{"id":24664,"date":"2017-11-15T19:18:08","date_gmt":"2017-11-16T00:18:08","guid":{"rendered":"https:\/\/digital.hbs.edu\/platform-rctom\/submission\/clinical-trial-recruitment-at-acurian-in-a-digital-age-lives-and-millions-of-dollars-are-at-stake\/"},"modified":"2017-11-15T19:18:08","modified_gmt":"2017-11-16T00:18:08","slug":"clinical-trial-recruitment-at-acurian-in-a-digital-age-lives-and-millions-of-dollars-are-at-stake","status":"publish","type":"hck-submission","link":"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/clinical-trial-recruitment-at-acurian-in-a-digital-age-lives-and-millions-of-dollars-are-at-stake\/","title":{"rendered":"Clinical Trial Recruitment at Acurian in a Digital Age: Lives and Millions of Dollars are at Stake"},"content":{"rendered":"

Acurian, little known outside the healthcare industry, often controls the destiny of blockbuster drugs for market behemoths such as Pfizer, Merck, JNJ, Novartis, Gilead, and others whose trials are at risk of enrollment failure. <\/strong><\/p>\n

The immunotherapy treatment Kymriah can result in full remission of terminally ill patients with certain forms of leukemia, some of whom have as little as a few weeks to live. The treatment took five years to develop, and with a price tag of $475,000 has potential annual revenue of $285 million[1]<\/a>. It is the first of the much-hyped CAR-T immunotherapy treatments approved by the FDA. Kymriah is truly life-saving, and yet with an addressable patient population of a mere 600 children annually, developing treatments such as these can hinge on identifying eligible patients with which to conduct trials[2]<\/a>.<\/p>\n

The problem is not small. Approximately $6 billion annually is spent on patient recruitment, and it is the number one cause of clinical trial delays and cost overruns[3]<\/a>. Patient recruitment is the single biggest cause of clinical trial delays, and 30% of Phase III study terminations are due to enrollment difficulty. Additionally, nearly 80% of clinical trials fail to meet enrollment timelines[4]<\/a>[5]<\/a>.<\/p>\n

Acurian has disrupted traditional methods through its \u201cPatients First\u201d recruitment model. However, properly mining its patient database remains an ongoing challenge. <\/strong><\/p>\n

As drug development increasingly turns to rare diseases with small patient populations, patient identification becomes even more difficult and important.<\/p>\n

Historically, patient recruitment has been \u201csite-focused\u201d in that trial sponsors first set up clinical trial sites, and then attempt to find eligible patients through traditional methods such as direct marketing in a local area, or connections through physicians at those sites. With increasingly complex study protocols, this approach requires either a larger site footprint or extended deadlines \u2013 in turn increasing costs.<\/p>\n

Acurian has developed a \u201cPatients First\u201d model, in which the Company utilizes its proprietary database consisting of 17 million pre-screened patients to first identify an eligible drug trial population, and only then develop the site network to reach those patients. It \u201ccombines tens of millions of proprietary patient data points\u2026to accurately predict how and when patient randomizations will occur, using study-specific enrollment algorithms rather than relying on what the sites say they can deliver.\u201d Additionally, the Company utilizes cross-device tracking, social listening, and programmatic advertising to reach patients[6]<\/a>.<\/p>\n

\"\"<\/a>
Acurian has effectively been able to increase the number of patients \/ trial site and decrease the overall number of targeting patient populations prior to site activation<\/figcaption><\/figure>\n

In the near term, Acurian is working to further grow its patient database and optimize its patient mapping algorithms. Longer term, the Company sees opportunity to apply its ability to screen patients to longitudinal studies which take 20-30 years of patient monitoring to fully utilize its data trove.<\/p>\n

Curing Alzheimer\u2019s is a prime example. There is a massive effort underway to screen and enroll healthy adults in trials before <\/em>symptoms arise. The goal is to track large swathes of the population to detect incremental changes long before individuals succumb to brain changes. The scale of such a trial has so far been unattainable \u2013 with appropriate scale encompassing 70,000 people, approximately 700,000 patients must be screened.<\/p>\n

\"\"<\/a>
Acurian believes that its custom-built software programs could be leveraged to find patients willing to join an Alzheimer\u2019s trial, and then most importantly track these patients over time . With the cost of caring for Alzheimer\u2019s patients expected to reach $1 trillion by 2050, new strategies for implementing longitudinal trials such as these are critical [9].<\/figcaption><\/figure>Further improvement is needed. A drug currently averages ~8 years to bring to market at a price tag of ~$2.6 billion[7]<\/a>.<\/strong><\/p>\n

To further improve the cost\/time horizon of drug approvals, Acurian should focus on (1) risk-sharing arrangements with pharma companies around enrollment and (2) using patient insights and motivations to improve recruitment methods. Risk-sharing arrangements can help pharma companies better predict and lower the costs to bring a drug to market, encouraging faster drug development. However, Acurian must accurately be able to predict and contract around appropriate timelines, and be willing to implement a new pricing paradigm in the industry. Additionally, gathering patient-specific data around clinical trial participation can improve the \u201cmoat\u201d around the Company\u2019s proprietary patient database.<\/p>\n

Going forward, Acurian must ask itself: are we capable of accurately predicting recruitment timelines to the extent that we are willing to undertake risk? Is our approach irreplicable, or are we primed to be disrupted by the latest and greatest patient identification algorithms?<\/p>\n

(799 words)<\/p>\n

[1]<\/a> “Novartis Receives First Ever FDA Approval For A CAR-T Cell Therapy, Kymriah(TM) (CTL019), For Children And Young Adults With B-Cell ALL That Is Refractory Or Has Relapsed At Least Twice | Novartis”. 2017. Novartis. https:\/\/www.novartis.com\/news\/media-releases\/novartis-receives-first-ever-fda-approval-car-t-cell-therapy-kymriahtm-ctl019.<\/p>\n

[2]<\/a> “FDA Approves First-Ever T-Cell Cancer Treatment, Pioneered At Penn, CHOP”. 2017. Philly.Com. http:\/\/www.philly.com\/philly\/health\/health-news\/fda-approves-novartis-t-cell-therapy-pioneered-at-penn-chop-20170830.html.<\/p>\n

[3]<\/a> “Delay No More: Improve Patient Recruitment And Reduce Time To Market In The Pharmaceutical Industry”. 2017. Www-935.Ibm.Com. http:\/\/www-935.ibm.com\/services\/us\/imc\/pdf\/g510-3320-00delay-no-more-improving-patient-recruitment.pdf.<\/p>\n

[4]<\/a> Hess, Jon, \u201cWeb-Based Patient Recruitment,\u201d Cutting Edge information, http:\/\/www.cuttingedgeinfo.com\/process\/?ref=122<\/p>\n

[5]<\/a> Li, Gen, PhD, MBA and Gray, Robert, MBA, \u201cPerformance-Based Site Selection Reduces Costs and Shortens Enrollment Time,\u201d Monitor, December 2011. Based on analysis of 5,000 terminated clinical trials<\/p>\n

[6]<\/a> “Defying Industry Assumptions With A Disruptive Approach To Solving Patient Enrollment Challenges”. 2017. Acurian.Com. https:\/\/www.acurian.com\/wp-content\/uploads\/2017\/05\/Acurian_Disruption.pdf.<\/p>\n

[7]<\/a> Cost of Developing a New Drug. 2016. Tufts Center for the Study of Drug Development.<\/p>\n

[8]\u00a0“The Expanding Web Of Clinical Trial Patient Recruitment”. 2014. Isrreports.Com. http:\/\/www.isrreports.com\/wp-content\/uploads\/2014\/04\/ISR-The-Expanding-Web-of-Clinical-Trial-Patient-Recruitment-Whitepaper.pdf.<\/p>\n

[9]\u00a0Cost of Developing a New Drug. 2016. Tufts Center for the Study of Drug Development.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Clinical trial delays can result in lost revenue to drug firms of $600k – $8 million per day, not to mention additional lost lives as life-saving treatments wait in the wings . Patient recruitment is the number one cause of clinical trial delays and cost overruns, and Acurian has led the digital transformation of the recruitment process. The Company better identifies and targets appropriate populations through its 17 million patient database and population mapping algorithms [8]. <\/p>\n","protected":false},"author":9710,"featured_media":25099,"comment_status":"open","ping_status":"closed","template":"","categories":[3844,2123,2417,2418],"class_list":["post-24664","hck-submission","type-hck-submission","status-publish","has-post-thumbnail","hentry","category-clinical-development","category-digitalization","category-drug-development","category-drug-development-process","hck-taxonomy-organization-acurian","hck-taxonomy-industry-health","hck-taxonomy-country-united-states"],"connected_submission_link":"https:\/\/d3.harvard.edu\/platform-rctom\/assignment\/rc-tom-challenge-2017\/","yoast_head":"\nClinical Trial Recruitment at Acurian in a Digital Age: Lives and Millions of Dollars are at Stake - Technology and Operations Management<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/clinical-trial-recruitment-at-acurian-in-a-digital-age-lives-and-millions-of-dollars-are-at-stake\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Trial Recruitment at Acurian in a Digital Age: Lives and Millions of Dollars are at Stake - Technology and Operations Management\" \/>\n<meta property=\"og:description\" content=\"Clinical trial delays can result in lost revenue to drug firms of $600k - $8 million per day, not to mention additional lost lives as life-saving treatments wait in the wings . 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