90% of clinical trials for drug development are unsuccessful.¹ To reduce the risk of your clinical trial falling into the 90% category—accuracy, speed, efficiency and cost-effectiveness are vital.
In this article, we share some of the best ways to help improve the strength, performance and accuracy of your clinical trials so that you can help to support their success.
How Can I Make My Clinical Trials Better?
Here are some of our top tips to help improve the productivity and performance of your medical research and clinical trials…
1. Consider Adaptive Clinical Trials
Traditionally during clinical trials, the protocols would be established and finalized prior to the trial.
Different aspects such as the number of patients and type of patients being included in the trial, the drugs being tested and their doses, and any other variables and desired outcomes were decided prior to the trial. And conventionally, these aspects wouldn’t budge throughout the clinical trial.
However, there are newer clinical trial methodologies which allow for more flexibility and adaptation if needed.
During adaptive clinical trials, you can flexibly change protocols as you’re going along in tandem with the trial. Adaptive clinical trials allow you to assess the data as its coming in, and you can modify your approach and protocol as the trial is carried out.
An adaptive clinical trial allows you to increase or decreases doses if required. You can alter the size of the trial or the duration. You can proactively react to feedback coming back from the trial participants, and you can also include different types of participants if required.
2. Consider Clinical Trial Simulation
Wherever feasible, consider exploring a clinical trial simulation to increase the trial’s chance of success. A clinical trial simulation helps you to understand the variables in your trial design, and can help you to explore different trial designs and their possible performances within different circumstances and scenarios.²
AI can considerably help to advance, accelerate and improve your clinical trial simulation when used correctly.
Many issues that arise during clinical trials (that can contribute to or lead to their failure) can be firstly identified, and then overcome, or avoided with an in-depth clinical trial development phase.
3. In-Depth Clinical Trial Development And Design Phase
Many issues and challenges in clinical trials that arise can be traced back to the clinical trial design phase. A good clinical trial development phase can prevent avoidable operational, clinical and financial issues from derailing the success of your clinical trial.
Here are some common issues that can arise:
- Poor protocol design
- Recruitment challenges
- Protocol amendments
- Data collection issues
- Safety issues
- Regulatory burden
- Lack of efficacy
- Budget
- Revenue
Along with a thorough clinical trial design phase, you can also help to mitigate arising issues by undertaking a clinical trial simulation.
4. Improve Accessibility, Convenience And Compliance
If you’re keen to improve your clinical trial retention of participants and compliance of trial protocols then considering accessibility and convenience is really key. If your clinical trial is hard to access or inconvenient it is much more likely participants will drop out.
Did you know that on average, 85% of clinical trials don’t retain enough participants and patients to complete the trial?³
It’s important to ensure that your clinical trial supports and encourages patients to abide by the protocols of the trial, whilst also remaining a participant of the trial until its completion.
For trials that are undertaken over significant amounts of time, it’s important to think about how patients and participants will be able to stay persistent, consistent, and dedicated to the trial protocols during their day-to-day lives in the ‘real-world’.
Often, a lack of imaging capacity, such as efficient and effective scanning and reading, can also contribute to participant drop-out during clinical trials!
5. Consider The Duration Of Your Clinical Trial And Patient-Friendly Protocols
Did you know that roughly 40% of participants and patients fail to adhere to clinical trial protocols and procedures after approximately 150 days of a clinical trial?⁴
Being aware of common norms within the clinical trial industry can help you to prepare your clinical trial for success.
And try considering more patient-friendly protocols such as telemedicine, and remote data collection through wearable health trackers and medical devices. The use of teleconsultations for virtual check-ups and reviews, along with remote data collection could help to decrease the effort required in order for a participant to complete the trial.
Remote data collection and telemedicine helps to reduce the need to take time off of work in order to travel to trial clinics (and the expense of travel)—which in turn improves patient experience in the real-world setting.
A clinical study on patient care and retention during clinical trials found that the inconvenience of travel was a major contributing factor to non-participation in clinical trials.⁶
Swopping to digital content forms is another way that you can try to minimize travel for your patients and participants—are there any other small changes that you can make?
6. Build Trust And Open Communication With Trial Participants And Patients
It’s important to build trust with those participating in your trial, and to thoroughly communicate expectations of them clearly—and as early as possible.
Good communication helps people to know what to expect, and it also increases the likelihood that they’ll adhere to protocols too.
Patients and participants are often keen to support public health and the trial as best as they can, and their commitment to the trial increases when they are valued and respected as part of the process.
A clinical study on the patient perspective of clinical trials found that the fear of side-effects was a common reason for non-participation.⁶
Being able to honestly and openly communicate with patients and participants could help to reduce dropout rates and increase recruitment. Be sure to discuss fears, challenges, obstacles, and possible risks—along with the trial’s purpose and benefits.
Accessibility is vital, so avoid hard to understand technical or medical jargon, and ensure that all the language used in conversation, digitally, and print, is easy to understand irrespective of socio-economic background, race, ethnicity, age, religion, sex, or nationality.
7. Explore AI And How It Can Improve Your Clinical Trial Productivity And Performance
Real-time communication and interaction during your trial can significantly increase patient retention and compliance with clinical trial protocols. Clinical research on stroke patients found that adherence improved by up to 50% when daily monitoring through AI was used within the trial.⁵
Consider using Electronic Patient-Reported Outcome software (ePRO) and digital patient diaries for daily reminders and different engagement strategies to help improve the chances of trial completion.
Remote digital data collection (through wearable health trackers and medical devices that monitor vital signs) is another way that AI can help to improve the chances of a successful clinical trial. Through the use of daily data collection, you can frequently capture data that gives a more in-depth insight than data captured on a single weekly clinic visit.
And with daily diaries, patients and participants can report symptoms as and when they arise every day, which leads to more in-depth and thorough data sets than weekly clinic check-ins too.
Imaging AI is another great example of how AI can improve your clinical trial productivity and performance. It usually takes two independent imaging readers—and a third who acts as an adjudicator during clinical trials. However, if one of those imaging reads is performed via AI, it helps to reduce time, resources, and costs whilst improving efficiency.
8. Post-Trial Protocol And Developing Communities
Ensure that you have a strong post-trial protocol. This can include follow-up sessions with participants and patients, surveys, and the creation and management of participant communities.
Creating a community for those in your clinical trial can be a really helpful way to help diffuse the worries of those going through the recruitment phase by connecting them with those who have already completed clinical trials with you.
The development of a strong community in which people can share their reservations, fears, feedback, and experience can help you to get valuable data from the trial participants to improve future trials, whilst also helping to improving patient and participant experience.
And good patient experience, results in people sharing and recommending trial participation to their friends, family, and colleagues—which in turn improves future recruitment for your trials too.
9. Patient-Centric Trial Design
One of your greatest assets are patients. Patients and caregivers hold a wealth of knowledge, and are usually more than happy to get involved in the clinical development phase of the trial.
By ensuring that you have patients and caregivers involved in the design phase, you can enhance the patient experience of the trail itself which leads to better retention rates. No-one knows the specific medical condition, disease, illness, or disability better than those who are experiencing it first-hand.
Patients and caregivers can help you to cover blind-spots that you may not have previously noticed (due to lack of personal experience, and therefore awareness).
10. Improve Participant Diversity
Did you know that roughly 20% of new and developing drugs have different effects and patient outcome dependent on the individual’s race?⁷
In order to ensure that your clinical trial results are representative of public health, health research has to include the ‘hard to reach’ from minority, underrepresented, and under-served groups in society.
11. Connect With Advocacy Groups And Patient Support Groups
If you’re ensuring that your clinical trial is patient-centric, accessible and diverse— there’s a high chance that advocacy groups and charities will support your clinical trial and could help with recruitment.
Network and connect with advocacy groups and patient support groups so that you can learn more about the illness, disorder, disease, or disability outside of just the clinical practice. And by doing so, you may also receive valuable support in return.
Choice Health supports patient advocacy, and can provide equality and inclusion impact assessment reports too. If you need help in this area, do not hesitate to contact us.
12. Discuss Support With Patients And Participants
Clinical trials can be tough on the participants—mentally, emotionally, and physically. Discuss the challenges and possible burdens with participants to ensure that they’re prepared, and ensure that they have a support network to lean on during any challenging times.
Keep in mind that clinical trials can be challenging (or even a burden) for participants and minimize or eliminate any unnecessary clinic visits, repeated or invasive procedures, tests, or surveys.
13. Inform Of Trial Results
It is key to inform all participants and patients of the treatment and trial results. The current ‘Make It Public’ strategy and policy in the UK is designed to increase research transparency.⁸
Informing participants of the trial results—and thanking them for their participation—helps to increase trust between members of society and healthcare organizations and institutions.
It also ensures that individuals understand exactly how they have contributed to the improvement of public health and drug development.
14. Ensure The Benefits Of The Clinical Trial Are Conveyed
If you’re struggling with recruitment, study sites, and getting sponsors onboard, firstly check that the clinical study is scientifically relevant and of interest to public health. Research which is scientifically relevant and of high interest to public health is going to have priority and favourability over other subject matters.
And secondly, ensure that the possible patients and participants of the clinical trial understand the relevance, scope, social value, and health benefits of the trial itself (and the medication if applicable)—and therefore, the importance of their participation in it.
Thirdly, ensure that the compensation for the trial is fair and in correlation with the amount of input, effort, and time required from the participant to adequately motivate contribution and compliance in the trial.
15. Consider Work Flow At The Study Site During Feasibility Analysis
It’s important to think about your trial design and how it will fit into the workflow of the study site. If your study processes and protocols are difficult to implement and integrate into the daily workflow of your study site this is a risk factor that opens you up to issues and vulnerabilities.
If the study teams find your workflow awkward and impossible to integrate into the daily workflow at the study site, they’ll be way less motivated to commit to the trial.
Consider the workflow and possible operational challenges during the clinical trial development phase, and you can even test different viable options and solutions during trial simulation too.
You can also discuss your trial procedures, protocol, and estimated time frames with your study team in order to get their feedback and vast experience (and expertise) on the matter. All of your feasibility analysis needs to be completed prior to the finalization of your trial protocols.
16. Invest In Experienced Industry Leaders
Clinical trials are costly, so it can become somewhat ‘intuitive’ to look for cost-effective measures where possible. However, it’s important to note, that investing into the right personnel is an advantage to your clinical trial, and not a cost.
Industry experts can help to advance your clinical trial and support its success due to their vast experience, wide professional network, and proven tested operational systems.
Instead of having to worry about changes in regulation, risk assessments and compliance—you can rest assured that your clinical trial experts have that covered on your behalf. This can save you a ton of time and prevent a lot of stress whilst protecting your budget too.
For example, at Choice Health we provide Medical Physics Expert (MPE), Clinical Radiation Expert (CRE), and clinical trial imaging solutions to those undertaking medical research and clinical trials.
Our independent advice, direct assistance, and rapid turnaround is highly sought after and beneficial to those undertaking clinical trials. With our guidance, you can ensure that your clinical trial runs smoothly and efficiently.
Conclusion
There are a variety of different ways that you can improve the performance of your clinical trial to increase the chance of success. Some of them are pretty simple shifts, whilst others will take a little more planning.
Do you have any more tips for improving the productivity and performance of medical research? Let us know in the comments.
Sources
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https://www.sciencedirect.com/science/article/pii/S2211383522000521
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https://www.amgen.com/stories/2018/10/a-strategy-for-making-clinical-trials-more-successful
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https://www.clinicalleader.com/doc/considerations-for-improving-patient-0001
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https://www.appliedclinicaltrialsonline.com/view/non-adherence-direct-influence-clinical-trial-duration-and-cost
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https://pubmed.ncbi.nlm.nih.gov/28386037/
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https://link.springer.com/article/10.1186/s12913-017-2090-x
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https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.61
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https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/research-transparency/make-it-public-transparency-and-openness-health-and-social-care-research/#informing
About The Author
Pauric Greenan is an experienced PACS consultant that has been PACS lead on several high-profile PACS projects in both the UK and Ireland. Pauric is internationally available for PACS consulting. Contact him here for more details.
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