Clinical Trial Process

|

Clinical Trials in 3 Steps

Step 1: The Start Up Period

Immediately after coming to an agreement on a clinical research partnership, the FSIHS Research team begins the Start-Up Period, which is the most labor-intensive step of your project.

During this step, all of the documents for your study are prepared, reviewed, and submitted, and all of the necessary regulatory authorizations are obtained. Evaluation of an existing IND, preparation and submission of the IRB applications to an accredited ethical review board, registration of clinical trials with a World Health Organization approved registry, and the preparation of any other regulatory documents are all included in this initial fee.

These regulatory steps are legally required, but also offer benefits to your study. During this process, regulatory authorities review the study's overall justification and ethics, the safety of all participants, and overall risks.

Your study's final protocol is developed and written during this step. The FSIHS research team must also fully develop the research methodology, including plans for data analysis and strategies to address unforeseen events such as potential injuries to subjects.

Site selection (if applicable) also occurs during this step. Selecting the best site(s) for your study protect your study from the leading cause of failure. Our team works with a wide range of medical centers across the country to match each study to the most appropriate site(s) for data collection. This ensures that recruitment of participants remains within the budget and timeline outlined for your study.

Factors that play a role in this process include your study's inclusion criteria, total number of participants required, and generalizability required. The costs of preparing each site to begin the study, including training for any medical personnel involved in the collection of data, and oversight preparation are also included in the budget for this step.

The Start Up process of a study takes, on average, 2-8 weeks. The total number of medical sites that must be trained is the biggest contributing factor to the projected timeline in this stage.

Study start-up averages three months, but in Canada requires an additional two to three months for regulatory review and approval. If the study is conducted in the US or is a food-based rather than dietary supplement study, two weeks to one month is usually required for ethics approval.

Step 2: The Active Study Period

Once a study has secured all necessary regulatory authorizations and all sites are fully trained, the active phase of a study begins. During this phase, each participant must be recruited for the study, informed of the risks/benefits of participating in the study, screened to ensure they fit the inclusion criteria, randomized to a study group, provided with study materials, instructed on their obligations, monitored for compliance, and evaluated according to the protocol for data collection. They are then monitored for adverse events, reimbursed for their participation, and debriefed after the study.

This is the most important step of the process because participant recruitment is the single most common reason for a clinical trial to be delayed or to fail. Nearly 80% of all studies fail to meet enrollment deadlines. Additionally, enrollment is typically a process that follows a predictable pattern. Studies are often slow to begin enrollment, then settle into a more consistent pace until enrollment numbers are met. Therefore, any disruptions to the process during this time may cause this process to be reset, resulting in significant delays to the study's timeline.

On average, about 3% of the general population is willing to consent to participating in a clinical trial. For studies with stringent inclusion criteria, this easily reduces the total potential participants to less than 1% of the adult population. To maintain the required pace to keep a study on schedule and prevent it from failing, an experienced research team is required. Our team protects your investment by developing strategies in the Start Up phase which ensure that your study maintains these critical deadlines.

Additionally, not all participants who are enrolled in a study continue participating through completion. Participants may withdraw from studies for a wide range of reasons. Sometimes participants withdraw due to a lack of follow-up from the research team, but unrelated factors (such as weather events or personal hardships) also cause participants to withdraw. Our team designs your study to allow for a reasonable level of participant withdrawals and takes action to protect your study from withdrawals that can be prevented. Participant retention is emphasized in protocol development, research oversight, site-specific communication, and multiple other factors.

This phase also includes data collection and management. Data collection must be secure, protecting the privacy of all participants. Data must also be cleaned and verified. These additional steps are taken by our team as participants are following the protocol. Federal law mandates that all data collected during the process of a clinical study be processed and archived according to strict criteria. These must be maintained and available in the case of an audit from any of the regulatory agencies that oversee research on human subjects. Our team securely archives and maintains all study-related data for future reference.

Step 3: Completion & Dissemination

Once all data are received, the study enters its final phase. Completion records are filed with ethical oversight agencies and registrations are updated in clinical trial registries. When this occurs, the database is locked and, subjects can no longer participate, and the study cannot be extended. Data are then analyzed according to the study's protocol. This step takes approximately 6-12 weeks, depending on the study's protocol and the number of research sites required.

Upon completion of the study, the FSIHS research team will produce a final report of the study and present our findings, if desired. In addition to a presentation of the findings, the study will be written into a completed manuscript, using the appropriate industry-accepted formats such as CONSORT or PRISMA. Completion costs also cover the presentation of findings to the funding agency, compilation of presentations, posters, and/or articles for dissemination in the field, and any printing, publication, or APCs (author publishing charges) related to dissemination of the findings. Studies with multiple outcomes or complex analysis may produce multiple manuscripts, findings, presentations, or articles.

If the study produces noteworthy results, whether positive or negative, the FSIHS Research Team reserves the right to present these findings at industry conferences or disseminate them through other methods, including submissions to scientific journals. Funding agencies cannot influence decisions regarding the dissemination of findings.

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.