How Clinical Precedent works

Selecting the right clinical investigator and site for the clinical trial of a new drug or biologic product can mean the difference between the success and failure of the trial, and whether the drug gets approved and onto the market.

The stakes are high.

The obligation to choose the correct clinical investigator sits with the sponsor. Under FDA's 21 CFR 312.53, a sponsor must select only investigators "qualified by training and experience as appropriate experts" to investigate the drug, and ICH E6 makes the same selection responsibility explicit.

Qualification is usually read as credentials: CV, licensure, trial experience, site capabilities, and the sponsor's own history with the clinical investigator. But a clinical investigator's regulatory history is part of the same question.

For example: has FDA inspected them before? If so, were deficiencies found, and what were they? Did they satisfactorily resolve the issues? Were disqualification proceedings opened? Or has the individual been debarred?

If any of those issues surface after site activation, it becomes the sponsor's problem.

That can mean enrollment delays, data-credibility questions in a marketing application, or a repeat finding at the sponsor's own inspection. Due diligence in vetting a clinical investigator is not only a regulatory requirement, it is also good business practice.

The inspection and regulatory history of clinical investigators is publicly available, but it lives in many disparate systems that do not talk with each other and are not easy to find or access.

Clinical Precedent accumulates and curates FDA clinical trial inspection data, as reported by its Bioresearch Monitoring program, or BIMO, no matter where in the world the inspection took place. It covers drugs and biologics: inspections, findings and warning letters, organized into a clinical investigator vetting tool, with every source checked daily for new activity.

The dashboard brings together the tools available to subscribers.

It also shows what FDA is citing right now, along with the most recent serious inspection findings and warning letters.

Let's begin with how to vet an individual clinical investigator.

Enter the name or FEI number of a clinical investigator to see the number of FDA inspections in the data sets we monitor, the number of NAI, VAI and OAI inspections, and any warning letters.

See how this record compares with the larger data set, and drill down to the actual inspection findings if desired.

Also see the problem areas and the regulations cited, and if there is a warning letter, as with this one, click to read the full text.

An AI assistant is included that can answer your questions and help you find what you are looking for. Ask anything and it will search across the site and answer your question and where appropriate link you to the correct page on the site.

If you have narrowed the list to two or three finalists, there is a tool to compare them head-to-head. There is also a check to see whether a clinical investigator has been disqualified or debarred.

You can also run a free-text search across the more than 7,000 inspection findings in the data set.

For example, here is a search for the term "coercion." It returns the broad problem types where the concept was found, with links to the findings, including in warning letters and disqualification documents where applicable. The search returns every record classified under that problem type, including ones that describe it without using your words.

The findings can also be browsed by problem area or by regulation.

By problem area returns the findings categorized into a standard GCP deficiency-area taxonomy, so broader areas of interest can be explored.

Here are some examples. As throughout the site, you can always drill down to the underlying findings from inspections or warning letters.

You can also explore findings by regulation. Filter by product type, drugs or biologics; by organization, clinical investigator, IRB, or sponsors and CROs; and by time frame. For the window selected, see whether findings against each regulation have been rising or falling.

Next, recent enforcement activity.

Here, recent OAI inspections and warning letters are listed by date, with links back to the letter or the inspection findings. This view is rebuilt, and the statistics recalculated, every time new data arrives.

It also includes a graphic representation of the numbers of warning letters and serious inspections, year by year,

and how long it took after an OAI inspection that resulted in a warning letter for the letter to be issued.

Here is an up-to-date checklist of what FDA has cited over the last five fiscal years: its current and recent areas of focus.

It can be filtered by organization type and product type. Use this list when preparing your own organization for inspection, or when auditing a potential clinical investigator, CRO or IRB. It updates as new findings come in, and can be printed or saved to PDF.

Also included is a brief GCP guide.

It offers a high-level discussion of reading the data and weighing a clinical investigator's history: how serious the findings are, how to interpret the results, and how to evaluate inspection findings. It also covers the fundamentals of GCP, with links to the FDA and ICH regulations and guidance. Note that this is a brief orientation, not a substitute for the regulations or formal GCP training. It offers discussion, not recommendations, advice or instructions.

Clinical Precedent also offers a set of free guides, open to everyone, with no account needed: plain-language explanations for the sponsor, CRO and quality teams that choose and oversee clinical investigators. They cover what the regulations require, what an FDA inspection produces, and what each document on a site's record means, from Form 1572 due diligence to debarment and disqualification.

Finally, there is a valuable watchlist feature.

Use it to keep the clinical investigators, CROs and IRBs you work with in one place, and spot new FDA activity against any of them. Any new inspection or warning letter since you last checked gets flagged. Check it on the site, download it as a CSV file, or tick the box to receive a weekly digest of new activity by email.

Thank you. Visit clinicalprecedent.com.