It is an exciting time in the pharmaceutical industry. According to industry organization PHRMA, there are currently more than 7,000 new medicines under development with many being first in class treatments. Digital technology combined with medicine, gene therapy and personalized medicine are driving a lot of this.
However, to bring these treatments to market, clinical trials must be run. Many of these trials are run by innovative biotech companies such as Moderna Therapeutics (conducting trials for personalized gene therapy to cure cancer) and Spark Therapeutics (using gene therapy to treat hemophilia and retinal disease). As a result, there are more than 75,000 studies currently open that need patients.
With the explosion of clinical trials, the need to recruit patients has grown exponentially but the patient population willing to participate in trials has not grown nearly as much. Not only are a lot more patients needed, but also it has become increasingly difficult to find the right trials for willing participants because there are many more trials to sort through to find the right one for them.
As a result, poor patient enrollment has become the biggest reason for clinical trial delays and failures.
The statistics are daunting. More than 50 percent of clinical trial sites fail to meet their enrollment goals and up to 20 percent of the sites fail to enroll a single patient. It is no wonder that 80 percent of clinical trials fail to meet their enrollment timelines and approximately one-third of Phase III studies are terminated due to enrollment problems.
However, this inability to recruit patients is not due to lack of effort or money. The industry spends over $5.9 billion on patient recruitment.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“The problem with ClinicalTrials.gov is it is totally unbiased,” Facebook cofounder and philanthropist Sean Parker observed at an industry event in reference to the government registry of clinical trials by NIH. “It is just a directory. A lot of those clinical trials are somewhere between useless and harmful. So, it is very difficult to know anything about whether you should enroll in a trial.”
While there is a bit of hyperbole in Parker’s comment about a lot of trials being “between useless and harmful,” you still can’t deny the fact that the information is, as Parker described, “unbiased” thereby making it difficult to discern whether to participate in a trial.
Although ClinicalTrials.gov rightfully gets a lot of credit for creating a listing of trials (it is required by law for pharmaceutical companies to register trials), perhaps it has reached the limits of its usefulness. Since its launch on Feb 29, 2000, despite having undergone several iterations, its functionality hasn’t changed and it remains a glorified “directory”.
In other aspects of our lives, directories have been replaced by services such as OpenTable that help users choose the provider and assist with the transaction in real time. For clinical trials, the same needs to be done and my company with its PatientWing offering strives to do just that by taking information from clinicaltrial.gov and providing it as a service for patients.
Regardless of how we get there, whether it is a private enterprise or a revamp of ClinicalTrials.Gov, here is what needs to be done:
Make the information useful
The National Cancer Institute (NCI) has researched and reported reasons offered by patients on why they participate in trials.
- Recommendation or influence of a doctor;
- Hope for therapeutic benefit;
- Altruism or to advance science;
- Lack of other medical options;
- Access to leading specialists;
- Ability to receive cutting-edge care and the latest treatment discoveries.
The above can be accomplished by clearly listing benefits and how the trial might impact patients. Providing more details about clinicians and research scientists conducting the trials as well as the clinical trial sites could also help.
Make it actionable
Online services such as OpenTable assist users in making contact and starting the transaction online. Can the same be done for clinical trials? The short answer yes. Making it easier for patients to initiate contact with the research site and start the process of enrollment makes a lot of sense. Would-be participants are online looking for the trials so why not give them the option to initiate contact with the site and request an appointment?
Photo: Rawpixel, Getty Images
