Compliance In Focus

The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death.

It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of these events occurred decades ago, medical devices still have the potential to cause harm.

These issues are documented in the FDA’s annual list of medical device recalls and (in some rare cases) even make headlines. Here are two examples of more recent medical devices that have hurt patients.

The history of clinical research is both fascinating and troubling. It’s a series of trial and error, followed by regulations that put patient safety ahead of profits.

In fact, it’s the reason IMARC Research exists—and why we're proud to be a partner in compliance for so many medical device companies. 

Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives.

Imagine being enrolled in a clinical trial without fully understanding the scope or the risks.

The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection.

In this post, we’ll discuss the key principles of the report, and in particular, how it clarified our understanding of informed consent.

With new technology and groundbreaking medical device news making headlines every day, there has never been a more exciting time to be involved in clinical research. So much is changing so fast — faster than at any other time in the history of clinical research.

At IMARC Research, we take pride in innovation. We’re constantly monitoring medical device trends and regulatory updates to determine how they might apply to the clinical research teams who enlist our oversight.

The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research. The FDA is one of the federal agencies most affected, as the budget for fiscal year 2019 is on hold until the shutdown ends and Congress can appropriate funds. FDA Commissioner Scott Gottlieb recently tweeted that “The lapse in funding represents one of the most significant operational challenges in FDA’s recent history…It’s not business as usual at FDA. Many key functions aren’t getting done”. Approximately 40% of FDA employees have been furloughed since December 22nd due to the shutdown. The reduced staff at the FDA has been allowed to continue performing specific duties associated with the regulation of clinical research using funding generated from carry-over user fee balances that were paid in 2018. As part of the review process for new medical device registration applications, the FDA charges what is known as Medical Device User Fees . Each type of FDA submission has an accompanying fee that must be paid by medical device companies in order for an application to be reviewed, such as $10,953 for a 510(k), $11,275 for an Annual Report, or $322,147 for a Premarket Approval Application (PMA). Similarly, under the Prescription Drug User Fee Act (PDUFA), user fees are charged for the review and approval of new pharmaceuticals, such as $2,588,478 for a new drug application when clinical data is required. While the FDA has been able to continue to carry out existing reviews that were funded during fiscal year 2018, this cannot serve as a long term solution as these funds are finite. The FDA Commissioner has already cautioned that agency funds from PDUFA user fees may run dry within a month’s time and medical device user fees may be close behind with only two-three months of funding remaining. Below are additional impacts related to the shutdown.

Recently the FDA released an announcement outlining plans to further modernize the 510(k) clearance pathway. This briefing falls in line with the latest efforts by the FDA to promote and improve safety and effectiveness in an efficient manner. The current 510(k) framework, which has been in existence since the 1976 Medical Device Amendments will undergo some much-needed updates in the near future to adapt to the ever-evolving medical device landscape. The FDA has already taken steps this past year to begin the transformation process, including the release of a draft guidance regarding the abbreviated 510(k) program. Additionally, the agency recently shared a “performance report” describing various measures implemented in the last 10 years to improve the 510(k) pathway, with a spotlight on recent efforts. These actions taken by the FDA include:

Clinical research professionals have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. Proper documentation is of the upmost importance in our work!

The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018. The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and improve public safety and detect safety risks earlier while keeping all those involved, including physicians, informed.

In the fiscal year of 2017, the Food and Drug Administration (FDA) performed over 900 inspections through the Bioresearch Monitoring (BIMO) Program. Of those 900 inspections, approximately 70% of the inspections targeted clinical sites. Without a doubt, there is some prediction about when and where the FDA will announce inspections during the course of clinical trial, both from the sponsor and the clinical sites.

When it comes to ensuring compliance, keeping your trial on track and bringing your medicaldevice to market faster, having independent oversight from a strategic partner makes all the difference.

Clinical project management is a logical and often desirable1 career progression for those in CRA roles. While the exact path from CRA to project manager (PM) varies from company to company and person to person, the first step for the budding PM usually involves education. For most, this training comes in the form of a project management course or seminar.

Entering the “home stretch” of a medical device trial is always an exciting time. You can see the finish line in sight. You’ve planned for success, and you’ve run the race well. But before you take your victory lap, you still have a few more hurdles to clear.

As Brexit negotiations continue between the UK and EU, clinical research sponsors are carefully considering the future of research in the UK, as the number of clinical trials held there has begun to decrease. From an average of 806 trials a year conducted between 2009 and 2016, to 597 trials in 2017, the numbers have diminished by over 25 percent. One medical research firm based in the US has halted its clinical trial activities in the UK due to the uncertainty in approval of medicines and acceptance of data by the European Medicines Agency.

In the daily chaos of running a medical device trial, it's a struggle to keep from dropping the baton. 

There are patients to enroll, protocols to follow, vendors and large volumes of data to manage. It’s enough to stress out even the most experienced clinical research professionals!

Take a deep breath. Remember all the work you’ve done to plan your trial before it started. Feel confident in your clinical research team, knowing they have been trained to understand and apply all the necessary regulations.

Then, follow these recommendations to keep your medical device trial running smoothly—and stay compliant.

IMARC Research will be represented at the MAGI Clinical Research Conference 2018 West in San Diego, October 21-24, 2018. The Director of Clinical Support Services, Rachel Silver-Kessler, will hold a work session for sponsors and CROs to share best practices for working with sites, and will present on adverse event reporting in medical device studies. Check out the full conference agenda here.

Conducting a medical device trial is a lot like running a race. It takes a lot of training and preparation before you even get to the starting line.

And the only way to ensure you reach the finish—bringing your medical device to market—is to ensure compliance at every stage in the clinical trial lifecycle.

That starts long before you sign up your first subject.

The planning stage is crucial because it sets expectations for how your team will work together to collect data, monitor results and protect your trial’s subjects.

In this post, the first in a three-part series, we’ll cover five important steps you can take to ensure compliance before you start your medical device trial.

FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.”

The FDA’s Bioresearch Monitoring (BIMO) inspection program ensures the protection of the rights, safety and welfare of human subjects during clinical research trials.

The most recent results represent findings from more than 1,300 clinical research audits of clinical investigators, sponsors and IRBs for the 2017 fiscal year.

This whitepaper covers the seven most common ones and how you can avoid them.

In Vitro Diagnostic (IVD) devices used in clinical trials are classified according to the risk that is involved based on the potential outcomes and impact if the test does not perform properly. The risk class (Class I, II, or III) determines the review pathway for regulatory assessment. If the device is classified as Class I or II, and if it is non-exempt, a premarket notification (510(k)) will be required for marketing. A 510(k) is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to a Premarket Approval (PMA).

Clinical research professionals have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. Proper documentation is of the upmost importance in our work! .

Your trial master file (TMF) tells the story of your entire clinical study, so you want to make sure it’s complete and accurate before the FDA reviews it. 

Hiring a third party to review your trial master file is the best way to ensure you’ve checked all the boxes.

However, the cost of a TMF audit can be significant.

Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Medical devices have undoubtedly improved the quality of life for millions of people, too. 

But a provocative new Netflix documentary raises an important question: Is there a point when innovation goes too far?

"The Bleeding Edge," produced by Academy-Award nominated filmmakers Kirby Dick and Amy Ziering, tells the stories of patients who say they’ve suffered serious health problems as a result of recent medical devices being used in their procedures.

Training programs should build proficiency in core job skills and be based on a strong regulatory foundation. Course curriculum should include practicum/on-the job training as well as exposure to emerging topics such as future trends in clinical data and patient centricity.

In order to comply with applicable regulations and requirements, the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data integrity, and ensure that the trial conduct is in compliance with the clinical investigational plan (CIP), agreements, GCP, requirements of the Institutional Review Board (IRB) / Ethics Committee (EC), and all applicable regulations.

In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now almost five years later, many sites and Sponsors have explored and implemented the electronic filing capability.

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset—the acceptance by all that, regardless of one's title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank. 

The purpose of clinical trial monitoring

In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits.

We have had many conversations with sponsors regarding their needs for monitoring support services. It is clear that while many sponsors consider the outsourcing of their monitoring needs to a CRO, they have many concerns that they have shared with us.

As many of us monitors are aware, there is high turnover in the research industry and clinical sites aren’t exempt from this. Quite often, we are likely to receive an e-mail with very little information regarding the current study coordinator or other study personnel leaving a clinical site. We may possibly receive a sentence that consists of who will be taking their place, or perhaps no notification at all.

Reviewing a medical chart can be a daunting task for anyone on the research team. However, ensuring proper data extraction and source data verification is paramount to ensuring data integrity and subject safety in your clinical trial.

While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset. The acceptance by all that regardless of the title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank. 

Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important for every trial participant—from the patients to the researchers. Whether the product being investigated is a drug or device, a well-organized, efficient clinical trial can save time and money for each individual and organization involved. Additionally, the faster and more accurately a trial is performed, the faster the new medication or clinical product can be introduced to the market and begins helping the community.

You may already know all the documents that your Trial Master File should contain to tell the right story about your study. (Check out our infographic for guidance.) And you can probably guess that a remote audit of your electronic Trial Master File could provide significant savings of time and money compared with hosting an in-person audit. So now you may be asking:

Anyone who’s ever prepared for an FDA Inspection of their clinical study has undoubtedly spent hundreds of hours sifting through all of the essential study documentation that makes up the Trial Master File (TMF) in an effort to make sure every single document needed to tell the study’s “story” is there, is accurate, and is complete. Sometimes this is handled internally and sometimes companies hire external contractors to assist. Either way, there can be a huge price tag associated with this. At two recent TMF audits, I found myself asking the following questions:

In clinical research, we often say “If it’s not documented, it’s not done.” Throughout a clinical trial, this adage guides decision-making processes when securing compliance. If a study team member was no longer working on the study, would the rest of the team know what happened well enough to explain?

Concomitant medications (con-meds) are any prescription or over-the-counter drugs and supplements taken in addition to an investigational therapy by a study subject. Many study protocols require capturing con-med usage into subject’s study record. This can be an extremely difficult task as it relies on the honest and accurate reporting by subjects as well as detailed review of medical records. It is not enough to simply submit the name of a medication, as most con-med reports typically require dosage, frequency, and duration of usage. Often, multiple con-med entries will need to be created in the study record for the same medication if the dosage changes or if the subject stops and restarts the medication. This can potentially lead to dozens or more errors of data point entries for a single study subject. So why are con-meds so important in research trials and how can researchers ensure that con-meds are being accurately reported?

The annual ACRP meeting will be held this upcoming weekend (27-30 April 2018) at the Gaylord National Resort and Convention Center in National Harbor, Maryland. This meeting presents an opportunity for clinical research professionals to meet and listen to/discuss the latest in clinical research. At this meeting, IMARC will be presenting on Saturday, 27 April 2018, from 11:30-12:30 on the topic of adverse event (AE) reporting for medical device clinical trials.

When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic. Under the FDA’s Clinical Data Summary Pilot Program, transparency of the approval process and access to more study-related documents are the goals, according to FDA commissioner Scott Gottlieb, M.D. who released a statement on 16 January 2018 about the new pilot program.

On May 25, 2018 the General Data Protection Regulation (GDPR) goes into effect in the European Union (EU). This regulation has a broad scope beyond companies performing clinical research – all personal data falls under this jurisdiction which includes web search engines, social media, and much more. But specifically, how does this new regulation affect personal data collected during a clinical trial and what do Sponsors and Contract Research Organizations (CROs) need to do to ensure compliance? Here we aim to address the highlights of the GDPR and its implications on clinical research.

In today’s competitive business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits.

A well-controlled clinical trial is much like a well controlled experiment. They are both rooted in the cornerstone of the scientific method. What exactly is a clinical trial? According to clinicaltrials.gov, “In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet.” In the 21 CFR 314.126, the FDA lays out regulations as to what makes an “Adequate and Well-Controlled study” as one that has:

This webinar will provide clinical research professionals with an understanding of safety oversight for clinical studies, including regulatory requirements and best practices. The presentation will include a discussion of the FDA’s Guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees, and help attendees understand the differences between Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and Medical Monitors. Professionals at research sponsors, CROs, sites, and IRBs will learn when each type of safety oversight is recommended and how to provide effective, efficient safety monitoring. Participants will also hear from a DSMB Chair about their experiences and the important impact of safety groups to research studies.

Clinical research professionals need to keep up to date with changes to the industry to ensure their studies remain compliant and human subjects are protected as research becomes more complex. Several important changes have taken place over recent years, including greater emphasis on risk-based and quality-focused thinking, as well as the increased use of electronic technologies to accomplish research activities.

The right clinical research project manager will keep your trial on track so you can bring your device to market faster. The wrong one can bring unwelcome interference, hindering progress.

You may think your team has covered all the bases when it comes to protecting the safety of human subjects in your clinical trial. You have a team of monitors in place to review reports and ensure your trial follows safety protocols. However, every trial needs a system of checks and balances.

Research sponsors and sites know the importance of implementing Quality Assurance processes for their clinical studies. For safety oversight, what steps can be followed to incorporate Quality Assurance into Data Safety Monitoring Boards, Clinical Events Committees, and Medical Monitoring? Take a look at these four tips:

1. Follow Thoughtful Procedures
2. Gain Consensus and Implement a Charter
3. Maintain Well-Organized Documentation
4. Build Quality Control Steps Into Processes

A safety monitoring group may be called many different things— a data monitoring committee, a data safety monitoring board, a clinical events committee, a medical monitoring group, among others. The sponsor will determine if and what type of safety monitoring group will be needed based on study risks.

What happens if you have a site that requests to use an unapproved device that could be life-saving for a patient without an Investigational Device Exemption (IDE)? The device has been through the phases of clinical trials and the Sponsor is working on submitting the premarket approval (PMA). The site in question was part of that clinical trial but now the study and enrollment goal has been met and the both the site and study are closed.

US FDA Commissioner Scott Gottlieb provided some key digital health initiatives along with his vision on how he wants the agency to work with the sector in the coming years.

Outsourcing clinical support services is a common practice, but can be a challenging process. Over the years, we have had many conversations with sponsors regarding their need for clinical support services and they have shared many of the challenges they have faced.

IMARC Research has moved to a new office in the Minneapolis area, in Minnetonka. The office will continue to be managed by Jim Moat, Director of Clinical Monitoring Services.

Jim is a Certified Clinical Research Associate with over 26 years of experience in medical device product development, having managed all phases of clinical studies – from pre-market strategy to post-market surveillance.

Writing great monitoring reports is not just about writing the report. It requires an in depth knowledge of the job, the study protocol, the site, their practices, the sponsor’s procedures, the monitoring plan, the report template, and of course, the regulations. Attention to visit preparation, clear notetaking during the visit, and prompt, clear report writing pays off in delivering a high-quality document. It is a difficult skill to master, but one that is rewarding, especially when faced with a regulatory inspection.

Having a well-trained clinical research staff is vital to ensuring compliance and securing regulatory approval. Providing training solutions for continuous improvement, understanding industry best practices and new clinical developments – is vitally important to employees. Yet many medical device companies face challenges on how best to provide high-quality training programs for their clinical departments.

You just got the phone call; the Food and Drug Administration (FDA) Inspector is coming for a visit.

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on 06 September 2017. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field. An interoperable medical device is one with the ability to exchange and use information with another medical or non-medical product, system, or device. An electronic interface is a medium by which these systems can communicate. This type of communication or exchange between systems and devices may include transmission and/or reception, storing, analyzing, or interpreting data. Medical device manufacturers are also designing interoperable devices to perform more advanced types of data exchange such as one device issuing commands or having control over another device(s).

On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.

Using this technique will give you confidence in resolving potential compliance issues and bridge the gap between knowledge and application. There’s a reason our FAIR Shake guide is one of our most-requested resources.

FDA is encouraging a quality systems approach to conducting clinical trials. The Clinical Trials Transformation Initiative (CTTI) established the Quality by Design initiative for clinical research. Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these products outweigh the risks.

In the healthcare industry, stories of patient harm can sometimes be the impetus for positive change. This was the case with the PIP breast implant scandal, where cost-cutting decisions that resulted in injuries eventually led to major regulatory updates. In 1965, plastic surgeon Henri Arion introduced breast implants to France. Jean-Claude Mas, a former butcher turned medical sales representative, and Henri Arion worked together in this field; following the death of Arion in a plane crash, Mas went on to launch Poly Implant Prothese (PIP) in 1991. It was the beginning of a company that would produce approximately two million sets of silicone breast implants over the course of a 20 year period and in its path, create a global health scare and shape medical device regulations. The silicone-based scandal came about when PIP implants made from a cheaper, industrial-grade silicone (that was not approved for medical use) were rupturing at a rate that was double the industry average. When compromised, the silicone gel was known to cause inflammation and possible scarring, and these implants continue to raise questions over the possibility of other harmful long-term affects. The timeline below summarizes the key points of the complex story:

Clinicaltrials.gov is a database of clinical research trials being conducted both in the United States and internationally and is intended to be a resource for patients and researchers alike. Housed by the United States National Library of Medicine, clinicaltrials.gov currently has postings for over 257,000 clinical studies that are being conducted in over 200 countries. On January 18, 2018, the “Final Rule for Clinical Trials Registration and Results Submission” will go into effect. This rule provides further clarification on the “What, How, and When” of clinical trial reporting requirements.

On August 31, 2017 The Food and Drug Administration (FDA) issued the finalized guidance manual for medical device companies’ use of real-world evidence (RWE) and real-world data (RWD) to gain FDA approval for their medical devices. The FDA draft guidance was originally issued on July 27, 2016 to the public to give those in the medical device industry an opportunity to provide comments prior to finalization. Additionally, the FDA hosted a webinar on the topic to provide additional guidance on October 10, 2017. Per the FDA, the guidance was issued “to clarify how we evaluate RWD to determine whether it may be sufficiently relevant and reliable to generate the types of RWE that can be used in FDA regulatory decision-making for medical devices.” This includes whether or not FDA will require an Investigational Device Exemption (IDE) to determine the safety and effectiveness of a device.

Most medical professionals enjoy being on the forefront of new clinical treatments, techniques and products. Drug and device research trials are a great opportunity for those in the healthcare field to learn about and assist in the development of revolutionary ways to treat patients, before they’re introduced to the public. These studies can provide invaluable information and learning experiences to everyone involved. IMARC has published a whitepaper on this important topic.

What is electronic informed consent?

Writing monitoring reports is an important responsibility. A well-written monitoring report tells the story of your clinical trial to the FDA and helps facilitate inspections. However, this important task doesn’t often get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list.

If you have run a clinical trial, you are most likely familiar with the Western Institutional Review Board, more commonly referred to as WIRB. They are the largest central IRB in the world, servicing pharmaceutical, device, and biologics trials across the globe. One of their most useful resources for clinical professionals is “A Guide for Researchers”, which outlines their current policies. These policies are based on an integrated regulatory framework, consisting of the Food and Drug Administration (FDA) regulations (namely 21 CFR 50 & 56), the Department of Health and Human Services (HHS) (45 CFR 46 Parts A-D), and the International Conference of Harmonization (ICH) Guidance for Industry (E6- Good Clinical Practice). As the clinical research landscape continues to evolve, the WIRB policies are adjusted to match that climate. This is evident in the four revisions/updates to “A Guide for Researchers”, updated August 17, 2017. These updates are described below.

It has been estimated that In Vitro Diagnostics (IVD) will play a role in around 70% of health care decisions, and market estimates predict the IVD market will be close to 75 billion dollars in 2010. The role of IVDs in health care decisions should only continue to grow as healthcare shifts away from a “one-size-fits-all” model. Furthermore, developments in technology and the scope and precision of some of these devices have led to the evolution of the IVD field and with it, the role the FDA has played in regulating these devices.

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).

Our latest guide is an in-depth look at how IMARC can work with you to ensure compliance throughout the Clinical Trial Lifecycle, including case studies within the following areas of service: Monitoring, Auditing, Project Management, Safety Management, Training and Consulting.

I was talking with a professional colleague recently, who referenced IMARC Research’s FAIR Shake™ method as a tool she uses regularly in her clinical research activities. It prompted me to feature our whitepaper on the FAIR Shake™ training program. Even though it is one of our older papers, it is still a useful tool for clinical research professionals. This technique helps you bridge the gap between knowledge and application.

Institutional Review Boards (IRBs) review clinical investigations that the FDA regulates, but the system of checks and balances goes both ways. The FDA has established regulations regarding IRB oversight, which are intended to protect the rights and welfare of human subjects. The FDA conducts inspections to ensure IRBs comply with these regulations and may issue warning letters for a variety of reasons.

Your friends from the FDA stopped by and noted several red flags at your site in a Form 483. Now what? The most important thing you can do as a principal investigator is accept responsibility for these violations and demonstrate you're taking steps to address them.

Informed consent is a process designed to protect the rights and welfare of a patient while providing a description of risks, alternatives, and any/all pertinent information that may alter a patient’s willingness to participate.

Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the rights, safety and welfare of human research subjects have been protected and that the validity of research data is accurate to support a marketing application.

IMARC Research has published a whitepaper outlining the similarities and differences between drug and device clinical trials. Since IMARC focuses primarily in the medical device space, we felt it was important to highlight the differences between the two trials. It has proven to be one of our more popular whitepapers, so we have decided to offer an infographic as a quick reference.

How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

The Food and Drug Administration (FDA) released an updated Guidance for FDA Staff for Sponsors, Contract Research Organizations (CROs) and Monitors on April 19, 2017 as part of the Bioresearch Monitoring (BIMO) program. The updated version contains revisions to Part III, section D, which provides additional instructions to FDA investigators related to www.ClinicalTrials.gov reporting and registration requirements that came into effect on January 18, 2017 in 42 CFR Part 11.

I ran across an article in a recent edition of Medtech Insight that focused on the 10 key details from US FDA agreements that will impact medical device and diagnostics companies. The article indicates that the US FDA user-fee reauthorization legislation is proceeding through Congress, most recently with a May 11 markup in the Senate Health, Education, Labor and Pensions Committee. Lawmakers would like to see a bill passed in July.

Evaluating patient data to ensure the continued safety of clinical trial subjects is an important part of a sponsor’s responsibility. Sponsors often enlist the help of independent boards to ensure expert oversight and eliminate the potential for bias.

Many believe good monitoring should heavily focus on Source Data Verification (SDV), which stripped down to its simplest meaning equates to “X=X” and “Y=Y”. And maybe some of you reading this are thinking “Isn’t that exactly what monitoring is?” While data integrity is absolutely essential, it is only the beginning of what comprehensive monitoring encompasses.

Monitors that perform their job at a high level can drive the growth and reputation of their company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.

Traditionally, Data Safety Monitoring Boards (DSMBs/DMCs) and Clinical Events Committees (CECs) have been set up to operate independently from each other. They have distinct functions and as such, membership generally does not overlap. However, since the FDA has no explicit regulatory requirement for the establishment of a DSMB/CEC (except in the case of emergency research conducted under 21 CFR 50.24 (a)(7)(iv)), it raises the question as to whether or not it may be feasible or even advantageous to combine their efforts into one safety monitoring board. To explore this option, consider the following Q&A’s:

Sandra Maddock, CEO & President for IMARC Research will be joining Tim Kulbago, Vice President, Imaging for ERT for a webinar entitled “Minimizing Risk in Imaging Clinical Trials” webinar on Thursday, June 15th at 10:00 a.m. EDT.

A clinical trial is required for all new drugs, but this is not the case for all medical devices. Medical devices start by undergoing a risk assessment in order to determine the severity of potential harm to the user and the probability of that harm occurring. Each device is assigned to one of three classes based on this assessment, and this classification dictates whether or not a clinical trial is necessary.

Patient A+0x3, ST with PVCs and PACs. Lungs clear bilaterally with POX 98% on RA and SOB on exertion, PPP, NPO after midnight. PERRLA. Normal BSx4 quadrants. Abd dressing C/D/I C scant amt of serosang drainage. MAE, SBA, and OOB as tolerated. BP WNL. NS infusing @75 ml/hr through RTL PICC, F/P.

Clinical Trials Day is celebrated around the world on or near May 20th each year in order to commemorate the day that a Scottish naval surgeon, James Lind, conducted what is often considered the first randomized clinical trial aboard a ship on May 20th, 1747. This year, Clinical Trials Day will be celebrated on Friday, May 19, 2017. In 1747, surgeon mate James Lind administered six different methods to attempt to heal sailors that were diagnosed with scurvy, with one of the methods involving oranges and lemons. This method healed the sailors, becoming a breakthrough for an intervention of scurvy, but more importantly demonstrating the potential power of a clinical trial.

In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits.

This week, May 1^st – 7^th, marks the third annual Clinical Trials Awareness Week, hosted by The Coalition for Clinical Trials Awareness (CCTA). The Coalition for Clinical Trials Awareness is a nonprofit group comprised of health care providers, patient advocates, medical researchers and industry and government stakeholders working together for one common goal - to increase public awareness about the importance of clinical trials participation. Established by the CCTA in 2015, Clinical Trial Awareness Week is observed annually the first week of May, encouraging patient advocacy organizations, medical societies, and other health organizations to rally together to raise public awareness about the importance of clinical trials and the benefits of participation.

The key players in a clinical investigation are infamously made up of Sponsors, monitors, investigative sites, and patients. A fundamental part of the team is also the Institutional Review Board (IRB), as they oversee the conduct of clinical research. Per the FDA’s IRB information sheet, “IRBs are responsible for continuing review of ongoing research to ensure that the rights and welfare of human subjects are protected.” That’s a tall order!

On Saturday, April 22nd, HBO will premier their film “The immortal Life of Henrietta Lacks.” We are excited to see the story becoming a film and thought we would republish a blog that we posted back in 2013 to honor the topic.

Clinical Monitors sometimes have a challenging job; they are often on the road, trying to balance work and home life.  They juggle multiple studies from different Sponsors, have many relationships to maintain, sites to visit, and reports to write.  At IMARC we want to always provide the very best monitoring services we can.  In order to do that we must have great monitors on staff, so, what makes a great Monitor?

Obtaining useful and significant data is paramount to a successful clinical trial; however for those studies with a limited amount of quantitative scientific data, results may be highly dependent on patient-reported outcomes (PROs). The FDA definition of a PRO is “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else”.

Many people are under the impression that Risk-Based monitoring equates to less monitoring, which isn’t actually the case. IMARC Research has utilized risk-based monitoring since the company was founded and we have always believed that Risk-Based Monitoring = Informed Monitoring.  In fact, if you step back and consider how you manage a clinical trial you will probably notice that you have been employing some level of risk-based methods yourself.  Maybe you have worked with one particular site many times before and you know you can count on them to deliver quality care to research subject while collecting accurate data.  Perhaps knowing this, you choose to postpone their monitoring visits until after site visits to newer less experienced sites can be made.  This is risk-based monitoring! 

Having independent oversight is critical to ensuring compliance, keeping your clinical
research trial on track and bringing your device to market faster.

For this reason, many companies hire a clinical research organization (CRO) to monitor, audit and even manage their trial. Outsourcing this work has become more common and is widely accepted throughout the industry, but it can still be difficult to turn over any or all aspects of your trial to a third party. 

Medical device trials in particular bring complex compliance challenges, so having a CRO with specific expertise in this area can be tremendously beneficial.

How can you be sure you hire a medical device CRO that is committed to ensuring compliance and is as invested in your success as you are?

This slideshare covers the five factors you need to look for when choosing one.

As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

Clinical research sponsors continue to outsource the management of their clinical trials, spending millions of dollars for a pivotal phase and significant risk medical device trial. Choosing a clinical research organization with compliance expertise will protect your investment and ensure your product is ultimately approved.

Dr. Robert Findling, Director of Johns Hopkins Division of Child and Adolescent Psychiatry and leading researcher in pediatric psychopharmacology, views being a principal investigator as “a privilege, not a right.” Dr. Findling has been noted as saying “with privilege comes great responsibility”. Principal investigators who subscribe to this philosophy can set themselves apart by leading the development of cutting-edge technology and novel treatments. According to 21 CFR 812.100, General Responsibilities of investigators, P.I.s are responsible for conducting research according to the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth by the IRB.