Yes. We provide a copy of our Data Security Protocol to all potential healthcare organization partners and our process in relation to HIPAA Privacy Rule is discussed below as well as during our introductory meeting.
No. We provide full indemnification and formal representations for the protection of partner healthcare organizations. By following two separate, approved processes for information sharing and patient outreach, we intentionally create redundant protection. Formal representations bind Modern Trials to all relevant privacy laws and regulations, including HIPAA. Further, the healthcare organization always controls how and when their patients are contacted, which opportunities are presented to their patients and may halt the process and/or terminate partnership with Modern Trials at any time.
Yes. All clients external to the healthcare organization must provide legal confirmation of IRB approval to use Modern Trials services.
There are no upfront costs associated with Modern Trials services for any healthcare organization partner. Costs following a free trial period depend on the terms of service determined by the healthcare organization and will be established in collaboration with Modern Trials leadership. These fees can be deducted from the revenue shared with the healthcare organization, potentially leaving no out of pocket expenses for the healthcare organization ever for Modern Trials services.
Modern Trials provides a user interface through which healthcare organization officials, as appropriate and designated by the organization, can search patient records by inclusion and exclusion criteria for its own internal research studies and clinical trials. This same user interface may be used to identify patients to promote scholarly activity among residents and GME faculty (e.g., the identification of patients with extremely rare diagnoses for case report writeup or patients who meet particular criteria for invitation to participate in quality improvement or research projects).
It depends on the amount of current patient data the healthcare organization has in its EMR database. Smaller clinics (<100,000 active patients) should not expect significant new revenue but should expect much needed treatment opportunities to be presented to many of their patients at no cost to the clinic or the patient, and with no additional burden placed on their clinical staff.
The facilitation of Diversity, Equity and Inclusion (DEI) in clinical trials enrollment is not only the right thing to do but also of growing interest to our Sponsor and CRO customers. The FDA recently published draft guidance that indicates they are more serious than ever about assuring that applications for product approval have clinical trial data representing the sex, race and ethnicity of the actual disease population. Failure to do so will start resulting in application delays and/or expensive post-marketing studies, neither of which does a sponsor want if it can be avoided. With that said, while it is not up to every site in a multicenter study to have a recruited population that matches that of the overall disease population, assuredly sites that can demonstrate that they are able to enroll and retain traditionally underrepresented populations will have a competitive advantage in site selection and budgets. Unfortunately, this is not something that happens without active effort. Modern Trials allows users to search by sex, race and ethnicity to ensure adequate representation of all groups in all trial samples. Having more representative samples will allow sponsors to evaluate safety data in all groups in which their therapeutics are used, reducing the number of required Phase IV trials and black box warnings.
Individuals may have dozens of different reasons for volunteering for clinical trials. However, for most people, there are two primary reasons, discussed below.
Many individuals have conditions that are not responsive to conventional treatments.
Individuals with cancer, Alzheimer’s disease, acne, irritable bowl syndrome, epilepsy, sleep disorders, severe depression, fibromyalgia and hundreds of other conditions have limited treatment options that often provide insufficient progress or relief. Clinical trials offer a way by which such individuals can receive newer and potentially better treatment options, under physician supervision and usually provided at no cost.
Many individuals experience serious side effects to conventional treatments.
Conventional treatments for cancer, schizophrenia, bipolar disorder, sleep disorders, back pain, depression and hundreds more often carry serious side effects. Such side effects can range from chronic diarrhea to death and are a leading reason that millions of people with debilitating diseases chose to live with their condition without seeking medical treatment. Of course, the treatments tested in clinical trials may also carry side effects; however, pharmaceutical manufacturers are continually trying to find treatments that are more effective with fewer and less severe side effects. Clinical trials offer an opportunity for such individuals to receive treatments for their conditions that act through different mechanisms relative to conventional treatments and, therefore, may carry fewer and less severe side effects.
Many individuals cannot afford conventional treatments.
In doing research for this piece, I ran across a headline that struck me and I wasn’t sure if it was more ridiculous or sad; “Spark gene therapy drug priced less than expected at $850,000.” Not a typo, 850 big G’s but, apparently, that’s a bargain. Click here to see for yourself. Of course, most treatments don’t carry that kind of price tag but it’s not unusual for them to cost tens of thousands of dollars. Some are fortunate enough to have most or all treatment expenses covered but millions are left with out-of-pocket expenses that can sometimes be more debilitating than the condition they’re designed to treat. The treatments provided in clinical trials are typically provided at no cost to volunteers.
One additional factor to consider is the medical monitoring received through a clinical trial. While some may see hospital visits and blood draws as an inconvenience, the level of monitoring (for improvement in biomarkers, any side effects, etc.) typically provided through a clinical trial would otherwise be extremely expensive (even with insurance), if available at all. Anyone who has ever had to pay for medical lab work their insurance company deemed “not medically necessary” understands this. Having a team of clinicians keeping a close eye on you can itself be of great benefit, especially for those with life-threatening medical conditions.
Thousands of clinical trials accept healthy volunteers and pay for participation.
To be clear, not all clinical trials accept healthy volunteers and not all trials pay their volunteers for participation, but many do. Some pay up to $10,000 or more but, remember, clinical trials pay what they think is fair compensation for what they require of their participants (e.g., how much time and effort participants need to put in) so you’re unlikely to find a study that will pay you $10,000 to visit once per month to eat pizza and watch movies.
Several classmates and I did this in graduate school for extra cash and never had a bad experience, but we were selective in choosing the trials in which we participated. Remember, clinical trials vary greatly in what is required of participants. Some may require a number of repeat assessment visits and may or may not reimburse you for travel. Some trials require no blood draws while others may require frequent blood draws. Some trials do not involve medications at all, while other trials may involve an experimental treatment or medication. For example, I was paid $1,000 to help test a new vaccine for Japanese Encephalitis (I’m still not entirely sure what it is but at least I don’t have to worry about getting it!). Participation required five 30-min visits to a site near where I lived and I had a small amount of blood drawn at each visit. As a poor graduate student, it was well worth it for me but every individual is different. Just be sure you know exactly what is expected of participants before you enroll in a study.
Clinical Trial Volunteers are also contributing to medical science.
Just about every FDA-approved intervention, medication and medical device had to prove its effectiveness and safety through clinical trials. That means that every clinical trial volunteer is helping to make new and better treatments available to those that need them, ultimately improving and even saving the lives of billions of people worldwide. Thank you.