Company:ClinLife

From HandWiki
ClinLife
TypePrivate Company
Founded2005; 19 years ago (2005)
HeadquartersHamburg, Germany
Number of locations
Berlin, Hamburg, London, Somerville, NJ, Belgrade, Shanghai
Area served
Europe, North-America, South-America, Asia, Oceania
Key people
Michael Stadler (Co-founder), Dr. Andree Beckerling (CEO), Stephanie Oelkers (CFO) and Axel Schulz (CTO)

ClinLife is the largest European-based patient portal for clinical trials with over 13 million unique visitors a year and 1 million registered patients from about 50 countries worldwide.[1] [2] [3] Founded in 2005 by the German company Clariness, it initially operated primarily in the DACH region but since has expanded to the United States, South America, Oceania and Asia. [4]

ClinLife started in 2005 with the aim to facilitate the participation in clinical research studies and thereby speed up the development of new medication and treatments. It aims to support Contract research organization, research site and Pharmaceutical Research who have historically struggled with reaching and informing patients about relevant clinical trials.[5] Researchers estimated in 2018 that 86% of all clinical trials are delayed due to a lack of qualified participants.[6] ClinLife's services are free of charge for participants and are financed in cooperation with research sites and sponsors.[7]

History

The demand for better access to clinical trials originates from before the introduction of the internet. In the late 1980s, HIV-infected men in the gay community pressured the US Congress to improve the accessibility to clinical trials that investigated medication and treatments for AIDS.[8][9][10] In response, U.S. Congress passed the Health Omnibus Programs Extension Act in 1988 (Public Law 100-607) which created the first (offline) database for clinical trials. In 1997, the US Food and Drug Administration Modernisation Act turned this databank into an online registry, as it obliged the National Institute of Health to set up a digital register for Clinical Trials [11] This went online in 2000 under the name ClinicalTrials.gov.

Other countries initiated similar initiatives in the mid-2000s, and for example Germany launched the Deutsches Register Klinischer Studien in 2008, while the France and the World Health Organization came with similar initiatives at the same time. [12] [13] Most of these platforms however exclusively focus on the national context and are only accessible in the countries language or English.[14] [15]

With the advent of the internet, patients increasingly began making use of digital platforms as dedicated forums, blogs and social media groups to find information about scientific research on their indications or diagnoses.[16] These various online health communities, besides functioning as support-platforms, also were used by patients to share information about new treatment options and clinical trial participation.[16]

History of ClinLife

As ClinicalTrials.gov focused primarily on the American context, and only provided descriptions in English, and mostly in specialist language, in the early 2000s there was no central clinical trial registry for patients in many other countries and languages. [17] [18] For this reason a group of German doctors and web developers decided to set up ClinLife, to simplify the access to clinical trials in Germany. [19] The first study that was hosted on this new ClinLife platform, was a clinical trial study on diabetes that took place in Berlin district of Charlottenburg in December 2005. [20]

While most patients in the early years of ClinLife were still informed about clinical trials through more old media as radio, television and print, by 2007 these efforts had moved largely to digital media. [21] In that same year, the original name of the digital portal was changed from Klinische Forschung Deutschland to ClinLife, opening up the possibility for multilingual use. The first clinical trial studies facilitated by ClinLife in an language other than German took place that same year in the United Kingdom. [22]

2008 saw ClinLife largest expansion to that date, with it becoming accessible for patients and clinical research sites in Belgium, the Netherlands, the Czech Republic, France, Italy, Poland and Portugal. The availability of clinical trials in these new regions and languages led to a rapid increase in visitors searching for information about clinical trial research, receiving over a million unique visits by the end of that year.[23]

By 2015 ClinLife was accessible in 25 countries, from almost all the countries in Europe, to the United States, Canada, most of South America and Oceania. That year the 500,000th member worldwide registered on the platform. [24] [25] [26] In 2018, Clariness, the mother company of ClinLife, acquired the German start-up Viomedo, by then the largest dedicated search engine for clinical trials in Germany. This formed a large stimulation for the further expansion of ClinLife, that with the expansion to China in 2019 became accessible in 50 countries. [27] It also completed the facilitation of its 1,000th clinical trial study in that same year. [28]

Clariness CEO Michael Stadler in 2019 joined the Advisory Board of The Center for Information and Study on Clinical Research Participation (CISCRP). This American non-profit organization, aims to educate the public and policy-makers about clinical trial research. [29]

Current status

In February 2021, ClinLife received funding from the European Union in the context of the EU innovation investment fund, part of the Framework Programmes for Research and Technological Development, that was launched during the COVID-19 crisis.[30] The European Union in its official release noted that the funding for ClinLife was given with the aim to further "expand its free and user-friendly website where patients worldwide can find relevant clinical trials for their condition".[31] [32]

As of March 2021, ClinLife has supported over 1,200 studies worldwide and has 1.4 million registered users. Partly in response to the rapid increase of visitors, the platform increasingly began focusing on providing information in plain language about various indications, illnesses and scientific research into new medications and treatments.[33]

It also hosts services as an online screening-tests and telephone interviews for potential participants, to ensure that they meet the in- or exclusion criteria for a clinical trials.[34]

Digital patient recruitment in the future

Participants in clinical trial studies traditionally are referred to studies by their private doctors, leading to large differences in participation between social, ethnical groups and gender.[35] Authorities for a long time have tried to address this problem, and in the United States the health authorities have since the early 2000s put up criteria that demand of clinical trials to include a certain proportion of participants that are women or from ethnical minorities.[36][37] Reaching minority communities has continued to be a problem for clinical trial researchers and even the seemingly widespread public participation in the recent COVID-19 clinical trials was criticized by some researchers and activists for not representing the entirety of the population.[37]

As governments in recent years have continued to extend requirements for diversity in clinical trials to address issues as sex differences in medicine and underrepresentation of minorities, some researchers have suggested that clinical trials should increase their online presence.[38] These studies note that online communication has been able to diversify study participation in clinical trials and, partly for this reason, speed up the process of clinical trials.<[38]



References

  1. BioSpace, 'Clariness Celebrates 10 year Commitment To Accelerating Clinical Trials With ClinLife Enhancements' (30 September 2015) https://www.biospace.com/article/releases/-b-clariness-b-celebrates-10-year-commitment-to-accelerating-clinical-trials-with-clinlife-enhancements-/
  2. EIF, 'Case-study Clariness and ClinLife' https://www.eif.org/what_we_do/equity/Case_studies/rcr-clariness-germany.htm (accessed 10.05.2021)
  3. TrialHealth, 'Clariness Announces Release of ClinLife ® Investigator Portal Version 2.0', January 17, 2018 http://trialhealth.org/2018/01/clariness-announces-release-of-clinlife-investigator-portal-version-2-0/ (accessed 10.05.2021)
  4. European Investment Fund, ‘EU support for innovative SMEs to accelerate vaccine development’ (2021) |url=https://ec.europa.eu/info/strategy/recovery-plan-europe/recovery-coronavirus-success-stories/jobs-and-economy/support-innovative-smes_en%7Cpublisher=European Investment Fund|access-date=2021-05-21|
  5. BioSpace, 'Clariness Celebrates 10 year Commitment To Accelerating Clinical Trials With ClinLife'(Sep 30, 2015) url=https://www.biospace.com/article/releases/-b-clariness-b-celebrates-10-year-commitment-to-accelerating-clinical-trials-with-clinlife-enhancements-/
  6. Huang, Grant D.; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N.; CTTI Recruitment Project, Team. (March 2018). "Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative". Contemporary Clinical Trials 66: 74–79. doi:10.1016/j.cct.2018.01.003. PMID 29330082. 
  7. Treweek, Shaun; Lockhart, Pauline; Pitkethly, Marie; Cook, Jonathan A; Kjeldstrøm, Monica; Johansen, Marit; Taskila, Taina K; Sullivan, Frank M et al. (2013). "Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis". BMJ Open 3 (2): e002360. doi:10.1136/bmjopen-2012-002360. PMID 23396504. 
  8. Edward, Kennedy (4 November 1988). "S.2889 - 100th Congress (1987-1988): Health Omnibus Extension of 1988". url=https://www.congress.gov/bill/100th-congress/senate-bill/2889
  9. Reagan, Ronald W. (May 4, 1987). "Statement by Assistant to the President for Press Relations Fitzwater on the Establishment of a National Commission on AIDS - May 4, 1987". Internet Archive. Washington, D.C.: National Archives and Records Service. p. 462. url=https://archive.org/details/4732393.1987.001.umich.edu/page/462
  10. ACTIS, 'AIDS Research and Clinical Trials' (accessed 10.05.2021) url=http://www.actis.org/AIDS-Research.html
  11. 105th Congress, public law 105-115 'food and drug administration modernization act of 1997' page 2295 url=https://web.archive.org/web/20081213120756/https://www.fda.gov/cder/guidance/105-115.htm
  12. In Germany, the governmental Deutsche Klinische Studien Register gained approval of the World Health Organization in 2008. See: DRKS, 'About the project' (05-26-2020) url=https://www.drks.de/drks_web/setLocale_EN.do for a similar French platform see: Recherche clinique, 'Professionnels de la recherche' url=https://www.e-cancer.fr/Professionnels-de-la-recherche/Recherche-clinique
  13. World Health Organization, 'International Clinical Trials Registry Platform (ICTRP)' (accessed 10.05.2021) url=https://www.who.int/clinical-trials-registry-platform
  14. DRKS, 'About the project' (05-26-2020) url=https://www.drks.de/drks_web/setLocale_EN.do
  15. Clinicaltrials.gov, 'What Is ClinicalTrials.gov?' url=https://clinicaltrials.gov/ct2/about-site/background (accessed 10.05.2021)
  16. 16.0 16.1 Nambisan, Priya (1 May 2011). "Information seeking and social support in online health communities: impact on patients' perceived empathy". Journal of the American Medical Informatics Association 18 (3): 298–304. doi:10.1136/amiajnl-2010-000058. 
  17. Clinicaltrials.gov, 'History' (accessed 10.05.2021 https://clinicaltrials.gov/ct2/about-site/history
  18. StatNews, 'It’s time to make ClinicalTrials.gov a better tool for patients', April 28, 2020 https://www.statnews.com/2020/04/28/make-clinicaltrials-gov-a-better-tool-for-patients/
  19. OpenPr Gesundheid & Medizin, 'Starke Nachfrage von Patienten nach Teilnahme an klinischen Studien' 13 November 2007 https://www.openpr.de/news/177517/Starke-Nachfrage-von-Patienten-nach-Teilnahme-an-klinischen-Studien.html
  20. Xtalks, 'Optimizing Clinical Trial Patient Recruitment from Lessons Learned: From the Burning House to Strategic Collaboration', November 12, 2015) https://xtalks.com/webinars/optimizing-clinical-trial-patient-recruitment/
  21. Life Science Nord Magazine, 'Quest for Success Three ways of turning a promising drug candidate into a marketable product' page 3-7 https://lifesciencenord.de/files/Magazin/LSN_4_2012.pdf
  22. Biologie Seite Deutschland, 'ClinLife Geschichte', https://www.biologie-seite.de/Biologie/Clinlife (accessed 10.05.2021)
  23. Parexel Teams with CLARINESS to Enhance Patient Access and Engagement in China June 12, 2019 https://www.businesswire.com/news/home/20190612005137/en/Parexel-Teams-with-CLARINESS-to-Enhance-Patient-Access-and-Engagement-in-China
  24. Clariness Facebook, 'celebrating 15 years of CLARINESS and ClinLife' (accessed 10.05.2021) https://www.facebook.com/ClarinessGlobal/videos/we-are-celebrating-15-years-of-clariness-and-clinlife-15-years-of-excellence-in-/889284928155016/
  25. Biologie Seite Deutschland, 'ClinLife Geschichte', https://www.biologie-seite.de/Biologie/Clinlife (accessed 10.05.2021)
  26. LIFEpr, 'CLARINESS eröffnet neue Niederlassung in den USA' 11 February 2010 https://www.lifepr.de/inaktiv/clariness-holding-ag/CLARINESS-eroeffnet-neue-Niederlassung-in-den-USA/boxid/146220
  27. Health Capital Germany, 'Clariness kauft Berliner Startup Viomedo', 29 October 2018 https://www.healthcapital.de/news/artikel/clariness-kauft-berliner-startup-viomedo/
  28. Clariness, 'ClinLife in Numbers' https://www.clariness.cn/clinlife/
  29. Applied clinical trials online, 'Michael Stadler joins Advisory Board at CISCRP' https://www.appliedclinicaltrialsonline.com/view/latest-business-and-people-news-32
  30. European Commission, 'EU support for innovative SMEs to accelerate vaccine development', accessed 11.05.2021 https://ec.europa.eu/info/strategy/recovery-plan-europe/recovery-coronavirus-success-stories/jobs-and-economy/support-innovative-smes_en
  31. European Commission, 'EU support for innovative SMEs to accelerate vaccine development', accessed 11.05.2021 https://ec.europa.eu/info/strategy/recovery-plan-europe/recovery-coronavirus-success-stories/jobs-and-economy/support-innovative-smes_en
  32. ECCP News, 'EU support for innovative SMEs to accelerate vaccine development', 9 February 2021 https://clustercollaboration.eu/content/eu-support-innovative-smes-accelerate-vaccine-development
  33. European Commission, 'EU support for innovative SMEs to accelerate vaccine development', accessed 11.05.2021 https://ec.europa.eu/info/strategy/recovery-plan-europe/recovery-coronavirus-success-stories/jobs-and-economy/support-innovative-smes_en
  34. TrialHealth, 'Clariness Announces Release of ClinLife ® Investigator Portal Version 2.0', 17 January 2018 http://trialhealth.org/2018/01/clariness-announces-release-of-clinlife-investigator-portal-version-2-0/
  35. Medical News Today, 'Increasing diversity in clinical trials: What can doctors, regulators, and patients do?', 10 July 2020 https://www.medicalnewstoday.com/articles/increasing-diversity-in-clinical-trials-what-can-doctors-regulators-and-patients-do
  36. NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research url=https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm and NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH - OCTOBER, 2001 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html
  37. 37.0 37.1 Flores, Laura E.; Frontera, Walter R.; Andrasik, Michele P.; del Rio, Carlos; Mondríguez-González, Antonio; Price, Stephanie A.; Krantz, Elizabeth M.; Pergam, Steven A. et al. (19 February 2021). "Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials". JAMA Network Open 4 (2): e2037640. doi:10.1001/jamanetworkopen.2020.37640. 
  38. 38.0 38.1 Brøgger-Mikkelsen, Mette; Ali, Zarqa; Zibert, John R; Andersen, Anders Daniel; Thomsen, Simon Francis (4 November 2020). "Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis". Journal of Medical Internet Research 22 (11): e22179. doi:10.2196/22179. PMID 33146627. 

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