How do I determine good regulatory guidance?

Running has long been a favorite fitness activity of mine.  Although I run for the sheer joy of it most of the time, I occasionally run “competitively” in mud races and in 5K outings.  I’ve read countless books, magazines, and articles on the right shoes, the proper running techniques, the necessity of sleep, and of course, proper nutrition.

Many “experts” provide recommendations on how to enhance performance and perhaps not surprisingly, there are lots of contradictory opinions.  In a recent example, one “expert” stated that stretching isn’t necessary and that one can best stretch while warming up during the first kilometer of a run whereas another “expert” said that stretching is the most crucial activity that a runner can do to enhance performance and avoid injury.  So, which expert (if any) should I believe?

This is a situation that small pharmaceutical companies are faced with on a routine basis.

How do I determine if I am getting good regulatory guidance, especially when it is outside my area of expertise and there are no regulatory experts internal to my company?

How do I decide what to do when I get different and sometimes even contradictory regulatory opinions from expert consultants?

What I am about to tell you is probably Mom and Apple Pie, but I think it’s worth putting it all in black and white.

Let’s return back to the fitness example because I think it provides a nice parallel.

The first thing I listen for when I hear fitness advice is:

  • Did the expert provide a sound rationale for why I should believe what he/she is saying?

A recommendation that has no justification or has a weak justification such as “I told you so” or “I’ve heard this works,” I tend to view with skepticism.  Instead, I look for guidance grounded in good science.  I’d be much more likely to believe an expert who says, “I recommend stretching because in a controlled study (Turki et al., 2012), highly trained male athletes who performed 1–2 sets of 20 minutes of active dynamic stretches in a warm-up showed enhanced 20 meter sprint performance.”  I’d be even more inclined to believe that stretching was the right thing to do if additional well-conducted studies corroborated this finding.

The second thing I consider is:

  • Can the guidance and rationale be generalized to me and my situation?

It’s all fine and good that a study has shown that elite male athletes benefit from stretching, but what about female athletes, such as myself?  Even if it does apply, I am not a sprinter.  Are the gains in sprint performance even applicable to a distance runner?

The third and final thing I consider is:

  • Has a sound rationale been provided for why not following the recommendation is or could be problematic?

Rosenbaum and Hennig (1995) showed that Achilles tendon reflex activity was significantly reduced in a subjects who did not warm-up as compared with those who either did static stretching or a 10-minute warm-up run.  This would suggest that even if the performance gains are less applicable to me, I’m less likely to get hurt if I stretch.

At VRS, it is our goal EVERY DAY to provide our clients with the best innovative, customized regulatory strategies and detailed justifications for why we have made the recommendations that we have.  A solid justification includes, but is not limited to, support based on international and local regulation, guidance documents, regulatory precedent, medical practice and sound scientific principles.

When providing regulatory strategies and guidance, we believe it is just as important to explain why alternatives are likely to be suboptimal.  If there is regulatory uncertainty and/or risk, we see it as our responsibility to identify and quantify the risk as well as provide several possible mitigations so that you can make the most informed decisions for your company about your product.

Finally, we firmly believe that regulatory strategies are optimal when they are formulated in the context of the company’s corporate goals and objectives.  I would fully expect a regulatory strategy to differ depending on whether a company wants to move a product from phase 1 to phase 2 and then divest it or if they want to develop a product through to approval.  With so much diversity in products, people, companies, and health authorities, no 2 regulatory strategies should ever be alike!

It is important to have confidence in your regulatory team.  If you are struggling to get clear regulatory guidance or are in need of a sound regulatory strategy that is thorough, scientifically-based, fully justified, and in line with your corporate objectives, contact VRS today.  We will be delighted to partner with you to achieve regulatory success!

References

Rosenbaum D, Hennig EM. The influence of stretching and warm‐up exercises on Achilles tendon reflex activity. Journal of Sports Science: 1995;13(6):481-490.

Turki O, Chaouachi A, Behm, D, Chtara H, Chtara M, Bishop D, Chamari, K, Amri M.  The Effect of Warm-Ups Incorporating Different Volumes of Dynamic Stretching on 10- and 20-m Sprint Performance in Highly Trained Male Athletes. Journal of Strength & Conditioning Research: 2012; 6(1):63-72.