From Treatment to Truth: How to Write a Concept Proposal for a Research Study

From Treatment to Truth: How to Write a Concept Proposal for a Research Study

Overview: Does your protocol actually reduce circulating spike protein? 

Best guesses, hope, and indirect biomarkers were sufficient early in the pandemic. Testing ability has matured, and with our quantitative spike protein assay, we can deliver direct, measurable data, and determine objective success and opportunities for improvement. 

Our Research Use Only (RUO) quantitative spike protein assay offers a way to measure and track unbound spike protein over time. It’s not for diagnosing or guiding individual treatment decisions. It’s a tool to generate trustworthy, population- or protocol-level evidence about what works.

Potential research applications of our RUO Quantitative Spike Protein Test:

-Evaluate protocol effectiveness: Does spike burden decline after a specific intervention? Over what time frame?
-Compare approaches: Do Protocol A and Protocol B show different spike clearance patterns?
-Correlate biology with symptoms: Do changes in spike levels align with fatigue, neurologic or inflammatory symptoms?
-Improve practice over time: Use results to refine strategies across your clinic.
-Support scholarly work: Publish, present, or apply for grants with structured data.

We are a company founded by physicians: We completely understand the complexity and constraints that clinicians face when seeking to evaluate treatment protocols for mysterious "Spikeopathy". 

We are seeking clinician research partners who are passionate about verifying their protocols at the population level. Data we gather may be able to paint a more complete picture, allowing us to classify spike-associated symptom clusters with disease staging. 

The Concept Proposal
A Concept Proposal is a short, clinician-written document (typically 2–5 pages) that clearly defines:

 -What you want to measure
-Why it matters
-How the research will be conducted

It is a non-intimidating architectural blueprint for your study. This allows you to explore feasibility, regulatory posture, and funding before committing to full execution.

Below is a practical framework of what to expect when working with us as your Specialized Research Services Provider, or working with another company / CRO:

      - Step 1: Define the exact question and endpoints
Primary question: Does Protocol X reduce circulating spike protein over Y weeks?
Main endpoint: Change in spike concentration from baseline to follow-up.
Secondary endpoints: Symptom scales, functional measures, inflammatory or immune markers.
This becomes your study backbone, funding pitch, and IRB proposal.

     - Step 2: Regulatory and ethical guardrails
Research Use Only: RUO results cannot be used to diagnose or drive clinical decisions for patients.
Protecting Human Subjects: If you collect identifiable data or interact with participants, you likely need IRB involvement.
Document directly: in the Concept Proposal Form to ensure RUO is clearly separated from clinical care.

    - Step 3: Study settings
Prospective observational studies: Patients consent to participate; samples collected at defined times; RUO results not returned to patients or used for care.
Interventional research: Treatment assignment as part of the study; higher IRB scrutiny.
Critical to remember: If RUO results influence clinical care or enter a medical record, you’re stepping into illegal diagnostic territory.

   - Step 4: Blinding
Blinding is not legally required, but strongly recommended to reduce bias:
Participant-blinded: patients don’t receive results
Clinician-blinded: clinicians don’t see results until study end
Double-blind: best protection for integrity

   - Step 5: Institutional Review Board
An IRB protects research participants and reviews study plans.
Involve the IRB if you’re collecting data from living people, if data are identifiable, or if you plan to publish or generalize findings. Even if you think your project is exempt, obtaining IRB confirmation helps protect you.

   - Step 6: Funding 
Develop a short, practical mini-protocol (2–5 pages) and a basic budget.
Pursue feasibility and funding in parallel:
Self-funded pilots: fastest and most flexible
Foundations, donor support, or industry sponsorship (with safeguards for independence)
NIH or foundation grants (slower, but scalable)
What funders want: why it matters, what success looks like, and how results will be used responsibly.
Submit IRB once the protocol is clear. Some IRBs review without full funding approval.

Summary: The Concept Proposal Is Your Launch Point
As a clinician pursuing RUO spike protein research, your first concrete step is the Concept Proposal.

This single document allows you to:

Define the claim in one sentence
Select endpoints and timepoints
Choose the simplest compliant study design
Decide who will (and will not) see results
Outline methods, blinding, and data handling
Confirm lab logistics and budget feasibility
Engage the IRB early and appropriately
Prepare consent language or exemption requests

From there, you can:

Run a small pilot
Refine methodology
Scale responsibly
Publish, present, or pursue additional funding

Our team not only offers America's first RUO Quantitative Spike Protein Test, we can also provide resources for clinician researchers to develop a Concept Proposal that is scientifically rigorous, RUO-compliant, and ready for IRB and funding conversations. We want to help you explore whether your current protocols are moving biology in the intended direction, separate meaningful signal from hope, and build evidence that stands up to scrutiny. Visit our website, and apply for a research study partnership with us today. From there, we will set-up a call with our team and get to know your research interests.