spacer
home > epc > autumn 2017 > ethical approaches
PUBLICATIONS
European Pharmaceutical Contractor

Ethical Approaches

Despite the continuous development of new treatments, availability of efficient and safe methods remains a great unmet need. This term, ‘methods’, refers to the vast range of approaches to chemical and biologic medications, cell-based therapies, medical devices, psychotherapy and so on. Testing new procedures against placebo is thought to provide the most reliable data on the value of a new solution.

However, it is not unusual that this comparison is unfeasible for technical or practical reasons or because it is considered unethical. The latter especially affects the development of treatments for severe diseases or for vulnerable populations, where the use of a placebo instead of an active comparator or standard-of-care may be dangerous for the subject. In some cases, the use of placebos can also be linked with a risk to other people, for example, due to an increased possibility of aggressive or asocial behaviours.

These considerations have fuelled many years of debate over the use of placebos in clinical trials. Regulators, opinion leaders, patient advocates and journalists express their opinions on this matter – noticing a disagreement between the stakeholders is easy.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Piotr Piotrowski is a Medical Director at KCR and holds a PhD in neurology. He is responsible for cross-therapeutic oversight of new and ongoing company projects from a medical perspective. Piotr’s professional experience includes more than 10 years in medical affairs, preclinical research, clinical development and regulatory affairs in the environment of the world’s top pharma industry and academic entities.

Dr Magdalena Czarnecka is a member of the Commercial Project Support Team at KCR, responsible for landscaping and development of clinical documentation. She gathered her professional experience during preclinical research at Georgetown University in Washington DC, US, and her work for a consulting firm focused on medical technology assessment. Magdalena holds a PhD in physiology and biophysics.

Dr Anna Baran
is a Chief Medical Officer at KCR. She leads the organisation’s early stages of study operations and provides cross-functional support to all service areas, ensuring the smooth integration of medical affairs and regulatory and business development efforts. Throughout her career, Anna has worked closely with recognised authorities across Eastern Europe and has been involved in developing national legislation for clinical trials registration.
spacer
Dr Piotr Piotrowsk
spacer
spacer
spacer
Dr Magdalena Czarnecka
spacer
spacer
spacer
Dr Anna Baran
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

MRC Technology monetises royalties on cancer drug Keytruda (pembrolizumab) to expand medical research activities, with a fund managed by DRI Capital


More info >>

White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
More info >>

 
Industry Events

CPhI India 2017

27-30 November 2017, Bombay Exhibition Centre & MMRDA Grounds, BKC

Connect, network and interact with 1,400+ exhibitors at India's largest and leading pharmaceutical event. CPhI and P-MEC India is the gateway for you to meet the movers and shakers in India’s pharma industry to source high quality pharma solutions at the most competitive prices. Register today for free via: gotocphi.com/india2017
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement