Increasing Productivity and Speed in Clinical Trials: The Low-Cost Solution You Haven't Considered"
A newsletter for Late Stage R&D Executives
It is not the clinical trial that demands innovation but the process by which it is delivered, "the clinical operation". The late stage development (LSD) leadership at Pharma/CRO and BioTech, should aim their innovation energy at the way in which their late-stage development department runs late-stage dev operations.
To the head of late-stage R&D, the entire process by which their departments run late-stage development is a marketing tool, a mechanism for finding and keeping customers.
But who are the customers in Late Stage R&D?
Now, depending on the heaviness of the disease indication and the investigator's involvement in therapy decisions, the customer who is the patient for low-grade indications (example: mild asthma, mild skin diseases, etc.) shifts towards the research site and investigators for high-grade diseases (Oncology, rare diseases, etc.).
The grade is defined based on the patient's confidence in making therapeutic decisions by themselves. Therefore, a patient-centric corporate strategy should vary in the spectrum of indication diversity, something I will discuss in more detail in the future.
In oncology, a patient-centric strategy requires a heavy focus on site and investigator experience. We can only ensure access to patients if we win the investigator's buy-in.
But how to get investigators buy in?
Each and every step and component of the clinical operation system is a means through which the head of late-stage R&D can differentiate his late-stage drug development (LSD) pipeline from all other Late Stage Dev pipelines in the mind of his consumer (patients or/and sites).
In clinical trials, the investigational medical product (IMP) is not the product. For a pharmaceutical company with a late-stage pipeline, the clinical operation is the product.
How the clinical operation team interacts with the customer (often referred to as stakeholders; research sites, patients) is more important than the medical innovation delivered and that one day the commercialization team will sell.
The majority of innovation efforts in clinical research are put into improving data capture, data access for Pharma and the obsessive hunt for patients (data source). The question that needs to be asked is: How to access the data source at scale and at speed?
The how is the clinical operation!
And the how doesn't have to be expensive to be effective. In fact, some of the most powerful innovations have required little more than the change of a few words, a gesture, the delivery of the message.
For example, during the site selection initiation, what does the CRA in a specific study team tell the investigator and study coordinator (CRC)? The CRA will contact the CRC in mail form and say, "Hi, we have a new study, would you be interested? If yes, please sign the CDA."
Have you heard this before? And how does the CRC or investigator reply? They write back, "Sure, send us more details."
It is the same phenomenon across all pharmaceutical and CRO companies. Now, why do we keep starting the process with the same unpersonalized messaging that requires waiting time, pushing the customer to live the redundancy of your operational lack of effectiveness and induce a disengaged relationship that lacks novelty and excitement at its beginning?
Because that's how it has always been. Disengaged exchange affecting speed and quality of interaction between the ClinOps team and research sites.
This is a perfect opportunity to try a simple and inexpensive innovation.
The innovation of words
Instead of asking, "Hi, we have a new study, would you be interested? If yes, please sign the CDA," try, "Have you seen the latest data from our study published and discussed at ASCO 2023?" The investigator will reply with either "yes" or "no." In either case, you are then free to pursue the conversation.
If they say "yes," you can say, "Great, based on those data, we have created a new trial special for patients x, y, z. Let me take a minute to tell you more about it."
If the answer is "no," you can say, "Great, let me tell you about the excellent data based on which we have created a new trial, special for patients x, y, z. Let me take a minute to tell you more about it."
Of course, you will have two different scripts prepared to talk about based on the answer. But that’s the easy part.
Just think about it. A few simple words. Nothing fancy. No digital innovation with a budget spending, but the results are guaranteed to increase the productivity of your pipeline delivery to research sites and put money in your pocket. How much?
Using this strategy, I have been able to run site selection and site qualification visits for complex oncology studies in two business weeks instead of the average 12 weeks.
Using this strategy, I have been able to gather important protocol feedback, revealing issues that might affect patient recruitment down the road, and organize SOS investigator meetings prior to study startup to discuss feasibility and risk mitigations.
This itself got KOLs actively involved in the operation, thinking on how to help a company successfully deliver the trial to sites, recruit patients on time, and ensure the success of the operation. All without even a contractual commitment.
Can you believe it? A few simple words and the timeline of study delivery went down, trustworthy relationships were built, and the customer was excited about that specific study! Not by just a little bit, but by a considerable amount!
Would you want to discuss how to improve your ClinOps productivity cost free? Email me to learn more.
Thank you for being an Insider
Zina Sarif, CEO at Yendou | LinkedIn
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