1. Clinical Writing for Interventional Cardiologists

2. What you will learn - hopefully! Introduction General principles for clinical writing Specific techniques Practical session: critical review of a published article Writing the Title and the Abstract Bibliographic search and writing the Introduction Principles of statistics and writing the Methods Practical session: writing the Abstract Writing the Results Writing the Discussion Writing Tables and preparing Figures Principles of peer-review Principles of grant writing/regulatory submission Clinical writing at a glance Conclusions and take home messages

3. What needs to be done before doing the study and drafting the manuscript? Get the money Grant proposal

4. What needs to be done before doing the study and drafting the manuscript? Get the money Grant proposal Obtain authorization for study conduct or product approval Regulatory submission

5. Different goals Getting everyday bread Fishing expedition

6. Why discussing today grant writing/regulatory submission? Grant writing and regulatory submission, like protocol drafting, encompass many of the tasks that should also be mastered to become accomplished in clinical manuscript writing.

7. Why discussing today grant writing/regulatory submission? The main difference lies in the aim, whereas with a manuscript you may want to diffuse a clinical message and recommend a medical behavior change, with grant writing/regulatory submission you look, respectively, for funding or authorization.

8. Grant proposal/writing: anatomy RESEARCHER IDEA INSTITUTION PROGRAM ANNOUNCEMENT GRANT APPLICATION 1 ST REVIEW2 ND REVIEW MAYBE NO 3 RD REVIEW MAYBE NO YES

9. Grant proposal/writing: myths Urban Myth of Grantsmanship It is not a process by which bad ideas get transformed into good ones … … rather, it is more often the case of a good idea disguised as a bad one

10. Grant proposal/writing: key issues 1.Significance 2.Approach 3.Innovation 4.Investigator 5.Environment

11. Grant proposal/writing: tips Focus on goals of funder and current vogues Follow the rules and finish early Less is more, except for the Methods section Prioritize and itemize, focusing on primary objectives Use simple language and avoid acronyms Focus on tasks, allocation of time, persons and resources Define budget appropriately Put your current grant proposal in the context of yours and others overall research endeavors Build alliances and lobby and with senior/key researchers

12. Grant proposal/writing: the review you want to avoid “This application is characterized by ideas that are both original and scientifically important… …unfortunately the ideas that are scientifically important are not original and the ideas that are original are not scientifically important.”

13. Regulatory issues distinguishing drugs from devices often, but not always, easy

14. What makes devices unique: product Pharmaceuticals (drugs & biologics) Molecular entities Limited shelf life Long market life Potential for interactions with other drugs Wrong drug/dose issues Devices Complex components Many = durable equipment Short product cycles – “tweaking” of design Device malfunctions User errors

15. What makes devices unique: firm Pharmaceuticals (drugs & biologics) Large, often multi- national firms Extensive clinical trial experience Devices Entrepreneurial firms common Device “developer” often involved Many have minimal clinical trial experience Sponsor-investigators common

16. What makes devices unique: studies Pharmaceuticals (drugs & biologics) Nonclinical toxicology Clinical 1000s of subjects phases routinely blinded placebo = common control Devices Nonclinical biocompatibility nonclinical studies may suffice Clinical 100s of subjects pilot study possible + pivotal blinding less common “controls” vary training often critical (Human Factor concerns)

17. Regulatory submission Follow the rules Emphasize safety and durability Explicit communication with plain language for patients, caring physicians, and decision-makers Do not overstate efficacy/safety Estimate time and costs appropriately Select, if possible, most competent AND speditive regulatory authorities The devil is in the detail

18. Useful regulatory tricks The intended use and manufacturers claims for medical products have a fundamental role on regulatory processes The majority of drugs and devices have a clear regulatory path to the market (eg, drug-eluting stents are medical devices with ancillary drugs) Regulatory strategies should be assessed and clarified at the earliest stage of product development, and revised regularly throughout the programme so that opportunities to correct the regulatory pathway are not missed

19. Questions?

20. And now, take a look at what you will be doing in the next future…

21. For further slides on these topics please feel free to visit the metcardio.org website: http://www.metcardio.org/slides.html http://www.metcardio.org/slides.html