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Summary in Thirty Seconds
A Chief Medical Officer serves as a physician and a business leader and is responsible for the success (or failure) of a compound/program in development.
Lack of awareness of clinical trials is a major reason for enrollment delays, so building awareness proactively and compliantly is critical for clinical trial success.
Awareness can be built through multiple steps, including holding ad boards, building SEO, creating trial websites, utilizing social media, and enlisting Patient Advocacy Group assistance.
The cost of these steps is minimal compared to the cost of delayed and failed clinical trials, which can cost companies millions.
As opposed to doing business as usual and getting similar results, a CMO knows ahead of time that awareness and enthusiasm are critical to enrollment and knows the importance of beginning early to maximize the effectiveness of such compliant campaigns.
The CMO as a Physician and Business Leader
The Chief Medical Officer (CMO; or VP of Clinical Development in firms without a CMO) provides leadership and direction for a pharma’s pipeline of clinical development program(s) and frequently works under enormous time pressure. A CMO serves as both a physician and business leader; thus, a CMO is ultimately responsible for the success (or failure) of a compound/program in development. Estimates are that a failed clinical trial costs a biotech company at least one billion dollars.[1],[2],[3] A widespread problem in the industry is that study centers report enrolling fewer eligible patients than anticipated,[4] resulting in failures to meet enrollment benchmarks or failure to enroll even one subject.[5]
What causes enrollment problems and what can a CMO do about it?
One major issue is that enrollment is slow or fails because patients and healthcare providers are not aware of the clinical trial, and the sponsoring biotech has not built proactive strategies around awareness. Rarely is the job of establishing and raising awareness assigned to anyone directly.
Who should be planning and raising awareness and when should this begin?
Building awareness of new clinical trials, biomarkers, and specific biomarker-driven illnesses is critical for successful trial enrollment. Staff within the pharma rarely have the time or expertise to build awareness, so this task is best contracted to an agency with expertise in awareness building. CROs do not do this well—it is not their job and a distraction from performing trial logistics—although many will claim ability and expertise. Compliant awareness campaigns should ideally begin a year before clinical trials start. Building awareness this early in the process is not yet the job of medical affairs because typically med affairs groups are not built and staffed until a successful Phase 3 trial and approval are likely.
How is awareness compliantly built while not jeopardizing the integrity of a clinical trial?
Awareness programs must follow careful compliance guidelines. The regulations to define compliance are regularly updated, but building awareness is not promotion, which is made clear, particularly when it comes to efforts involving the public. Awareness is not marketing; it’s not pushing a particular drug. Awareness campaigns are unbranded—not tied to a specific pharma or compound. It’s helping healthcare providers and patients learn of and talk about a particular biomarker or the availability of clinical trial options. Furthermore, awareness campaigns may spur pathologists to look for a specific biomarker, drive people to their doctor for a diagnosis, and/or encourage patients and their families to ask their healthcare providers about appropriate clinical trials given their biomarker-driven diagnosis.
The First CMO Need-to-Know: What Is Awareness?
Awareness is how much a specific element or issue is being discussed, studied, and developed both at a given time and over time. At Celerity, we define awareness at a given time as the term ‘trending’, while ‘awareness’ is built over time. Once aware of something, someone doesn’t become “unaware” of it, so awareness is cumulative, always showing a progression; whereas, trending will rise and fall. These metrics can encompass both the disease/condition of interest, the biomarker driving that disease, and the compound targeting that biomarker. Biomarkers can be differentiated by specialty and region, and typically, awareness of the biomarker is greater than that of the compound with trending peaking earlier for the biomarker than for the compound.[6]
The Second CMO Need-to-Know: How Is Awareness Built?
Some specific steps to build compliant awareness include:
Hold ad boards. A side effect of holding an ad board can be building awareness in KOLs who then take this raised awareness back to their colleagues as well as clinical and academic work sites.
Build SEO. It takes time—at least 9 months of regular, tailored work without shortcuts—for SEO to take effect.[7] Given the lead time necessary to build SEO, it is vital to start early in the process.
Create a trial website. Link a trial website to clinicaltrials.gov. This can go live about a month before the first clinical trial site opens.
Use Facebook/Google/Instagram Ads. Such ads are done with IRB approval within the regions/countries on which these ads focus. This outreach also needs to be language-specific if the clinical trials expand into other countries.
Utilize Patient Advocacy Groups (PAGs). PAGs can be partners in increasing clinical trial and biomarker/tumor mutation awareness. Good PAGs are eager to build awareness of the specific condition for which they are advocating, which means a willingness to work with companies testing new compounds targeting the specific biomarker or disease around which the PAG was built.
Monitor awareness over time. Monitoring trending and awareness of specific biomarkers or conditions gives a baseline level to which the effectiveness of awareness-building campaigns can be measured over the time of outreach efforts. You can’t improve what you don’t measure.
The Third CMO Need-to-Know: What Does Building Awareness Cost?
Turn the question of the cost of building awareness on its head. The cost of not building awareness is huge. At least 85% of clinical trials will be delayed by a month or more[8] with many experiencing delays of 6 months or more. The Tufts Center for Study of Drug Development reports that 71% of oncology studies and 94% of all clinical studies take twice as long as planned to meet patient enrollment goals.[9] Such delays cost between $600,000 to $8 million per day in study and sales costs.[10] Reviews of failed cancer trials have found that 30-39% of trial failures were due to poor patient accrual[11],[12] with the cost of a pivotal cancer clinical trial running as high as $442 million,[13] and the cost of bringing a cancer drug to market running a median of $2.8 billion.[14]
Back to the CMO, who is both a physician and a business leader. When clinical trials are delayed, the costs are human and financial: people with an illness experience delays in getting potentially life-saving treatments, and businesses lose millions of dollars daily. The cost of building awareness is minuscule when viewed in light of the price paid for launching a clinical trial where little-to-no awareness exists.
The Typical Clinical Trial Tale–Slow and Slower
The clinical operations team under the CMO establishes and opens new trial sites as has been done for decades. The logistics of opening these sites is usually well orchestrated by most teams – each site requires an IRB approval and a negotiated budget–two items typically consuming a couple of months but that can be done in parallel. Country-specific approvals have to be completed. The CMO then does a site initiation visit—the best biotechs bring a strong leader from their company to show support—and answers questions, ensures the protocol is clear and generally builds enthusiasm in opening the trial. After all this effort, the good news is that the site is open, and patients can be enrolled—if you open it, they will come.
The bad news is that from the time the trial opens until it is complete, nearly every board meeting includes a time when the CMO must explain why enrollment is slower than planned. When the clinical team asks the Primary Investigators why enrollment is lagging, they rightly respond that there are many other trials they’re dealing with, they’re woefully understaffed, and they have no bandwidth for doing anything more than announcing the trial is open at their center. The CMO and staff make and show slides about why this compound is novel and exciting, attempting to raise enthusiasm. Yet, all this work is too late to really impact enrollment velocity. Maybe a trial website is built, or maybe a company is engaged to try to help them find patients. But still, everything runs slowly and behind schedule.
An Alternative Story
Consider an alternative: A CMO knows ahead of time that awareness and enthusiasm are critical to enrollment and knows the importance of beginning early—months before clinical trial launch. The clinical team thinks carefully about what kinds of keywords and search terms patients will be looking for as they decide if they are appropriate for this trial. They might use novel awareness AI approaches to determine the awareness levels of referring physicians (by occupation) for a given biomarker and competing programs. The team will determine the real things behind people’s searches and will assess the awareness of the particular disease and the biomarker driving that disease. The team will enlist help to build SEO around the terms most critical for finding the trial. The CMO knows that most people will build their awareness and find a clinical trial by digital searching. The plan ties in Patient Advocacy Groups (PAGs) that can help patients navigate the clinical trial and medical care landscape so foreign to most newly diagnosed people, and picks and works with a handful of strong PAGs to ensure that both awareness is adequately and clearly messaged to the PAGs and the patients they represent. A CMO who directs steps such as these will then go to the board meeting and deliver the news that enrollment is going well because foresighted efforts have built compliant awareness.
1] The High Price of Failed Clinical Trials Time to Rethink the Model (clinicalleader.com) [2] JAMA. 2020; 323(9):844–853 [3] INQUIRY: J. of Health Care Org., Prov., and Financing. 2021; 58 [4] JNCI J Natl Cancer Inst. 2016; 108(2):djv32 [5] Clin. Trials, 2010; 7:312-321 [6] The Need for Awareness of Clinical Research | National Institutes of Health (NIH) [7] How Long Does SEO Take? (searchenginejournal.com) [8] Patient-Centric Clinical Trials: The Acceleration of Decentralized Patient Monitoring (forbes.com) [9] Impact Reports — Tufts CSDD [10] www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss [11] JNCI J Natl Cancer Inst. 2014; 106(9):dju229 [12] Clin Trials. 2015; 12(1):77–83 [13] JAMA Intern Med. 2018;178(11):1451-1457 [14] JAMA. 2020; 323(9):844-853
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