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MDRingClinical Partner Network

Compliance & Study Integrity

The oversight is the point, not the paperwork.

A laboratory-manufactured cell product, grown from donor cells and given intravenously, is regulated as a drug. It requires the FDA's permission before it can be given to anyone in a study, and the FDA's approval before it could ever be sold. There is no shortcut around that, and this network is not looking for one.

We are saying this on the second page a physician reads, rather than in a footnote, because it is the main reason a serious practice should want to be involved. Evidence generated any other way is not evidence anyone can use.

Our commitment

Four standards the network holds itself to, in every market and at every site.

  • One

    Studies run under FDA oversight

    Any administration of this investigational product within the network happens inside a clinical study conducted under the FDA's investigational pathway, with a protocol the agency has reviewed. A patient registry is not a substitute for that, and neither is anything else.

  • Two

    One federal standard, everywhere

    The same federal requirements apply to every site in the network regardless of where it is located. We do not operate an alternative route in any state, and no site is asked to rely on one.

  • Three

    Independent ethics review at every site

    No site enrols a participant before an institutional review board has approved the study for that site, and review continues for as long as the study runs. The board is independent of MDRing, of Cellenkos and of the site, and it can require changes or stop the study.

  • Four

    Participants selected on clinical grounds

    Eligibility is set by the protocol and rests on clinical criteria and scientific need. An IRB is required to satisfy itself that subjects are selected equitably, and we design for that requirement rather than around it.

Two terms, in plain English

Both come up constantly in conversations about this network. Neither is complicated once stated clearly.

IND

Investigational New Drug application

The FDA's permission to give an experimental product to people in a study.

Before an experimental drug or cell product can be given to a person in the United States, the sponsor files an IND with the FDA. It sets out how the product is manufactured and tested, what laboratory and animal work has been done, what is known about safety, and exactly what the proposed study would do — who would be eligible, what they would receive, what would be measured and how risks would be monitored.

The FDA reviews the submission and has a defined period in which to object. If it does not, the study may proceed; if it has concerns, it can place the study on hold until they are resolved. The IND stays in effect for the life of the programme, and the sponsor must report safety findings to the FDA as they arise.

An IND is permission to study a product. It is not approval, and it says nothing about whether the product works.

What this means for the network

Studies in this network will be conducted under an IND covering the indication being studied. Placeholder, information still required: [TODO: confirm with MDRing — IND number, sponsor of record, and regulatory status for the joint and autoimmune programme.]

IRB

Institutional Review Board

An independent ethics committee that reviews the study to protect the people in it.

An IRB is a committee — including scientists, non-scientists and members unaffiliated with the institution — that reviews a study before it begins and continues to review it while it runs. Its job is not to decide whether the science is interesting. It is to protect participants.

To approve a study, an IRB must satisfy itself that risks are minimised and reasonable in relation to any anticipated benefit, that the consent process genuinely informs people of what they are agreeing to, that participant privacy is protected, that safety is adequately monitored — and that subjects are selected equitably, meaning that the burdens and any benefits of research are distributed fairly rather than falling on whoever is easiest to enrol or most willing to agree.

The IRB has real authority. It can require changes to the protocol or the consent form, it can suspend enrolment, and it can withdraw approval entirely.

What this means for the network

Every site in the network requires IRB approval before enrolling anyone, and every site is subject to continuing review. Placeholder, information still required: [TODO: confirm with MDRing — whether a single central IRB will be used across the network or sites will use local boards.]

What we ask of investigators

These obligations are not unique to this network — they are the standard duties of a clinical investigator. They are listed here because they are real work, and a practice should see them before it agrees to anything.

Informed consent

Consent is a conversation, documented — not a form handed across a desk.

  • Use only the IRB-approved consent document, in the approved version.
  • Ensure the participant understands that the product is investigational, that it has not been approved by the FDA, and that benefit is not known.
  • Give the person time to consider and to ask questions, and answer them plainly.
  • Obtain and document consent before any study-specific procedure takes place.
  • Re-consent participants if the protocol or the risk profile changes materially during the study.

Adverse event reporting

Safety information is only useful if it moves quickly and completely.

  • Record adverse events as the protocol defines them, including those that seem unrelated.
  • Report serious adverse events through the network's central route within the protocol's timelines.
  • Assess and document severity and the investigator's view of causality.
  • Follow events through to resolution, not just to the next scheduled visit.
  • Notify the reviewing IRB in accordance with its reporting requirements.

Data quality

A study is only as good as what is written down at the time.

  • Maintain source documentation that supports every entry in the case report form.
  • Enter data promptly and correct queries within the agreed window.
  • Follow the protocol's visit schedule and assessment procedures; document any deviation and why it happened.
  • Keep drug accountability records covering receipt, storage temperature, thaw and administration.
  • Retain study records for the required period and make them available to monitors, auditors and the FDA.

A registry is not a study

The two get spoken about interchangeably, and they are different instruments doing different jobs. The network runs a registry alongside its studies; the registry does not stand in for one.

A registry compared with a clinical study, across five attributes.
AttributeA registryA clinical study
What it isA database that tracks how patients do over time.A prospective investigation conducted under a protocol to answer a predefined question.
Regulatory basisNot a substitute for FDA authorisation to administer an investigational product.Conducted under an IND, with the protocol reviewed by the FDA.
OversightTypically governed by its own protocol and privacy terms.Reviewed and approved by an IRB before enrolment, with continuing review throughout.
DesignObservational; records what happens.Predefined eligibility, endpoints, comparison and analysis plan, fixed before data collection begins.
What it can establishPatterns, signals and long-term follow-up worth investigating.Evidence capable of supporting a regulatory submission.

Registry data is genuinely valuable, particularly for long-term follow-up. It cannot answer whether a therapy works, and it cannot authorise giving one to anybody.

Why we lead with this

Cell therapy has a credibility problem that it largely earned, and practices in this field are right to be cautious about who they associate with. The distinction that matters is not how carefully a programme describes itself. It is whether it works through the FDA's investigational process or around it.

Working through it is slower. It means a protocol, an ethics committee that can say no, monitoring visits, queries on your data, and a wait before anyone knows anything. It also means that when the studies report, the result counts — with the FDA, with journals, with colleagues, and with the patients a practice will eventually have to advise.

For a practice, the oversight is protective as well as burdensome. An approved protocol, a documented consent process and a central safety route are the things that stand behind a physician's judgement if a study participant does badly. That is worth more than speed.

Ready to look at this seriously?

The FAQ answers the practical questions — time, staffing, ethics submissions, data systems and how sites are chosen. If you would rather just talk, start with an enquiry.

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