MANFRED STAPFF MD PHD

Stapff M. The Importance of Real-World Evidence in Medical Research and Drug Development. January 2025. Applied Clinical Trials, February 18, 2025

Stapff M. Controlling the Covid-19 Pandemic without Killing the Economy: About Data Driven Decision Making with a Data Model Assessing Local Transmission Risk. Journal of Public Health International - 3(2) 2020:22-29. DOI: 10.14302/issn.2641-4538.jphi-20-3621

Stapff M, Palm S. “More on Long-Term Effects of Finasteride on Prostate Cancer Mortality.” N Engl J Med 2019; 380:e38. DOI: 10.1056/NEJMc1902700

Stapff M, Hilderbrand S. “First-line treatment of essential hypertension: A real-world analysis across four antihypertensive treatment classes.” J Clin Hypertens. 2019;21:627–634. https://doi.org/10.1111/jch.13531

Stapff M, Stacey, J. “How Can Real-World Data Support Clinical Trials and Medical Research?” Clinical Researcher—January 2019 (Volume 33, Issue 1): 10-27

Stapff, M. „Using real world data to assess cardiovascular outcomes of two antidiabetic treatment classes”, World J Diabetes 2018 December 15; 9(12): 252-257, DOI: 10.4239/wjd.v9.i12.252

Stapff, M. “Use of Electronic Health Data in Clinical Development” (Die Verwendung elektronischer Gesundheitsdaten in der klinischen Entwicklung), Pharm. Ind. 79, Nr. 2, 204–210 (2017)

Stapff, M. „Quality by Design aspects applied to Clinical Study Protocol Development“, Chimica Oggi – Chemistry Today, vol 32(6), 50 -51 (2014)

Stapff, M. “Clinical Trials under IND Conditions” (German: “Klinische Prüfungen unter IND Bedingungen”), Pharm. Ind. 75, Nr. 5, 756-763 (2013).

Lewin A, Punzi H, Luo X, Stapff M. “Nebivolol Monotherapy for Patients With Systolic Stage II Hypertension: Results of a Randomized, Placebo-Controlled Trial”, Clin Ther. 2013 Jan 15

Weber MA, Basile JN, Stapff M, Khan B, Zhou D. “Blood Pressure Effects of Combined b-Blocker and Angiotensin-Converting Enzyme Inhibitor Therapy Compared With the Individual Agents: A Placebo- Controlled Study With Nebivolol and Lisinopril”, J Clin Hypertens (Greenwich). 2012;14:588–592.

Stapff M., Die Welt der klinischen Forschung von morgen: Deutsche Zeitschrift für klinische Forschung 9/10-2009, 25-29

Stapff M., Clinical Trial Trends: Tomorrow's world - what does the future hold? GCPJ 2008 17 – 22

Stapff M., Investigator Sponsored Trials (Kommentar): Deutsche Zeitschrift für klinische Forschung 2005 56

Hundt F., Reinken S., Schmidt J.H., Schrag-Floss D, Stapff M., Stolzenburg K.. Klinische Prüfungen: Die neue Rolle des Sponsors: Dt. Ärzteblatt 2004 A 91-A93

Stapff M., Klinische Forschung im Zeitalter der DRGs. Mögliche Einflüsse der diagnosebezogenen Fallpauschalen auf Arzneimittelstudien im Krankenhaus: Deutsche Zeitschrift für klinische Forschung (9/10) 2004 16-25

Stapff M., Fallgrube Statistik: Deutsche Zeitschrift für klinische Forschung (8) 2004 30-37

Ludwig M., Stapff M., Ribeiro A., Fritschka E., Tholl U., Smith R.D., Stumpe K.O. Comparison of the effects of losartan and atenolol on common carotid artery intima-media thickness in patients with hypertension: Clin Therapeutics 24 2002 1175-1192, https://doi.org/10.1016/S0149-2918(02)80028-5

Stapff M., Reinken U., Lerner-Hiller P., Klein W., Hundt F.. Zusammenarbeit mit Ethik Kommissionen bei klinischen Prüfungen : pharmind 64 2002 543-548

Stapff M., Professionalität fördern : Arzneimittelzeitung, Nr. 18 1998 12 - 15

Scholze J., Stapff M., . Start of therapy with the angiotensin II antagonist losartan after immediate switch from pretreatment with an ACE inhibitor: Br J Clin Pharmacol 46 1998 169-172

Tiebel R., Vahlbruch A., Stapff M., . Efficacy, safety, and effects on hypertension- associated symptoms of losartan, alone or in combination with HTZ versus amlodipine: Current Therapeutic Research Vol 59 1998 325 - 340

Weigold B., W. Zoller, M. Stapff, F. Spengel, N. Zöllner. Überlebenswahrscheinlichkeit von Patienten mit nicht operierten Bauchaortenaneurysmen : Klin. Wochenschr, Suppl. XIX 68 1990 281

Kellner H., M. Stapff, W.G. Zoller, P. Herzer, . Sonographische Befunde bei Chondrocalcinose : Ultraschall Klin Prax Suppl. 1 1989 79

Zoller W.G., M. Middeke, H. Hermanns, M. Stapff, . Duplexsonographische Diagnostik der Nierenarterien- stenose: Vergleichende Untersuchungen mit der arteriellen DSA: Ultraschall Klin Prax Suppl. 1 1989 131

Stapff M., F.A. Spengel, . Sonographische Befunde bei zystischer Adventitia- Degeneration und Entrapment-Syndrom der A. poplitea : Ultraschall Klin Prax Suppl. 1 1989 109

Zoller W.G, Stapff M., . Diagnostische Möglichkeiten der abdominellen Duplex-Sonographie : Bildgebung/Imaging 56 1989 82-88

Stapff M., Steckmeier B., Küffer G.V., Spengel F.A., . Ein Patient mit zystischer Adventitia-Degeneration und Entrapment-Syndrom der A. poplitea : Bildgebung/Imaging 56 1989 77-80

Weigold B., W.G. Zoller, M. Stapff, F.A. Spengel,, N. Zöllner. Sonographische Verlaufsbeobachtung von Patienten mit nicht operierten kleinen Bauchaortenaneurysmen : Ultraschall Klin Prax Suppl. 1 1989 118

Stapff M., Artefakte, in: Zoller e.a. (Hrsg.) Abdominelle Ultra- schalldiagnostik, Aufbau- und Abschlußkurs: Bildgebung/Imaging Suppl. 2 1989 80-84

Stapff M., Zoller W.G., . Physikalische und biologische Wirkungen des Ultraschalls unter diagnostischen Bedingungen - eine Übersicht.: Digit Bilddiagn 9 1989 83-88

Kellner H., M. Stapff, . Artrosonographie, in: Zoller e.a. (Hrsg.),Abdominelle Ultraschalldiagnostik, Aufbau- und Abschlußkurs : Bildgebung/Imaging Suppl. 2 1989 73-79

Stapff M., W.G. Zoller, F.A. Spengel, . Image-Directed Doppler Ultrasound Findings in Adventitial Cystic Disease of the Popliteal Artery : J. Clinical Ultrasound 17 1989 689-691, 

https://doi.org/10.1002/jcu.1870170916

Zoller; W.G., Middeke M., Stapff M., Schewe S.,, Hermans H., Hahn D.. Nichtinvasive Untersuchungen bei renovaskulärer Hyper- tonie mit der Duplexsonographie : Klin Wochenschr Suppl. XVI 1989 185

Stapff M., G. Betzl, F.A. Spengel, . Duplexsonographische Diagnostik der tiefen Bein und isolierten Unterschenkelvenenthrombose : Ultraschall Klin Prax Suppl. 1 1989 25

Stapff M., F.A. Spengel, . Duplex-Sonographische Diagnostik tiefer Bein- und Beckenvenenthrombosen : Herz 14 1989 335-340

Zoller W.G., W. Schneider, M. Stapff, H. Füeßl,, B. Eibl-Eibesfeld, N. Zöllner. Stellenwert der Sonographie in der Tumornachsorge kolorektaler Karzinome. Vergleichende Untersuchung mit dem Verlauf des carcinoembryonalen Antigens (CEA).: Ultraschall Klin Prax Suppl. 1 1989 84

Stapff M., Betzl G., Küffer G.V., Hahn D.,, Spengel F.A.. Stellenwert der Duplex-Sonographie in der Diagnostik der tiefen Bein- und Beckenvenenthrombose : Bildgebung/Imaging 56 1989 52-56

Zoller, W.G., Stapff, M., Weigold, B., Spengel, F.A., Zöllner, N.. Duplexsonographische Messungen bei Bauchaorten- aneurysmen : Ultraschall Klin Prax Suppl. 1 1988 65

Stapff, M., Zoller, W.G., . Duplexsonograohische Messungen kontinuierlicher Blut- strömungen in vitro : Ultraschall Klin Prax Suppl. 1 1988 69

Bönhof, J.A., Kremer, H., Bönhof, B., Stapff, M.,, Zöllner, N.. Bedeutung der Schallkeulendicke in der real- time Sonographie : CT-Sonographie 3 1983 38-41

Bönhof, J.A., Stapff, M., Kremer, H., Zöllner, N., . Das Bogenartefakt in der B-Bild Sonographie : CT- Sonographie 3 1983 133-137

Stapff, M., Nebenkeuleneffekte bei der Diagnostik mit dem Ultraschall B-Bild : Inaugural-Dissertation 1982 Ludwig Maximilian Universität München, 1982

  Manfred Stapff, Real World Evidence Unveiled. Navigating the Maze of Modern Misinformation. Columbia, SC, USA 2025 

Stapff M., Projektmanagement. Vom Chaos zur Perfektion: Projekte richtig planen, stressfrei durchführen, korrekt abschließen: 1. Aufl. 2013 W. Zuckschwerdt Verlag, München, Bern, New York

Stapff M., Arzneimittelstudien - Ein Handbuch zur Durchführung klinischer Prüfungen für Ärzte und medizinisches Assistenzpersonal: 6. Aufl. 2012 W. Zuckschwerdt Verlag, München, Bern, New York

Stapff M., From Panic to Perfection, Essential Project Management Skills, Strategies and Savoir-faire. Outskirts Press, Inc., Denver, CO, 2010

Stapff M., Project Management in Science and Development: Berlin University for Professional Studies, Freie Universtitaet Berlin / Klett Gruppe, 2010

Stapff, M., Physikalische und technische Grundlagen, in: Zoller WG. Weigold B., Gresser U.: Grundkurs abdominelle Ultraschalldiagnostik: Bildgebung/Imaging 56 Suppl.1 1989 5-9

Bönhof, J.A., Bönhof, B., Stapff, M. Schallkeulendimensionen als Artefaktursache in: Otto, R.(Ed), Ultraschalldiagnostik 1982: 1982 Georg Thieme Verlag, Stuttgart, 1982

Palm S, Stapff M. A Real-World Investigation of Finasteride and the Risk of Prostate Cancer. Dia 2019 Global Annual Meeting, San Diego, CA, June 2019

Stapff M. Febuxostat versus Allopurinol in Patients with Gout: A Real World Comparison. Dia 2019 Global Annual Meeting, San Diego, CA, June 2019

Stapff M. Extracorporeal Shockwave Lithotripsy or Ureter Stent after Kidney Colic? A Real-World Data Analysis of Short Term and Long-Term Outcomes. Academy Health Annual Research Meeting 2019. Washington, DC, June 2-4 2019

Kashambwa, R., Stapff, M. Diabetic Complications Associated with SGLT2 and DPP4 Inhibitors: A Real- World Approach, ISPOR International Meeting 2019, May 18-22, 2019, New Orleans, LA, USA.

Stapff M., Palm S. Aktives Screening elektronischer Krankendaten zur Erkennung und Objektivierung von Arzneimittelsicherheits-Signalen: Beispiel Finasterid und Depression. 5. Deutscher Kongress für Patientensicherheit bei medikamentöser Therapie. AkdÄ Berlin, 18. Okober 2018

Stapff M., Palm S., Stacey J. Using Real World Data To Establish An Optimal Treatment Target For Hba1c In Diabetes Type 2. ISPOR 23rd Annual International Meeting, 2018, Baltimore, MD, USA

Stacey J., Hilderbrand S., Stapff M. A Real-World Data Analysis Evaluating The Time To Glycemic Control After Initiation Of Basal Insulin In Type 2 Diabetic Patients. ISPOR 23rd Annual International Meeting, 2018, Baltimore, MD, USA

Stapff M. Comparison Of Bleeding Events, Strokes, And Myocardial Infarcts On Warfarin Or Dabigatran For Treatment Of Atrial Fibrillation: Results Of A Real-World Data Analysis. ISPOR 23rd Annual International Meeting, 2018, Baltimore, MD, USA

Stapff M., Use of Electronic Health Records for Development and Feasibility Testing of Clinical Trial Protocols. Poster presented at the 28th DIA EuroMeeting, April 6-8, 2016 Hamburg, Germany and at the i2b2 AUG-SHRINE 2016 Conference, Harvard Medical School, Boston, MA

Weber MA, Khan B, Basile JN, Zhou D, Stapff M. Efficacy of Combined Therapy With Nebivolol and Lisinopril Compared With the Individual Agents. Poster presented at the 27th Annual American Society of Hypertension, Conference; May 19-22, 2012; New York, NY

Stapff M., Luo X., He J., Nebivolol in Obese Individuals with Systolic Stage II Hypertension: Safety and Efficacy Shown in a Post Hoc Analysis of a Randomized Trial, Hypertension 2011, 58:e167, Poster presented at the American Heart Assoication’s High Blood Pressure Research Scientific Sessions, September 21-24, 2011, Orlando, Florida

Scholze J., Stapff M., Direktes Umsetzen von Captopril auf Losartan - ABDM erfasstes Blutdruckverhalten und Arzneimittelsicherheit: 1996 20. Wiss. Tagung der Deutschen Hochdruckliga, Aachen

Stapff M., KD Dueck, F. Richard, RE Schmieder. Evaluation of the Antihypertensive Efficacy of Losartan Compared to Captopril Using 24h ABPM: 1995 7th European Meeting on Hypertension, Milano

Betzl G., Stapff M., Spengel F.A., Diagnostik der tiefen Beinvenenthrombose mit Dopplersonographie, Duplexsonographie und Phlebographie: Eine prospektive Studie an 66 Patienten: 1991 19.

Jahrestagung der dt. Ges. f. Angiologie, Aachen

FDA-2019-N-6084 Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control. Guidance for Industry

FDA 2019-D-11978 Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs. Draft Guidance for Industry

FDA 2019-D-0481 Rare Diseases: Natural History Studies for Drug Development; Draft Guidance for Industry; Availability

FDA-2018-N-4000 Framework for FDA’s Real-World Evidence Program

Six lessons to learn after more than a year of Covid-19 and more than 500K deaths in the U.S.MedCityNews Community, May 17, 2021

Influenza: Per Zucker durch die Schleimbarriere - DocCheck, (Influenza: via sugar through the mucus barrier), 01/24/2024

Kolonkarzinom: Hype um Diät-Spritzen - DocCheck, (Colon carcinoma: Hype about diet injections), 01/18/2024

Stroke: How dangerous are ACE inhibitors? DocCheck, 02/02/2024

The King's Cancer: Wild Diagnosis Speculation DocCeck 02/13/2024

Carfentanyl: Doctors, are you prepared? DocCheck 02/26/2024

Hypertension: How strenuous does exercise have to be? DocCheck 03/11/2024

Study: First “woke”, then depressed? DocCheck 03/25/2024

Olive oil from the doctor – it's better DocCheck 06/01/2024

Re: Comparative effectiveness of second line oral antidiabetic treatments among people with type 2 diabetes mellitus: emulation of a target trial using routinely collected health data Rapid Response, BMJ 2024;385:e077097

What Power Does to Physicians - DocCheck DocCheck 07/12/2024

Anti-cancer lifestyle: First of all, throw in an aspirin DocCheck 08/05/2024

Drunk Colleagues vs. AI: Who Do You Trust More? - DocCheck 08/05/2024  

ePA: Physicians soon in a data frenzy? - DocCheck 11/13/2024

Semaglutide: Tiny dose, big effect? - DocCheck 12/14/2024

Late meals: Pacesetter for obesity? - DocCheck 12/22/2024

Nutrition: Are all studies cheese? – DocCheck 3/22/2025

Mirror, mirror: Who makes the most dangerous virus in the country? – DocCheck 3/27/2025

Cardiac death due to antidepressants? – DocCheck 4/10/2025

Flu through flu vaccination – huh? - DocCheck 5/2/2025

Beyond Trial Replication: Using Real World Data To Bridge The Efficacy-Effectiveness Gap In Healthcare”, workshop: - ISPOR 2019, May 18-22, 2019, New Orleans

“Real World Data and Real World Evidence in medical research” - NHS Research and Development Forum, Brighton, UK

“Real-World Data to support clinical trials - MIRACUM Consortium, Frankfurt University, Germany

“Using Real World Data To Drive Research & Clinical Trials”, Research Seminar: - 

     Singapore Health Services Research Centre (HSRC), Feb 28 2019. -

     IJN Institut Jantung Negara, Kuala Lumpur, Malaysia, Mar 2nd 2018. - 

     Health Informatics Society of Australia Ltd. (HISA), Brisbane, Australia, April 11th 2017

“Leveraging Real World Data to Streamline Clinical Trials”: - SCOPE Summit, Cambridge Healthtech Institute, Orlando, FL, 2018

“Overcoming the Unknown: Managing the Most Common Perils in the Study Planning Phase”: - SCOPE Summit, Cambridge Healthtech Institute, Miami, FL, 2014

„Klinische Prüfungen unter IND Bedingungen“: Seminar - FORUM Institut für Management, Frankfurt, Germany, 2014

“Risk Management Plan: Identifying, Managing, and Mitigating Contingencies”: - Clinical Project Management, Clinical Summit, Cambridge Healthtech Institute, Boston, MA, October 2011

“Protocol Complexity: Seven Recipes to Simplify Protocols for Better Study Site Compliance”: - Clinical Protocol Optimization, Clinical Summit, Cambridge Healthtech Institute, Boston, MA, October 2011

“Project Management”, Keynote speech at Outsourcing Clinical Trials East Coast, Somerset, NJ, 2011 - Outlook 2015: The future of R&D”, ACRP Global Conference and Exhibition, Denver, CO, 2009

“Project Management in Science and Development” Seminar Series - 

     FORUM Institut für Management, Frankfurt, Germany - 

     Deutsche Universität für Weiterbildung, 

     Berlin University for Professional Studies, Berlin, Germany