As we navigate through the new year of 2024, the clinical trial landscape is experiencing transformative changes, particularly in the aspect of inspection-readiness. This abbreviated article provides a focused look into how these changes are influencing trial preparedness for regulatory inspections.
Advancements in Inspection-Readiness The integration of new technologies and methodologies has brought about a significant shift in how clinical trials prepare for inspections. Innovations such as digital documentation systems and AI-driven compliance tools are streamlining the process, ensuring trials are always inspection-ready.
Real-Time Data Monitoring The adoption of real-time data monitoring systems is a game-changer. These systems provide continuous oversight of trial data, flagging inconsistencies and areas of concern well before an inspection, thus reducing the risk of non-compliance.
Decentralized Trials and Inspection Challenges Decentralized clinical trials (DCTs), while offering numerous benefits, also present unique challenges in maintaining inspection-readiness. Our article discusses strategies to overcome these challenges, ensuring DCTs adhere to regulatory standards effectively.
Conclusion The full article, accessible to our subscribers, delves deeper into how these trends are reshaping inspection-readiness in clinical trials and explores the evolving regulatory expectations and how companies are adapting to meet these new standards. 🔗 Subscribe now for full access to in-depth insights.
Your Insight Counts How do you think technology will further impact inspection-readiness in clinical trials beyond 2024? Let us know in the comments section. We look forward to hearing from you!
World Quality Day, celebrated on a global scale every year on the second Thursday in November, serves as a reminder that quality is not just a buzzword or a department in your organization—it’s everyone’s business. Whether you work in clinical operations, healthcare, manufacturing, or any other industry, ensuring quality should be a shared responsibility. In this blog post, we’ll explore why quality is crucial, how it impacts various aspects of your business, and why fostering a culture of quality is essential for long-term success.
Quality Breeds Trust
Quality is the cornerstone of trust. When you consistently deliver high-quality products or services, your customers and clients develop trust in your brand. Trust is not just important for customer satisfaction but also for building lasting relationships. In clinical operations, trust is paramount, as patients rely on healthcare professionals to provide accurate diagnoses and effective treatments. The link between trust and quality is evident, making it clear that quality is everyone’s responsibility.
Quality Enhances Efficiency
Poor quality can lead to inefficiencies, causing wasted time and resources. When a product or service lacks quality, it often requires rework, leading to increased costs and delays. By prioritizing quality, each team member can contribute to streamlined processes, reducing errors, and boosting productivity. In clinical operations, efficiency can save lives, making the pursuit of quality a shared mission.
Quality Reduces Risk
Quality control and risk management go hand in hand. Ensuring high-quality products or services minimizes the potential for defects, recalls, or adverse events. In clinical operations, such as drug development, the consequences of poor quality can be catastrophic. By making quality everyone’s business, organizations can proactively identify and mitigate risks, safeguarding the well-being of patients and the reputation of the company.
Quality Drives Innovation
Innovation and quality are interconnected. When every team member is committed to delivering high-quality results, they’re more likely to seek creative solutions and improvements. Quality-driven innovation can lead to better products, services, and processes, setting your organization apart from the competition. In clinical operations, innovation can lead to groundbreaking treatments and advancements in patient care.
Quality Fosters a Culture of Excellence
A culture of quality doesn’t happen by chance; it’s a result of collective effort. When quality is everyone’s business, it becomes a part of your organization’s DNA. This shared commitment to excellence encourages employees to take pride in their work and continuously strive for improvement. In clinical operations, a culture of quality can save lives and contribute to the development of groundbreaking treatments.
In conclusion, quality is not a solitary responsibility but a collective one. From the boardroom to the front lines, everyone plays a vital role in ensuring quality. By fostering a culture where quality is valued and upheld by all, organizations can build trust, enhance efficiency, reduce risk, drive innovation, and ultimately achieve long-term success.
Now that we’ve established that quality is everyone’s business, it’s time to take action. The success of your clinical operations depends on a collective commitment to quality. As we acknowledge WORLD QUALITY DAY, let’s make a collaborative effort to act on the principles discussed in this article. Implement a culture of quality within your clinical operations. Start discussions within your team, set quality benchmarks, and continuously strive to exceed them. Remember, quality is not a destination but a journey, and it’s a journey that’s everyone’s business.
Together, we can build a future where the quality of our work is synonymous with the quality of life for countless patients. It’s a journey worth taking, and it starts with you.
Quality is not a department. It’s not a job title. It’s a mindset, a commitment, and a culture. Make it everyone’s business, and you’ll be one step closer to achieving excellence in clinical operations. So, let’s celebrate World Quality Day by embracing quality as everyone’s business, and don’t forget to join our mailing list and subscribe to our newsletter for regular quality insights and updates.
The task of documenting and maintaining records can prove to be a daunting one in the world of clinical research. Effective resource allocation constitutes a delicate equilibrium. Striking the right balance between dedicating resources to training and compliance initiatives while judiciously managing costs becomes an intricate endeavor for organizations. It is critical to be attentive to resource needs in addition to ensuring that employees receive comprehensive inspection-readiness training in preparation for health authority inspections. The do’s and don’ts of inspection readiness training that contributes to readiness success includes the following:
Consistent Training Plan – Establish a regular schedule for training sessions, ensuring that all team members acquire a comprehensive understanding of health authority regulations and adherence to documented standard operation procedures.
Exemplary documentation standards – Stress the importance of meticulous and comprehensive documentation. Implement and practice the most effective methods for maintaining impeccable records.
Comprehensive cross-training – Promote cross-functional training initiatives aimed at nurturing a corporate culture deeply ingrained in compliance across various departments within your organization’s structure.
Realistic scenario simulations – Create mock inspection scenarios that closely resemble real-world situations. This valuable exercise will help identify weaknesses and areas in need of improvement.
Proactive regulatory awareness – Continuously monitor and stay informed about regulatory updates, adjusting your training programs to align with these evolving regulations.
Discount the gravity of compliance – Never underestimate the gravity of aligning with regulations. Forgoing due diligence or shortcutting compliance requirements can result in grievous regulatory issues.
Neglect training documentation – Never depreciate the importance of documenting training, both in terms of accuracy and completeness. Neglecting to properly oversee and document training can furnish a breeding ground for critical compliance and data discrepancies.
Neglect post-training reinforcement – The failure to revisit training and scrutinize employee compliance can vitiate the efficacy of the training initiative. Assure that senior leadership exudes unwavering commitment to the training program.
Defer compliance or cultivate a culture of blame – Do not defer the serious consideration of compliance until impending regulatory inspections materialize. Shun the cultivation of a culture that lays blame upon employees who are may not be main contributors to the errors or data discrepancies.
Underestimate resource allocation – Do not underestimate the resource allocation requirements for the efficacious execution of training and compliance endeavors. Insufficient resource allotment can enervate the quality of training and impede compliance endeavors.
In conclusion, maintaining inspection readiness is a continuous process that demands diligence, commitment, and a robust training program. The challenges posed by evolving regulations and complex documentation can be overcome by following the dos and don’ts outlined above. By investing in comprehensive inspection readiness training program, organizations can safeguard their reputation, product quality, and, most importantly, patient safety in an ever-evolving regulatory landscape.
If you need to develop an inspection-readiness training program and need assistance,Contact us for a free consultation! We would love to hear from you to discuss strategies!
Q: When is the best time to start preparing for an inspection?
After database lock
After the inspection announcement
After IND/IDE Submission
A: If you answered C, you are correct. Inspection Readiness is an ongoing process that starts at the beginning of the trial.
We all know that inspections can be quite stressful; however, a stressful environment can be minimized with proper preparation and inspection readiness techniques. This article will discuss the 5C IRS (Inspection Readiness Success) Model as one of the strategies that can be utilized as an inspection readiness technique for clinical research sites.
The 5Cs are:
Collect Information – In collecting information, it’s important to consider researching from both internal sources (e.g., prior audits, inspections and monitor visit reports) to determine existing gaps in your processes in addition to external sources (e.g., websites of regulatory authorities such as USFDA, EMA, Health Canada, etc.) to review guidance materials, requirements and expectations.
Collaborate with the sponsor – Be proactive in utilizing inspection readiness tools and collaborating with the monitor & sponsor’s inspection team for additional support in preparing for inspections and implementing effective inspection readiness strategies.
Communicate with stakeholders – Communicate with internal stakeholders (colleagues, PI, monitor) to address gaps in study-related documentation to ensure that they are present, complete and accurate. It’s equally important to ensure that staff are properly prepared to communicate with external stakeholders (e.g., regulatory authorities) and able to interact effectively with the Inspector/FDA Investigator prior to, during and after the inspection.
Correct via CAPA (Corrective and Preventive Action) Plans – Part of having an effective Corrective and Preventive Action plan for each finding is to include all of the elements such as:
Root Cause – Why did this happen? Was it a systemic or isolated event?
Correction – What correction was done to immediately resolve this finding?
Corrective Action – What will be your corrective action and how will you implement to ensure this finding does not recur? For example, you may need to create, improve, revise SOPs and checklists/templates and retrain staff on the revised processes.
Preventive Action – What are you checks and balances? Incorporate preventive measures within a timeframe (e.g., 3- 6 months) to ensure similar finding(s) never happens again.
Conduct Compliance Checks – Compliance checks involve the evaluation of the implemented processes from your CAPA. Utilize checklists at frequent intervals to reveal gaps and determine what’s working vs. what’s not. In addition, review findings from monitoring visits as gauge for compliance checks especially if time and resources are limited at your clinical research site.
Remember, inspection readiness is an ongoing process. Incorporating an Inspection Readiness strategy, such as the 5C IRS (Inspection Readiness Success) Model, in your daily operations not only creates a culture of compliance, but also allows your site to proactively prepares for and contributes to the success of future inspections.
Need a checklist for your site? Become a subscriber to download our free Inspection Readiness Checklist!
Audit and inspections are critical methods in achieving compliance. Both are systematic, and documented processes conducted to verify that a certain set of standards, guidelines and procedures are being met; however, they are used interchangeably according to their processes.
As an FDA Investigator, the term “inspection” was used most often; however, as I ventured out into the industry to work for sponsor companies and CROs, I heard both terms “audit” and “inspection” used interchangeably depending on who was conducting them. At the same time, professional organizations like ASQ (American Society for Quality) primarily used the term “audit”.
According to the sponsor companies I have worked for in the industry, the term “audit” is used when it is conducted either internally within the organization or externally with a supplier. The term “inspection” is used when conducted by a regulatory authority such as FDA, EMA, ISO, etc.
So, what’s the difference?
Inspection vs Audit
Regulatory Authorities such as the USFDA(United States Food & Drug Administration), EMA (European Medicines Agency), etc. use the term “inspection” which is routinely done to:
Determine the safety and protection of subjects
Ensure adherence to federal regulations
Determine the validity of clinicals trials supporting approval applications
According to professional organizations like ASQ (American Society for Quality), everything is considered an audit broken down into different types (e.g., process, product, system, etc.) and parties such as:
Second-party audit or
Third party audit
First party audits, or internal audits, are conducted within an organization to measure its strengths and weaknesses against its own procedures and processes against external standards.
Second party audits, or supplier audits, are conducted externally on a supplier by a customer to determine that products are being handled properly according to the customers’ procedures / industry stands and services are done according to the requirements of contractual agreement.
Third party audits are conducted independently from outside organizations or regulatory authorities and can result in certification, registration, recognition, approval, etc.
According to the sponsor companies I have worked for in the industry, the term “audit” is used when it is conducted either internally within the organization or externally with a supplier. The term “inspection” is used when conducted by a regulatory authority such as FDA, EMA, ISO, etc.
The best way to minimize confusion is to consider First and Second party audits conducted internally or externally by clients or consultant companies as AUDITS and Third-party conducted by regulatory authorities as INSPECTIONS both with the ultimate goal to achieve compliance and adherence to set standards, guidelines and procedures.
How are audits and inspections differentiated in your company or department? Feel free to contact us with your comments, questions or feedback. Looking forward to hearing your thoughts on this topic!
Checklists are invaluable tools in Inspection Readiness programs within regulated industry of pharmaceutical, medical device and biotech companies. They provide a structured approach to ensure that all necessary preparations are made for inspections, audits, and regulatory assessments. The importance of checklists in Inspection Readiness cannot be overstated, as they help organizations mitigate risks, and ensure the quality and safety of their products or services. They also help with:
Standardization: They create a consistent framework for preparing for different types of inspections, promoting a structured approach to compliance.
Accountability: Checklists assign tasks and responsibilities to individuals or teams, reducing the likelihood of oversights or delays.
Training and Awareness: They educate employees about regulatory requirements and steps for inspection readiness, fostering a culture of compliance.
Documentation Management: They ensure that all required documents are up to date, organized, and readily accessible, simplifying document retrieval during inspections.
Continuous Improvement: Regularly updating checklists based on previous inspection experiences and changing regulations promotes a culture of continuous improvement.
What to Include in an Inspection Readiness Checklist
The following areas should be part of checklists that encompass your Inspection Readiness program:
Regulatory Requirements: List and be aware of specific regulations, guidelines, or standards applicable to your industry or organization (ie. FDA, EMA, Health Canada, etc).
Document Review: Verify the accuracy and completeness of essential documents, such as SOPs and regulatory records.
Training and Competency: Document employee training and certifications to ensure competence and qualification.
Facility and Equipment maintenance (if applicable): Regularly inspect and maintain infrastructure and equipment to meet regulatory standards.
Quality Control and Assurance: Evaluate quality control and assurance processes to prevent deviations and non-conformances.
Risk Assessment: Identify potential risks within processes and develop strategies to mitigate them.
Corrective and Preventive Actions (CAPA): Track and address open CAPAs to demonstrate a commitment to improvement.
Internal/Mock Inspections: This will include internal and mock inspection schedules, simulations and documentation to help identify gaps and improve readiness.
Communication Plan: This helps to outline how your organization will communicate with regulatory agencies and inspectors during the inspection.
Emergency Response Plan: Prepare for unexpected situations with an emergency response plan.
In conclusion, checklists are indispensable. An effective checklist should encompass all relevant aspects of the organization’s operations, from regulatory compliance to documentation management, to guarantee a successful Inspection Readiness program.
If you are seeking alignment within your team but are struggling with where to start in regard to creating an Inspection Readiness checklist for your company, Contact us! We’d love to hear from you to discuss strategies!
Recently approved medications and those already on the market can benefit from pharmacovigilance to help ensure patient safety. While pharmacovigilance practices are highly regulated in the context of clinical trials, post-marketing incidence reporting is not properly adopted or enforced. As a result, it is anticipated that adverse events related to medications that are already in the market are underreported by about 90%. Therefore, it can be difficult to identify drug safety problems in individuals who have numerous comorbid conditions and complex disorders.
What is Pharmacovigilance?
The research and practices involved in the identification, evaluation, comprehension, and avoidance of side effects or any other issue involving medications is known as pharmacovigilance.
Before a treatment is approved for use, the only available proof of its efficacy and safety comes from clinical trials, in which patients are carefully chosen and monitored under carefully controlled settings. This indicates that a treatment has only undergone brief testing in a very small number of carefully chosen patients at the time of its authorization.
Following approval, the medication may be administered to a large number of patients, continuously, and in conjunction with other medications. In such cases, some adverse effects could manifest. Therefore, it is crucial to continuously assess the safety of all medications used in medical procedures.
How is Drug Safety Ensured?
For the evaluation of prescription medications, there are regulatory frameworks. First, the FDA examines the efficacy and safety of new pharmaceuticals that manufacturers want to market in the United States during the premarket approval process. The FDA’s examination of the studies in which people use the investigational new medicine in meticulously controlled, typically randomized trials such as Phase 1, 2 and 3 trials.
Second, the FDA takes action through its post market regulatory processes once a maker has sufficiently shown a drug or device safety and effectiveness for a specific population and set of conditions. Clinicians and patients may also report any significant or unusual adverse effects to the FDA.
According to the law, the FDA is authorized to take only limited action if it determines that a product’s post-approval use entails a higher risk of a negative outcome. However, many argue that in addition to needing a wider variety of enforcement measures, FDA also has to make better use of the authority it already possesses.
Six areas are discussed, including the FDA budget, the industry’s role, the opportunity to leverage the drug approval process to improve post market operations, the paucity of post-market data, and the limited public access to data obtained. The FDA is able to execute some of the recommended adjustments. Others would necessitate legislative action.
It is important to understand that no medication is 100% risk-free. A prescription drug is actually one that has “toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug,” according to the Federal Food, Drug, and Cosmetic Act.
Therefore, it is important to ensure that the drug safety plan is working in all areas of the healthcare sector to ensure utmost safety. Regulatory authorities and pharmaceutical medicine pupils must adhere to the fundamental principle and primary objective of pharmacovigilance.
Jones, R. (2022, April 16). Pharmacovigilance – a complete guide to Pharmacovigilance and Drug Safety – Clinical Research Certification. CCRPS Clinical Research Taininrg. Retrieved September 24, 2022, from https://ccrps.org/clinical-research-blog/pharmacovigilance-training
The theory and definitions of drug safety — pharmacovigilance. (2019). Cobert’s Manual of Drug Safety and Pharmacovigilance, 1–7. https://doi.org/10.1142/9789813278851_0001
Yehia, D. H. (2022, June 24). Introduction to pharmacovigilance: How drug safety is enforced by pharmacovigilance – pharmacovigilance foundations. Pharmacovigilance Foundations – Simplifying Healthcare Professionals Workspace. Retrieved September 24, 2022, from https://www.pharmacovigilancefoundations.com/pharmacovigilance-introduction/
As part of a sponsor’s inspection readiness activities, storyboarding is a crucial step that provides a solid framework for addressing challenging or important areas of noncompliance via corrective and preventive actions. With the aid of organizational and risk assessments, sponsor companies should be able to pinpoint issues and utilize storyboards to systematically discuss the implementation of action plans with inspectors as requested during an inspection.
Utilizing storyboards has various benefits. The top five benefits include the following:
They offer a structure for formulating concise content that the inspection team can convey reliably.
They are particularly beneficial in circumstances where an organization has gone through a transition or considerable change, for closing gaps that have already existed, and in other exceptional cases of self-identified compliance.
They point out the corrective measures taken to guarantee patient safety and maintain data integrity.
They assist in removing ambiguity, potential disagreement, and pressured decision-making while responding to inspection questions about challenging and perplexing clinical trial components.
They lessen the possibility of issues occurring during an inspection as a result of several facilitators or SMEs accidentally giving conflicting accounts of what happened, and the steps taken to address associated problems or gaps.
Being proactive and starting development when a problem or situation emerges can save a ton of time and work later on when attempting to put together a summary later. Therefore, it is a recommended practice to generate storyboards as early as possible.
The following are useful tips regarding a storyboard:
A storyboard should be utilized as a tool to assist the facilitators in making sure that important information is accurately and succinctly communicated, and that those informing inspectors are on the same page.
The location of pertinent supporting paperwork should be listed on a storyboard so that facilitators can respond to inspection demand swiftly.
Storyboards should not be lengthy things of the past with background or unnecessary material, but rather brief and to the point. They are designed to contain minimum amount of information necessary to properly respond to an inspection request.
A storyboard’s content can be discussed verbally with an inspector but storyboards themselves should not be shared or mentioned because they are not meant to be discussed in full during an inspection.
Storyboards shouldn’t include statements that unintentionally encourage facilitators to disclose information that an inspector might not have otherwise asked, as this could raise further questions and create confusion or ambiguity.
In conclusion, storyboards can offer the foundation required to communicate important information in a clear and simple manner with assurance and in synchronization across all departments of the organization, making the inspection readiness process considerably simpler for all parties involved.
Gwizdak , S., & Marshall, M. (2020, December 10). 4 ways to Adapt Your Inspection Readiness Framework in a post Covid-19 World. Halloran Consulting Group. Retrieved August 1, 2022, from https://www.hallorancg.com/2020/06/19/4-ways-to-adapt-your-inspection-readiness-framework-in-a-post-covid-19-world/#:~:text=Storyboarding%20is%20an%20important%20activity,critical%20aspects%20of%20a%20study.
HealthResearchBC. (2020, October 27). Regulatory update: Clinical trial storyboards. Clinical Trials BC. Retrieved August 1, 2022, from https://www.clinicaltrialsbc.ca/regulatory-update-clinical-trial-storyboards/
LifeScienceLeader. (2020). 09.28.20 — bringing clarity to Regulatory Inspection Readiness & Facilitation. 09.28.20 — Bringing Clarity To Regulatory Inspection Readiness & Facilitation. Retrieved August 1, 2022, from https://www.lifescienceleader.com/doc/bringing-clarity-to-regulatory-inspection-readiness-facilitation-0001
One of the primary goals of every clinical trial is to evaluate an intervention’s safety and effectiveness to that of a control or other care. As a result, all studies expose participants to risk, and these are risks that may be similar to those they encounter in ordinary clinical practice in many circumstances. It is critical to document instances of injury or poor outcomes that occur during the study to ensure that both expected and unforeseen hazards are identified.
Several phrases are frequently misconstrued as synonyms, including adverse events, adverse drug reactions, adverse effects, serious adverse events, serious adverse effects, side-effects, complications, and damages. When it comes to drug safety, though, both terms are often used interchangeably.
The following are examples of adverse events (AEs):
A physiological occurrence, such as a rash.
A psychological occurrence, such as altered cognition.
An abnormality in the laboratory, such as a high creatinine level.
Increased severity of a pre-existing ailment, such as uncontrolled blood glucose levels
Documenting and reporting adverse events; especially those events related to the study intervention helps in:
Informing health authorities, clinical investigators, and others of new and important information about events that occur on a clinical trial
Contributing to the summary of adverse experiences related to the development the drug, device or regimen toxicity profile
Documenting Adverse Events
All adverse occurrences must be recorded in the medical record of the patient. The study team must first grasp how AEs should be collected before documenting them. To avoid bias in AE collection, patients should not be questioned about specific occurrences that may be expected while on the trial.
AEs should be reported or elicited from a person at each study visit in the following situations:
during open-ended inquiries
The collection of AE data begins when the study intervention (drug/procedure) is started. The AE data should be collected from the commencement of a placebo lead-in period or other observational period intended to establish the patient’s baseline status. The AEs should be observed until they resolve or stabilize. All AEs that necessitate interruption or termination of the study drug, or those that are present at the end of study treatment, must be followed up on.
Reporting Adverse Events
Clinical trials can be conducted in a single or multi-center setting. Multicenter studies include a larger number and a wider range of research participants, making it more difficult to track adverse events, and certain incomplete safety reports from these multi centers may reduce the overall understanding of the adverse event.
The regulatory authorities must be able to analyze the safety information based on accurate documentation. The severity, study intervention relationship, action taken about the study intervention, adverse event outcomes, and if it was serious should all be documented.
All observed adverse events, as well as all adverse events reported by study participants, must be documented by the investigator. Regardless of the seriousness of the information presented, it should be recorded and reported. This data is saved in the safety database for the medicine or device under evaluation.
Each adverse event must be understood, as well as its relevance and significance to the drug or device being tested. Patient safety is increased as a result of the recording and reporting of these incidents.
Need inspection readiness assistance in your safety department or specialized training in the area of adverse events? Contact us! We’d love to hear from you to discuss strategies!
ClinicalTrails.gov. ClinicalTrials.gov. (n.d.). Retrieved June 11, 2022, from https://clinicaltrials.gov/ct2/help/adverse_events_desc#:~:text=Adverse%20Events%20are%20unfavorable%20changes,specified%20period%20following%20the%20trial.
MB;, G. R. E. D. N. A. L. (2014). Registries for evaluating patient outcomes: A user’s guide [internet]. National Center for Biotechnology Information. Retrieved June 11, 2022, from https://pubmed.ncbi.nlm.nih.gov/24945055/
What are ‘adverse events’ and why is it necessary to record and report them? students 4 best evidence tutorials and fundamentals. Students 4 Best Evidence. (2021, March 26). Retrieved June 11, 2022, from https://s4be.cochrane.org/blog/2021/03/26/what-are-adverse-events-and-why-is-it-necessary-to-record-and-report-them/
The selection of the appropriate research participants is critical to the success of any clinical trial. Regrettably, the majority of clinical trials done are severely lacking in diversity. All too frequently, cultural and genetic factors unique to Asians, African-Americans, Latino-Americans, and other ethnic communities can contribute to differences in treatment responses and risks of adverse events.
Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data. This disparity in diversity can lead to poor drug development and increase minority health inequities; however, there are ways to close this diversity gap.
Three Ways to Close the Diversity Gap
1. Educate Staff About Importance of Diversity in Trials
The importance of diversity in clinical trials guarantees that they are being conducted properly and strategically. It’s important to learn more about the significant unmet needs of patients who could benefit from a therapy or medicine. If we know, for example, that a health problem would affect a diverse patient community in terms of “race” and ethnicity, we should plan ahead of time to ensure that those patients are equally included in the recruiting and selection process.
2. Build Partnerships
Engaging patients is a mission in which we are not only collaborating with various groups, advocacy organizations, and patients, but also building a method in which patients feel like they are a part of our scientific study from start to finish. A clinical researcher’s job entails analyzing real-world and secondary data to better understand disease and treatment trends, track patients’ healthcare journeys, and find strategies to demonstrate its worth in improving health outcomes. The idea is to have a varied group of people at the table in order to come up with solid and relevant solutions.
You learn to value patient, advocate, and expert collaboration. You will learn how to form relationships and engage in discourse from a variety of viewpoints. So that when it comes to performing research at various stages of the drug development process, you already have those partnerships in place and can use them to improve your knowledge and influence.
3. Start at a Micro-Level
Using more community-based routes that are congruent with how people may be familiar with acquiring information, such as barber shops, beauty parlors, or community centers, to contact and deliver information to possible study volunteers is an important tactic. Non-traditional outreach tactics not only help create valued relationships, it also provides essential information about the concerns of the community as it relates to participation in clinical trials. Many in the community have difficulty participating in trials because of the historic and unethical Tuskegee Syphilis Study so of course, building trust in these communities is an important factor as well.
Minority involvement in clinical trials should be a primary focus for the entire health-care system. Participating in the aforementioned measures will help us develop medications more effectively, reduce minority health disparities, and improve overall public health. However, in order to reduce the diversity gap, more businesses and government agencies must support programs like these and be more empathic to the concerns of the minority communities.
Barron, D. (2015). Bridging the diversity gap in clinical trials: Reuters events: Pharma. Bridging the Diversity Gap in Clinical Trials | Reuters Events | Pharma. Retrieved May 23, 2022, from https://www.reutersevents.com/pharma/clinical/bridging-diversity-gap-clinical-trials
Bodicoat, D. H., Routen, A. C., Willis, A., Ekezie, W., Gillies, C., Lawson, C., Yates, T., Zaccardi, F., Davies, M. J., & Khunti, K. (2021). Promoting inclusion in clinical trials—a rapid review of the literature and Recommendations for action. Trials, 22(1). https://doi.org/10.1186/s13063-021-05849-7
Buckman, P. (2022, May 11). Council post: Bridging the gap: Why clinical trials have a diversity problem and how to fix it. Forbes. Retrieved May 23, 2022, from https://www.forbes.com/sites/forbesbusinessdevelopmentcouncil/2022/05/10/bridging-the-gap-why-clinical-trials-have-a-diversity-problem-and-how-to-fix-it/?sh=2b074b4a5078
Janssen Oncology. (2021, December 16). Working together to close the diversity gap in clinical trials: Industry and researcher perspectives. STAT. Retrieved May 23, 2022, from https://www.statnews.com/sponsor/2021/12/06/working-together-to-close-the-diversity-gap-in-clinical-trials-industry-and-researcher-perspectives/
Our Mission and Purpose
The mission of 2K Clinical Consulting, Inc. is to ease the burden of GxP compliance and to transform the effectiveness of professionals and compliance systems worldwide.
2K Clinical Consulting, Inc. is the vision of former FDA Investigator, Kimberly Kiner, who empathized with facilities and sites that struggled with understanding and complying with regulations. After years in the field, Kimberly transitioned into the private sector and acquired international experience in compliance, monitoring and study management while she worked for pharmaceutical and invitro/medical device companies as well as CROs. This work experience is what sparked her desire to work as a consultant for organizations such as the Association for Clinical Research Professionals and the Society of Clinical Research Associates. Kimberly later went on to train providers such as Compliance Online and Fx Conferences. This exposure became the gateway to connecting with other experts and teaching professionals resulting in an engaging experience for clients that closes the gap in best practices within the realm of compliance.