#### Potential Partners
* The Clinical Trials Transformation Initiative (CTTI)—a public-private partnership whose members include representa- tives from the FDA, National Institutes of Health, the Centers for Medicare and Medicaid Services (CMS), and academic, industry, and patient advocacy groups.
## What are the risks associated with your solution?
Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mis- matched expectations and a perception that patient groups lack scientific sophistication and that “wishful thinking” may cloud their recommendations. Conclusions: Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.
### What is your product's value proposition?
The value of the Accurity network will stem from the following features:
## Market Timing
YOU ARE HERE ->
2017 - September
FDA Guidance "[Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm478821.pdf)" _TLDR = a plea to drug makers to innovate and a truly unusual level of support for novel ideas to be put into practice. Page 1 footnote exerpt: __2 For the purpose of this document, emerging technology should be novel in the context of the pharmaceutical and related industries and it should have the potential to modernize the pharmaceutical manufacturing body of knowledge related to product quality. Emerging technology will be new to FDA in the context of pharmaceutical quality, with limited prior experience and knowledge. 3 This program is also open to companies or manufacturers that intend to include emerging technology in a drug master file (DMF) that will be referenced by the planned application(s). The steps to request participation in the program are described in section III.B Process._
## 2017 - July
FDA Guidance "[IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subject](https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM566948.pdf)". TLDR = Studies that meet the following criteria can be waived from requiring consent of human participants (guidance released without public comment period):
1\. The clinical investigation involves no more than minimal risk **(as defined in 21 CFR 50.3(k) ****or 56.102(i)) to the subjects**;******
2\. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3\. The clinical investigation _**could not practicably be carried out without the waiver or**__**alteration**_; and
4\. Whenever appropriate, the subjects will be provided with _additional pertinent information _**after** participation.
don't look this up. I didn't and a potential study participant won't have enough time to either. the **bottom line** is that minimal risk is no longer what you or I define as minimal risk but rather what some **governing body** (_think DAO ~ solution ~ patient-defined)_ says is the "minimal risk". There are patients on both sides of the spectrum. Most with the more terminal conditions tend to not give a shit be as concerned about risk. This guidance in the hands of those who aren't putting patients first can be dangerous. Fortunately, there are very few stakeholders involved that might think along those lines.
## 2017 - August (draft released July 27)
The Meat & Potatoes.
FDA Guidance - "[Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices](https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf)"
TLDR = read the last 2 paragraphs on page 12 and then read them again. RWE and RWD must be understood. The following couple of pages can be skimmed as it is merely the FDA laying out bulletpoint by bulletpoint the ways in which the Quality and Reliability will be measured. (makes that deliverable easier to some extent). Pages 17 up through the glossary define remarkably clear use-cases/pathways to testing a protocol like TrialPhi rather than beat ourselves to death trying to come up with one now we have to struggle with limiting ourselves to only one. (or not).
TK it might not hurt to glance over the glossary in all honestly. its short but very relevant should we continue down this path not traveled.