Communication – we hear it every day. You would think with all the electronic communication we have access to today we’d be much better at it than at any other time in history! But I have witnessed the growth of, and participated in at times, unclear communication. This is especially the case in the pharmaceutical industry where the pressure to run clinical trials becomes more expensive, and the competition to get a new drug to market becomes very intense.
Clinical supply specialists have to deal with a multitude of timing pressures, from patient enrolment and study startups to manufacturing timing and customs delays. And that doesn’t include lost and damaged shipments that have to be quickly replaced.
As clinical supply specialists, the teams we work with rely on our expertise to deliver investigational medicinal products (IMPs) to clinical sites on time for study startup. Furthermore, they depend on our know-how for patient dosing as well as drug accountability post-study to keep study costs down.
We are constantly communicating with our teams about timings and we have to clearly communicate those dates so there’s no misunderstanding. What I have noticed as humans under a deadline is that we hear what we want to hear. For instance, when I have communicated to certain clinical teams a time range for the delivery of an IMP to a clinical site, responses are wide and varied:
- Secondary packaging and labeling: 12-16+ weeks
- Quality release: One week
- Ship to depot preparation, importation, receipt and inspection at depot, enter into inventory and prepare to ship to sites: 2-3 weeks
- Total time to site: 20 weeks ±
What they hear is: “IMP will be delivered and on site in 12 weeks.”
With manufacturing teams, when I tell them I ideally need the bulk IMP tablets or vials in six months to allow for any potential delays with a drop dead at seven months, they typically hear they have seven-plus months.
We typically hear what is best for us, not the reality. So the teams we interact with get upset when we do not meet the timelines that are in their minds. This is why we need “clear communication” and not just “communication.”
What do I mean by “clear communication?” I don’t mean just a phone call or a scheduled teleconference. You need to follow-up any voice communication with a clearly written email or an email with an attached document to the team that clearly shows the timelines for delivery. We all want to give positive information to make people happy, but it needs to be realistic information too.
One impediment to clear communication can be the way your organization is structured to run clinical trials.
In-house or CRO, or In-house/CRO Hybrid
The ‘In-house Clinical Supply and Clinical Teams’ structure usually allows clinical supply specialists to get information about a clinical trial in a less complicated route, allowing input earlier in the planning process. The clinical team members are typically more experienced and knowledgeable in the study’s therapeutic area. If there is miscommunication, this scenario allows for a quicker fix of mistakes.
In-house Clinical Supply & CRO Clinical Teams
In this situation, the clinical supply specialist should have more control when getting supplies prepared for a study. But the communication process with the CRO clinical team is still very important. The clinical team members are not necessarily experienced in the study’s therapeutic area, and you will probably need to do more explaining of the drug supplies and its associated ancillary equipment. You will need to ensure there’s a robust plan or process in place for communicating with the CRO clinical team and site if something goes wrong.
Develop Your Strategy
Set up your clinical supply communications with associated teams as early as possible in the planning process. Make it clear you’re the subject matter expert (SME) for drug supplies and equipment, and that team members should feel free to contact you about clinical supply issues whenever they have questions. Respond to team email and voicemail communications that are directed to you as quickly as possible.
If during the planning stage you hear something that doesn’t sound correct, or the team has misconceptions regarding your supply plan, speak up. Diplomatically point out any issues or concerns you may have about their study plans that might adversely affect clinical supplies.
When you cannot answer a question, that’s OK! Tell them you will get back to them with an answer – THEN DO IT!
Critical Forecasting and Budget Discussions Required
As soon as you have enough clinical trial information, forecast the needed drug supplies, equipment and ancillaries using a company acceptable percentage overage to allow for loss and frontloading sites. Provide the clinical team with a realistic budget without going overboard with costs. Include all possible dosing scenarios if the study is unique. Ensure you have agreement with the drug manufacturing team on anticipated overages, and negotiate agreement on drug manufacturing installment deliveries, if needed.
Include additional costs in the budget forecast for:
- Multiple regional depots
- Shipment packaging configurations
- Drug accountability
- IMP destruction scenarios
- Multiple site resupply shipments
- Lost or damaged shipments having to be replaced
Evaluate the costs for required equipment, determining whether buying or renting equipment is more cost-effective. Find out from the clinical team if the equipment manufacturer and model are required to be consistent for all clinical sites. Investigate if local country sourcing or importation will be more worthwhile.
If ancillary supplies are required, ensure those are included in the budget. Ask your import/export team if importing supplies will require documents that are difficult or may be impossible to obtain. You may find that sourcing locally is less expensive and quicker than importing certain or maybe all supplies.
Input into Country Selection Process: Set Team Expectations
Clinical supply specialists typically have very little say, if any, into the country or region selection process for a clinical trial. The typical factors that affect the selection process are the prevalence of the targeted disease in a country or region, patient availability, and recruitment populations.
Set the expectations for clinical supply teams looking to setup trials in different countries. Discuss the import license approval times for individual countries. Point out political issues in regions of the world that could add cost and time delays to getting clinical supplies into a country. When a large number of countries are brought into a study, there are added costs for language translations and for large booklet labels. There’s a longer lead time needed to deliver multiple translations, and there are countries with very long import approval times with high import duties or non-recoverable VAT per shipment.
When shipping supplies, determine the IMP’s shipment packaging configuration. This is essential as temperature monitors may be required for each shipment.
Be aware of global weather conditions as they could affect the type of shipping container, as well as the cost per shipment. Ensure the site staff is correctly trained to receive shipments and store the IMP properly. Find out clinical site operating days to know when they are open and staffed to receive shipments. This is includes during holidays and weekends, if necessary.
Interactive Response Technology
If the clinical trial is using an interactive response technology (IRT) system to enroll, randomize and assign dosage kits to patients, ensure the system can handle the complexity of the trial dosing scheme and patient visits. Evaluate whether or not it is user friendly for site staff. Assess if voice and web systems are needed or whether you can save money by using a web-based system.
If the clinical trial isn’t using an IRT system, then determine what manual system will be used, it’s cost, the time to set up, and how emergency unblinding will be handled in case of patient emergencies.
Be realistic and clear when communicating with clinical teams and CRAs as they are NOT, in general, experts on clinical supply management. At study start-up, clinical teams are trying to determine site initiation dates. Tell them if you cannot make the date, but give them a date when you can deliver. CRAs are very busy or rushed during clinical site monitoring visits. If you require storage temperature logs or physical inventory checked at a site, tell the clinical team if these items MUST be checked at every visit for that site. If you are having problems getting the information you need about supplies at a clinical site, don’t hesitate to call.
Think outside-the-box by considering the what ifs when assembling your supply plan. Think about what you might do if a situation arises that you cannot control. When something unexpected does go wrong, relax and think about how to fix it. Talk to professionals and experts when there are issues outside your area of expertise. Be creative and bounce ideas off one another for discussion.
EVERY PROBLEM is a learning opportunity. Learn the solution, so history does not have to repeat itself!
Manager, Clinical Oversight of Supplies