Today I was joined by guest guru Darshan Kulkarni. Darshan discussed clinicaltrials.gov and his recent presentations at an industry function. ClinicalTrials.gov is a portal run by the Food and Drug Administration that lists what is supposed to have all clinical trials from phase 2- phase 4 and connected to the United States. Darshan basically broke the news to me that the FDA has been reappointed with the task of managing clinicaltrials.gov in order to ensure that more studies are being registered as required by law. This interview gives a great overview on why clinicaltrials.gov would be useful to a would-be clinical trial participant. Darshan also blogs at Conform Law.
In an official report from the Health and Human Services Department that you can read here, the Food and Drug Administration has been given the duty of monitoring the clinical trial registry portal clinicaltrials.gov which was previously the duty of the NIH. Interestingly enough, the NIH has completely revamped their own website complete with study participant testimonial videos as well as making the overall feel of the site more user friendly. In addition to directing interested participants to clinicaltrials.gov, they also lead interested persons to the NIH trial portal. Speculation abounds as to why the HHS mandated this change, but it is widely believed from several sources reporting that it is a direct response to the fact that most clinical trials are still not being registered on clinicaltrials.gov as is required by law. It is believed that the FDA will have a better ability to enforce this regulation. Stay tuned for further details on this developing story.
UPDATE: I just did an interview on this here.
Today’s video was inspired by a study participant who emailed me previously and telling me that he doesnt understand why the research clinic screen failed him after he signed a “contract”. I asked him what contract they gave him, and quickly figured out he was talking about an Informed Consent Form. In this video, I discuss why an Informed Consent is not a contract, but rather a document which discloses the nature of the study and much more. Hope this helps.
Today’s guest post is written by Stacey Carmody, a clinical research coordinator. It discusses what you can expect to go through from a research clinic’s perspective, when a PI leaves your site for any reason. Thank you Stacey and any others who would like to contribute articles please email me email@example.com
When a PI Leaves: Surviving the Transition
I had been a clinical research coordinator with the same principal investigator for over a decade. Then, with little warning, a bombshell was dropped: I learned that this principal investigator was leaving his position at the site.
Aside from all the sad emotions you experience when an enduring professional relationship ends, there is the also feeling of crisis, and the feeling of “What do I do next?” Transitions are not easy. I would like to share what I learned from my experience and give tips for getting through what will be a chaotic period.
Firstly, call a meeting. If possible, meet with your departing PI along with the sub-investigators and other research staff. Come up with a plan about who will assume the role as PI. The quicker you have a new PI in place, the better. Make sure the new PI knows the studies throughly and knows all the responsibilities that come with being a PI. Conducting a study without a PI in place is not only prohibited, but can spell disaster for your participants and anyone else involved. Studies must have PI oversight at all times!
Let the sponsors know. The sponsors of your studies selected your site partly based on your PI’s experience and credentials, so a change in PI is a huge deal to them. You want to let your sponsors know right away about the change in PI and you must be willing to supply any information they want to know about the new PI (CV, licence, clinical trials experience, etc) . They will need to give their approval for the new PI. If the sponsor approves the new PI, get the approval in writing, as you’ll need to give this to your IRB. Work with the sponsors to get the appropriate regulatory paperwork changed from the outgoing PI’s name to the new PI’s name. Many papers will need this change such as the contract, the 1572, the consent forms and central lab reports. The delegation logs in your regulatory binders will have to reflect the change in PI as well. And, of course, your study subjects will need to be informed of the change.
Contact your IRB. When I got the news that my PI was leaving, I contacted my IRB the next day. I needed to know what kind of paperwork I had to submit . If your outgoing PI needs to sign any IRB paperwork, if possible, obtain the signatures before he or she leaves. Also, if possible , obtain a signed letter from the outgoing PI denoting the date of departure from the site, the reason for departure, and the date the new PI took over. If it is not possible to get a letter , then make a note to file with this information. It is important that you document that the studies have oversight from a PI and that there is not a “gap” between PI’s when the studies are in progress.
Meet with the new PI often. This will be a transitional for him or her, and we all know how much PI’s depend on us coordinators! Be there to help with any questions regarding the conduct of the studies and keep the PI abreast of any communication from the sponsors, and set up meetings with the study monitors/CRA’s so communication will flow and the transition will go smoother.
Lastly, don’t panic. And have a plan. I know that is easier said than done! But keeping calm and focused makes a big difference. It also helps to have a plan in place in case your PI leaves unexpectedly. Even if your PI seems like a permanent fixture, you never know when life will throw a curve. It is a good idea to keep a list of what steps to take and who to contact. Preparedness makes all the difference. The dust will settle in time.
A major response that the pharmaceutical companies recently made due to a good amount of patent expirations was outsourcing as much of the research and development process that they could to the CROs. As explained earlier on TheClinicalTrialsGuru, a CRO is a company that is solely focused on conducting the phase 1 – 4 clinical trials in collaboration with the pharmaceutical companies. Because these CROs specialize in conducting clinical trials, strategic partnerships have been created starting from as early as 2005 and gaining momentum in 2010. The justification in these strategic partnerships is that the pharmaceutical companies would like to continue innovating and discovering new products in the lab. Ideally, they would like the CRO to handle the entire clinical trial process, from phase 1 to phase 4. This includes selecting the research clinics that would participate in conducting the trial, co-developing the study protocol with the pharmaceutical company, and as of recently, sharing in both the risks and rewards of an investigational product’s potential success or failure. The issue of core competency is the key behind this strategy. Since the CRO industry was essentially formed in the early 1980s, they have been getting better and more efficient at conducting clinical trials. In lieu of this, they have developed sophisticated industry “know how,” and are also much more experienced at bringing an investigational product through the clinical trial pathway. These strategic partnerships are just beginning to solidify themselves and are here to stay for the long haul. One of the trickle-down effects of this is the formation of strategic partnerships between CROs and research clinics. As of the time of this writing, informal as well as formal relationships and master site agreements are being made between some of the larger research centers and CROs. I believe that this is just the beginning of a new trend that is here to stay and will make many more posts related to this topic in the future.
Today, I get into a little known benefit of clinical trials. Most people understand some of the more obvious benefits such as perhaps better treatments or cures, better medical attention, etc. But very little has been said about this topic that I speak about in this video. I’d love to hear your thoughts on this.