McKesson : Community Oncology Practices as Clinical Trial Partners

Pharmaceutical manufacturers developing new cancer drugs and community oncology practices seeking new therapies for patients are ideal clinical trial partners.

In my previous blog post, I described how community oncology practices can access clinical trials and optimize their participation to drive more value for businesses and their patients.

In this blog post, I will outline the benefits to drug manufacturers of using community oncology practices as clinical trial sites and offer some suggestions to manufacturers on how to select practices that best meet their clinical and financial needs.

Challenges facing pharmaceutical manufacturers developing new cancer drugs

How drug manufacturers use clinical trials to test new drugs, seek FDA approval and take approved drugs to market has changed dramatically over the past two decades. Twenty years ago, after a drug manufacturer identified a new biologic target to pursue, the company would set itself on an eight-year journey from the first phase 1 clinical trial to final approval from the FDA. It likely was the only company pursuing that biologic target.

Today, pharmaceutical manufacturers are operating in a much different environment. First, the number of biologic targets has increased. Second, the number of competing manufacturers pursuing the same biologic targets has increased. Third, because of the increased competition described above, the journey from the first phase 1 clinical trial to FDA approval has shortened to as little as 18 months.

All this has created a tremendous amount of competition among pharmaceutical manufacturers. Owning the first drug approved in a class versus the fifth drug in the same class could mean the difference of billions of dollars in the cancer space.

Three benefits to drug manufacturers of using community oncology practices to test new drugs

It's important to understand the challenges facing pharmaceutical manufacturers in order to understand why community oncology practices can be invaluable clinical trial partners for new cancer drugs.

Community oncology practices offer three unique benefits to drug manufacturers:

• Scale. Because of the way clinical trials are designed today, drug manufacturers need more eligible patients faster. If a cancer drug proves safe with an initial set of 15 to 20 patients, the patient enrollment goal on the initial phase 1 trial might expand at the clinically appropriate dose and accrue dozens if not in excess of 100 patients. For highly effective agents in a competitive class, a manufacturer can't wait for three or four eligible patients a month to arrive at a marquee cancer institution and sign up for the trial. Large community practices or networks can provide significant patient volume needed for the new clinical trial design is community based oncology practices.

• Patient type. Manufacturers are seeking eligible patients for their clinical trials who are the typical or 'real world' patients using their new cancer drugs. Age and other clinical risk factors are a great example. Most people diagnosed with a specific type of cancer in the community are representative of the typical demographic and baseline medical conditions associated with that cancer setting. Patients with the same type of cancer being treated at a marquee cancer institution are healthier and much younger. Information on the effectiveness and toxicity of the novel drug in this 'atypical population' can mislead a manufacturer regarding the safety and effectiveness of their drug in a typical population.

• Market. The bulk of patients who would benefit from the new cancer drug are being treated by community oncology practices. It makes sense from a market standpoint to use those practices as clinical trial sites. Community oncology practices that have experience with the novel agent as part of a clinical trial are familiar with the agent, know its administration, toxicity and perhaps are already impressed with its effectiveness. Accelerating the update of a drug soon after launch can help secure market share and position the drug for early success.

Three competencies drug manufacturers should look for in a community practice clinical trial site

In theory, community oncology practices are ideal clinical trial partners for drug manufacturers because they offer the right scale, patient population and market. But how do they provide those benefits in practice? I would suggest that pharmaceutical manufacturers seek out community oncology practices that excel at the following three competencies:

• Research culture. The ideal community oncology practice embraces research and has clinical trials top of mind continuously. The practice knows what clinical trials are open and are seeking to match eligible patients up with those trials. Research and clinical trials are forethoughts when a patient visits, not afterthoughts days or weeks after they leave.
• Clinical protocols. The ideal community oncology practice has a team of well-trained individuals that rigorously follow the clinical protocols for each clinical trial of a new cancer drug. The protocols typically are more stringent than those for existing therapies as drug manufacturers need to know exactly how the new drugs are affecting patients and that the new drugs are being administered safely. Diagnostic tests like CT scans, blood draws or urine samples may need to be done at precise times rather than when most convenient.
• Data reporting. The ideal community oncology practice is efficient and timely at collecting and reporting all the required clinical trial data back to the manufacturer or the contracted research organization. That may include all diagnostic test results if not the actual images, slides and tissue samples themselves.

Five ways pharmaceutical manufacturers can help their community oncology clinical trial sites succeed

If a practice can do those three things-accrue patients, follow protocols and do the paperwork-it's an A site, and drug manufacturers will want the practice for its clinical trial. But pharmaceutical manufacturers also have a role to play in ensuring the practices succeed as clinical trial partners. They should thoroughly vet their clinical trial protocol checklist and capability requirements with the following goals:

• Match clinical protocols to community practice setting. Community oncology practices are not academic medical centers. The requested clinical trial requirements like the timing of blood draws, vital signs, and other observations and tests should be tasks that can be performed by a physician's office during normal business hours.
• Align clinical protocols to available medical equipment. Community oncology practices again are not academic medical centers with highly specialized equipment that might be found in research laboratories. The requested clinical trial protocol activities should be able to be performed by equipment found in a physician's office as compared to a hospital or research laboratory.
• Match clinical protocols to available medical specialists. Community oncology practices are not large, multidisciplinary medical specialty practices. The requested clinical personnel should be found in an oncologist's office. For example, time-sensitive evaluations by cardiologists, ophthalmologists or pulmonologists might be hard to coordinate on a frequent schedule.
• Define standard and non-standard therapies up front. Community oncology practices typically carry significant financial risk and should ensure that the trial covers unusual procedures that might not be covered by most insurers. Having a plan that identifies costs covered by manufacturers and costs covered by insurers is important.
• Install adequate drug and supply distribution and storage capabilities. Most community oncology offices have limited storage space for investigational drugs and kits for collecting blood, tissue, slides and other required samples. Sending a site several months of drugs for multiple patients and dozens of kits for the collection of samples does not work well in sites with limited space. Adopting 'just in time' inventory processes can alleviate the space limitations.

These five critical success factors along with the three desired competencies should help manufacturers choose the right community oncology practices as clinical trial sites for their investigational therapies. If they choose wisely, they will enjoy the three unique benefits that only community oncology practices can deliver to drug makers.

Related: Learn more about McKesson's clinical trial services for pharmaceutical manufacturers.