6 Questions to Ask When Assessing Your Clinical Trial’s Performance

Biotechs need to assess their trial’s performance throughout the study if they want to obtain the quality of data that is required to get the product to market as quickly and cost-efficiently as possible.?

The advantage of doing regular benchmark reviews is that any problems can be identified as soon as possible, ensuring they can be fixed before the trial is adversely affected.?

It’s not just problems that you’re on the lookout for: continually assessing the trial’s performance once it has begun means that adjustments can be made that may work better in practice.????

During benchmark reviews, it’s important to keep the following questions in mind to evaluate how the trial is going:?

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1. Does the protocol work well in practice??

Irrespective of how detailed and well-structured your protocol is, it’s important to remember that the protocol needs to work for your study, not the other way around. A clinical trial that is ticking the boxes on paper, but in practice is not adequately achieving necessary goals in a workable and efficient way, will likely fall short in the long run.?

If the rest of these questions highlight the need for changes to be made, the protocol can and should be amended as soon as possible.?

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2. Are our timelines efficient and are we meeting our milestones??

Biotechs and their sponsors are acutely aware that time means money. With trials costing anywhere between $600,000 and $8 million per day, everyone wants things to move as quickly and smoothly as possible.?

If they’re not, why not? Is your start up taking too long, and if so, would it be beneficial to consider ways to speed it up???

Being efficient with time will be the best indicator as to whether the trial will keep within budget, and the number one thing investors will look for on your track record.??

Identifying and amending the factors that are hindering time efficiency is key to the rest of the trial meeting the necessary milestones on time and within budget.?

Even if you are meeting milestones, continual assessment is helpful to see if there are ways to be even more efficient.????

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3. Is recruitment going as smoothly as it could be??

If recruitment has been slow, or there isn’t an optimal level of diversity, it may be worthwhile considering adding additional sites, countries or regions to expediate recruitment and trial timelines.?

Looking at the recruitment processes will not only highlight possible reasons for missed milestones and inefficiency, but will also play a role in the overall quality of the data. A product trialled on diverse ethnicities and people from multiple countries will offer far greater potential to be marketed to larger segments of the population.??

Keep in mind that your CRO’s location will play a big role in your ability to access diverse populations for recruitment. Ideally, they should have established relationships with the local trial sites and communities they recruit from.?

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4. How is the clinical data looking??

Don’t think of the data as just the result of the trial. Looking at it regularly throughout the process can also be an opportunity to learn along the way.??

Constantly review the clinical data, identify adverse events or any new opportunities to be considered. Are there any inconsistencies, and how should the processes be changed now to avoid this going forward??

Closely monitoring your data may make you aware of trends that hadn’t been considered before, so this is an excellent opportunity to increase the scope of your trial and collect information that may be increasingly relevant.??

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5. Are we leveraging technology to our advantage??

Conducting trials remotely, if done correctly, could significantly decrease costs.??

Decentralised Clinical Trials (DCTs) use remote technologies, which not only means that patients can stay at home, but also makes it possible to recruit further afield without driving up cost.?

Virtual visits, wearable devices, and telemedicine can all play a role in streamlining and enhancing efficiency.?

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6. Is everyone fulfilling their role the way they should be??

It is important to remember that it’s people who drive successful trials, and this often means that multiple parties must work well together to achieve the desired outcome.??

All essential clinical trial vendors need to be performing as expected, and good working relationships are essential for success.?

If this is not the case for any reason, it needs to be addressed and amended as soon as possible.?

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How HiRO ANZ Can Help?

If you have assessed your clinical trial and concluded that things aren’t going so well, it’s important to remember that studies can be successfully rescued mid-way.?

If you act promptly with the confidence to change what isn’t working, you can still get quality data within the required timeframe.?

Sometimes, this may require bold moves, like making significant adjustments to the protocol, or changing your CRO altogether.???

HiRO ANZ can help you assess your processes so that you can get the best quality data from your trial. Get in touch with our consulting experts to make sure your trial stays on track.?