Clinical trials are an enormous undertaking involving massive amounts of financial support and study design efforts that can take years to complete. With so much time and money involved, what are some top qualities of clinical trials that can lead to success?
1. Optimized Trial Protocol
Successful clinical trials start with a well-designed, patient-centric protocol. The study protocol dictates the study proceedings, from identifying the research aim for the trial to methods of patient recruitment and ultimately statistical analysis.
The study protocol can have massive downstream effects if not optimally designed. Some of the largest protocol issues can be related to the target study population, study sites, statistical interpretation, and the use of surrogate endpoints.
Targeting the wrong study population can be detrimental from the outset of a clinical trial. Inclusion and exclusion criteria are essential to making sure a study is conducted on the appropriate patient population while still remaining applicable to applying the study results upon completion. Some issues with the target study population can be related to unbalanced or underrepresented patient demographics.
For example, some studies exclude older patients due to the high degree of morbidity and concomitant disease states found in these individuals that can bias a trial’s results. However, many disease states are experienced by the elderly at a higher rate when compared to younger, relatively healthier individuals. Not studying the older patient population is a major limitation when it comes to a study’s external validity.
Additionally, picking the wrong or insufficient study sites can set up a trial for failure. Study sites are the backbone to running a well-designed study. Decisions such as location and number of sites, as well as amount of funding and personnel training allocated to each site, are critical to clinical trial success. Sites that are too sparse, underfunded, or undertrained can result in poor study recruitment and retention and ultimately cost a study additional time and money to bridge the gap to realization.
Another flaw in protocol design pertains to statistical analysis. Researchers commonly misuse or misrepresent study data, often unintentionally. These errors can dramatically affect a study’s validity and interpretation and single-handedly derail the entire study.
When interpreting statistics, researchers commonly make mistakes such as misinterpreting the p-value and assuming association or correlation versus causation. Sometimes the best decision when handling complex or intricate statistics is to enlist the services of a clinical research organization (CRO) that can help reduce the risk of statistical error and poor judgment in handling trial data.
Somewhat related to the mishandling of statistical data, surrogate endpoints are sometimes used in place of true event endpoints. While often necessary in the context of a study, surrogates must be utilized carefully to make sure study results are not misleading.
Surrogates are used in place of event endpoints, so we can extrapolate and interpret long-term study results when we simply do not have the time or capacity to run a study to observe enough true events. They are commonly implemented in oncological clinical trials when a patient’s overall survival could be a decade or longer.
Instead, those trials will use progression free survival over the course of 5 years instead to decrease trial time and money expenditure.
However, while we must be careful interpreting surrogates as they are not true events, correctly instigating them in a clinical trial can be essential to study success.
2. Finding the Right Biospecimen Provider
In addition to optimizing the study protocol, finding a biospecimen provider that can help you meet even the most rigorous trial needs can be invaluable. This partner can come in the form of a CRO or independent biorepository or biobank.
Successfully identifying the right tissue sample provider for clinical trials can be a multifaceted approach. Finding a company with a well-established history and profile, access to the right type and amount of tissue samples, and having access to the right resources for shipping and logistics can result in productive partnership to ensure clinical trial success.
Identifying the company profile is a great starting point when looking for a biospecimen provider. A well-established, experienced company usually translates into a well-networked partner that can quickly and affordably grant access to the right biospecimens.
In addition, larger organizations or biorepositories have access to greater quantities of tissue samples and in bulk which may be beneficial depending on the trial needs.
On the other hand, smaller organizations may be able to produce more specific or prospective tissue samples. While the timeline to acquire these samples may be longer or more expensive, the decision to go with a smaller tissue sample provider may be appropriate depending on trial needs.
Company profile also includes accreditation and certifications, including the ability to navigate regulatory requirements. The American Association of Tissue Banks (AATB) is the largest international accreditation program in the United States, and there are many more similar programs found globally. Finding the right partner includes finding one that is accredited and experienced enough to handle regulatory requirements.
Access to the right kinds of tissues is another major consideration when choosing a biospecimen provider. The availability, quantity, and custom tissue procurement factors need to be weighed to ensure access to the tissues that will enable trial success. Knowing where the tissues come from, how they are stored, and what type of storage and shipment capabilities the company has will be important as well.
Finally, shipping and logistics should not be overlooked. A possible Human tissue sample provider should have the ability to ship tissues efficiently and affordably while adhering to shipping laws and regulations. International shipping and large shipments can be an obstacle for some companies and should be a discussion beforehand in choosing the right partner.
3. Maximized Recruitment
The final two qualities of a successful clinical trial pertain to trial recruitment and retention. Clinical trials cannot be conducted without adequate study participants, so these two areas must be carefully considered when designing the trial.
Recruitment is the ability for a trial to find the right type and number of study participants to meet the needs of the trial. After considering the financial burden and importance of patient-centric protocol optimization, there are many strategies clinical trials take to optimize their recruitment.
Clinical trial feasibility is a term used to describe the ability of a trial to designate adequate money, time, and resources to obtain trial data in a given geographical area and patient population. Feasibility is an absolutely essential consideration prior to conducting a clinical trial.
Many companies such as CROs can conduct a feasibility request for your clinical trial. A feasibility assessment looks at site selection, number of targeted patients to be recruited at each site, and other things such as mathematical modeling to ensure recruitment success. It also can periodically assess certain sites during the active recruitment phase to see how sites are performing and if recruitment or randomization needs to be halted at one site or increased in another.
Besides feasibility, successful trials maximize their patient recruitment utilizing strategies such as patient-centric communication materials, appropriate incentives for study involvement, the use of technology to keep patients involved and informed.
4. Maximized Retention
Successful clinical trials have sufficient patient retention in addition to recruitment. Retention refers to the ability of a trial to retain as many study participants as possible throughout the study. Similar to recruitment, poor retention can affect a trial’s deadline and lead to significant delays costing time and money.
Retention maximization strategies can be comparable to recruitment strategies, such as adequate continued communication about trial progress, incentivizing the patient as the trial progresses, and selecting sites that are conducive to patient follow-up visits. Technology can facilitate improved patient retention using patient study databases and telehealth capabilities.
Maximizing retention can be paralleled with the ability of a trial to plan for dropouts. Even the most well-designed trials will experience patient-dropout to a degree, so sometimes planning for a certain attrition or withdrawal rate will benefit the success of the trial long term.
Industry benchmark data suggests that only about 10% of patients identified for a given clinical trial will ever be randomized, and nearly another 20% of those patients will drop out over the course of the study. Planning for this amount of withdrawal can help studies establish recruitment goals that are above and beyond the needs for the trial.
When To Consider a Clinical Research Organization (CRO)
Choosing to utilize a clinical research organization, while initially an investment, can streamline your clinical trial to ensure success.
At iProcess Global Research, you can expect to work with an established organization with over 17 years of experience in facilitating successful clinical trials. We are a leader in biospecimen procurement having shipped over 100,000 specimens globally with over 1,000 sites on 6 continents.
We offer exceptional teams and operations to provide cutting-edge research to help organizations with their clinical trials.
Contact iProcess to receive a quote or free feasibility assessment today.
Sources:
Keys to Success with Clinical Trials | PMC
