field, close to 80% of clinical trials fail to meet enrollment deadlines and nearly half of all sites enroll either one patient or no patients at all. Even with highly trained statisticians, experienced scientists, and medical advisors, clinical research is unlikely to product results without the oversight of a research team with expertise in conducting human clinical trial research projects. Before investing in a clinical trial, it's important to look at ways in which your trail can be made fail-proof.
Studies Fail Because:
Unnecessarily Complex Protocols
Clinical trial participants are the most important individuals in a research study. They are responsible for complying with the study's protocol, and are the source of the study's data. High quality data is the core of a high quality study.
Therefore, it is critical that the study be simple to follow, for both patients and partner medical providers (if applicable). Complexity in a clinical trial protocol should be minimized wherever possible. Needlessly complex protocols result in an increased risk of study failure do to noncompliance and incomplete data collection.
Limiting Inclusion/Exclusion Criteria
Inclusion/Exclusion criteria ensure that the study's participants reflect the end user. A clinical trial's patients should be limited to patients who share the same demographics and socioeconomic status as the product's consumer. However, excessive inclusion/exclusion criteria produce a target sample that often proves difficult to obtain. Each limitation on study participation creates an additional hurdle to patient enrollment. When patient enrollment is limited, a study is more likely to fail.
Lack of Patient Recruitment of Patient Non-Adherence
Even when study populations are diverse and protocols are simple-to-follow, studies can fail if the research team fails to recruit sufficient patients or they fail to monitor patient adherence to the protocol sufficiently. Recruiting patients and monitoring patients through completion of a study is a labor-intensive task. When neglected, a study may fail due to lack of participation from the patients, which can ruin the validity of a dataset.
Insufficient Research Team Attention or Resources
Overseeing a clinical trial requires attention to detail and sufficient highly trained staff to manage a patient sample in a way that is both beneficial to the study and is ethical/in compliance with human participant research regulations. This careful balance requires oversight from individuals specifically trained to manage research participants. Many research teams set out to conduct clinical research overlooking this crucial component. Without this element, a study is likely to fail.
Meet Dr Hawkins
Dr. Hawkins brings 20 years of expertise in the integrative health field to her role as Executive Director of the Franklin School of Integrative Health Sciences and the leader of our clinical research team.
She holds a Bachelor’s Degree in Environmental Health from Union Institute and University, a Master’s Degree in Health Education & Promotion from the University of Alabama, a post-graduate certificate in epidemiology from the London School of Hygiene and Tropical Medicine, a PhD in Health Research from Middle Tennessee State University, and is completing the post-doctoral Global Scholars Research Training Program at Harvard Medical School. She also holds certifications in numerous natural health fields including aromatherapy, aromatic medicine, herbalism, childbirth education, and labor support.