Choosing an Independent Review Board for your drug development company usually isn’t a choice at all – You're most likely using a company you've contracted for years. If your past clinical trials went off without a hitch, it’s pretty likely you will continue to use the same IRB again and again. An IRB with a strong track record is a great asset to a drug developer, but what happens when that IRB suddenly can't meet your timeline or becomes less responsive to your needs? Do you have a backup plan? IRBs like any business can get overloaded with studies and it may be one day soon that yours turns to you and says, “Unfortunately, we won’t be able to review your protocols for four weeks,” or worse yet, simply doesn’t respond to your emails or phone calls.
That’s why I suggest my clients always have a relationship with at least one other IRB.
Alpha IRB CEO Marianne Thornton said that the majority of her new business comes from drug developers who find themselves scrambling after their usual IRB hits them with a delay, threatening to disrupt their whole trial and the loss of thousands, possibly millions, of dollars each day that the company's drug is not on the market.
Her Southern California based firm is fully AAHRPP accredited, offers a safe web-based portal, and a single point of contact for each of its clients. She often finds it difficult to break through those relationships of habit that big developers have with their IRBs. That is, until there is a problem.
Recently, Alpha IRB was contacted by a pharmaceutical sponsor company that was getting the run-around from their current IRB. The IRB office wasn’t returning the sponsor’s emails or phone calls. They later were told that their submission was “lost” while being physically handed off from one contact to the next. There was no way to track or recover the submission, therefore the process needed to start all over again. Rather than face another potentially devastating delay, the sponsor company contacted Alpha IRB and asked for assistance. Alpha’s secure web-based system made it easy for the sponsor to compile information and submit and track the study electronically. Because Alpha uses a single point of contact, the sponsor was in constant communication with their IRB study management specialist who helped ensure the submission was ready for IRB review. The sponsor company was thrilled with the Alpha’s efficiency and continues to use them for their current trials.
Doubting that your IRB will ever need replacing?
Let’s say that for your next trial, you have a very limited window in which you need to begin screening of subjects. You contact your IRB but they don’t respond to your email and phone message and you end up having to call back a few days later. You finally get someone on the phone and they tell you to submit your study and they’ll let you know when they think it will be reviewed. You end up having to call back after almost a week of no follow-up and, after being passed around several times, they tell you they haven’t looked over the submission yet. After waiting several more days the IRB contacts you to tell you that several things are missing and they can’t schedule the review until the submission is revised. By the time the submission is scheduled for review it’s been three weeks and the study won’t be reviewed for another week and a half on top of that! That means you’ve just lost your screening window and possibly your enrollment goal.
That kind of delay could stall, or worse, totally derail your trial. However, if you have a good backup IRB that you can contact, your study could be saved without more than a hiccup.
Drug developers are also subject to the pricing whims of IRBs. According to Thornton, many of her new clients come to her after their IRB raised their prices when they knew they had the drug developer in their pocket.
What’s more, IRBs like any business are subject to vulnerable, natural disasters. Devastating storms like Sandy and Katrina can destroy not just facilities and documents, but the subject’s ability to continue a trial in a disaster zone. Having a qualified IRB ready to step in could mean the difference between a small delay and the big loss of study.
If you’re ready to start a fall back relationship there are a few important points to consider in your choice of IRB.
- Accreditation – First and foremost, check that the IRB is listed with the Association for the Accreditation of Human Research Protection Programs, Inc. With dangerous and unethical CROs making the news, this accreditation can be one safeguard to ensure rigorous standards for ethically sound research and the protection of subjects.
- Experience – Make sure the IRB you consider has experience reviewing Phase I-IV studies in both multi-center and single site study designs. Inquire about continuing education for IRB members.
- Online services – Insist on an IRB that offers 24-hour access to important documents through cloud based technologies. The IRBs online system should be user friendly and transparent so you can actively see the status of your submissions and your sites.
- Single point of contact – Your IRB should offer a study management specialist who will work hand in hand with you from study start-up through close out. If you need a change to your documentation, you want the assurance of direct contact with your specialist, who can give your study personal attention.