Post-Trial Access: Compliance Lessons Hidden In Plain Sight

By Edye T. Edens, JD, MA, CIP, CCRP, founder and CEO, EEDEE Law

In clinical research, we often treat “the end” of a trial as a finish line. Database lock, last monitoring visit, or last patient out are the milestones that define closure for sponsors and CROs. But for the participants who gave their time, their health, and sometimes their hope, that finish line often marks the beginning of a new uncertainty: What happens when the trial ends and the investigational product is no longer available?

Too often, the answer has been silence. For years, some sponsors dismissed post-trial access as an ethical aspiration rather than a binding responsibility. But ethics and compliance are not mutually exclusive. In fact, the regulatory environment has evolved to make clear that they are one and the same. Failing to anticipate and plan for post-trial access is not just a moral lapse — it is a compliance failure with cascading legal, contractual, and reputational consequences.

For those of us in clinical trials, it is imperative that we see this not as a gray area but as one of the clearest examples of how ethics and compliance converge. Post-trial access is no longer optional philanthropy. It is a compliance-critical function that defines whether a trial truly protects participants or leaves them exposed to avoidable harm.

When Ethics Become Regulation

The first misconception to set aside is that regulatory obligations end when the last data point is collected. In fact, U.S. sponsors are required under 21 CFR §312.50 to “assure proper conduct of the investigation.” That language is intentionally broad and has been interpreted by regulators to include the continuing protection of participants, not merely their protection while data is actively gathered. Similarly, ICH E6(R3) §2.3 emphasizes that a sponsor’s duty is to ensure “the rights, safety, and well-being of trial participants” across the entire life cycle of the study, not just while they are formally enrolled.

Ethics and regulation thus converge. What IRBs or ethics committees once encouraged as best practice now operates as a compliance expectation. The Council for International Organization of Medical Sciences (CIOMS) Guidelines go further, stating that sponsors “must make provisions, as appropriate, for continued access” when participants have no viable alternatives (CIOMS 2016, Guideline 6). In short, regulators and ethics bodies are no longer speaking past each other; they are saying the same thing.

The Legal And Contractual Blind Spot

If regulatory frameworks are increasingly clear, why do sponsors still stumble? One major reason is the absence of explicit contractual language. Clinical Trial Agreements (CTAs) often devote pages to payment terms, publication rights, and indemnification, but remain silent on post-trial access. This silence creates fertile ground for disputes.

Consider a site that assumed the sponsor would continue supplying the investigational product after study closure. The sponsor believed the opposite, assuming the site or treating physician would transition patients to the standard of care. Without clarity, both parties are exposed. And under 21 CFR §312.52, delegation of responsibility must be explicit and documented. Silence is not a defense.

Moreover, vague or inconsistent commitments can become liabilities. If the informed consent form promises “continued access will be provided if beneficial,” but the CTA is silent, the discrepancy itself may be cited during an inspection. FDA warning letters frequently highlight such inconsistencies as evidence of poor oversight. Thus, what begins as a contractual oversight becomes a compliance finding.

From Oversight To Outrage

Even if regulators never open a file, the reputational consequences of neglecting post-trial access can be devastating. In an era of instantaneous communication, stories of participants being abandoned after a trial’s end are picked up quickly by media outlets and amplified by patient advocacy groups. Companies have faced organized campaigns, shareholder questions, and widespread social media criticism for cutting off access, sometimes overshadowing positive trial results.

And reputational harm is not confined to the public sphere. Communities remember. Once a region perceives that trial participation leads to abandonment, recruitment in future studies suffers. Physicians become reluctant to refer patients, and regulators may take a harder line in protocol approvals. The fallout from one misstep can ripple across an organization’s global portfolio.

The Human Consequence

At the center of these compliance, contractual, and reputational risks lies the most important factor: human harm. Participants who experienced clinical benefit from an investigational product may decline rapidly if access is withdrawn. Families lose faith in healthcare institutions. Communities perceive research as exploitative. This erosion of trust undermines not only the single study but the broader ecosystem of clinical research.

Ethics committees recognize this, which is why U.S. IRBs are required under 45 CFR §46.111(a)(2) to ensure risks to subjects are minimized. Abrupt discontinuation is not risk-neutral; it is a foreseeable harm. Regulators, courts, and communities increasingly treat it as such.

Designing Compliance, Not Apologies

The solution is not reactive apology campaigns after negative press or post-inspection remediation plans. The solution is anticipatory design. Sponsors, CROs, and sites must build post-trial access into their compliance frameworks from the start. Doing so requires a step-by-step framework that integrates legal, operational, and ethical considerations:

1. Budgeting at Protocol Development

Post-trial costs must be anticipated at the design stage, not treated as an afterthought. Sponsors should budget for continued product supply in parallel with monitoring and pharmacovigilance costs. Regulators increasingly question whether a protocol is feasible without such planning, especially in therapeutic areas where withdrawal carries significant risk.

2. Contract Precision

CTAs and vendor agreements must explicitly allocate obligations for post-trial supply. This includes not only who provides access but also how long it will be provided, under what conditions, and at whose expense. Delegation under 21 CFR §312.52 requires clear documentation; silence is indefensible.

3. Consent Alignment

The informed consent document must accurately reflect what participants can expect at trial’s end. Overpromising access creates exposure; under-explaining creates mistrust. Language should align precisely with the CTA and protocol. This alignment is increasingly scrutinized during FDA and EMA inspections.

4. Regulatory and Ethics Engagement

Early engagement with regulators and ethics committees sets expectations. In some jurisdictions, post-trial commitments may be a condition of approval. In low- and middle-income countries (LMICs), where no standard of care exists, regulators may mandate access. Sponsors who anticipate these demands avoid delays and disputes later.

5. Oversight and Documentation

Just as with serious adverse event (SAE) reporting or data integrity, access plans must be monitored, tracked, and auditable. This means documenting when the product was dispensed post-trial, to whom, and under what authority. Absent documentation, compliance cannot be demonstrated.

6. Transition Planning

Not all products can or should be provided indefinitely. Transition planning — whether to commercial product, expanded access, or referral to local care systems — should be part of the design. Regulators are increasingly asking not only “What is your access plan?” but “What is your transition plan?”

Conclusion

Post-trial access sits at the intersection of ethics, compliance, and trust. When it is neglected, four consequences recur with predictable regularity: contract disputes, regulatory scrutiny, public backlash, and human harm. None of these are unforeseeable. All of them are preventable.

The lesson is straightforward but urgent: Sponsors, CROs, and sites must stop treating post-trial access as a discretionary afterthought, and start designing for it as a core compliance requirement. That means embedding obligations in contracts, aligning consent language, budgeting realistically, engaging regulators early, and documenting access with the same rigor as safety reporting.

Compliance is always strongest when it is designed — not when it is defended after the fact. Post-trial access is a prime example of this principle. By aligning ethical duty with regulatory expectation, organizations can not only safeguard participants but also fortify their reputational and legal standing in an industry where scrutiny is relentless.

The future of clinical research depends on trust. And trust depends on what happens after the trial.

About The Author:

Edye T. Edens, JD, MA, CIP, CCRP, is the founder & CEO of EEDEE Law (Edye Edens Life Sciences Law Group), where she focuses on clinical research compliance, contracting, and regulatory risk management. She has over 15 years of experience across academic medical centers, IRBs, and sponsor-site oversight, advising clients on FDA regulations, ICH-GCP compliance, and global trial operations.