The entire process to obtain participants in Cancer Critical Trials (CCT) is full of bottlenecks and all of those bottlenecks need to be addressed at one time. Otherwise the process will still be slowed by any remaining bottleneck(s). Bottlenecks include less than adequate recruitment by every medical personal that the cancer survivor encounters which includes finding CCT that the survivor could be part of. Presentation of the CCT description is presented with too much information at the beginning and needs to be done in the patient language. And the bottom line is signing the consent form which has legal and medical connotations but must also be explained in simpler terms first of all to not turn the participant off.
Obstacles to my solutions would include the following: Lack of time on the part of the PCP and the difficulty of finding appropriate CCT But also all of the other medical personal that come in contact with the patient Presenting the description of the CCT in the language of the participant at their level of literacy and medical knowledge and to include all of the possible audio-visual formats along with written ones available could be seen as overkill. I don’t foresee any obstacles to presenting a participant with a layman language format of the consent form first since there is such a problem with the lengthy and complicated final consent form
I anticipate an increase of at least 100%, a doubly in number of participants, to as much as 300% The reason why is that at each stage of the recruitment process there is a large loss of signed participants and so taking care of these three barriers will make for a significant gain in final numbers Proof is simply by a count in the final numbers as compared to today Length of time to achieve this increase would be a minimum of 2 years to possibly as much as 3 years We have retraining of medical personal and the rewriting of the CCT descriptions and the consent forms in the different formats
Maintaining this increase will simply require follow-ups mainly with the PCP and other medical personal participation in the recruitment process which can be done by survey work
I do not foresee any legal or regulatory hurdles since there aren’t any actual changes to that part of the process
Why hasn’t this been done before? Can’t see the trees for the forest type approach or simply only looking at the particular researcher interest and not the entire pipeline Not in any way to put down the cancer survivor looking for a solution but this is a process to get a person into a CCT and their interests need to be looked at first of all And that I do not see having been really done in the past.
