Clinical trials are essential in testing the safety and effectiveness of new drugs and medical devices. The success of these trials is heavily dependent on the site selection process, especially during Phase I, where sponsors conduct tests on volunteer patients. For start-up biotech companies, selecting the right site is critical for their study’s success. In this article, we’ll explore the importance of Phase I site selection and provide a list of questions to ask clinical research facility managers. So, let’s dive in and learn how to choose the right site for your clinical trial.
What is Phase I of a Clinical Trial?
Phase I clinical trials are crucial in generating safety data that forms the basis for all later-phase trials. During this stage, researchers aim to gather vital information on the pharmacokinetics and pharmacodynamics of the experimental treatment. These trials can either be conducted in healthy volunteers for first-in-human studies or in a small patient population seeking a new indication for a previously approved therapy. The foundational pharmaceutical information obtained during Phase I is necessary to proceed to larger-scale Phase II and Phase III trials.
Why is It Crucial to Select the Right Site?
Per a report by Coalition for Clinical Trials Awareness, 11% of clinical trial sites fail to enroll a single patient, while 37% do not meet their enrollment goals. Of the participants in the survey, 40% did not understand the concept of a clinical trial in the first place.
Failure to meet enrollment goals could mean a failure of the clinical trial as a whole – leading to exorbitant costs and a delay in bringing the new therapy to the market. There are several factors that go into the selection and initiation of a clinical trial site, including:
- Site-specific informed consent development
- Ethics Committee/Institutional Review Board submissions
- Staff training
- Investigator/site coordinator meetings
- Site initiation visits
Given this, start-up fees alone can be upwards of $7,500 plus a 30% administrative overhead. In addition, there are EC/IRB fees, close-out fees, storage fees, and per-patient stipend amounts. This means the cost of opening a clinical trial site could easily reach tens of thousands of dollars – exponentially more if the sponsor is opening several sites at once.
Choosing the most appropriate site minimizes financial risk and boosts the success rate of the clinical trial. A site with the proper resources and logistical support in place, alongside its access to eligible patient populations, means the trial will likely be more productive and effective. If the Phase I trial succeeds, sponsors and researchers can proceed to the next phases and move closer to releasing a new treatment to the market.
Questions Biotech Sponsors Should Ask During Site Selection
Obtaining relevant information from prospective clinical sites lessens the risk of selecting an unsuccessful clinical trial site, and lets sponsors evaluate their options more carefully. Therefore, when selecting a site, sponsors should consider the following questions:
#1 — What is the general location and appearance of the site?
When initially visiting the site, it should be accessible to patients, so its location and appearance are key factors. If sponsors select a site that is far from the eligible demographics, then they risk seeing little to no enrollment for the study.
Moreover, the facilities themselves should be properly set up and equipped to handle the trial. To sufficiently conduct a clinical trial, sponsors need to ensure that sites provide a safe, controlled environment that has appropriate oversight. When selecting a site or facility, it is essential to consider location and structure so that you can carry out the trial under the best conditions.
#2 — Does the site have additional initiatives (i.e. patient research group)?
Sites with access to patient research or advocacy groups are often poised for more patient-centric trials. Sponsors should ask about the forms of assistance the facility offers its patients in terms of transportation, psychological and physiological support, emergency services, and more. Do they take the initiative to workshop patients regarding the process of drug discovery and clinical trials?
All these actions keep patients fully informed and engaged with the trial itself, which could lead to heightened compliance and enthusiastic participation. This can also increase the success of the trial overall.
#3 — What access does the site have to the patient population?
It is important that the site has access to diverse patient populations for several reasons. Firstly, clinical trials aim to evaluate the effectiveness and safety of new treatments across a wide range of patients, including those with different ethnicities, races, genders, and medical histories. Therefore, enrolling diverse patients in clinical trials ensures that the results are applicable to the wider population.
Secondly, access to diverse patient populations helps to reduce potential biases in clinical trial results. Without diverse representation, there is a risk that the trial results may not accurately reflect the effectiveness and safety of the treatment for certain populations. Additionally, clinical trials may uncover differences in how people from diverse backgrounds respond to a treatment, which is vital information for ensuring that the treatment is safe and effective for everyone.
Finally, diversity in clinical trial participation is essential for promoting health equity and ensuring that all patients have equal access to the latest treatments. Therefore, sites that have access to diverse patient populations are more likely to produce accurate and generalizable results that benefit everyone.
#4 — Does the site have feedback from previous clinical trial participants?
If the facility has hosted previous clinical trials, it is vital to review the patient feedback, retention rates, and the number of times a site reached its enrollment goal. This will give you an idea of the efficiency of the study staff and how they treated patients during these trials. These factors are critical to the success of a trial – if the site staff are efficient and considerate, the trial is more likely to succeed.
Reluctance to produce feedback or lack of feedback should not necessarily exclude a site from consideration, but it should raise some concern. A site should readily and easily be able to “sell itself” and show it is more than capable of handling the clinical trial and managing clients with compassion.
#5 — What clinical research experience does the site have?
For a Phase I trial, it may be necessary to ensure that the site has experience in running clinical trials under similar therapeutic areas. For example, if a sponsor is planning to run a trial on treatments for irritable bowel syndrome (IBS), they should check whether their potential facilities have previously worked on trials within gastroenterology or specific GI indications such as IBS clinical trials.
Experience in a specific therapeutic area means the site should have the proper equipment to run these types of niche trials and knows the SOPs for executing the study correctly.
#6 — What is the historical performance of enrollment on the site?
It is important to determine how successful the clinical trial facility has been at recruiting, enrolling, and onboarding patients for studies. If they are consistently able to reach or exceed their participant goals, then it shows the site is reliable. Historical moderate to high rates of patient enrollment increase the likelihood that a study will reach its participant goals.
#7 — Does the site have a high retention rate for staff?
Sponsors should ensure that a clinical research facility is capable of retaining its key staff, without a concerning turnover rate. A consistent loss of key staff (particularly in managerial and patient-facing positions) signals the potential for unreliability and a poor working environment – both of which could impact your study.
How CROs Help Select Sites
Startup biotech companies may lack the experience and industry knowledge to properly evaluate and select clinical trial sites. This is where CROs like IQVIA, ICON, PPD, and Vial can step in. CROs (contract research organizations) have the expertise and network to appraise different sites and select the most appropriate, optimal facility for the proposed study.
Vial is a full-service CRO powered by next-generation technology that reimagines clinical trials as a way to empower scientists to cure disease. Our experienced ClinOps and technology team collaborate to deliver faster, more efficient trials at less cost to sponsors. Here at Vial, we work in a variety of therapeutic areas in order to support the next medical breakthrough.
If you’d like to receive a proposal from Vial regarding your clinical trial, contact us today!