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Apr
29

A Strategic Imperative for Herbal Companies: Unlocking the Potential of Herbal Products through Clin …

Elevate your herbal brand by embracing clinical trials—uncover how scientifically backed validation can transform herbal products into trusted, market-leading solutions

Abstract

The herbal product industry is undergoing a transformative shift as companies increasingly integrate clinical trials to validate the safety and efficacy of their offerings. This article delves into the evolving paradigm of clinical research in the herbal sector, exploring the types of herbal products entering trials, the FDA regulations governing these interventions, and the strategic advantages of evidence-based validation. As demand surges for scientifically backed
natural solutions, clinical trials are emerging not just as a regulatory necessity but as a catalyst
for innovation, consumer trust, and competitive positioning in the dynamic wellness industry.

Introduction

For centuries, herbal products have served as the cornerstone of traditional medicine across
cultures. Today, they form a booming, multi-billion-dollar industry. Consumer behavior reveals a
seismic shift towards plant-based wellness alternatives, encompassing everything from dietary
supplements and functional beverages to herbal skincare and therapeutic nutrition. However, the modern marketplace is evolving rapidly becoming increasingly data driven, consumer conscious, and regulatory bound. To stay ahead in this competitive space, many companies are partnering with a US based clinical research company that understands both the traditional heritage and the scientific rigor needed for market success. Relying solely on anecdotal or traditional knowledge is no longer sufficient clinical trials are fast becoming a strategic imperative.

The Strategic Importance of Clinical Trials for Herbal Products

1. Establishing Scientific Credibility in a Saturated Market

In a crowded landscape filled with unverified claims, products supported by clinical research
stand apart. Clinical validation demonstrates a brand’s commitment to transparency and product
integrity, which is essential for long-term growth and trust-building.
As an example, companies leveraging clinical trial management solutions in the USA are
better positioned to launch products with scientifically supported health claims, setting a new
standard in the wellness industry.

2. Navigating Regulatory Complexities with Confidence

Meeting FDA regulations is no longer an afterthought—it’s central to successful product
development. In the U.S., companies must comply with standards outlined in the Dietary
Supplement Health and Education Act (DSHEA) and ensure that dietary supplements are
safe and marketed truthfully.
By working with a Clinical Research Organization USA, herbal brands can design trials that
align with regulatory requirements while ensuring compliance for future product claims. These
partnerships provide the scientific backing essential for entering high-barrier markets.

3. Unlocking Premium Pricing and Global Market Expansion

Clinical trial data not only boosts consumer confidence but also supports premium pricing and
international market entry. Evidence-based positioning opens doors to new demographics, such
as healthcare professionals and export markets, that require scientific proof of efficacy and
safety.
Forward-looking companies are collaborating with experts that offer end to end CRO services
in the USA to capitalize on these growth opportunities and maintain compliance across global
jurisdictions.

Categories of Herbal Products Benefiting from Clinical Research

1. Herbal Supplements

The rise of evidence-based dietary supplements has sparked increased investment in clinical
trials targeting immune function, stress relief, and cognitive enhancement. Botanicals like
ashwagandha and turmeric are undergoing rigorous testing to validate centuries-old claims with
modern data.
Partnering with a CRO specializing in oncology trials USA can also be beneficial for herbal
products that aim to support complex health conditions, including inflammation and immune
modulation.

2. Functional Beverages

From herbal teas to adaptogenic energy drinks, functional beverages are being clinically
studied for their effects on metabolism, sleep, and stress management. Ingredients such as
green tea and hibiscus are moving from folk remedies to evidence-backed solutions.
Companies that utilize clinical development services in the US are ensuring their products  are positioned as serious wellness interventions rather than fleeting trends.

3. Herbal Skincare and Cosmetics

Topical products containing chamomile, calendula, and aloe vera are gaining traction for their
anti-inflammatory and anti-aging properties. Clinical trials measure their efficacy in reducing skin
irritation, promoting healing, and enhancing complexion.
With rising consumer expectations for proof over promise, partnering with a Clinical Research Organization USA is critical for entering dermatological markets with confidence.

4. Functional Foods and Nutritional Products

Plant-based protein powders, superfood blends, and wellness snacks often include herbal
components like moringa and fenugreek. Clinical research supports their role in digestion,
weight control, and metabolic balance.
Using a US based clinical research company to validate these formulations ensures
compliance and enhances consumer trust, particularly when claims involve measurable health
outcomes.

5. Herbal Medical Devices

Herbal-infused devices—such as pain-relief patches or wound-healing bandages—are subject
to complex regulations. Clinical validation is necessary to demonstrate both the herbal
component’s efficacy and the device’s functionality.
For such novel combinations, partnering with an experienced team offering biotech clinical trials USA can be essential to ensuring success across development and regulatory approval.

Understanding FDA Regulations for Herbal Products

1. DSHEA and the Classification of Herbal Products

Under the Dietary Supplement Health and Education Act (DSHEA), herbal supplements are
treated as food rather than drugs. This allows easier market entry, but companies must
substantiate safety and avoid unverified health claims.
Brands seeking to maintain integrity and avoid penalties often collaborate with a US based clinical research company to navigate regulatory nuances effectively.

2. Adherence to Good Manufacturing Practices (GMP)

The FDA mandates Good Manufacturing Practices (GMP) to ensure consistency, quality, and
safety in herbal products. Trials built on GMP-compliant formulations are more likely to yield
trustworthy, repeatable results.
Many firms choose clinical development services in the US to ensure that trials meet these
stringent expectations from the outset.

3. Substantiating Health and Disease Claims

Structure/function claims such as “supports heart health” are permitted, but they must be
supported by reliable clinical data. If a product implies treatment or prevention of disease, it
enters drug territory and may require a New Drug Application (NDA).
Engaging with a Clinical Research Organization USA allows herbal companies to prepare
appropriate documentation, thereby mitigating legal risk and ensuring accurate product
positioning.

4. GRAS (Generally Recognized as Safe) Status

Herbs with GRAS (Generally Recognized as Safe) status are easier to market. However,
those without such designation must undergo clinical safety assessments. Trials play a vital role
in establishing new GRAS status, paving the way for regulatory approval.
Working with clinical trial services in the USA ensures a seamless pathway from concept to
compliance.

Conclusion

Integrating clinical trials into the development pipeline is no longer optional for herbal
companies—it’s a strategic imperative. Evidence-based validation provides not only a platform
for premium pricing and global expansion but also fosters deep consumer trust in an
increasingly informed market.
By collaborating with a US based clinical research company and adhering to FDA
regulations, Good Manufacturing Practices (GMP), and GRAS guidelines, herbal brands can
lead the next phase of innovation in the wellness industry.
Science and tradition no longer need to exist in separate silos. By investing in rigorous clinical
research, herbal companies are uniquely positioned to elevate centuries-old remedies into modern, credible, and global health solutions.

 

Jun
28

Food and Dietary Supplements Clinical Trials Regulations in USA

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The FDA defines ‘food’ as per the Food, Drug, and Cosmetic (FD&C) Act as articles for food or drink for man or other animals, chewing gum, and articles used for components of any such article. According to the Dietary Supplement Health and Education Act (DSHEA), a dietary supplement is a product intended for ingestion that, among other requirements, contains a “dietary ingredient” intended to supplement the diet.

The term ‘dietary ingredient’ includes vitamins and minerals; herbs and other botanicals; amino acids; “dietary substances” that are part of the food supply, such as enzymes and live microbials (commonly referred to as “probiotics”); and concentrates, metabolites, constituents, extracts, or combinations of any dietary ingredient from the preceding categories. The FDA regulates dietary supplements under a different set of regulations than those applicable to conventional foods and drug products under the DSHEA Act.

The rise in the uptake and use of alternative treatments has led to a rapid increase in the market share for dietary supplement for the purposes of ensuring proper nutrition and preventive measures related to aging and development of certain diseases. A study in 2021 showed the global dietary supplement to be valued at USD 152 billion with a projected increase to USD 300 billion by 2028.

This has made it important for the FDA to regulate food and dietary supplements. Regulation of the safety and health claims of food in the USA is under the FD&C Act. In general, unless the food is claimed to have certain health benefits, clinical trials are not necessary. Dietary supplements are considered a subset if food and not drugs and are regulated by the FDA differently from drugs under the DSHEA. However, the FDA can require premarket approval of certain food additives and colour additives to make sure that they are safe for human consumption. Issues related to efficacy and safety of dietary supplements, presence of toxic contaminants and heavy metals, pesticide residues, adulteration, and misidentification of ingredients plague the supplement industry requiring comprehensive characterization of the ingredients, in vitro and preclinical studies, animal-to-human extrapolation, and clinical research to ensure safety and efficacy.

Additionally, the competitive market for dietary supplements has prompted many companies to conduct trials to provide substantial evidence for their benefits helping with product differentiation. It is important to bear in mind that clinical studies for dietary supplements differ from those with drugs in subject population, study end points, sample sizes, and surrogates or biomarkers.

Although the FDA does not have the authority to approve dietary supplements, manufacturers of dietary supplements containing new dietary ingredients need to submit a premarket notification to the FDA at least 75 days prior to introduction into the market. Premarket notifications are necessary to be submitted to the FDA for food and food additives.

Whether a clinical trial is required for dietary supplements depends on the claim that is reported. If the dietary supplement claim’s structure/function benefits or nutrient content claims, clinical trials are not required, and substantial scientific evidence is enough. However, if health claims are made, both foods and dietary supplements require clinical trials to support the claim that the food or dietary ingredient directly affects individuals’ health-status.

As with drug clinical trials, the regulations for clinical trials of dietary supplements purporting health claims require the following:

:

  • Investigational New Drug (IND): The need for an IND to conduct clinical trials for dietary supplements depends upon whether the endpoint is disease-related and leads to an approvable indication. The Centre for Drug Evaluation and Research (CDER) determines if an IND is required to initiate clinical research based on the study endpoint (diagnostic or disease-related), population and indication, and dosage. The FDA/CDER does not require the sponsor to submit an IND for structure/function claims but requires one when disease claims are made. In case of surrogate end points (cellular mechanisms and diagnostic findings), it is necessary for CDER to review the data thoroughly and use their discretion to determine if an IND is required.
  • Informed consent: This is necessary for all studies involving human subjects to protect their safety and well-being. It is important to ensure that all participants are informed of the risks and benefits associated with the dietary supplement and are well-versed of their ability to withdraw from the study at any time.
  • Institutional Review Board (IRB) approval: The IRB determines if an IND is required based upon the claims made for marketing the dietary supplement and ensures that the protocol is sound with patient safety at the forefront.
  • Good Clinical Practice (GCP): The trial must comply with GCP guidelines and all personnel conducting the trial must be trained on GCP.
  • Good Manufacturing Practices (GMP): It is necessary that the investigational dietary supplement is manufactured, packaged, and stored in a facility that follows GMP ensuring their identity and purity.
  • Safety reporting: Adverse event reporting practices must be implemented and continually updated such that the FDA is aware of any potential safety concerns that the supplement may have. Safety signals should be reported to the FDA in a timely manner and detailed records must be maintained.

Complying with the above-mentioned regulations ensures that dietary supplement clinical trials are trustworthy, reliable, and accurate and meet the health claims that they are purported to have. The FDA’s rigorous standards to make sure that the dietary supplements are safe when used in the general population.

Read More:

Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management

References

 

Apr
01

Technology in Clinical Research

Technology in Clinical Research

The technologies we use on a daily basis – from search engines to streaming music services – recognize patterns in our behaviors and, coupled with vast amounts of data from millions of other individuals, make predictions of what each of us may want in the future. In so doing, the power of data at scale has transformed almost every industry, personalizing our experiences with different platforms in many aspects of our lives. Yet in Clinical Research we’ve only scratched the surface.

The dream of bringing about this transformation in clinical research has been around for several years, but it wasn’t achievable because the digitization of clinical research has never been at the requisite level, until recently. Depending on who you ask, the future of personalized clinical research data can mean many different things, but the unifying theme is that it will be about meaningful data at scale.

In our view, that means utilizing technology to acquire more data from each patient than ever before and bringing together data from more patients to arrive at a deeper understanding of how to treat an individual based on these ultra-high resolution profiles. Only then can we visualize what distinguishes each of us as individuals, and translate that into a clear, personalized path towards improved care for every person.

We know that the use of real-world evidence, molecular information generated from next-generation sequencing, data from wearable devices and mobile apps, and results of novel clinical trials can help transform the future of care. However, we need to combine and aggregate this information in a manner that enables answers to questions that meet the needs of patients. And for us to get to those meaningful answers, we need to have a certain breadth and depth – and quality – of that data.

Sep
30

“Patient engagement and Quality design – key for the clinical trial success”

Patient engagement & Quality design – key for the clinical trial success

Working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused requires transformational shifts in the design and conduct of clinical research (clinical trials). Let’s take a look at the evolution of clinical trials in three key areas, among many, in which ProRelix Research has played a critical role in moving the clinical trials toward more efficient, high-quality, and patient-centric trials:

1. Trial Quality:

Regulators have long acknowledged a need to change how the industry approaches clinical trial quality in order to focus on reducing errors that undermine data integrity and patient safety, essential for the clinical data management systems. Drawing on the expertize  of key stakeholders, ProRelix Research implemented an effective and efficient trial monitoring, risk-based approach to monitoring which reflects our principles of work. We have developed the concept of Quality by Design, taking the focus from a reactive approach using our internal audits to a proactive approach that builds quality into clinical trials at the outset.

2. Patient Engagement and Centricity

ProRelix Research has been a pioneer in patient engagement, involving patient representatives in the project design and throughout its project execution for better recruitment retention. This released landmark recommendations that are currently used by multiple stakeholders to facilitate productive relationships with patient groups around clinical trials.

We define patient centricity as acknowledging the value of the patient’s own experience with their medical condition and applying this experience toward the design of a clinical research study or similar initiative. In the context of clinical trials, patient centricity refers to engaging with patients throughout both the study design and execution.

In all aspects of healthcare, this movement has led to higher levels of patient collaboration, engagement in key decision-making, better medical outcomes, and greater access to innovative treatments. One aspect that is crucial for your clinical trial is the recruitment stage. Here, patient centricity and engagement play a foundational role in any study’s success and significantly impact on financial benefit for our clients.

3. Real-World Evidence

Since ProRelix Research’s inception, we have recognized that “real-world evidence” from electronic health records, mobile devices, and other sources can provide unique insights into important clinical questions and could improve the efficiency of clinical trials. We have developed a system to link safety data from multiple sources, paving the way for the use of connected datasets in clinical trials.

Before conducting a real-world review of a product, it’s vital to study the existing product and competitor data to see whether it’s likely that your product will perform better or worse in the real world. This should be done as early as possible and includes consulting with experts who can evaluate and predict the channeling and other confounding factors that are expected to arise when the product enters the market.

A plan for RWE is needed to support market access and pricing. It should not only consider benefits, but also take possible risks of real-world effectiveness into account, and have plans to mitigate the impact of potentially biased outcomes.

Jul
14

Beyond COVID-19! Learn to live with New Normal Life

Beyond COVID-19! Learn to live with New Normal Life

The world is now several months into the “Coronavirus disease (COVID-19)” global pandemic caused by the SARS-CoV-2 virus. As lockdown restrictions slowly begin to lift in certain regions, the pursuit for a safe and effective vaccine against the virus continues – and more research groups are joining the efforts.

Over the course of 2020, the COVID-19 pandemic has caused an unprecedented global crisis, resulting in a devastating death toll and threatening our economic order and societal structures. It started in late 2019 and now has infected more than 200 countries and territories. On 20th June 2020, WHO has reported globally 8,525,042 confirmed cases (Americas- 4,163,813; Europe- 2,509,750; Eastern Mediterranean 878,428; South-East Asia- 560,825; Africa- 208,535; Western Pacific- 203,490) including 456,973 deaths over time.

The COVID-19 (coronavirus) pandemic has substantial health, social, and economic impacts in all countries, rich and poor. It is a sharp reminder that everyone everywhere should have access to quality and affordable health services. We will be living with COVID-19 and its consequences for a long time to come.

Humans are blessed with the clinical research industry. This industry is working around the clock efficiently to find the treatment or cure for COVID 19. There are so many clinical trials that are ongoing in the whole world to get a permanent treatment for this novel coronavirus.

The World Health Organization recognizes that, as of July 9, there are over 140 vaccines in various stages of development. Some are being fast-tracked by regulatory authorities, whilst others remain at the very early stages of pre-clinical testing.

Clinical research industry has escalated the efforts in the development of vaccines against COVID 19. The pharmaceutical industry and research sectors are working to develop the prophylactic vaccine by using different platforms including mRNA, DNA, adenoviral vector, and recombinant protein. We at ProRelix Research are feeling privileged in supporting some of the industrial efforts through our clinical research services.

Health systems has now been facing the dual challenge of responding to the outbreak and maintaining routine services which we have never thought that we would be facing.

COVID-19 demands that we think about global protection and calls for a renewed and urgent focus on specific public health systems to overcome this critical situation that mankind has been facing now. This includes special attention to disease surveillance, laboratories and diagnosis, health information systems, communications about changing behaviors, engagement of communities, and building public trust in the health system.

COVID-19 is a global crisis requiring sustained international solidarity and action. Strengthening our community and health care system has an important role to play in bringing partners together on a joint vision for resilient health systems and priority actions.

Conclusion:

Hopefully, a new norm is emerging where we share information across countries, collectively coordinate resources, and work jointly for the survival of the human race. And more importantly, live on a planet where we don’t mess with nature. Hopefully, we find the balance and make sure that we don’t overconsume what we have given, we spend more time with our families and take care of our health more.

References:

1. https://pubmed.ncbi.nlm.nih.gov/32365466/
2. https://covid19.who.int/
3. https://pubmed.ncbi.nlm.nih.gov/32295814/
4. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novelcoronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
5. https://www.ayush.gov.in/docs/123.pdf
6. http://apjai-journal.org/wp-content/uploads/2020/03/1.pdf
7. file:///C:/Users/Admin/Downloads/novel-coronavirus-landscape-covid-19-24062020.pdf
8. https://www.who.int/health-topics/international-health-regulations#tab=tab_1
9. https://www.who.int/health-topics/common-goods-for-health#tab=tab_1

Dec
03

A Glimpse of CRO Industry in India

A Glimpse of CRO Industry in India

In the Drug Development process, clinical research plays a key role because the approval from the FDA requires clinical trials to signify the safety and efficacy of pharmaceutical products. Clinical research helps in grasping and applying knowledge for products or processes in the prediction, prevention, diagnosis, treatment, and cure of disease in humans. Clinical research includes research on humans, epidemiological, behavioral, and health services research.

Patient-oriented research explores the process of human diseases, effects of drug therapies, etc. Epidemiological and behavioral research assesses the division of and factors associated with disease, behavior, and health in general. Research related to health services analyzes the effectiveness and efficacy of the treatment in the real world.

Clinical trial industry is a booming industry and perpetually evolving and advanced clinical studies are being established at an ever-growing pace. Clinical trials are the main part of the clinical research and are organized in four phases which have different causes and helps scientists to find the answers to different questions.

Pharmaceutical and Biotechnology companies have been experienced the crucial task of minimizing their drug costs which had forced to most of the companies to analyze cost-saving options such as outsourcing. Most of the companies in this area have already acquired the strategy to outsource their processes to specialist service providers such as CRO.

This approach helps to bring improved efficacy in terms of timelines, regulatory norms, and costs. In India, Contract research organization is one of the growing markets. The market is majorly bifurcate into Drug Development/ clinical trials, Drug Discovery, and Postmarketing services.

Additionally on the basis of drug discovery services type the market is segmented into clinical services, biology services, chemistry services. India Contract Research Organization Market is projected to grow at a CAGR of 20.4% and is expected to reach US$ 6,310.5 million by 2022.

In India, contract research organization market, drug development/clinical trials accounted for the largest market share in 2016. India became fully adaptable to TRIPS in 2005. In order to promote clinical trials in INDIA, policymakers have been trying to make some changes in the policy framework and regulatory environment. These changes have stimulated the International Clinical Research Organizations (CROs) to broaden their clinical research in India.

Nearly a fifth of all trials globally are hosted by India which are having huge potential for financial and scientific gains. CROs are taking an edge of gaining a large patient pool, qualified medical investigators, lower drug development costs, and winding up the clinical trials in India on time.

There are multiple reasons global pharmaceutical companies are outsourcing their projects in India for enhancing profit, cutting the cost of drug development, and shoot the regulatory approval. In India, clinical trials are 50% cheaper as compared to developed countries.

Cheap human resources are the main reason for the low cost of drug development, low recruitment cost, and the lesser rate of compensation for an injury sustained or death during the process of clinical research. The Government of India summons the multinational companies for the clinical trials to be conducted in India in order to allure foreign investments for financial and technological gains in this area.

The dogma of clinical research is that it should be of broader welfare to society. Societies cannot be of two different types- one that takes risk whereas the other harvests the benefits. Clinical trials.gov is a registry and result database of public and clinical trials which are privately supported on human participants conducted globally.

On the other hand, CTRI dataset, is conventionally published by the Indian Council of Medical Research (ICMR) and it has been made mandatory by the Drug Controller General of India (DCGI) to register the trials on CTRI before enrollment of the first participant of any category of intervention including drugs, surgical procedures, preventive measures, lifestyle modification, devices, educational and behavioral treatment, rehabilitation strategies and trials are conducted in the Department of AYUSH.

A Clinical Research Organization/ Contract Research Organization (CRO) is an organization that offers services in the pharmaceutical, biotechnology, and medical devices industries in a form of research services outsourced on a contract basis. Services include but are not limited to Product development, formulation activities, Phase 1 to 4 activities, data entry and clinical data management, Project management, IRB approval, statistical analysis, and other necessary activities to apply for a New Drug Application (NDA).

India has been a hub for organizing and regulating clinical trials. The CDSCO headed by DCGI has set forth some rules and regulations for the clinical trials to be done in India.  The drug approval process in India has faced challenges in recent years some around mandatory licensing of patents, Government price control, and narrow standards of patentability.  It is compulsory that clinical trials in India should be as per ICH-GCP guidelines followed by amended Schedule Y of the Drugs and Cosmetics Act.

The CDSCO handles the approval process and apart from CDSCO approval, DCGI has given authorization to each state’s drug control authority to regulate the manufacture, sale, and distribution of drugs. The objective of the Drugs and Cosmetics rule was to upgrade patient’s safety, reporting patient’s timeliness of serious adverse events including deaths.

Who are we?

ProRelix Research is a leading global award-winning clinical research organization (CRO). Apart from India, ProRelix Research also functions as the best Clinical research organization (CRO) in US where it provides services like clinical data management (CDM).  Since 2011 we are specialized in providing pharma/Biotech with clinical project management, feasibility, and site selection to meet the timely enrollment goals and site management.

We provide a full range of clinical trial implementation in United States also. Our innovative approach supports biopharmaceutical clients who perform complex clinical trials. Our core services provide expertize in various therapeutic areas such as oncology, CNS-Including Pain and Psychiatry, Autoimmune Inflammation, cardiovascular, Ophthalmology, Endocrine/Diabetology.

As a company that assists in complex clinical trials, we know how to support the demands and needs of the customers with flexibility and clarity through the study, by providing high-quality services to meet current and future needs.  As a skillful Clinical research organization, we assist our clients with clinical Data management and regulatory expertize.  ProRelix research has become an excellent supplier of choice for many top pharmaceutical companies.

Oct
24

Efficient Clinical Trials is the key on Efficient Orphan Drug Development

Efficient Clinical Trials is the key to Efficient Orphan Drug Development

FDA officials shared their insights on how drug makers can be more efficient when developing treatments for rare diseases, according to comments at the National Organization for Rare Disorders (NORD) Summit in Washington, DC.

Despite the growing number of new therapies in development for rare diseases and approved each year, relatively little is known about many rare conditions.

“Unlike common diseases, there’s a lot of information lacking when you want to develop a drug or other intervention for a rare disorder,” noting a lack of information about the natural history of a disease or its impact on a patient’s daily life.

This is particularly important in the orphan territory because there are often few patients in total and there are usually very few near the centers that want to do the studies, Because of the challenges inherent in identifying and enrolling patients with rare disorders in studies, having detailed natural history data “can make a tremendous difference in identifying the manifestations you want to try to treat and identifying the patients you should include” in a study.

http://www.raps.org/Regulatory-Focus/News/2017/10/17/28704/FDA-Officials-Offer-Advice-on-Efficient-Orphan-Drug-Development/

Oct
04

Safety Monitoring Oversight Adds Value to Your Study

Safety Monitoring Oversight Adds Value to Your Study

Researchers agree that the highest standards in clinical research need to be preserved to maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary consideration, the implementation of safety monitoring is paramount. One means of adding this value to a study is utilizing a Data Safety Monitoring Board (DSMB) and/or a Clinical Events Committee (CEC).

A Safety Monitoring Committee can have many different names, but they each have the same goals – patient safety and data integrity, will be sure to add value to your study.

  • Data monitoring committee
  • Data safety monitoring board
  • Clinical events committee
  • Medical monitoring group
  • A DSMB will review cumulative safety data, and possibly effectiveness data as well, and make recommendations to the sponsor regarding whether it feels the study should continue, continue with modifications, or be terminated. The overall goal of a safety monitoring group is always the same: additional, independent oversight of a study involving human subjects. A safety monitoring group such as a DSMB or CEC is an investment in safety and data integrity that goes beyond checking a box. Seek qualities in an independent, high-quality safety management team that will be sure to add value to the study.
  • The CEC instead reviews individual qualifying adverse events and provides adjudications to the sponsor, often to assess relatedness to the investigational product and/or study procedure.
  • The sponsor will determine if and what type of safety monitoring group will be needed based on study risks. The objectives and procedures may vary depending on the role of the safety monitoring group or depending on the risks involved in the study.
Sep
27

ICH-GCP E6 R2 Current Updates

ICH-GCP E6 R2 Current Updates

In a Publication Report from the Institute of Medicine (IOM) was based on a workshop held with the focus on the importance of “Public Engagement and Clinical Trials.”

As we all know that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal. Patient recruitment challenges for a range of medical conditions, illustrate the role of stakeholders’ perspectives in shaping their engagement with the clinical trials enterprise. In this report, IOM points out the fact that lack of engagement of the stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials. Advances in the field of medicine are dependent on the quality of research that is conducted.

As the report points out, “Clinical Trials are the linking step that enables basic research findings to emerge at the patient’s bedside and the physicians’ examining rooms. The questions clinical trials seek to answer change over time, depending on advances in basic research and the population health problems they are intended to address. Potential new treatments must be tested in humans in order to find out whether they succeed and whether they cause harm.”

Unfortunately, some of the public’s opinion of clinical trials, or “human research,” has been influenced by a haunting past. From the Tuskegee Syphilis study to the clinical Trial Disaster In France Last year, these are examples of serious research misconduct. No person wants to be seen as a “means to an end.” Could these trials have an effect on the general public’s trust of the research industry?

This is why Good Clinical Practice is so important. Yes, most investigational treatments must go through clinical trials, but each study team should have a mindset that is absolutely essential to protect patients’ rights and assure data integrity. Take the time to download and read from Guideline for Good Clinical Practice – ICH to better understand the process of Good Clinical Practice.

The new ICH GCP E6 R2 regulations

To address the concerns from GCP regulatory inspections in June 2015, the ICH released an amended version of the international guidelines for GCP: ICH GCP E6 (R2). The new GCP draft represents the biggest revision of the international ICH GCP guidelines for over 20 years and has the potential to fundamentally alter the way in which clinical research is managed (2). The EMA welcomed the R2 changes, stating that these new guidelines “will provide increased clarity and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting” (3). The new ICH GCP E6 (R2) Addendum introduced 26 new items covering three main areas of clinical research: data management, and sponsor and investigator responsibilities
Please share your thoughts on steps our industry can take to engage the public in clinical trials.

Aug
31

Indian Government Eases Norms To Test & Launch Drugs

In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries. Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General of India, under the health ministry, said in a latest circular issued this week.

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