Patient recruitment is essential for pharmaceutical trials, but typically, clinical trial sponsors face difficulties when advertising their trials to source the right number of patients. 

While it’s necessary, clinical trial advertising can be tricky: There are strict clinical trial advertising guidelines that you have to adhere to. Plus, there are substantial risks for non-compliance, including legal ramifications and a potential impact on trial recruitment.

Here’s a complete overview of clinical trial advertising guidelines to help seamlessly recruit patients while remaining compliant.

Overview of Clinical Trial Advertising Regulations

Regulatory bodies govern and detail the clinical trial advertising guidelines that sponsors should know, whether using digital or traditional advertising methods. 

The Food and Drug Administration (FDA) oversees clinical trials in the United States. It ensures that “they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations.”

The FDA considers all clinical trial advertising for study patients part of the “informed consent and subject selection process.” Therefore, the FDA requires an Institutional Review Board, or IRB, to “review the methods and material that investigators propose to use to recruit subjects.” This includes ad copy for social media advertising and digital channels, video ads, and print advertisements. 

The European Medicines Agency (EMA) assesses and supervises clinical trials in the European Union. In its Guidelines for Good Clinical Practice, the EMA outlines, in a similar fashion to the FDA, that any “recruitment procedures” (such as advertisements) need to be reviewed by an IRB or Independent Ethics Committee (IEC). 

While ads are common clinical trial recruitment tools, they must meet the strict criteria that govern clinical trial materials. 

Essential Guidelines for Compliance

When it comes to clinical trial advertising guidelines, there are several main elements that stakeholders and health professionals must be aware of to protect not only participants but the integrity and legality of the recruiting process and trial. 

Accuracy and Truthfulness

One of the most critical aspects of clinical trial advertising is maintaining accuracy and truthfulness in all communications. For example, all information must be factually and clearly presented. The FDA also states that “no claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective.”

Patient Safety and Protection

Patient safety is paramount in clinical trial advertising. For example, the FDA dictates that advertisements don’t “promise a certainty of cure beyond what is outlined in the consent and the protocol.” Patient privacy is also essential, as the HIPAA Privacy Rule governs it.

Informed Consent

Informed consent is a cornerstone of ethical clinical trials, ensuring that participants fully understand the research’s nature, purpose, risk, and benefits. While the formal informed consent process occurs after recruitment, the materials used to attract participants must be consistent with the full disclosure required under informed consent. This means that materials should clearly convey all information necessary for participants to make informed decisions about trial participation. 

Claims and Benefits 

There are very strict guidelines regarding the claims and benefits touted in advertising materials. In addition to the safety and efficacy claims previously discussed, the FDA also states that studies should not use the terms “new treatment,” “new medication,” or “new drug” without explaining that the treatment is investigational.

Targeting and Audience Considerations 

When advertising for clinical trials to potentially eligible patients, it’s important to appropriately target the right audience without applying coercive tactics or exerting undue influence. For example, advertisements should avoid exploiting vulnerable populations or creating a false sense of urgency, and they must be designed to protect the autonomy of potential participants.

Best Practices for Creating Compliant Advertising

Creating advertising materials for clinical trials requires a careful balance of clarity, transparency, and adherence to regulatory guidelines. With that in mind, here are some best practices to help guide the advertising creation process and support patient recruitment efforts.

Content Creation Tips 

When crafting messaging, be sure to:

• Use simple, clear language: To meet clinical trial advertising guidelines while still creating compelling ads, use clear and factual language. Avoid advanced medical terminology and scientific jargon, which can confuse potential participants, and clearly state eligibility criteria. Necessary complex terms should offer simplified explanations. Clinical trial recruitment companies should provide expertise in crafting simple, effective copy. 
• Highlight the investigational nature of the study: Be transparent about the nature of the trial and clearly state that the treatment is investigational. In general, seek to be clear that positive outcomes are not guaranteed and ensure that interested patients know that the treatment you’re studying is not equivalent or superior to any other treatment on the market.
• Keep participant motivation in mind: When crafting advertising materials, consider why participants might want to join your study in the first place. For example, top incentives include monetary compensation and access to better treatment for their condition. Other patients might be interested in no-cost health examinations. Create advertising materials that speak to these motivations. 

Review and Approval Processes 

Any advertising materials created for clinical trials must be IRB-reviewed and approved. This includes materials for social media platforms, websites, other digital advertising avenues, and print materials. 

Drafts of ads (along with any images or visual materials) require approval before being shared with patients, whether via direct-to-patient methods or tapping into a local patient community or advocacy groups. 

Staying Updated 

Be sure to stay informed and up-to-date on the latest regulations and guidelines, as they are subject to change. Monitor the websites of the relevant regulatory bodies and consistently check for any updates to clinical trial advertising guidelines.

Successful Studies Start With Compliance

Clinical trial advertising is vital in recruiting the patients necessary for trials. But, these particular outreach methods can be delicate: Advertising materials can’t just be “good.”

Instead, marketing efforts need to be compliant and meet strict requirements. By knowing the laws and regulations governing clinical trial advertising in your area and keeping clinical trial advertising guidelines, campaign stakeholders can create patient-facing outreach materials for clinical trials that prove effective and compliant. 

The Role of AutoCruitment in Ensuring Compliance

Sourcing patients for clinical trials is crucial, but finding the right number of patients when you need them can be challenging. That’s why AutoCruitment assists with creating compliant clinical trial advertising, guidelines, and other patient recruitment solutions.

AutoCruitment uses targeted, direct-to-patient advertising methods that are 100% compliant with all laws and regulations. It uses advanced algorithms to identify motivated patients who meet the study’s population needs. 

AutoCruitment also offers patient identification and screening services, site engagement assistance, patient engagement tools, and enrollment services. It acts as a partner in connecting you with interested patients who meet your eligibility.

Leave the regulatory requirements to the experts, and trust AutoCruitment to ensure all of your study materials and campaign assets are ethical and comply with the FDA and IRB. 

Connect with us today to learn more.