Marketing a clinical research site to sponsors and CROs

A clinical research site sells to a small, expert audience. Its buyers are study sponsors, contract research organizations (CROs) and site networks, and they choose sites on the strength of a feasibility questionnaire, a phone call with the coordinator and whatever the site says about itself on its website, in pitch decks and on LinkedIn. A dedicated research center, a physician practice that runs a few studies a year and an independent site that belongs to a network all face the same question: how do you make the case for your site without overstating it, without promoting the products you test, and without exposing patient information in the process?

This guide is for site owners, principal investigators, business development staff and the agencies that work for them. It covers the claims sites make to sponsors, how investigator experience and sponsor quotes fit the FTC endorsement guides, how patient counts for feasibility relate to HIPAA, and where business marketing stops and patient recruitment begins. Recruitment ads aimed at patients have their own rules, which we cover in our guide to clinical trial recruitment ads.

The short version

• Sponsor-facing claims are advertising. A site’s statements about enrollment, retention, data quality and speed fall under the FTC Act’s ban on deceptive practices, so each one needs records behind it and a clear definition.
• Investigator experience must be real and current. List studies, phases and therapeutic areas you can document, and do not let a former investigator’s record stand in for your current team.
• Quotes from sponsors or CRO staff are endorsements. They must reflect the person’s honest view, cannot be reworded to change their meaning, and any material connection needs disclosure.
• Never promote the product under study. FDA rules bar sponsors, investigators and anyone acting for them from presenting an investigational drug or device as safe or effective for the use under study.
• Patient counts are not patient data, but they come from patient data. Pulling counts from records for feasibility and contacting patients for a study are separate steps with separate HIPAA rules.

Who buys from a research site, and which rules apply

Most of a site’s business development is business-to-business. Sponsors and CROs compare sites on therapeutic experience, access to eligible patients, start-up speed, staff and equipment, and the quality of past data. That is a commercial pitch like any other, and section 5 of the FTC Act (15 USC 45) prohibits unfair or deceptive acts or practices in commerce. A sophisticated buyer does not make a false claim acceptable; it makes it easier to catch, often during a site qualification visit or an audit.

A research site also carries rules a typical vendor does not. Its investigators sign commitments to the sponsor and to FDA, its patient-facing material goes through an institutional review board (IRB), and the products it tests are not approved for the use under study. Keeping three kinds of content apart makes the rest of this guide easier:

• Business content aimed at sponsors and CROs: capabilities pages, feasibility answers, pitch decks, LinkedIn posts, conference booths.
• Recruitment content aimed at patients: study ads, a study listing page, screening forms. This needs IRB review before use.
• Patient education about research in general, such as what a clinical trial is and how informed consent works, with no claims about a particular product.

Enrollment, speed and quality claims

Enrollment numbers are the claims sponsors care about most and the ones sites most often state loosely. “We always hit enrollment” or “top enrolling site” is a factual claim. Under the FTC’s approach, a factual claim needs a reasonable basis before it is made, and a vague superlative with no defined comparison can mislead as easily as a wrong number. Before any figure goes on your website or into a deck, decide exactly what it measures:

• Which studies and which period. All studies since the site opened, or the last three years? Studies in one therapeutic area, or all of them?
• Which stage. Patients prescreened, screened, consented, randomized, or completed are very different numbers. Say which one you mean.
• Against what target. “Met enrollment targets” needs the target the sponsor set, not one the site set for itself after the fact.
• Ranking claims. “Top enrolling site” needs a source, usually a ranking a sponsor or CRO shared with you, and permission to repeat it under your agreement.
• Start-up time. If you quote a typical time from site selection to first patient in, define both end points and base it on your own records.

Keep a short claims file: each figure, how it was calculated, the dates and the record it came from. Clinical trial agreements often make study details confidential, so check before naming a sponsor, a protocol or a product, even in a success story. Our guide to case studies and client success stories covers consent and confidentiality for stories in general, and our guide to white paper claims for health companies covers longer documents with data.

Investigator and staff experience

Sponsors select sites partly on the people. Under 21 CFR 312.53(a), a drug study sponsor must select only investigators qualified by training and experience as appropriate experts to investigate the drug, and under 312.53(c) it collects a signed investigator statement (Form FDA 1572) and a curriculum vitae before the investigator starts. Your marketing will be compared against those documents, so keep them consistent:

• Count studies the same way everywhere. If a principal investigator’s page says “over 50 trials”, the CV should support it, and you should be able to say whether that means as principal investigator or as sub-investigator.
• Separate the site’s record from a person’s record. An investigator who joined last year brings their own history; the site’s history is what the site did. Do not merge the two into one site total.
• Keep it current. When an investigator or a lead coordinator leaves, take their name, photo and experience off the site and out of templates.
• Credentials and certifications. Board certification, research certifications and training claims should name the issuing body and be current on the date the material is used.

Quotes from sponsors and CRO staff

A quote from a monitor, a clinical research associate or a sponsor’s study manager is persuasive because it comes from the buyer side. The FTC endorsement guides (16 CFR Part 255) apply to it. Section 255.1(a) says an endorsement must reflect the honest opinions, findings, beliefs or experience of the endorser and may not convey anything that would be deceptive if the advertiser said it directly. Section 255.1(b) lets you shorten a quote, but not present it out of context or reword it so it distorts the endorser’s opinion or experience.

Section 255.5 requires clear and conspicuous disclosure of a connection between the endorser and the seller that might materially affect the weight or credibility of the endorsement and that the audience would not expect, such as payment, free services or a family or business relationship. A quote from someone who has a financial stake in the site, or from a consultant the site pays, needs that disclosure. Practical points:

• Get written permission from the person and check whether their employer allows staff to give quotes. Many sponsors and CROs do not, so expect to rely on facts rather than names.
• Do not attribute a quote to a sponsor company when it was one employee’s view in an email.
• Do not imply that a sponsor or FDA endorses your site. A completed FDA inspection is a fact you can state accurately; it is not an approval of the site.

Do not promote the investigational product

This is the rule that most clearly separates research site marketing from other health marketing. Under 21 CFR 312.7(a), a sponsor or investigator, or any person acting on behalf of either, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation, or otherwise promote the drug. The same section says it is not meant to restrict the full exchange of scientific information, including publishing findings in scientific or lay media. For devices, 21 CFR 812.7 bars promoting or test marketing an investigational device until FDA approves it for commercial distribution, and bars representing that it is safe or effective for the purposes under investigation.

For a site, the risk usually comes from enthusiasm, not intent. Watch for these in your own channels:

• Posts that call a study drug or device “new”, “breakthrough”, “promising” or “effective”, or that describe how well it worked for participants.
• Capabilities pages that name products under study and describe them in marketing language rather than by protocol title and phase.
• Social posts by investigators about interim results or patient stories from an ongoing study.
• Business pitches that use a product’s expected benefits to sell the site’s experience with it.

Describe your work by therapeutic area, phase, study design and the procedures your site can perform. If you need to mention a specific study, use the neutral title and registry identifier, and check the clinical trial agreement first. Sponsors that ask sites to share their own content should supply it, and a site should not edit it into something more promotional.

Patient databases and feasibility counts

Sponsors often ask how many patients you see with a condition, and sites often advertise a patient database. Both draw on protected health information, so the HIPAA Privacy Rule applies to how the numbers are produced, even if only a count leaves the building. Under 45 CFR 164.512(i)(1)(ii), a covered entity may let a researcher review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research, if the researcher represents that the review is solely for that purpose, that no protected health information will be removed from the covered entity during the review, and that the information sought is necessary for the research.

That provision is about reviewing records, not about contacting patients or sending lists to a sponsor. For other research uses, 164.512(i)(1)(i) requires documentation that an IRB or privacy board approved a waiver or alteration of authorization, and otherwise the patient’s authorization under 164.508 is the general route. Information de-identified under 164.514(b), by expert determination or by removing the listed identifiers, is no longer protected health information. In practice:

• Give sponsors aggregate counts, not records, and agree internally who runs the query and how small counts are handled, since a very small count in a narrow area can point to a person.
• Describe your patient base honestly. “Access to” a number of patients should mean patients your site or its affiliated practices actually see, within a stated period, not a regional population estimate.
• Treat contacting patients about a specific study as recruitment: it goes through the IRB-approved process for that study, under the HIPAA route your privacy officer and IRB agree on.
• If an outside recruitment vendor or software touches patient information, check what HIPAA requires for that arrangement before it starts.

Where business marketing ends and recruitment begins

A site website usually serves both audiences: sponsors looking for capabilities and patients looking for studies. FDA’s Recruiting Study Subjects information sheet treats advertising for study participants as the start of the informed consent and subject selection process and says ads meant to be seen or heard by prospective subjects should be reviewed and approved by the IRB. That covers a study listing page, a recruitment landing page and a social ad for a study, but not a capabilities page written for sponsors.

Keep the two apart so that IRB-approved recruitment copy is used exactly as approved, and business copy never slips onto a patient page. Our clinical trial recruitment ads guide covers what a study ad may and may not say. If your sponsors pay your site or investigators for services beyond the study budget, our guide to Open Payments and the Sunshine Act explains what gets reported.

Channels that work for research sites

• A capabilities page with therapeutic areas, phases, equipment, storage, staff roles and certifications, written so a feasibility manager can answer their checklist from it.
• Investigator pages that match the CVs on file and state roles accurately.
• LinkedIn for business development staff and investigators, with the same claims discipline as the website. Our guide to LinkedIn marketing for healthcare companies covers company pages and employee posts.
• Conference presence at research industry events, with handouts reviewed for the same claims as the website.
• Search visibility for searches such as a therapeutic area plus “research site” and a city, supported by a clear site name, address and Business Profile for the physical site.

An illustration

Take a hypothetical multispecialty practice that has run dermatology and rheumatology studies for several years and wants more sponsor work. Its first draft website says the site has “thousands of patients ready to enroll”, that it is a “top enrolling site”, and features a post about a study drug that “cleared skin” for participants. A review against this guide changes all three. The patient line becomes the number of patients with the relevant diagnoses seen in the past year, produced by the practice’s own staff from aggregate data. The ranking claim is removed because nobody can find the sponsor ranking it was based on. The post about the study drug comes down, and the study is listed instead by therapeutic area, phase and registry identifier. The site then adds a capabilities page and investigator pages that match the CVs sponsors already hold.

Checklist

• Every enrollment, retention, start-up or quality figure has a definition, a period and a record behind it.
• Ranking and superlative claims have a written source and permission to repeat it.
• Investigator pages match CVs and Forms FDA 1572 on file, and departed staff are removed.
• Quotes from sponsor or CRO staff are accurate, permitted and disclose any material connection.
• No channel describes an investigational drug or device as safe, effective or promising for the use under study.
• Feasibility answers use aggregate counts produced inside the covered entity, and patient contact for a study follows the IRB-approved process.
• Patient-facing recruitment content is IRB-approved and kept separate from sponsor-facing pages.
• Confidentiality terms in each clinical trial agreement are checked before a sponsor, protocol or product is named.

How we help

We build websites, capabilities pages and lead generation for health companies and practices, and for research sites we keep a claims file behind every figure and keep sponsor pages and recruitment pages apart. See our lead generation service or browse more marketing and compliance guides.

Sources

• 15 USC 45: Unfair methods of competition and unfair or deceptive acts or practices
• 16 CFR Part 255: Guides Concerning the Use of Endorsements and Testimonials in Advertising (255.1, 255.5)
• 21 CFR Part 312: Investigational New Drug Application (312.7, 312.53)
• 21 CFR Part 812: Investigational Device Exemptions (812.7)
• 45 CFR Part 164: 164.508, 164.512(i), 164.514(b)
• FDA: Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators (January 1998)

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