Clinical trials are an essential component of drug development and medical research. The results of clinical trials help determine the safety and efficacy of new drugs and medical devices. The clinical laboratory is an integral part of clinical trials as it is responsible for generating reliable and accurate data that is critical to the success of the trial. To ensure that the data generated by the clinical laboratory is of high quality, it is important to follow the tenets of good clinical laboratory practices (GCLP).

Good clinical laboratory practices (GCLP) are a set of guidelines that provide a framework for the conduct of laboratory studies in support of clinical research studies or clinical trials. GCLP helps to ensure that the laboratory data generated during the study is reliable, accurate, and of high quality.

In this article, we will discuss the tenets of good clinical laboratory practices in clinical trials.

The best way to accrue patient-reported outcomes (PRO) is through censored clinical outcomes assessments (COAs). This provides a structured instrument to capture their perspectives while increasing the likelihood of approvals from sponsors. Ensuring the most from patients requires a strategy that amplifies their voices without burdening them as they have limited time or stamina for rigorous surveys and assessments.

Surveys have confirmed that electronic COAs allow for flexibility via a dedicated device or personal phone/tab which would make it easier for them to record and upload responses without excessive site visits. It also expedites access to PROs data, providing real—time insights that can inform trial progress and demonstrate results.  

The FDA encourages trials planners to consider the following 5 aspects when creating assessments;

Xcene Research believes it is important to consider what role an assessment will play in the research, how it will add new knowledge or insights, and how best to engage patients in the process. Accelerating trials and strengthening systems for patient experiences will ensure quicker interventions and medicine production.

Clinical trials are an integral part of medical research and play a critical role in advancing healthcare.

They provide a way to test new treatments and medicines, determine their safety and effectiveness, and improve patient care. For people in Africa, participating in clinical trials can have numerous benefits, both for individual health and for the advancement of African healthcare as a whole.

Access to new treatments: One of the most significant benefits of participating in clinical trials is the opportunity to access new treatments and medicines that are not yet available to the general public. For people in Africa who may not have access to the latest medical advancements, participating in a clinical trial can provide an opportunity to receive cutting-edge care that can improve their health and quality of life.

Improved health outcomes: Clinical trials are designed to evaluate the safety and efficacy of new treatments and medicines, and participants in these trials have access to a high level of medical care and attention. This often results in improved health outcomes for trial participants, as they receive more comprehensive and individualized care than they would receive in a typical healthcare setting.

Contribution to medical research: By participating in clinical trials, patients in Africa have the opportunity to contribute to the advancement of medical research and help improve healthcare for future generations. The information gathered from clinical trials is used to develop new treatments, improve existing ones, and advance our understanding of medical conditions.

Opportunity to participate in the decision-making process: Clinical trials offer patients the opportunity to participate in the decision-making process regarding their care. Participants are informed about the trial’s purpose, potential risks, and benefits, and are given the opportunity to ask questions and make informed decisions about their participation.

Financial incentives: Participating in clinical trials can provide financial benefits to individuals, such as compensation for their time and travel expenses. These incentives can help alleviate the financial burden of medical care and improve access to healthcare for those in need.

In the global healthcare industry, clinical trials play a crucial role in testing new treatments and medicines, determining their safety and effectiveness, and ultimately improving patient care. Clinical trial participation has the potential to have many positive effects on Africans. With more and more studies being undertaken throughout the continent, now is a better time than ever for Africans to become engaged and make a difference.

By participating in clinical trials with Xcene Research; a pioneer CRO in Africa, individuals in Africa can gain access to cutting-edge treatments and medicines, receive high-quality medical care and attention, contribute to medical research and the advancement of healthcare, and even receive financial incentives. The opportunities are abundant, and the impact can be significant.

So, if you want to make a difference in your health and the healthcare industry, consider participating in a clinical trial. Africa is open for business, and your participation can help shape the future of healthcare for generations to come.

The lack of diversity in Clinical Trial participants has some significant negative effects on both the African population and the Clinical Trial sponsors. Sponsors pass up the chance to carry out very inexpensive research with a broad patient group, frequently enrolling people who have never had any therapy for their ailment while the populace has a shortage of effective medications.

We are aware that some diseases are more common in particular ethnic groups, and that a person’s responsiveness to treatment can be substantially influenced by their genetic makeup. This means that results from Caucasians cannot necessarily be extrapolated to apply to Africans.

Perhaps you are already aware that studies known as Clinical Trials are used to examine the effectiveness and safety of your medications. But you might be shocked that there isn’t much diversity in terms of race or ethnicity among the participants in these Clinical studies. And that lack of variety may have an impact on how well we comprehend how effectively medications work in various racial populations throughout the world.

Benefits & Significance of diversity in Clinical Trials.

• Diversity in Clinical trials is intended to mirror how well a drug works in an actual population where people of diverse ages, genders, and ethnicities may use it.
• Pharmaceutical firms are creating more specialized and complex medications, yet it is hard to determine a medication’s safety and effectiveness across a range of groups without conducting Clinical studies with sufficient variety.
• “Increasing diversity better reflects the range of populations that will use the therapy, or vaccine being studied. Medications can affect various racial and ethnic groups differently, sometimes to the extent that the U.S. Food and Drug Administration (FDA) recommends separate prescribing instructions​.” – (Echezona Ezeanolue, MD, MPH, FAAP, FIDSA​Vice-President, HealthySunrise Foundation USA)
• All of “Us” is part of a new era in which researchers, health care providers, technology experts, community partners, and the public work together to develop individualized health care.​
• “Data from All of “Us” could someday help researchers: ​
• Identify what makes people more likely to develop a disease​
• Find out how environment, lifestyle, and genes can impact health​
• Build better tools for detecting a health condition and encouraging healthy habits”- (Echezona Ezeanolue, MD, MPH, FAAP, FIDSA​ Vice-President, HealthySunrise Foundation USA)
• When some groups are underrepresented in Clinical Trials, there is a risk of collecting insufficient data to assess effectiveness and safety in those populations. *
• Racial and or ethnic background, in combination with other interdependent factors including social determinants of health and genetics, can contribute to differences in drug exposure or response. *
• Clinical Trials contribute to scientific knowledge for treatment options that may potentially benefit wide categories of patients, Physicians, Equitable access to clinical trials is integral to achieving health equity. *
• Diversity in Clinical Trials improves trust and acceptance and spreads risk evenly. *                 

                                                                           * (Kwame Jabari: Msc CRM, BMI)

Xcene Research aims to be a catalyst for patient accelerated access to clinical trials in Sub-Saharan Africa region and has championed this cause through the Impact Africa summit- a unique platform for relevant stakeholders to collaboratively address key issues and trends surrounding pharmaceutical research & development and clinical trials in Sub-Saharan Africa. The 3rd edition was held on the 1st-3rd of December 2022 and addressed the subject of Clinical Trials: Diversity with Inclusion of Africa- Achieving clinical research equity, a key step towards healthcare innovation in Africa.

Keep up to date on the 4th […]

In the last decade, there has been a gradual increase in the acceptance of decentralized clinical trials (DCTs), one trend that has accelerated dramatically due to the pandemic.

Now, there will be no going back, primarily due to the convenience and flexibility for patients. By minimizing the burden of participating in a clinical trial, sponsors simplify recruitment and increase retention and compliance. Study effectiveness is amplified, and drugs get to market faster, saving patient lives and sponsors’ money. 

Largely conducted remotely, these trials use technology and other novel solutions to minimize the patient’s need to travel. Site visits may be replaced by visits from a home nurse, or to the patient’s own primary care physician. At the same time, wearables, apps, and home-monitoring devices collect data on an ongoing basis. With all the complexities needing carefully tracked, analyzed, and managed data, it’s not surprising that while patients prefer this alternative to site-anchored studies, DCTs are not always simple for sponsors and contract research organizations (CROs).

This has led to sponsors being as wary of Decentralized Clinical Trials as patients are appreciative of them. Sponsors often feel that DCTs increase operational complexity, business risk, and regulatory hurdles. However, with the right technology, the seven mentioned below, those fears are unjustified;  

·       Collects all data in any form: A platform that is able to aggregate, analyze, and visualize all the data collected across trials, including data from wearables, apps, and more traditional forms of data collection is pertinent. 

·       Harmonizes that data: Collecting the data is not enough, but finding a system that can integrate data across 

·       Supports detailed examination: The same attention to detail that clinical research associates traditionally supply onsite—is needed remotely. Look for a system with dynamic drill-down capabilities for further interrogation of issues with source data. 

·       One able to process calculated metrics: Comprehensive risk management requires in-depth analysis. You want the flexibility to set user-defined metrics for more relevant analyses and greater actionability.  

·       Should have a built-in audit trail: Regulatory bodies require demonstrated proof of monitoring and risk-based data management; some systems provide that automatically. 

·       Offers machine learning capabilities: Machine learning enables systems to quickly analyze data and provide near-real-time insights, facilitating many aspects of risk-based monitoring. 

·       Supports independent system set-up and use: The ideal platform should self-sufficiently enable receiving support from the vendor when you want it, but not require perpetual services in order to operate effectively.  

Xcene Research believes that being armed with these seven features in a data-management platform, will strengthen sponsors’ and CROs’ belief that data management can be streamlined, risk-based monitoring will be readily accomplished, and that all regulatory requirements will be met automatically.

There’s no shortage of digital solutions in today’s innovation-fueled clinical research space at every stage of the clinical trial journey. Still, there’s a lot of room for improvement, especially when it comes to the patient experience.

Consider the rapid increase of patient and site-facing technologies – from digital patient outreach to eConsent, sensors and wearables, telehealth, and study retention tools.

The introduction of novel digital solutions often misses the mark when it comes to integrating them into the clinical trial workflow. There’s a common perception that many technology providers don’t consider where a given solution fits into the overall patient and site workflow, and how it interacts with other systems.

Technology is critical to clinical trial efficiency and data quality, particularly for supporting the increased operational complexities of research, but we need to think broader about effective implementation.

What can we do to improve the clinical trial experience for patients?

In addition to mapping current pathways of a clinical trial journey, this is a huge opportunity to use technology to redesign the clinical trial patient experience by finding more opportunities to educate, engage, and enable meaningful communications.

eConsent may not be the first digital interaction that a patient has with the clinical trial process, but it’s a make-or-break decision touchpoint. However, before we get to the “e” part, let’s talk about experience, or lack of it when considering patient needs. Informed consent packs a lot of complex medical, technical, and legal jargon into lengthy documents that patients are expected to digest and make decisions about participation during a short session with an investigator. Clinical trial participation is a long-term commitment and, in most cases, does not just impact one person. It involves partners, caregivers, and families.

Patients considering clinical trials want to discuss the benefits of participation with their own circles, which typically involves any combination of family, friends, healthcare providers, or other trusted advisors. As standard practice, our industry treats it like a one-time opportunity.

Ongoing discussions and workshops have urged sponsors and sites to design informed consent as a process instead of an event. In process terms, it means slowing it down, allowing patients more time and (potentially) multiple visits to consider if they want to participate. In user experience terms, it means using alternatives to long-form communication documents. Video, audio, graphics, and animation convey complex information more effectively than a long-form document. When provided through an app or online portal, asynchronous delivery can help educate potential participants ahead of, or in between meetings with investigators.

eConsent is just one example of how we need to rethink the clinical trial patient journey, so technology is an integration instead of an overlay. Clinical trial technology can bring transformative benefits but requires a deep understanding of the entire process and the lived experience of patients who navigate that journey. Improving the Patient Experience in Clinical Trials

Work has experienced a major transformation and this shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.

Years ago, it would be had been an abnormality in the clinical trial industry to propose any notion of conducting clinical trial procedures or trial monitoring activities in any form except in-person and on-site. However, employee demand for a more flexible module of hybrid and remote work has got researchers and sponsors adapting to this new paradigm. The onset of the pandemic forced the industry to pivot and adapt abruptly. Continually evolving technological advances continue to enhance the fields of medicine and clinical research. Although complex in nature, it has become essential to rejig the conduct and clinical monitoring in clinical trials.

Conduction of Studies
The pandemic has brought to the fore that we can conduct a fully robust, and detailed monitoring visit without always needing to be on site. With advancements in technology, we can conduct every type of visit remotely. For example, Site Qualification Visit can be performed completely remotely where a site tour can be conducted with the site using a live video feed to show the research facility. While site Initiation Visits were conducted remotely before the pandemic, this became normal after the onset of the pandemic.

Improving Systems
In 2020, the Food and Drug Administration (FDA) released guidance on the Conduct of Trials Medical Products During the COVID-10 Public Health Emergency, then released draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations for public comment in December 2021. This guide provides best practices for how digital health tech can be implemented/used to support data.

These two guidance documents indicate the FDA recognizes that there is a shift in the industry that will most likely be a permanent change and is imperative to create an avenue and guidance to ensure that clinical research and monitoring are adapting to the new demands.

Monitoring
The knowledge we had garnered pre, during, and post-epidemic is that the clinical research industry can pivot at any point in time to meet the demands of society. The epidemic has accelerated the ongoing pivot to remote clinical trial monitoring, where remote site access and remote monitoring programs are now the new standards and crucial parts of clinical trial development. Although the pivot started before the epidemic, the industry as a whole had been slow to adapt to recommendations from the FDA to transit to remote monitoring. So, let us look at questions that were answered during the epidemic;

• Does SIV necessarily 8+ hours for a Site Initiation Visit?
  • With the shift in focus and methodology, we have discovered that Visits such as Site Qualification Visits and Site Initiation Visits do not need to be long as we have all been used to. These visits are far more efficient than before.
• Is it possible to have risk-based monitoring used efficiently?
  • Absolutely yes. It is more direct, efficient, and strategic in monitoring and catching any outliers.
• What tasks can be performed virtually?
  • Every monitoring task can be completed remotely. There are eSources now which helps sites upload documents and serves as a channel for CRAs to review Source Documents remotely.

Dependency on online meeting platforms like Google and Teams went up significantly during the pandemic and remains the new normal. Training and meetings can now also be […]

Clinical monitoring refers to the supervisory and administrative activities that track a participant’s health and treatment efficacy. So, what does clinical research monitoring entail?

Monitoring is an integral part of any research project because it ensures ethical behavior, effective data collection and documentation, accurate records of study processes and subject contacts, and adherence to the authorized protocol. 

The goal is to ensure that: Human participants’ rights and well-being are protected. The trial data given are correct, full, and verified through source documentation (records of clinical findings, observations, or other activities in a clinical trial). 

Types of monitoring in clinical trials: 

on the job: On-site monitoring requires an in-person examination of the investigation location by sponsor employees or representatives. 

through the internet: The monitor performs off-site evaluations distant from the site where the clinical trial is taking place. 

from a single location: Centralized monitoring entails an analytical examination by sponsor employees or representatives at a central location other than the clinical trial site. 

Our mission at Xcene Research is to accelerate access to life-saving treatments in Africa, and we believe that one way to do so is through quality and effective clinical monitoring plan in the various stages of clinical trials, which is why we pay meticulous attention to detail at every stage of our clinical trial processes. 

Until the previous decade, all clinical studies were conducted in person. Volunteers had to go to a study site, which may be near their home or across the nation. The inherent flaws of these particular studies are that they;  

• Are more expensive, slower, and inefficient.  
• Create time and cost impediments for patients to participate.  

• Reduce participation and enrollment times.  
• Assist in the lack of variety among clinical trial participants.  

Many patients who would otherwise be interested in participating are unable to take time off work or lack the financial resources or ability to travel.  

Virtual clinical trials  

Mobile devices, apps, remote monitoring equipment, and online social interaction platforms are all used to perform virtual clinical trials or studies. It lowers some of the barriers to participation by allowing study volunteers to communicate with researchers and healthcare experts via telemedicine, having nurses visit patients in their homes, and letting patients travel to local labs rather than a study site. These trials, also known as decentralized clinical trials, have the following advantages:   

• They provide better convenience and a more inclusive study design for participants, especially those with mobility issues, who reside in rural areas far from study locations or face other obstacles to participating.  
• Increasing the number of people who can enroll in studies and stay for the course of the study.  
• The ability to track participants’ health throughout time rather than just on-site provides a more accurate picture of their health.  

• Making the process of developing and approving novel treatments more efficient.  
• Allowing for a more patient-centered clinical trial design.  

This virtual study can have several risks and drawbacks, including:  

• Concerns about the sharing of patient health information over the internet.  
• Problems with the apps or platforms required to participate in the study.  

• A lack of face-to-face communication with healthcare professionals.  

It’s fantastic to learn that technological advancements have improved clinical trials in Sub-Saharan Africa by allowing for the utilization of virtual clinical trials. Traditional clinical trials, on the other hand, cannot be completely eliminated due to their own benefits and the slow expansion of virtual clinical trials due to other vices that impede consistent progress. Hybrid clinical research is becoming more popular in Africa. Some research tasks are conducted remotely using mobile phones, wearables, or other devices in hybrid clinical trials, while others are conducted in person at traditional study locations. Hybrid trials provide the advantage of allowing participants to participate in some research activities remotely while still having the opportunity to contact study staff in person.  

At Xcene Research, we think that therapeutic advancement is impossible without innovation. That is why we are always looking for new methods to revolutionize the industries wherein we engage.