Don’t sweat an FDA sIRB mandate in clinical research – It’s good news for everyone (2024)

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Don’t sweat an FDA sIRB mandate in clinical research – It’s good news for everyone (1)

We knew it was coming, and now it’s close. By the end of 2024, the US Food and Drug Administration (FDA) is expected to formally make reviews by a single institutional review board (sIRB) the standard for most multisite, regulated clinical research in the United States.

Reviews have been moving in this direction for several years. In 2018, the National Institutes of Health (NIH) officially made sIRB the policy for all NIH-funded research. In 2020, the sIRB mandate extended to nearly all federally funded research through the Federal Policy for the Protection of Human Subjects (also known as the “Common Rule”). And once the FDA issues its latest mandate, sIRB will be the model for the remainder of non-federally funded research, with nearly all multisite research conducted in the US requiring sIRB review.

It’s good news for everyone, even if it represents a shift in control from clinical trial sites to the industry sponsors, who will now have final say over IRB selection and greater leverage to control study timelines.

Why is this such a positive change? Because one sIRB of record for all trial sites removes the complexity and often disparate criteria of multiple local IRBs, significantly reducing study start-up timelines. It shrinks the administrative burden on investigators, sites, and sponsors. And it promotes consistent study conduct and information to patients across sites, which in turn leads to more reliable data.

At a time when both the number and complexity of clinical trials have entered unprecedented territory – with a 6% increase in the average number of trial endpoints since 2003 – the centralised sIRB approach helps trim the fat by increasing speed to approval and eliminating duplicative costs. In one recent multisite trial of an influenza vaccine, the NIH compared the sIRB model to a local IRB approach and found the mean time to approval was “substantially faster”, at 81 versus 121 days. Time to first enrolment was also faster (126 vs. 149 days, and faster compared with published averages of 169 days). And getting a product approved more than a month sooner using sIRB equates to millions of dollars saved.

From the mouth of a believer

Granted, once the expected FDA mandate takes effect, universities, hospitals, and health systems that have previously used their own local IRBs for clinical trials may experience some disorientation. It can be a big shift to go to one IRB of record, particularly when the power to choose that sIRB is in the hands of the sponsor. Dr Christina Brennan, senior vice president of clinical research for Northwell Health, said local IRBs will also continue to have a role when it comes to patient safety, verification of staff, and more.

But to the institutions who conduct the trials, the advantages of the sIRB model outweigh most disadvantages. Dr Brennan would know. Northwell Health, the largest private employer in New York state with 21 hospitals and more than 900 walk-in clinics, has a team of around 500 clinical investigators who work on about 1,000 active clinical trials every year, including industry-sponsored ones, with enrolments of 2,000 patients or more. That’s a lot for a local IRB to handle, so Northwell has long been following an sIRB model, even without an FDA mandate.

“The change to moving to a single IRB is not going to be a problem for our institution,” Brennan said. “It is something we’ve allowed our investigators to choose to follow for over 10 years. Since we have a high volume of investigator-initiated trials and academic scholarly activity, the use of a single IRB takes much of the burden off our local IRB to focus on these other studies.”

And it stands to streamline processes even more.

“I think the mandate is great – and it’s a long time coming, giving sponsors the ability to know what’s going on in their trial in real time and bringing efficiencies in study start-up and turnaround times,” Brennan said. “Academic medical centres are known to often take a long time to open because of institutional requirements and local IRBs insisting they must be the local reviewer. But metrics clearly show that sIRBs have a faster turnaround time. Ultimately, it’s all for the patient, and anything we can do to improve study timelines will lead to trials opening faster, creating opportunities for potential treatments to reach patients. I only see it as a positive to get all sites on the same page.”

The efficiencies of sIRB continue after start-up, too – throughout the life cycle of the study.

“Protocol amendments are very common, so one IRB facilitating everything for all the sites in the trial will help tremendously,” Brennan said. “A sponsor is right back where they started if they must wait for multiple institutions to get their IRB approvals. When safety is being reported to the one IRB, then they have that knowledge in one location in real-time – and knowing is everything.”

A checklist for sponsors

To ensure a smooth transition when sIRB becomes the standard, it’s sponsors who will need to take the lead, especially when it comes to assuaging the concerns of academic institutions that may be used to the more stringent processes of their own local IRBs. Here are three steps that trial sponsors and contract research organisations (CROs) can take now in working with commercial and institutional IRBs to determine the best way to implement new requirements:

1. Establish clear standards for selecting an sIRB of record

Identify who will make the final decisions on standard operating procedures – is it an individual or a selection committee? Determine how the process will be documented. Set up training on the SOPs. Create a baseline list of mandatory characteristics for sIRBs that includes the following:

  • Is accredited by AAHRPP
  • Has demonstrated substantive experience (defined by length of time and geography) overseeing multisite trials
  • Has proven scientific expertise in the therapeutic area under study
  • Has previous experience reviewing trials for the academic medical institutions (AMCs) expected to be involved

2. Collaborate with AMCs and other sites to align on new workflows

Once sponsors have selected their preferred sIRBs, they should prepare research sites to work most efficiently with these sIRBs. Don’t assume all sites are proficient at working with commercial IRBs. Every IRB has different processes, workflows, operation, and a preferred contract language, so it’s critical to make sure all stakeholders are familiar with each other’s working patterns. Take time upfront to:

  • Introduce sites to the preferred sIRB(s) so the sIRB and site teams can work together directly to tailor processes
  • Provide the sIRB(s) with the sponsor’s preferred site list, so they can see which sites already have sIRB service contracts or other reliance agreements in place, and which ones still need to be set up
  • Collaborate with sites on the institutionally required informed consent language before a study, so the sponsor and site agree upon what should be included without hampering sIRB processes
  • Establish preferred communication channels and train staff to ease collaboration

3. Reevaluate site performance with the goal of consistent improvement.

Now is a great time for sponsors to take a good, hard look at commonly used trial sites and analyse their performance based on key and standardised indicators, such as study start-up time, enrolment diversity, and participant retention rates. Using consistent metrics, sponsors can make objective comparisons of sites – not just relying on institutional reputation or name recognition – to understand which sites are contributing best to efficient and compliant clinical research. In other words, don’t just blindly go with the same sites you always have. They may still be the right sites – but let the evidence determine that.

Dr Brennan calls the sIRB model a “win-win”, a way to improve efficiencies for all parties involved in clinical research, but none more so than the patients who await (desperately, in some cases) the treatments that may come from these studies.

With sponsors thoughtfully leading the way, even before the FDA mandate takes effect, the road to victory can start today.

Don’t sweat an FDA sIRB mandate in clinical research – It’s good news for everyone (2024)

FAQs

What is the role of the FDA in clinical research? ›

Protecting the rights, safety and welfare of people who participate in clinical trials is a critical aspect of the FDA's mission. FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations.

Do clinical trials require FDA approval? ›

Learn more about Clinical Trials. Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research. In the IND application, developers must include: Animal study data and toxicity (side effects that cause great harm) data.

What are the four phases of clinical trials in FDA? ›

Information For
  • Step 1: Discovery and Development.
  • Step 2: Preclinical Research.
  • Step 3: Clinical Research.
  • Step 4: FDA Drug Review.
  • Step 5: FDA Post-Market Drug Safety Monitoring.
Jan 4, 2018

Why is clinical research important? ›

They allow us to evaluate new medical interventions – including new drugs, devices, vaccines, and lifestyle modifications – and identify those that are most likely to benefit patients. They show us what we cannot learn in a lab or in animal testing – how these interventions affect actual people.

What are the three responsibilities of the FDA? ›

What are the FDA's responsibilities?
  • Determines if the medication is safe and effective, and if the benefits outweigh the risks.
  • Evaluates if product can be manufactured to FDA standards.
  • Regulates prescription medication advertising.
Jun 10, 2022

What does the FDA do for research? ›

The FDA regulates research that involves food, dietary supplements, drugs, medical devices as well as electronic products to ensure that the data collected from these investigations was done so in an ethical, compliant, and sound manner before any product developed from the research is marketed and readily available to ...

What is the difference between clinical research and clinical trials? ›

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people. Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate.

Who pays for FDA clinical trials? ›

You may be wondering if clinical trials cost money and who pays for them. Many clinical trial costs are covered by the sponsor of the study, a patient's insurance plan if one is available, and sometimes there are out-of-pocket costs.

Do clinical tests need FDA approval? ›

Under the government's plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be FDA approved within 3 1/2 years. Lower risks tests will have four years to obtain approval.

What makes a good clinical trial? ›

Optimized Trial Protocol. Successful clinical trials start with a well-designed, patient-centric protocol. The study protocol dictates the study proceedings, from identifying the research aim for the trial to methods of patient recruitment and ultimately statistical analysis.

How long does FDA approval take? ›

The clinical trial phase can take years to complete. However, once research has shown that the drug is safe and useful, the FDA typically reviews and either approves or denies an application for a new drug within 6 months.

What counts as clinical research? ›

Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.

What is the ultimate goal of clinical research? ›

The ultimate goal of clinical research is to increase medical knowledge and improve patient care. For the conclusions resulting from clinical research to be valid and applicable, the research must be conducted deliberately via systematic investigation and data collection.

Should clinical trials be made public? ›

Transparency of clinical trial information, including through ClinicalTrials.gov, is essential to scientific advancement. Making clinical trial information publicly available fulfills the commitment to volunteer research participants and also enhances public trust.

What are two benefits of clinical research? ›

There are many possible benefits of being part of clinical research, including:
  • You may have the chance to help scientists better understand your disease or condition and to advance treatments and ways to prevent it in the future.
  • You may feel like you're playing a more active role in your health.
May 18, 2023

What are the duties of a researcher in the FDA? ›

The typical researcher is at the lab bench, doing experiments to test different products. Then they analyze all that data and put them into reports and presentations. Researchers have meetings with other scientists, where they discuss a product and the types of results they are getting.

Which of the these is a role that the FDA is responsible for? ›

FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

What is the FDA clinical approval process? ›

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

What is the regulatory role in clinical research? ›

Furthermore, regulatory affairs professionals play a crucial role in the post-approval phase of clinical research. They are responsible for submitting regulatory filings and maintaining compliance with regulatory requirements throughout the lifecycle of a product.

References

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